NOTE: This page is an archive of the faculty list use for events prior to July 2018.
It is provided for reference only.
Individuals’ information on this page may be outdated.
The persons below have been gracious enough to serve as faculty for current and past SBIA events.
Click here for the glossary of FDA acronyms and abbreviations
| Anna Abram Deputy Commission for Policy, Planning, Legislation and Analysis FDA |
As Deputy Commissioner for Policy, Planning, Legislation and Analysis, Anna Abram plays a critical role in overseeing the development and implementation of key policy initiatives and provides strategic policy direction to advance FDA’s mission and vision of protecting and promoting public health. Prior to being appointed to this senior leadership position at the FDA, Ms. Abram served in the Office of the Secretary at the Department of Health and Human Services (HHS). Ms. Abram is a respected FDA policy thought leader with more than thirteen years of health care policy experience, including more than a decade of working on health care policy in the United States Senate. Ms. Abram was previously appointed by President George W. Bush to serve as an Associate Director at the Domestic Policy Council at The White House. In this role, Ms. Abram coordinated the development and implementation of a range of health care policy issues, including food, drug and public health policy. She coordinated the White House-led, interagency policy process to reauthorize the President’s Emergency Plan for AIDS Relief (PEPFAR) in 2008. Ms. Abram graduated magna cum laude from the University of Pennsylvania.. |
| Allison A. Aldridge, PhD Global Compliance Branch 3, Division of Drug Quality II, Office of Manufacturing Quality (OMQ), Office of Compliance (OC), CDER FDA |
Dr. Aldridge joined FDA as an Interdisciplinary Scientist-Chemist in the Office of Compliance in 2011. She is currently a lead consumer safety officer in the Office of Manufacturing Quality (OMQ). Dr. Aldridge previously worked in the personal care industry and started her pharmaceutical career at Abbott Laboratories. Prior to coming to FDA, she held managerial positions in analytical services for contRACt manufacturing, pharmaceutical development and contRACt laboratory firms. She received a BS degree in biology from the University of Illinois at Urbana-Champaign and a PhD degree in chemistry from Loyola University Chicago. |
| Kassa Ayalew, MD, MPH Branch Chief Good Clinical PRACtice Assessment Branch Division of Clinical Compliance Evaluation, CDER, FDA |
Kassa Ayalew, MD, MPH is a Branch Chief for Good Clinical PRACtice Assessment Branch at the Division of Clinical Compliance Evaluation (formerly known Division of Scientific Investigations (DSI)) at Center for Drug Evaluation and Research (CDER) in FDA. Dr. Ayalew oversees verification of the integrity of efficacy and safety data submitted by sponsors to the FDA in support of new drug and biologic applications. Dr. Ayalew has over 15 years of experience in regulatory medicine. He is also a pRACticing Pediatric Infectious Disease specialist. |
| Huascar Batista Imports Exports Compliance Branch Chief Office of Compliance, CDER, FDA |
Huascar Batista is the Imports Exports Compliance Branch Chief at FDA Center for Drug Evaluation and Research Office of Compliance. The Compliance Branch is located in the new Office of Drug Security, Integrity and Recalls. The new Office within the Office of Compliance handles all compliance aspects of drug supply chain, drug shortages, and recall coordination.Mr. Batista worked with the previous Division of New Drugs and Labeling Compliance prior to the CDER Office of Compliance reorganization. Prior to his work at CDER Mr. Batista worked with the FDA Office of Regional Affairs in the New York District Imports Branches. |
| Andrea Bautista, JD, MBA Regulatory Counsel DLRS | OGDP | OGD |
Andrea Bautista is a regulatory counsel in the Office of Generic Drug Policy, Office of Generic Drugs (OGD). Before joining OGD in February 2016, Ms. Bautista worked as a regulatory counsel in FDA’s Center for Tobacco Products. She holds a JD degree from Catholic University’s Columbus School of Law, and MBA and BS degrees from the George Washington University. |
| Elizabeth Bearr, PhD Microbiologist Division of Microbiology Assessment (DMA) Office of Process & Facilities (OPF) | OPQ |
Elizabeth Bearr has worked as a quality microbiology reviewer at FDA since 2015 in the Division of Microbiology Assessment, which is part of the Office of Process and Facilities in the Center for Drug Evaluation and Research. She received her doctorate from Johns Hopkins University-School of Medicine and her B.S. from the University of Wisconsin-Madison. She previously worked as a patent agent for a pharmaceutical company and as Associate Director of Scientific Programs for the Endocrine Society. |
| Nicole M. Bell, MS Lieutenant Commander, USPHS Consumer Safety Officer OC | DBM | BCB I CDRH | FDA |
LCDR Nicole Bell began her career with FDA in 2009 as an investigator in the Florida District’s Miami Resident Post, and transferred to the Atlanta District Office in July 2011. As a Bioresearch Monitoring (BIMO) Specialist, she conducts complex domestic and foreign BIMO inspections of clinical investigators, sponsors, institutional review boards, and preclinical testing facilities in addition to providing training and guidance to BIMO investigators, industry, and international regulatory bodies. LCDR Bell earned a Bachelor of Science degree in Biochemistry from Xavier University of Louisiana and a Master of Science degree in Analytical Chemistry from Louisiana State University. |
| Robert T. Berendt, PhD Branch Chief, Branch I Division of Modified Release Products Office of Lifecycle Drug Products (OLDP) | OPQ CDRH | FDA |
Dr. Robert Berendt is a branch chief in the Office of Lifecycle Drug Products (OLDP), where he specializes in the quality assessment of modified-release drug products, including transdermal systems and topical delivery systems. Previous work in CDER has included primary quality assessment of ANDAs for injectables, solid orals (IR and MR), and transdermal systems; and he supported regulatory review and policy activities for three years as a pharmaceutical scientist in the FDA laboratories at White Oak. He earned his doctorate in pharmaceutical chemistry from the University of Kansas. His dissertation research focused on solid-state characterization of pharmaceutically relevant systems, and he specialized in the application of solid-state NMR spectroscopy to understand the crystallization of small-molecule drug substances. He is a member of the CDER Transdermal Working Group and the CDER Excipients Working Group, and he maintains a research interest in the solid-state chemistry of drugs. |
| Lisa Bercu, JD Regulatory Counsel Division of Policy Development (DPD) Office of Generic Drug Policy (OGDP) | OGD | CDER |
Lisa Bercu is a regulatory counsel in the Office of Generic Drug Policy, Office of Generic Drugs (OGD). Before joining OGD in October 2016, Ms. Bercu worked at a medical society providing strategic advice on issues including pain medicine, drugs, and devices. She holds a JD degree from Georgetown University Law Center and a BA from the University of Michigan. |
| Amy Bertha Program Manager Office of Executive Programs (OEP) | CDER |
Amy Bertha has worked at FDA’s Center for Drug Evaluation and Research for the past 12 years in regulatory affairs program management, in the Office of Pharmaceutical Sciences (now the Office of Pharmaceutical Quality), Office of New Drugs, and currently in the Office of Executive Program. Prior to joining FDA, Ms. Bertha worked for 10 years in the pharmaceutical industry, in research and development as an organic chemist and in regulatory affairs. |
| James Bertram, PhD, RAC Regulatory Advisor and Product Jurisdictional Officer Office of Device Evaluation CDRH, FDA |
Dr. James Bertram is a Regulatory Advisor in the Office of Device Evaluation (ODE) and Product Jurisdictional Officer in the Center for Devices and Radiological Health (CDRH). As Regulatory Advisor, he works within ODE in developing policies and procedures as well as ensuring consistency across various device evaluation programs and activities. As the CDRH Product Jurisdictional Officer, Dr. Bertram interfaces with the Office of Combination Products and other FDA Centers as it pertains to Agency regulations and policies for combination products. In 2009, Dr. Bertram came to the FDA as a Regenerative Medicine Fellow under the Commissioner’s Fellowship Program. In 2011, he transitioned to ODE, where he served as a pre-market reviewer in the Division of Ophthalmic, Ear, Nose and Throat Devices until April of 2014, after which he served briefly as Acting Branch Chief of the Posterior Spine Device Branch in the Division of Orthopedic Devices. Dr. Bertram received a Bachelor of Science degree in Mechanical Engineering at the Pennsylvania State University and a Doctorate degree from Yale University. |
| Ksenia Blinova, PhD Senior Technical Laboratory Manager Induced Pluripotent Stem Cell and Electrophysiology Core Facility Staff Fellow Division of Biomedical Physics Office of Science and Engineering Laboratories CDRH | FDA |
Dr. Ksenia Blinova leads an Induced Pluripotent Stem Cell and Electrophysiology Core Facility at FDA. It was established to foster collaborative regulatory research supporting review and assessment of FDA-regulated products based on human induced-pluripotent stem cells, including lab-developed in vitro diagnostic tests, stem cell based combination products, high-throughput cardiotoxicity and neurotoxocity screening of new drugs, and patient-specific precision medicine. Dr. Blinova joined FDA in 2008. Dr. Blinova received a Ph.D. in Physics and Mathematics from Moscow State University and completed a postdoctoral fellowship at the National Heart, Lung, and Blood Institute and FDA Commissioner’s Fellowship Program at the FDA. |
| Ashley B. Boam, MSBE Director (acting) Office of Policy for Pharmaceutical Quality (OPPQ) Office of Pharmaceutical Quality (OPQ), FDA/CDER |
Ashley Boam currently serves as acting Director of the Office of Policy for Pharmaceutical Quality in the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER). Before the formation of OPQ, Ashley served as acting Deputy Director of the Office of Pharmaceutical Science for just over a year, focusing on regulatory and policy issues related to pharmaceutical quality assessment. Prior to joining CDER, Ashley spent nearly 20 years in the Office of Device Evaluation (ODE) in FDA’s Center for Devices and Radiological Health (CDRH), serving as a scientific reviewer, a Branch Chief in the Division of Cardiology Devices, and finally as Associate Director for Regulations and Guidance for ODE. Ashley received her MSBE from the University of Alabama at Birmingham and her BSE from Tulane University, both in Biomedical Engineering. |
| CDR Dawn M. Braswell Commander, Public Health Service Investigator – Medical Device Specialist Atlanta District Office of Regulatory Affairs FDA |
CDR Dawn M Braswell began her career in the Commissioned Corps of the USPHS in 2001 with the U.S. Food and Drug Administration. Stationed at FDA’s Winchester Engineering and Analytical Center (WEAC) in Winchester, Massachusetts, CDR Braswell tested aftermarket medical devices and radiation emitting electronic products for compliance with FDA Quality System (QS) Regulation performance standards and commercial claims. She also occasionally performed Electronic Product Radiation Control (EPRC) inspections of overseas manufacturers of radiation emitting products. In 2008, CDR Braswell transferred to the position of Medical Device Investigator at the New England District Office in Stoneham, Massachusetts. During this time she also achieved certification to conduct Mammography Quality Standards Act (MQSA) inspections of facilities providing breast imaging services. CDR Braswell served a one-year detail on the Dedicated Foreign Device Cadre performing Quality System and combination EPRC inspections throughout Europe, Asia and other international locations before transferring to the Atlanta District in 2014 where she currently holds a position as one of the District’s Medical Device Specialists. CDR Braswell received a Bachelor of Science in Electrical Engineering from North Carolina A&T State University in Greensboro, North Carolina. |
| Eric Brodsky, MD Associate Director Labeling Development Team Office of New Drugs (OND) CDER | FDA |
As the Associate Director of the LDT, Dr. Brodsky oversees OND’s implementation of prescribing information regulations, guidances, and policies to help promote consistency in labeling practices across CDER; provides labeling review training; develops labeling resources for CDER staff and industry; provides oversight of labeling quality; and assists review teams in review and development of the prescribing information. Previous OND roles included the labeling team leader of the LDT [previously known as the Study Endpoint and Labeling Development (SEALD) labeling team]; and medical officer in three review divisions (i.e., the Division of Pulmonary, Allergy, and Rheumatology Products; the Division of Anesthesia, Analgesia, and Addiction Products; and the Division of Gastroenterology and Inborn Errors Products). Prior to joining the FDA, Dr. Brodsky practiced as an internist with a focus in primary care and hospital medicine in the Washington D.C. area. He received his medical degree from Tufts University School of Medicine, completed an internal medicine residency program at the University of Massachusetts Medical Center, and is board certified in Internal Medicine. |
| Regina T. Brown Division of Internal Policies and Programs (DIPAP) Office of Policy for Pharmaceutical Quality (OPPQ) Office of Pharmaceutical Quality (OPQ), CDER |
Regina Brown currently serves as a senior policy advisor within the Office of Policy for Pharmaceutical Quality (OPPQ), Office of Pharmaceutical Quality (OPQ). Her previous FDA experience includes positions held as an Office of Regulatory Affairs (ORA) New Jersey District Investigator; ORA HQ National Expert Drug Manufacturing Technology; Office of International Programs (OIP) Policy and Program Analyst at New Delhi, India and CDER Office of Manufacturing and Product Quality (OMPQ) Compliance Officer. Ms. Brown has also worked with Tea research and as a synthetic organic chemist. Ms. Brown attended Rensselaer Polytechnic Institute and Michigan State University. |
| Kevin B Bugin, MS, RAC Senior Regulatory Health Project Manager Division of Gastroenterology and Inborn Errors Products Office of Drug Evaluation (ODE) III CDER | FDA |
Kevin Bugin serves the OND Director and Chief of Staff as the Lead for Change Management. Change management is a discipline that guides how organizations prepare, equip, and support staff through change to drive organizational success and outcomes. Kevin joined FDA in the Office of Business Process Support, in the electronic review and regulatory support division to help the Office of New Drugs and the Office of Generic Drugs during a transition to more electronic review work. In 2010, Kevin joined the Division of Gastroenterology Products in OND as a Regulatory Health Project Manager, eventually becoming Chief of Project Management in 2015. Prior to joining FDA, Kevin worked in multiple areas of drug development beginning with basic molecular biology at the Virginia Bioinformatics Institute, later technology transfer at the NIH’s Office of Technology Transfer, and safety and pharmacovigilance for the National Cancer Institute’s Cancer Therapy Evaluation Program (CTEP). Kevin also worked in regulatory affairs and quality assurance at a budding contract research organization, Amarex Clinical Research, just prior to joining FDA. He teaches at The George Washington University on topics in clinical research administration in the School of Medicine and Health Science. |
| Yen Anh Bui, PharmD Lieutenant Commander, USPHS Team Leader Division of Project Management (DPM) | ORO | OGD CDER | FDA |
LCDR Anh Bui is a registered pharmacist currently working at the Office of Generic Drugs (OGD) as a Regulatory Project Manager Team Leader (RPM TL). She received her Doctor of Pharmacy from the Virginia Commonwealth University School of Pharmacy in 2004. Prior to joining OGD, she spent nine years with CVS Pharmacy as a Pharmacy Manager. To better serve the public, she joined OGD in 2013 and became an officer with the United States Public Health Service in 2014. She manages the review of all Positron Emission Tomography (PET) ANDAs for OGD. As a Team Leader with the Division of Project Management, she leads a team of Regulatory Project Managers to fulfill the mission of the OGD/FDA and the requirements of the Generic Drug User Fee Amendments (GDUFA). |
| Lucinda (Cindy) Buhse, PhD Director Office of Testing and Research (OTR) OPQ | CDER | FDA |
Dr. Buhse joined DPA in 2001 as Deputy Director of the Division of Pharmaceutical Analysis for Center for Drug Evaluation and Research in the FDA. She was promoted to Division Director in June, 2004 and has been Director for Office of Testing and Research since June 2013. Dr. Buhse received a B.A. in Chemistry from Grinnell College and a Ph.D. in Physical Chemistry from the University of California, Berkeley under the direction of John H. Clark and George C. Pimentel. Before joining FDA, Dr. Buhse worked in management positions in Production, Validation and Analytical Services at Sigma Aldrich Corporation and as a Senior Research Scientist for Rohm and Haas Company. She leads a laboratory based office in the Center for Drug Evaluation and Research (CDER) responsible for supporting FDA review, investigation and enforcement actions and for conducting research programs to advance the science needed to regulate the quality of human drugs. |
| Kara D. Burke, PharmD Pharmacist Division of Drug Information CDER Office of Communications |
Kara is a pharmacist in the Office of Communication’s Division of Drug Information and has been with the FDA since 2008. Prior to joining the FDA, she worked as a Pharmacy Manager for CVS pharmacy. She received her Doctorate of Pharmacy Degree from Duquesne University in Pittsburgh, PA in 2004. |
| Robert M. Califf, MD, MACC FDA Commissioner |
Robert M. Califf, MD, MACC is the Food and Drug Administration’s commissioner of food and drugs. As the top official of the FDA, Dr. Califf is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health. Previously, Dr. Califf served as the FDA’s Deputy Commissioner for Medical Products and Tobacco from February 2015 until his appointment as commissioner in February 2016. In that capacity, he provided executive leadership to the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products. He also oversaw the Office of Special Medical Programs and provided direction for cross-cutting clinical, scientific, and regulatory initiatives, including precision medicine, combination products, orphan drugs, pediatric therapeutics, and the advisory committee system. Prior to joining the FDA, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He also served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. A nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature. Dr. Califf has served on the Institute of Medicine (IOM) committees that recommended Medicare coverage of clinical trials and the removal of ephedra from the market, as well as on the IOM Committee on Identifying and Preventing Medication Errors and the IOM Health Sciences Policy Board. He has served as a member of the FDA Cardiorenal Advisory Panel and FDA Science Board’s Subcommittee on Science and Technology. Dr. Califf has also served on the Board of Scientific Counselors for the National Institutes of Health and the National Library of Medicine, as well as on advisory committees for the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute of Environmental Health Sciences and the Council of the National Institute on Aging. While at Duke, Dr. Califf led major initiatives aimed at improving methods and infrastructure for clinical research, including the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by the FDA and Duke. He also served as the principal investigator for Duke’s Clinical and Translational Science Award and the NIH Health Care Systems Research Collaboratory coordinating center. Dr. Califf is a graduate of Duke University School of Medicine. He completed a residency in internal medicine at the University of California, San Francisco and a fellowship in cardiology at Duke. |
| Christina Capacci-Daniel, PhD Quality Assessment Lead (Acting) Division of Inspectional Assessment OPF | OPQ | CDER | FDA |
Christina Capacci-Daniel is an acting Quality Assessment Lead and Reviewer in the FDA/OPQ Office of Process and Facilities, Division of Inspectional Assessment. She has a PhD in Organic Chemistry from Georgetown University where she studied crystallization process design and polymorphic control. As part of the early technical research and development group at Novartis Pharmaceuticals, she designed drug products for clinical trials, developed analytical methods, and worked on innovative drug delivery and manufacturing technology. Since joining the FDA in 2013, she has reviewed manufacturing facilities for new drug applications in addition to performing pre-approval inspections and inspectional review. |
| Sergio M. de del Castillo De Novo Policy Analyst (Acting) Office of Device Evaluation Center for Devices and Radiological Health |
Sergio M. de del Castillo serves as the De Novo Program Lead for the Office of Device Evaluation (ODE) in the Center for Devices and Radiological Health (CDRH). In this role, he works with ODE management in the development of policy and procedures for the Office’s rapidly evolving De Novo program. Since his arrival at FDA over 16 years ago, Mr. de del Castillo has served as a scientific reviewer in the Orthopedic Devices Branch and Orthopedic Spine Devices Branch in the Office of Device Evaluation (ODE). From 2012-2015, he served as Regulatory Advisor to the Director of ODE, working with the ODE review divisions in the formulation of new regulations, guidance documents, policies, and procedures, as well as providing counsel to external stakeholders for various device regulatory programs (510(k), IDE, PMA, De Novo, etc.). In the first quarter of 2015, he served as Acting Branch Chief of the Premarket Programs Branch in the Division of Industry and Consumer Education (DICE) in the Office of Communication and Education (OCE). Mr. de del Castillo received a Bachelor of Science degree in Biomedical Engineering from Johns Hopkins University. |
| Rosanne Chandra, PharmD Supervisory Pharmacist Division of Filing Review (DFR) ORO | OGD | CDER | FDA |
Rosanne is currently a Supervisory Pharmacist in the Division of Filing Review (DFR) within the Office of Regulatory Operations. Previously, she was a Team Leader and a Regulatory Filing Reviewer with DFR. Prior to working at the FDA, she was practicing retail pharmacy. She received her Doctorate of Pharmacy from University of Florida College of Pharmacy. |
| Howard D. Chazin, MD, MBA Director Clinical Safety Surveillance Staff OGD | CDER | FDA |
Dr. Chazin is currently the Director of CDER’s Office of Generic Drugs’ Clinical Safety Surveillance Staff, a multidisciplinary team of pharmacists, medical officers and data analysts tasked with identifying and assessing emerging complex safety issues related to potentially inferior generic drug product quality, adverse events and other generic drug safety concerns. He facilitates postmarketing safety process improvements and provides oversight on critical aspects of challenging, controversial and sensitive generic drug safety issues. Dr. Chazin received his MD from Rutgers/Robert Wood Johnson Medical School and his MBA in Medical Services Management from The Johns Hopkins University Carey Business School. |
| Eric Chen Director, Humanitarian Use Device Designation Program Office of Orphan Products Development Office of Special Medical Programs |
Eric Chen serves as the Director of the Humanitarian Use Device Designation Program in the Office of Orphan Products Development, in the Office of Special Medical Programs at FDA, a position he has held since February 2010. In this role, he leads the program whose mission is to promote the development of devices for the diagnosis or treatment of rare diseases or conditions. Prior to this position, from 2002 – 2010, he served as Expert Biomedical Engineer in the Circulatory Support Devices Branch in the Office of Device Evaluation’s (ODE) Division of Cardiovascular Devices, where he was responsible for the review of mechanical circulatory support devices. Mr. Chen received a Master’s of Science Degree in Bioengineering from the University of Pittsburgh and a Bachelor of Science Degree in Biomedical Engineering from Johns Hopkins University. |
| Min Chu Chen Acting Director Division of Pharmacovigilance, Office of Surveillance and Epidemiology CDER, FDA |
Min Chen is currently the Acting and Deputy Director of the Division of Pharmacovigilance, Office of Surveillance and Epidemiology at the Food and Drug Administration (FDA) in White Oak, Maryland. Ms. Chen is a clinical pharmacist and joined the FDA over 26 years ago. At the FDA, she is involved in all key aspects of postmarketing safety activities, most notably directing the pharmacovigilance pRACtice using available data sources for safety signal detection, evaluation and recommendation for management of risk for all U.S. marketed medicinal products, and the development of the FDA Adverse Event Reporting System (FAERS) database.Ms. Chen is closely involved with the postmarketing reporting regulation and guidance development both in the FDA and International Conference on Harmonisation (ICH). Ms. Chen has also chaired international pharmacovigilance conferences with regulatory authorities from the (European Medicines Agency) EMA, Canada, Australia, New Zealand and Singapore. She has received over 25 awards during her time at the FDA, including the highest citation award from the FDA Commissioner. Ms. Chen is a graduate of the National Taiwan University College of Pharmacy, holds a Master of Science in Pharmacology from the National Taiwan University and a Pharmacy degree from the University of Missouri, Kansas City. |
| Loretta E. Chi, JD Senior Regulatory Counsel Informatics Staff Office of Center Director CDRH | FDA |
Loretta E. Chi, JD, PMP has been with FDA since November 2012. She is currently Senior Regulatory Counsel with the CDRH/Informatics Staff where she develops policy and advises on the implementation of the UDI program. Ms. Chi was a life sciences entrepreneur for more than 15 years, and has over a decade’s experience as a corporate, FDA and government relations attorney, including serving as Assistant General Counsel at Pharmaceutical Research and Manufacturers of America. Ms. Chi also is Adjunct Professor at Johns Hopkins University where she teaches Food and Drug Law. Ms. Chi received her J.D from George Washington University Law School in Washington, DC, and is a member of the Maryland and District of Columbia bars. She also is a certified Project Management Professional. |
| Nallaperumal Chidambaram (Chid), PhD Branch Chief (Acting) Division of Process Assessment III Office of Process and Facilities(OPF) OPQ | CDER | FDA |
Dr. Nallaperumal Chidambaram (Chid) is a Branch Chief (Acting) in the Office of Process and Facilities (OPF) dealing with both Generic and New drug applications. Before standup of the Office of Pharmaceutical Quality, he was the CMC Lead handling post-marketing issues for Cardio-Renal, Neurology, Psychiatry and Oncology clinical divisions. He previously served as a review chemist for Oncology, and Cardio-Renal Drug Products, as a Chemistry Team Leader for Oncology in the Office of New Drug Chemistry (ONDC), and as a Branch Chief (Acting) for the Office of Oncology and Hematology Products in ONDQA. Chid received his Bachelor’s Degree in Chemistry from Madras University, Master’s Degree in Chemistry from Annamalai University, and his Ph.D. in Organic Chemistry from the Indian Institute of Technology (IIT), Kanpur. Before joining the FDA, Dr. Chidambaram did post-doctoral work at King’s College, London, U.K., Georgetown University and Duke University and he worked as a Senior Scientist at IA Inc. in Ann Arbor, Michigan. |
| Simon Choi, PhD, MPH Senior Science Health Advisor Office of Center Director CDRH | FDA |
Dr. Simon Choi is a Senior Science Health Advisor with the Digital Health Unit. He serves as an expert in Digital Health Policy. Dr. Choi has worked on multiple digital health related guidances. He is currently involved in providing stakeholder feedback on digital health policies and digital health initiative. During his 15 year FDA career, he has served as network leader for radiological products and as a senior science health advisor for cross cutting public health and regulatory science issues. Prior to joining the Agency, he directed the Master of Public Health program and served as faculty in the Department of Preventive Medicine at the University of Kansas School of Medicine. Dr. Choi received a Doctoral degree in Public Health from the University of Southern California (USC) and Master of Public Health degree from California State University – Long Beach. |
| Julian Chun, PharmD, MBA Pharmacist Drug Registration and Listing Staff OC | CDER | FDA |
Julian Chun is currently a Pharmacist with the Drug Registration and Listing Staff in CDER’s Office of Compliance. Prior to his current position, Julian served in managerial and clinical roles for Johns Hopkins Outpatient Pharmacy and Giant Pharmacy. Julian received his Doctor of Pharmacy degree from University of Maryland and a Master of Business Administration degree from Johns Hopkins University. He holds a specialty board certification in ambulatory care pharmacy. |
| Chrissy Cochran, PhD Acting Division Director Division of Enforcement and Postmarketing Safety (DEPS) Office of Scientific Investigations (OSI) CDRH, FDA |
Dr. Chrissy J. Cochran is the Acting Division Director for the Division of Enforcement and Postmarketing Safety (DEPS) within the Office of Scientific Investigations (OSI), Office of Compliance, Center for Drug Evaluation and Research. She previously held the positions of Acting Branch Chief for the Compliance Enforcement Branch, and Branch Chief for the Postmarketing Safety Branch within OSI. As the DEPS Division Director, Dr. Cochran is responsible for oversight of bioresearch monitoring (BIMO) related enforcement actions, and the postmarketing adverse drug experience (PADE) and risk evaluation and mitigation strategies (REMS) compliance teams. Prior to OSI, Dr. Cochran was responsible for regulatory compliance and enforcement of the good laboratory pRACtice (GLP) regulation for the Center for Devices and Radiological Health (CDRH). Dr. Cochran also provided regulatory guidance to CDRH’s Office of Compliance on toxicology and biocompatibility aspects of post market safety issues including recalls, risk assessments, and enforcement actions. Prior to joining FDA Dr. Cochran worked at a large clinical research organization. She started by performing in-house study activities, moving on to monitoring clinical sites, and eventually becoming the clinical team lead overseeing clinical monitors. Dr. Cochran has received several CDER, CDRH, and FDA awards for her work. She received her PhD in Toxicology from the University of Maryland Baltimore. |
| Troy Cu Technical Information Specialist DRLS Staff OC | CDER | FDA |
Troy has been with FDA since 2013. Prior to joining FDA, I worked at International Monetary Fund as a system administrator. He has an Associate of Computer Information System degree and an MCSE and CCNA. |
| Arindam Dasgupta, PhD Deputy Director Division of New Drug Bioequivalence Evaluation Office of Study Integrity and Surveillance (OSIS) CDER | FDA |
Dr. Dasgupta received his B.S. from the Department of Zoology, Presidency College, Kolkata, India in 1989 followed by his M.S. in Biophysics, Molecular Biology, and Genetics from the University of Calcutta, Kolkata, India in 1994. After finishing his Ph.D. in Molecular Biology from Jadavpur University, Kolkata, Arindam joined the University of Virginia Department of Biochemistry and Molecular Genetics as a Research Associate in 1999. He later completed a three-year postdoctoral fellowship at the National Institutes of Health (NIH), National Cancer institute (NCI). Dr. Dasgupta has authored numerous scientific publications in prestigious peer-reviewed journals. After completing his fellowship, Arindam joined the Center for Drug Evaluation and Research (CDER) in 2008 as a Pharmacologist in the Division of Scientific Investigations, GLP and BE Investigations Branch. He served as the Acting Team Lead in the Office of Scientific Investigations, Division of Bioequivalence and GLP Compliance (DBGLPC), Bioequivalence Branch from June to July 2012. Arindam also served as the Acting Team Lead in the Division of Bioequivalence and GLP Compliance (DBGLPC), GLP Branch from May to December 2014 and was appointed as the permanent Team Lead in December 2014. Following the reorganization of the Office of Scientific Integrity and Surveillance (OSIS) in January 2015, Arindam continued to serve as one of the Team Leads in the Division of New Drug Bioequivalence Evaluation (DNDBE) before talking up the role of Deputy Director of the Division of New Drug Bioequivalence Evaluation under OSIS. |
| Judith A. Davis, DVM, MS Senior Staff Fellow Division of Cardiovascular Device Office of Device Evaluation CDRH | FDA |
Dr. Judith Davis is a Senior Staff Fellow in the Division of Cardiovascular Devices, in CDRH’s Office of Device Evaluation. She serves as a Division expert in the review of preclinical animal studies for first-in-human cardiovascular device use. While at the Agency, Dr. Davis worked on the Guidance for Industry and FDA Staff. General Considerations for Animal Studies for Cardiovascular Devices (July 2010) and General Considerations for Animal Studies Intended to Evaluate Safety of Medical Devices, Draft 2017. She is currently involved in other Agency initiatives regarding revisions of the Good Laboratory Practice (GLP) regulations. Prior to her current position Dr. Davis was Animal Program Director of the National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute on Deafness and Other Communication Disorders (NIDCD) at the National Institutes of Health (NIH). While at NIH, Dr. Davis served on many policy and strategic planning committees involving biomedical research, including an appointment to the National Leadership Workshop on Mentoring Women in Biomedical Careers (2008). Dr. Davis earned two specialties in veterinary medicine: American College of Laboratory Animal Medicine (ACLAM) and the American College of Veterinary Preventive Medicine (ACVPM) and is an active member of numerous professional organizations. She was also honored by selection as the Public Health Service Veterinarian of the Year (2003) and the Joseph Held Clinical Veterinarian of the Year (2009) by her peers. Dr. Davis received a Master of Science with an emphasis on Reproductive Physiology from the University of Missouri-Columbia and a Doctor of Veterinary Medicine from Oklahoma State University. |
| Suranjan De, MS, MBA Deputy Director, Regulatory Science Staff Office of Surveillance and Epidemiology (OSE) CDER |FDA |
Suranjan De has over seventeen years of demonstrated achievements, across Food and Drug Administration (FDA), National Institute of Health (NIH) & Pharma, impacting superior program performance through alignment of policies and regulation and innovative healthcare informatics solutions with strategic business objectives. His experience includes providing strategic direction to the life sciences industry for the use of innovative tools and products. He has also served as a SME/liaison between the IT management and the business owner in integrating methods and process with technology. Suranjan received a Masters in Computer Science from the Institute for Technology and Management, India and a Masters in Business Administration from Johns Hopkins University. Currently, Mr. De is the Deputy Director at FDA’s CDER, Office of Surveillance and Epidemiology, in the Regulatory Science Staff. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products. This includes interpretation of regulations, guidance documents and/or other policies relevant to activities in the Office of Surveillance and Epidemiology (OSE) in order to implement best practices and provide the right tools and technology. His current work includes, but is not limited to compounding reporting guidance, data management of FDA Adverse Events Reporting System (FAERS) and automating triaging of voluntary reporting and Safety Reporting Portal for mandatory post-marketing electronic submissions. |
| Kevin Denny, PharmD Lieutenant Commander, United States Public Health Service Regulatory Project Manager Office of Regulatory Operations (ORO) OGD, CDER, FDA |
LCDR Kevin Denny is an acting Team Leader in the Division of Project Management in the Office of Generic Drugs at the Food and Drug Administration (FDA). He has been with the FDA for the last two years currently working at the White Oak Campus in Maryland. Kevin graduated from Idaho State University, with a Doctor of Pharmacy degree in 2001. Kevin is currently working on a Master’s of Science in Health Sciences in Regulatory Affairs degree from George Washington University. |
| Lysette Deshields, PharmD Lieutenant Commander, United States Public Health Service Regulatory Officer Pharmacist Drug Registration and Listing System Staff OC, CDER, FDA |
LCDR Lysette A. Deshields has been a regulatory officer pharmacist with the Food and Drug Administration (FDA) and a Commissioned Corps officer in the United States Public Health Service for over five years. In her role as a pharmacist at the FDA with the Drug Registration and Listing System (DRLS) Staff, she assists in managing FDA training seminars and supports the DRLS helpdesk by answering questions related to the practice of pharmacy, human drug compounding, and relevant regulations. In addition to her roles in the Drug Registration and Listing regulatory environment, LCDR Deshields also serves as a mentor to pharmacy students and junior Public Health Service Officers. LCDR Deshields received a Doctor of Pharmacy degree from Rutgers University. |
| Denise DiGiulio NDA/ANDA Facility Reviewer Office of Process and Facilities CDER, FDA |
Denise DiGiulio, is a NDA/ANDA Facility Reviewer in the Office of Process and Facilities in CDER. She has been with FDA for 16 years. She began her service with FDA at the Philadelphia and New Jersey District Offices as an investigator and performed primarily drug manufacturing inspections, both domestic and international. In 2009, she transferred to CDER Office of Compliance as a compliance officer in the Division of Good Manufacturing PRACtice Assessment (DGMPA). In 2015, she transferred to her current position. DiGiulio’s main responsibility in the Office of Process and Facilities includes the scientific review and quality evaluation of the manufacturing process and facilities filed in A/NDAs. |
| Maureen Dillon-Parker Chief, Project Management Staff Division of Anti-Infective Products (DAIP) Office of Antimicrobial Products (OAP) OND | CDER | FDA |
Ms. Dillon-Parker is Chief of the Regulatory Health Project Management Staff in the Division of Anti-Infective Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Office of New Drugs. She is a graduate of the University of Maryland and has worked at FDA for over 20 years. In addition to her supervisory duties she also manages a portfolio of antimicrobial, antifungal and anti-parasitic investigational new drug (IND) and new drug applications (NDA) and is an active member on many Agency committees. |
| Donovan F. Duggan II, BS, MBA Team Lead, Helpdesk Drug Registration and Listing Staff OC | CDER | FDA |
Donovan F. Duggan II has been in CDER’s Office of Compliance since 2008. Don is the team lead for the Helpdesk group within the Drug Registration and Listing staff. Don started his career at Boise Cascade as an Office Services manager and eventually became the East Region Total Quality Manager. He has been a consultant with Unisys and Booz, Allen and Hamilton and has over 20 years of experience at the FDA. Don has worked in Information Technology – Helpdesk, Network , and Desktop Configuration, the Office of Business Informatics – electronic submissions, Electronic Submission Gateway, SPL, eCTD, and at the Office of Compliance – SPL, Drug Registration and Listing. Don has B.S. and an M.B.A. from the University of Maryland. |
| Andrew Durfor Chemist Foreign Enforcement Branch Division of International Compliance Operations Office of Compliance CDRH | FDA |
Andrew Durfor is a Chemist in the Foreign Enforcement Branch, Division of International Compliance Operations, in CDRH’s Office of Compliance. His work consists primarily of reviewing the results from internationally-conducted FDA inspections and ensuring that FDA uses a benefit-risk based approach to protecting and promoting the public health. In 2014 – 2015, Mr. Durfor participated in the Mike and Maureen Mansfield Fellowship, and worked in the Japanese Pharmaceutical and Medical Devices Agency (PMDA) and Ministry of Health and Labour Welfare (MHLW) to strengthen the ties between US FDA and the Japanese government. In 2010 Andrew Durfor began working in FDA’s Office of Science and Engineering Laboratories. He joined the Office of Compliance later that year. Prior to his career at FDA, Mr. Durfor received a Master in Chemistry from the University of Virginia and a Bachelor of Science in Chemistry at the College of William and Mary. |
| Beth Duvall Associate Director for Regulatory Affairs Office of New Drugs, (OND) CDER, FDA |
Beth Duvall is the Associate Director for Regulatory Affairs in the Office of New Drugs Immediate Office (OND IO) in the Center for Drug Evaluation and Research (CDER), FDA. In her position, Beth manages the Regulatory Affairs Team (RAT) in OND IO and provides leadership for the regulatory project manager (RPM) discipline throughout CDER. RAT is responsible for implementing and overseeing 21st Century Review processes and PDUFA V provisions, including the Enhanced Communications Team and Breakthrough Therapy designation requests, and for providing support and oversight for the DARRTS Program, Formal Dispute Resolution, OND Process Improvements, and other cross-cutting initiatives within CDER. She is also the lead facilitator of the 505(b)(2) clearance and coordinating committees and a member of the CDER Exclusivity Board. Ms. Duvall joined the FDA in 1996 as a Regulatory Project Manager in the Division of Anti-Infective Drug Products (CDER/OND) where she worked until joining OND IO in 2003 as the Postmarketing Requirement/Commitment Program Manager, followed by a Team Leader role in 2006, and finally her current position in 2011. Ms. Duvall earned a BS Degree in Chemistry (minor in mathematics) from the University of Delaware. She is an Excellence in Government senior fellow 2008 |
| Lynne Ensor, PhD Acting Director Division of Microbiology Assessment Office of Process and Facilities OPQ, CDER, FDA |
Dr. Lynne Ensor currently serves as the Division Director (Acting) for the Division of Microbiology Assessment (DMA) in the Office of Pharmaceutical Quality’s Office of Process and Facilities. Currently DMA is responsible for the product quality microbiology assessment of new, generic and biologic drug products, with an emphasis on sterile drug manufacture. During Lynne’s 18 years of regulatory experience at the FDA, she worked the vast majority of them in the Office of Generic Drugs, followed by a detail to the Office of Pharmaceutical Science briefly prior to the creation of the Office of Pharmaceutical Quality. Dr. Ensor serves on several committees overseeing the creation and stand-up of CDER’s Office of Pharmaceutical Quality and the initial implementation of the Generic Drug User Fee Act. Lynne earned her BS in Biology and PhD in Microbiology from the University of Maryland, College Park. In addition to her regulatory experience at FDA, Lynne served as a clinical medical technologist at Roche Biomedical Laboratories, a post-doctoral research fellow at the University of Maryland at Baltimore’s School of Medicine, and a script consultant for the Discovery Channel. |
| Tamara Felton Clark, MS, RAC Branch Chief (Acting), Global Compliance Branch 4 (GCB4) Division of Drug Quality II (DDQII) Office of Manufacturing Quality (OMQ) Office of Compliance (OC), CDER |
Tamara Felton Clark joined FDA in 2006 in the Center for Devices and Radiologic Health’s (CDRH) Office of In Vitro Diagnostics and in 2008 transferred to the Center for Drug Evaluation and Research’s (CDER) Office of Compliance where she helps to enforce CGMP regulations for domestic and foreign drug manufacturers. Prior to joining FDA, she worked in the National Institutes of Health, Clinical Center, Department of Transfusion Medicine, manipulating blood and human cellular/tissue based products utilized in phase I/II clinical trials in the areas of hematopoietic stem cell transplantation, adoptive immunotherapy, genetic immunotherapy, and pancreatic islet transplantation. In addition, early in her career she spent a few years working as a production specialist for a biopharmaceutical contRACt manufacturer performing large-scale cell culture and protein purification activities. Tamara holds a BS degree in Biology from Morgan State University and a MS degree in Biotechnology (w/a concentration in Regulatory Affairs) from Johns Hopkins. |
| Mathilda Fienkeng, PharmD LCDR, USPHS Team Lead, Neurology and Psychiatry Products Office of Prescription Drug Promotion CDER, FDA |
LCDR Mathilda Fienkeng, is a licensed pharmacist and commissioned officer with the U.S. Public Health Service Commissioned Corps. LCDR Fienkeng is currently a Team Leader in FDA’s Office of Prescription Drug Promotion (OPDP). As the Team Leader of OPDP’s Team 1, she manages a team of four reviewers who focus on neurology and psychiatry drug products. In addition, LCDR Fienkeng is an active member of the management team in OPDP and contributes to the development of new policies relating to prescription drug marketing. Prior to becoming a team leader, she served 4 years as one of the primary reviewers within FDA-OPDP for reviewing promotional materials for Anesthesia, Analgesia and Addiction drug products. LCDR Fienkeng joined OPDP in 2008, after receiving her Doctorate in Pharmacy from the University Of Maryland School Of Pharmacy in 2008. Prior to that, she earned an Associate Degree in Nursing in 2000 at CCBC-Essex, and a Bachelor in Arts degree in Bilingual Studies & Education from the University of Yaoundé in Cameroon in 1995. Previously, she pRACticed as a Registered Nurse for 8 years, and a Middle/High School teacher for 2 years. |
| Keith Flanagan, BA, JD Director, Office of Generic Drug Policy OGD, CDER |
Before joining FDA, Keith served on the Senate HELP Committee staff for eight years, most recently as Senior Health Counsel. He co-authored the Food and Drug Administration Safety and Innovation Act, the Biologics Price Competition and Innovation Act, the FDA Food Safety Modernization Act, the pediatric and device provisions of the Food and Drug Administration Amendments Act and the reauthorization of the Pandemic and All-Hazards Preparedness Act. He also conducted Congressional investigations. Before serving on Congressional staff, Keith pRACticed corporate and intellectual property law at a large law firm. He earned his BA from Colgate and his JD from the University of Southern California. |
| Forest “Ray” Ford, Jr., PharmD, CDR, USPHS Consumer Safety Officer Division of Drug Information CDER Office of Communications |
Ray is a Consumer Safety Officer in the Office of Communication’s Division of Drug Information and has been with the FDA since 2011. Prior to joining the FDA, he served in the Indian Health Service as a Clinical Pharmacist and Safety Officer for the Fort Yuma Service Unit. He graduated from the Medical University of South Carolina in 1999, and 2001. |
| Anike Freeman Consumer Safety Officer Postmarket and Consumer Branch Division of Industry and Consumer Education Office of Communication and Education CDRH | FDA |
Anike Freeman is a Consumer Safety Officer in the Postmarket and Consumer Branch, Division of Industry and Consumer Education (DICE), in CDRH’s Office of Communication and Education (OCE). Her work consists primarily of helping external stakeholders locate and understand various regulatory resources and requirements established by FDA. In 2010, Ms. Freeman began working as a research assistant in FDA’s Office of Science and Engineering Laboratories. She then transitioned to the Office of Device Evaluation as a Scientific Reviewer in the Dental Devices Branch, where she reviewed premarket medical device applications such as oral appliances, restorative materials, bone grafting materials, and dental implants. Ms. Freeman received both Bachelor of Science and Master of Engineering Degrees in Bioengineering from the University of Maryland at College Park. |
| Patrick Frey, MPP Director, Office of Program and Strategic Analysis FDA Center for Drug Evaluation and Research |
Patrick J. Frey is the Director of the Office of Planning and Analysis in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA). Before joining CDER in 2008, Mr. Frey was a Research Chemist at Merck and Co., Inc. in West Point, PA. He received his BS summa cum laude in Chemistry from the University of Pittsburgh, and a Masters in Public Policy from the Gerald R. Ford School of Public Policy at the University of Michigan. |
| M. Scott Furness, PhD Deputy Director Office of New Drug Products (ONDP) OPQ | CDER | FDA |
Scott Furness is the Deputy Director of the Office of New Drug Products (ONDP) in CDER’s recently reorganized Office of Pharmaceutical Quality (OPQ). Prior to that reorganization, he previously served as Deputy Director for Review and Operations in the former Office of New Drug Quality Assessment. Scott previously spent six years in OND ‘s Office of Drug Evaluation IV (ODE IV) where he has served as Director, Division of Nonprescription Regulation Development (DNRD). While in ODE IV (formerly the Office of Nonprescription Products), Scott has led several initiatives to modernize the OTC monograph system with respect to quality, biopharmaceutics, and manufacturing process development. Prior to joining ODE IV, Scott served as a Chemistry Reviewer and Team Leader in the Office of Generic Drugs (OGD). He served as Co-Chair of the OGD Impurities Working Group, and as a member of the CDER Drug Substance Technical Committee, the CDER Risk-Based CMC Drug Substance Working Group, the CDER BACPAC-II Working Group, the CDER Chiral Drugs Working Group, and the OGD Polymorphism Working Group. Scott has coauthored a number of peer-reviewed publications relating to Pharmaceutical Solid Polymorphism and Impurities. Before coming to FDA/CDER in 2000, Scott was a NIH Postdoctoral Fellow in the Laboratory of Medicinal Chemistry at the National Institute of Diabetes and Digestive and Kidney Diseases. While at NIH, he worked on the design, synthesis, and pharmacological evaluation of molecules directed at various central and peripheral drug receptors. Scott received his undergraduate degree in chemistry from Virginia Tech and his Ph.D. in synthetic organic chemistry from the University of Georgia. |
| Robert Gaines, PharmD, MBA CDR, USPHS Division Director Division of Regulatory Business Process Management 2 OPRO | OPQ | CDER | FDA |
CDR Robert Gaines is the Division Director for the Division of Regulatory and Business Process Management II within the Office of Pharmaceutical Quality/Office of Program and Regulatory Operations (OPRO). Before joining FDA in 2010, CDR Gaines occupied various pharmacy roles with the Indian Health Service and the Substance Abuse and Mental Health Services. While with FDA, he has worked as a Product Quality Regulatory Project Manager and a Regulatory Project Manager in the Office of Generic Drugs, as a Senior Regulatory Reviewer on the PDUFA user-fee team in the Office of Management, and as the transition Quality Project Management Team Leader during the transition from Office of Pharmaceutical Sciences to the Office of Pharmaceutical Quality. |
| Hanan Ghantous PhD, DABT Supervisory Interdisciplinary Scientist Division of Anti-Viral Products (DAVP) OAP | OND | CDER |
Dr. Ghantous joined the US Food and Drug Administration as a pharmacology/toxicology reviewer in 2001, and since 2007 she has been the Pharmacology/Toxicology supervisor at the Division of Antiviral Products, Center for Drug Evaluation and Research. Before coming to FDA, Dr. Ghantous worked for approximately 10 years at the DuPont Company. She has been a member of the Society of Toxicology since 1989 and the American College of Toxicology since 2000. Dr. Ghantous received a B.Sc. in Pharmacy from the University of Baghdad, Iraq, an M.Sc. in Pharmacology from the University of Strathclyde, Scotland and a PhD in Toxicology from the University of Uppsala, Sweden. She was a postdoctoral fellow in the Department of Anesthesiology, University of Arizona, and received her board certification as a Diplomate of the American Board of Toxicology (DABT) in 1995. Dr. Ghantous has over 20 years of combined experience in general and regulatory toxicology and has published pier reviewed scientific papers and book chapters. |
| Ankit Ghodasara, PharmD Supervisory Pharmacist Division of Filing Review (DFR) ORO | OGD | CDER | FDA |
Ankit is currently a Supervisory Pharmacist in the Division of Filing Review (DFR) within the Office of Regulatory Operations. Previously, he was a Team Leader and a Regulatory Filing Reviewer with DFR. Prior to working at the FDA, he was practicing retail pharmacy and collaborating on patient improvement initiatives in an Outpatient Pharmacy setting with the Johns Hopkins Home Care Group. He received his Doctorate of Pharmacy from Hampton University School of Pharmacy. |
| Krishna Ghosh, PhD Senior Policy Advisor/ SME Division of Inspectional Assessment ,Office of Process and Facilities Office of Pharmaceutical Quality (OPQ), CDER, FDA |
Krishna Ghosh, PhD is a Medicinal Chemist with over 20 years of industry experience in Product Development, Manufacturing /Operation/ Business Management, Quality Assurance, Quality Control and Regulatory Affairs in biotech and pharmaceutical companies. She is the Subject Matter Expert for PET Drug GMP for CDER Office of Compliance. Krishna Ghosh has closely working with various PET facilities with regards to compliance issues associated with Pre-Approval inspections for various ANDA and NDA applications. Krishna has worked closely with firms and regulatory bodies like AAMI and BSI to develop novel regulatory approaches for web based applications, cyber security and cloud computing technologies and currently and is FDA chairperson for a cross center working group in “ Cloud Computing”. She has extensive knowledge of GMP, GLP, GCP and Quality Systems Regulations. She has conducted manufacturing facility audits in Europe, US and Japan and has established FDA compliant manufacturing facilities in Europe and US for API’s, biologics and devices. She served as an advisory member at FDA and NIST from 2001-2003 for Gene Expression Technologies. Krishna was awarded the “AWIS Professional Award” in 2003 for her outstanding work in mentoring scientists and students to transition from academics to industry. She was nominated as a “Distinguished Executive VP of Operations” in 2006 Cambridge’s Who’s Who Directory during her tenure with Genemed Biotechnologies Inc. Krishna assisted several Bay Area Biotech/ Diagnostics/ Pharmaceutical startup companies to build an effective and robust quality & regulatory infrastructure with FDA compliant policies and regulations. |
| Tapash Ghosh, PhD Branch Chief (Acting) Division of Biopharmaceutics ONDP | OPQ | CDER | FDA |
Tapash Ghosh is the acting Branch Chief of the Division of Biopharmaceutics at the Office of New Drug Products (ONDP) under the new Office of Product Quality (OPQ) at CDER/ FDA supporting multiple pre- and post-marketing divisions covering eight therapeutic areas for both new drug and generic drug applications. At his current position, he supervises review activities of a team of primary and secondary reviewers related to various dosage forms and participates in various key regulatory decision making processes. He is the member of various working groups within CDER/FDA. He is also a FDA-USP liaison of the Dosage Form Expert Committee. He is an avid speaker and coordinated short courses/symposiums in various national and international meetings on the regulatory aspects of different dosage forms. Beside a number of publications in different peer reviewed scientific journals, he is the principal editor of three scientific books in the Marcel and Dekker series and fourth one is on its way. |
| Elizabeth Giaquinto, JD and LLM. Regulatory Counsel Office of Generic Drug Policy Office of Generic Drugs (OGD) CDER, FDA |
Elizabeth Giaquinto is a regulatory counsel in the Office of Generic Drug Policy, Office of Generic Drugs (OGD). Before joining OGD in October, 2013, Ms. Giaquinto was a staff member in CDER’s Office of Executive Programs since 2008. Ms. Giaquinto holds JD and LLM. degrees from Seton Hall University School of Law. |
| Francis Godwin Director, Division of Drug Quality 2 (DDQ2) Office of Manufacturing Quality, CDER, FDA |
Francis Godwin received his undergraduate degree from MIT in Chemical Engineering in 2001. After graduation he worked as a process engineer in the chemical industry, designing, building, and optimizing chemical plants. He became certified as a Black Belt in Six Sigma performing quality improvement projects and teaching Six Sigma principals. He moved into pharmaceutical process validation where he worked on both batch and continuous processes for APIs and finished dosage manufacturing. Later he managed an analytical chemistry laboratory directly related with production, QA, and research testing. In 2009 he received an MBA from Georgetown University and since then, has been working at FDA in CDER’s Office of Compliance. He served as a Team Leader dealing with international inspections and enforcement actions, as well as a Branch Chief overseeing Compliance’s reviews related to manufacturing sites named in pending ANDAs. Currently he is the Director of the Division of Drug Quality 2 (DDQ2), in the Office of Manufacturing Quality, overseeing regulatory and enforcement actions for both foreign and domestic drug GMP cases. |
| Jonathan Goldsmith, MD, FACP Associate Director for Rare Diseases in the Office of New Drugs Center for Drug Evaluation and Research |
Dr. Jonathan Goldsmith started his career with FDA in 2005 in the Center for Biologics Evaluation and Research as Deputy Director of the Office of Blood Research and Review. From 2008 to 2014, he was a Deputy Branch Chief of the Division of Blood Diseases and Resources at the National Heart, Lung, and Blood Institute/NIH. In 2014, he returned to FDA, joining the Center for Drug Evaluation and Research as Associate Director of the Rare Diseases Program in the Office of New Drugs. Dr. Goldsmith earned his medical degree from New York University School of Medicine, received post-graduate training in Internal Medicine at Vanderbilt University Hospitals, and completed specialty training in Hematology and Blood Coagulation at the University of North Carolina. Prior to his Federal Service, he had an extensive career in academia as a tenured professor, in regulated industry where he focused on clinical drug development, and with orphan disease foundations. |
| Lillie Golson, PharmD CPT, USPHS Acting Deputy Director Division of Labeling Review (DLR) OGD | CDER | FDA |
Lillie Golson currently serves as Deputy Director of the Division of Labeling Review (DLR) in the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research at the Food and Drug Administration. This division is responsible for the review and approval of labeling for Abbreviated New Drug Applications. CAPT Golson began her career with OGD in 1995 and has held the positions of Labeling Reviewer, Team Leader, and Acting Supervisor. She received her PharmD from the University of Florida and is a Captain in the U.S. Public Health Service Commissioned Corps. |
| Candace Gomez-Broughton, PhD Microbiologist Division of Microbiology Assessment OPQ | OPF | CDER | FDA |
Candace Gomez-Broughton, Ph.D. has been with the FDA for 5 years. She is currently Microbiologist in the Office Pharmaceutical Quality’s Division of Manufacturing Assessment Branch IV. Candace earned her Ph.D. in Microbiology and Immunology from the University of Illinois at Chicago. She received her post-doctoral training at the University of North Carolina Chapel Hill Lineberger Cancer Center and earned her B.S. Degree in Biology from Spelman College in Atlanta, Georgia. |
| Jennifer Goode Policy Analyst Office of Device Evaluation CDRH | FDA |
Jennifer L. Goode currently serves as the Biocompatibility Program Advisor for CDRH’s Office of Device Evaluation (ODE). Ms. Goode has served as a premarket reviewer/biomedical engineer for almost 23 years, with experience reviewing devices and combination products for surgical and interventional treatment of the peripheral vasculature, as well as cardiac monitoring, pacing, neurology and obstetrics and gynecology devices. For the past ten years, Ms. Goode has served as an FDA primary liaison to several ISO Working Groups responsible for the development of international standards for the biocompatibility evaluation of medical devices, including ISO 10993-1 and ISO 10993-4. Since 2008, Ms. Goode has been one of two ODE representatives to the Biocompatibility Standards Task Group (STG) at the Center for Devices and Radiologic Health. This Biocompatibility STG is responsible for coordinating FDA input to, and scientific review and recognition of all biocompatibility standards used by CDRH. Ms. Goode received a Bachelor of Science in Biomedical Engineering from Boston University. |
| Vidya Gopal Consumer Safety Officer Postmarket and Consumer Branch Division of Industry and Consumer Education Office of Communication and Education CDRH | FDA |
Vidya Gopal is a Consumer Safety Officer in the Postmarket and Consumer Branch, Division of Industry and Consumer Education (DICE) in CDRH’s Office of Communication and Education (OCE). Her work consists primarily of helping external stakeholders locate and understand various regulatory resources and requirements established by FDA, with a specialization in quality system regulations (21 CFR 820). Ms. Gopal also currently serves as an FDA instructor for the Association for the Advancement of Medical Instrumentation (AAMI) Quality System Requirements and Industry Practice Course, Design Controls Course and Corrective and Preventive Action (CAPA). In 2012, Ms. Gopal began working in the FDA’s Office of Compliance as a senior reviewer in the cardiovascular devices branch. Prior to her FDA career, Ms. Gopal has over 15 years of experience in FDA-regulated device industry. She was worked as a Research and Development Engineer in Cardiovascular and Women’s Health device companies, primarily responsible for design and clinical trials. Ms. Gopal received a Bachelor Degree in Engineering (Polymer Science) from India, and a Master of Science in Material Science from University of Utah. |
| Brian Hasselbalch Deputy Director (Acting) Office of Policy for Pharmaceutical Quality (OPPQ) | OPQ | CDER |
Brian Hasselbalch is currently acting Deputy Director in CDER OPQ’s Office of Policy for Pharmaceutical Quality. OPPQ is responsible for the development and implementation of regulations, policies, and programs governing the quality ‘lifecycle’–pre-market through commercialization. Mr. Hasselbalch has been with FDA since 1990, when he began his career in FDA’s San Francisco District Office inspecting drug operations there and overseas. He transferred to CDER in 1995 to work on enforcement actions and drug quality policy. |
| Donna Headlee, RN, BSN, CCRP Chief, Premarket Programs Branch Division of Industry and Consumer Education Office of Communication and Education CDRH | FDA |
Donna Headlee is the Premarket Programs Branch Chief, Division of Industry and Consumer Education (DICE), in CDRH’s Office of Communication and Education. In this role, Ms. Headlee leads the branch in the development of medical device industry education on premarket issues and the Small Business Determination (SBD) program. She joined FDA in 2004 as a Consumer Safety Officer with the Office of Compliance (OC), Division of Bioresearch Monitoring in the Special Investigations Branch. In 2009, she joined the Premarket Application Section of the Program Operations Staff, in the Office of Device Evaluation. She joined DICE in February 2016. Prior to her FDA career, Ms. Headlee served as a Research Nurse Coordinator at the National Institute of Health (NIH), with the National Cancer Institute (NCI), where she served as a Research Coordinator for Phase 1 oncology clinical trials. Ms. Headlee received a Bachelor of Science in Nursing from Salisbury State College and a Masters Certificate in Regulatory Compliance from Hood College. |
| Maida Henesian Medical Device Investigator Division 3, Group 4 Office of Regulatory Affairs FDA |
Maida Henesian serves as a medical device investigator in Division 3, Group 4, of the Office of Regulatory Affairs (ORA) Office of Medical Device and Radiological Health Operations. She is stationed in San Francisco, California. Ms. Henesian has been with FDA since 2002 and started performing medical device inspections in 2007. She is a certified Medical Device Investigator and has conducted over 134 medical device inspections, including several high-profile cases resulting in warning letters and other regulatory actions. She has also performed several foreign inspections since 2013 as a member of ORA’s Medical Device Foreign Inspection Cadre. She received a Bachelor of Science degree in Pharmacy and Master of Science degree in Health Service Administration. |
| Don Henry Associate Director for Business Operations (acting) Office of Programs and Regulatory Operations (OPRO) OPQ | CDER | FDA |
Don is the acting Associate Director for Business Operations in the Office of Programs and Regulatory Operations (OPRO). He joined the Agency in 2008 as a Project Manager in the Office of New Drug Quality Assessment (now part of OPQ). Prior to joining the FDA, Don gained experienced working in industry managing validation and process development and scale-up. Don has a BS in Mechanical Engineering at the University of Delaware. |
| Thomas Hinchliffe, PharmD CDR, USPHS Immediate Office Generic Drug Regulatory Affairs Team OGD | CDER |FDA |
CDR Thomas Hinchliffe currently serves as a Regulatory Affairs Coordinator on the Office of Generic Drugs Immediate Office Generic Drug Regulatory Affairs Team, working closely with leadership teams on ad hoc and long-term projects, providing oversight and outreach, strategic liaison, and integration of cross-OGD and cross-Center regulatory programs and initiatives. Prior to this, CDR Hinchliffe served as a special assistant to the OGD Director, leading the initial implementation efforts in OGD for the various changes required as a result of the Generic User Fee Amendment of 2012 (GDUFA). From 2002 to 2012, CDR Hinchliffe served as a ANDA/Chemistry Project Manager in the OGD Review Support Branch. CDR Hinchliffe obtained his Doctor of Pharmacy degree from the University of Pittsburgh, College of Pharmacy. |
| Puii Huber Technical Information Specialist DRLS Staff OC | CDER |FDA |
Lalnunpuii (Puii) Huber began her career with the FDA in 2006 as a contractor where she worked on various projects such as DAARTS, DRLS, development of eDRLS, eSubmitter, eSubmitter ICSR and User Fee Facility Data Management systems. In 2012, she accepted a position as a Technical Information Specialist for eDRLS, CDER/Office of Compliance. |
| Minerva Hughes, PhD, RAC Branch Chief (acting) Division of Regulations, Guidances, and Standards Office of Policy for Pharmaceutical Quality (OPPQ) |
Dr. Minerva Hughes currently serves as acting Branch Chief of the Policy Development and Evaluation Branch I in the Office of Policy for Pharmaceutical Quality (OPPQ) within the Center for Drug Evaluation and Research’s new Office of Pharmaceutical Quality (OPQ). Before joining OPPQ, Dr. Hughes was a Senior Scientist in the former Office of New Drug Quality Assessment were she performed in depth science and risk-based evaluations of the chemistry, manufacturing and controls (CMC) and biopharmaceutics information in regulatory submissions and engaged in a number of research and policy development initiatives for improving pharmaceutical quality standards. She received her B.A. in Chemistry from Georgia Southern University and her PhD in Chemistry from The Johns Hopkins University.. |
| Tasneem Hussain, PharmD Pharmacist DRLS Staff OC | CDER | FDA |
Dr. Hussain joined FDA in 2016. Previously she has worked as a Staff Pharmacist, Immunizer, MTM Coordinator, and Pharmacy Technician. She has a PharmD degree from Howard University |
| Robert Iser, MS Acting Director Office of Process and Facilities OPQ, CDER, FDA |
Bob joined the FDA in 2003. He is currently the acting Director of the Office of Process & Facilities (OPF), a part of the new Office of Pharmaceutical Quality (OPQ). Prior to the formation of OPQ, Bob was acting Associate Director for Policy Development in the Office of Pharmaceutical Science. He was also a Division Director and CMC Team Leader in the Office of Generic Drugs. Prior to joining the FDA, Bob spent seven years in the pharmaceutical industry with industrial experience related to management of quality systems, analytical method development, and support of manufacturing process development, scale-up and validation. |
| Faranak Jamali, M.D. Medical Officer, Compliance Enforcement Branch Division of Enforcement and Postmarketing Safety (DEPS) Office of Scientific Investigations (OSI) Office of Compliance (OC) | CDER | FDA |
Dr. Jamali is a medical officer at the Division of Enforcement and Postmarketing Safety (DEPS), Compliance Enforcement Branch (CEB), within the Office of Scientific Investigations (OSI), Office of Compliance, Center for Drug Evaluation and Research. She has been involved with review of inspection reports related to sponsors and clinical investigators as part of bioresearch monitoring (BIMO) Good Clinical Practice Compliance (GCP) program for the last 8 years. Dr. Jamali’s role is to assess data reliability and human subject protection of CDER-regulated clinical studies. Previously, she served as a clinical reviewer in the Office of New Drugs, Office of Oncology Drug Products, focusing on the hematology products. Dr. Jamali is an anatomic and clinical pathologist by training, She completed fellowships in hematopathology at Georgetown University and transfusion medicine at Johns Hopkins. |
| Kumar Janoria, PhD Chemist Division of Process Assessment – III | OPF OPQ | CDER | FDA |
Dr. Janoria received his Ph.D. in Pharmaceutical Sciences in 2008 from the University of Missouri-Kansas City. Prior to joining FDA, Dr. Janoria has worked in Pharmaceutical industries primarily in the development of parenteral products. At Office of Process and Facilities his work involves assessing the adequacy of pharmaceutical manufacturing process from its development to scale-up. He has reviewed several new, generic and investigational drug applications employing lyophilization process. |
| Edwin Jao, Ph.D. Division director (acting) Division of Inspectional Assessment III OPF | OPQ | CDER | FDA |
Edwin Jao is currently the division director (acting) for FDA/CDER/OPQ/OPF/DPAIII, overseeing process and facility reviews for ANDAs, NDAs, and IND meeting packages. Edwin joined the FDA in 2003 as a CMC reviewer, after a successful career in major pharmaceutical industry. Edwin received his Ph.D. degree in medicinal chemistry from Rutgers University. |
| Wenlei Jiang, PhD Deputy Director (Acting) Office of Research and Standards OGD, CDER, FDA |
Dr. Wenlei Jiang is the Acting Deputy Director of the Office of Research and Standards in the Office of Generic Drugs. She provides oversight on Generic Drug User Fee Act (GDUFA) regulatory science research activities to help develop ANDA review standards and ensure the therapeutic equivalence of generic drug products. She has been mainly responsible for developing bioequivalence standards of generic complex drug products such as liposomes and nano drug products, revising ANDA review policy of narrow therapeutic index drugs, and initiating post-market generic drug research including generic substitution studies in patient populations, generic drug surveillance method development, and patient perception about generic drug usage. Previously, Dr. Jiang worked in the Division of Chemistry, OGD to review the chemistry and manufacturing control (CMC) sections of ANDAs. Prior to joining FDA, she was at Novartis Pharmaceutical Corporation where her responsibilities included formulation development of conventional liquid and solid dosage forms, as well as parenteral drug delivery systems. She received her PhD in Pharmaceutics and Pharmaceutical Chemistry from The Ohio State University in 2001. |
| Xiaojian Jiang, PhD Deputy Director Office of Bioequivalence OGD | CDER | FDA |
Dr. Xiaojian Jiang is currently the Deputy Director for the Division of Bioequivalence II, Office of Bioequivalence. The Division of Bioequivalence is responsible for the review of bioequivalence studies (with pharmacokinetic endpoint) submitted to support approved of ANDAs. Dr. Xiaojian Jiang received her Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore. She joined the Division of Bioequivalence in 2003 as a pharmacologist reviewer. In 2009, she was promoted to Team Leader. During her tenure in the FDA, Dr. Jiang made significant contributions to the approval and regulation of generic locally acting GI drug products, including vancomycin, mesalamine and orlistat. She is the principle investigator on a CDER RSR project, and is an active member on multiple FDA committees and working groups. Over the past 13 years, she has received numerous awards and honors from CDER and FDA for her dedication and accomplishment as a scientist, reviewer, and leader. She has presented and published on a range of complex regulatory, scientific issues including BE approaches for locally acting drug products, highly variable drug products, in vitro dissolution testing, and in vitro BE approaches for nasal spray products. |
| Connie T. Jung, RPh, PhD Senior Advisor for Policy Office of Drug Security, Integrity, & Response (ODSIR) Office of Compliance, CDER, FDA |
Dr. Jung is currently Senior Advisor for Policy in the Office of Drug Security, Integrity, and Recalls in FDA’s Center for Drug Evaluation and Research, Office of Compliance. Her work focuses on development of policy and regulatory strategies to improve the security and integrity of the U.S. drug supply. She received her BS in Pharmacy from The Ohio State University and her Ph. D. in Pharmaceutical Sciences from the University of Cincinnati. Dr. Jung joined the FDA in 1999 as a researcher in the Center for Food Safety and Applied Nutrition, conducting toxicology research involving skin absorption and metabolism of topically applied compounds, and later served as a Regulatory Reviewer in the Division of Bioequivalence in the Office of Generic Drugs where she analyzed bioequivalence studies of generic products before working on supply chain issues. |
| Soma Kalb, PhD Director, Investigational Device Exemption Program Clinical Trials Program Office of Device Evaluation CDRH | FDA |
Dr. Soma Kalb is the Director of the Investigational Device Exemption (IDE) Program in the Office of Device Evaluation’s (ODE) Clinical Trials Program in the Center for Devices and Radiological Health (CDRH), a position she has held since 2013. As part of the Clinical Trials Program, she oversees the operations of the IDE and Q-submissions programs in ODE and engages in analysis, development and implementation of regulatory policies for medical device clinical trials. Dr. Kalb started her career at FDA in 2005, sharing her time between the Office of Science and Engineering Laboratories (OSEL) and the Office of Surveillance and Biometrics (OSB). In OSEL, she conducted research to support CDRH’s regulatory mission in the area of cardiac electrophysiology. In OSB, she served as an analyst in the Division of Postmarket Surveillance in the area of cardiac rhythm devices, such as implantable defibrillators. In 2007, she transitioned to ODE, where she served as a premarket reviewer in the Division of Cardiovascular Devices, leading reviews in several program areas (PMAs, IDEs, 510(k)s, and Pre-submissions) for implantable electrophysiology devices. Dr. Kalb received a Bachelor of Science in Electrical Engineering at the University of Maryland, a Master of Science in Biomedical Engineering from the Johns Hopkins University, and a Ph.D. in Biomedical Engineering from Duke University. |
| Alyson Karesh, MD Pediatric Team Leader Division of Pediatric and Maternal Health Office of New Drugs (OND), CDER, FDA |
Dr. Alyson Karesh is a Pediatric Team Leader in the Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research (CDER) at the FDA. Dr. Karesh and her team provide scientific and regulatory advice regarding the development of drugs and biologic products in the pediatric population to FDA review divisions, pharmaceutical companies, and other agencies. Dr. Karesh received her medical degree from Medical College of Virginia and completed her pediatric residency at Children’s Hospital of Pittsburgh. |
| John Kauffman, PhD Division of Pharmaceutical Analysis (DPA) Office of Testing and Research (OTR) OPQ | CDER | FDA |
Dr. John Kauffman is currently the Acting Director of the FDA Division of Pharmaceutical Analysis, a CDER laboratory responsible for supporting application review, investigation and enforcement actions, and research to advance the application of new technologies in regulatory science. From 1991 to 2004, Dr. Kauffman served as Professor of Analytical and Physical Chemistry at the University of Missouri, Columbia. He joined the FDA in 2004 to evaluate applications of process analytical technologies to pharmaceutical manufacturing. His research interests include applications of chemometrics and vibrational spectroscopy to pharmaceutical analysis, quality by design for analytical methods, rapid screening technologies for pharmaceutical surveillance and analysis of elemental impurities in pharmaceuticals. He is currently the Rapporteur of the Implementation Working Group for ICH Q3D: Guideline on Elemental Impurities. |
| Savan Khanna, PharmD Quality Assessment Lead (Acting) Office of Program and Regulatory Operations(OPRO) OPQ | CDER | FDA |
Savan Khanna is currently Acting Quality Assessment Lead in Office of Program and Regulatory Operations. He has been with FDA for four years where he started his career as Regulatory Business Process Manager (formally known as Chemistry Project Manager in Office of Generic Drugs). In his current role, he is responsible for managing review team activities including organizing meetings, tracking the review process, and acting as a liaison for quality related issues. Prior to joining FDA, Savan worked as a pharmacy manager for five year in retail. Savan received his Doctor of Pharmacy degree from University of Maryland School of Pharmacy. |
| Akm Khairuzzaman, PhD Branch Chief (Acting) Branch I, Division I, OPF | OPQ | CDER |
Dr. Khairuzzaman is a Branch Chief at FDA’s Office of Office of Pharmaceutical Quality, CDER, where he leads a group of review scientist responsible for assessment of chemistry, manufacturing, controls (CMC) for investigational new drug applications (IND), new drug application (NDA), and abbreviated new drug application (ANDA) seeking approval in US market. Prior joining to FDA as a Fellow in the year of 2008, Dr. Khairuzzaman worked for Barr Pharmaceuticals Inc. (currently owned by TEVA) for seven (7) years as a Scientist and Research Investigator in its research and development group. Dr. Khairuzzaman has published eight (8) scientific papers in internationally renowned peer review journal, presented eleven (11) abstracts at international science meetings (AAPS and CRS) and was an invited speaker by many institutions notably, the National Institute of Health (NIH), the United States of Pharmacopeia (USP), International Society for Pharmaceutical Engineering (ISPE), International Forum for Process Analytical Chemistry (IFPAC) and US universities. Dr. Khairuzzaman has a bachelor degree (B.S.) in Pharmacy. His graduate degrees, M.S. in Industrial Pharmacy and Ph.D. in Pharmaceutics are from Long Island University, New York, USA. |
| Rachel Brown Kichline, B.S. Enhanced Communication Team Leader Immediate Office OND | CDER | FDA |
Rachel Brown Kichline has been the leader of the Office of New Drug’s Enhanced Communication Team since it’s begining in 2012. The team is under the OND Immediate Office Regulatory Affairs Team. It was developed as part of the PDUFA V implementations. |
| Craig Kiester, RPh, MS, RAC Commander, United States Public Health Service Branch Chief (acting) Regulatory and Business Process Management I, Branch II Office of Program and Regulatory Operations (OPRO) OPQ, CDER, FDA |
CDR Craig Kiester is a graduate of Duquesne University, with a Bachelor of Science in Pharmacy and a Master of Science in Health Science from Trident University. Prior to joining the FDA, he worked in home infusion pharmacy, most recently as an Operations Manager. He started his career with the United States Public Health Service when he came to the Office of Generic Drugs as a Chemistry Project Manager. In addition, he has held positions as a Regulatory Review officer and a Microbiology Project Manager within the Office of Generic Drugs. Currently he is an Acting Branch Chief in the Office of Product Quality, for the project management staff responsible for the review of the quality portion of original ANDA’s. |
| Carol Kim, PharmD Acting Team leader in ANDA Team Division of Clinical Review Office of Bioequivalence (OB) | OGD | CDER |
Dr. Carol Kim is ANDA team acting team leader in the Division of Clinical Review in the Office of Bioequivalence in OGD. Her area of expertise is in the review of clinical endpoint bioequivalence study for ANDAs for which standard pharmacokinetic studies are not appropriate for evaluating bioequivalence. She received her Pharm.D. degree at Howard University College of Pharmacy and Pharmacal Sciences in Washington DC |
| Dawn Kimble-Vance, RPh, PN Regulatory Project Manager Division of Project Management ORO | OGD | CDER |
Dawn Kimble-Vance is a Pharmacist and Practical Nurse by training. She joined CDER’s Offic of Generic Drugs in October 2014. She has 20+ years in industry leading all aspects of Global R&D: concept and formulation development, process scale up, manufacturing and launch activities. Partnered with marketing and supply groups to effectively design and launch health care & beauty products. She has Launched over 80 products globally, helped develop 10 new brands and obtained 3 US / International patents. Dawn has also managed the development and launch process within OTC drugs: formulator then moved to process scale up and manufacturing. In the past, she has launched acceptable and compliant products with the FDA, EMA, Japan’s PMDA and China FDA regulations. Involved in FDA audits of manufacturing facilities and R&D centers. |
| Maarika Kimbrell, JD, MS Director Division of Legal and Regulatory Support Office of Generic Drug Policy OGD | CDER | FDA |
Maarika Kimbrell currently serves as the Director of the Division of Legal and Regulatory Support within the Office of Generic Drug Policy and has held other positions within the Office of Generic Drug Policy. Prior to joining FDA, Maarika practiced for over a decade as an attorney in private practice with a focus on intellectual property licensing and other corporate transactions on behalf of clients in the life sciences industry both at Covington & Burling LLP in Washington DC and Morrison & Foerster LLP in San Francisco, CA. Maarika earned her J.D. from Yale Law School in 2003 and a Master of Science in genetics from Yale University in 2000. Maarika earned her B.A. in Molecular Biology and Biochemistry from Rutgers, the State University of New Jersey in 1998. |
| Kimberly Kontson, Ph.D. Biomedical Research Fellow Human-Device Interaction Laboratory Division of Biomedical Physics Office of Science and Engineering Laboratories CDRH | FDA |
Kimberly L. Kontson received her B.S. from the Pennsylvania State University, State College, PA and Ph.D. from the University of Maryland, College Park, MD in Biomedical Engineering. She is currently a Biomedical Research Engineer with the U.S. Food and Drug Administration’s Center for Devices and Radiological Health, Office of Science and Engineering laboratories, and also serves as a regulatory consultant to the Office of Device Evaluation Human Factors Premarket Review Team. Her current research interests include clinical outcome assessment development for advanced prosthetics, population variability of noninvasive electrophysiological measurements, and the potential role of “big” data in medical device evaluation. |
| Michael Kopcha, PhD, RPh Director, Office of Pharmaceutical Quality (OPQ) CDER, FDA |
Michael Kopcha is a leader in the development of innovative solutions to resolve scientific, manufacturing, and commercialization issues worldwide – and in standardizing and harmonizing global processes. With more than 25 years of pharmaceutical industry experience, his areas of expertise include formulation and process development, process validation, technology transfer, off-shoring/outsourcing, and change management. Dr. Kopcha recently served as vice president, and global research and development franchise head, for cough, cold, and respiratory products at Novartis Consumer Health, Inc. in New Jersey. |
| Mary Kremzner, PharmD, MPH CAPT, USPHS Director of Division of Drug Information Office of Communications CDER, FDA |
CAPT Kremzner is the Division Director, in the Food and Drug Administration’s (FDA), Center for Drug Evaluation and Research (CDER), Division of Drug Information. CAPT Kremzner leads a team of pharmacists and Consumer Safety Officers responsible for the Center’s Small Business Program, Trade Press Staff, and also serves as a focal point for a broad range of stakeholders, including regulated industry, academia, consumers, health care professionals, and others for education and outreach using traditional and social media channels. CAPT Kremzner received her degrees from the University of Maryland, School of Pharmacy and Morgan State |
| Sarah Kurtz, PharmD Senior Advisor Office of Regulatory Operations (ORO) | OGD CDER | FDA |
Sarah Kurtz currently serves as a senior advisor within the Office of Regulatory Operations. She began her career at the FDA as a Labeling Reviewer and then served as a Supervisor in the Division of Labeling Review within the Office of Regulatory Operations. The division is responsible for the evaluation and approval of labeling for Abbreviated New Drug Applications. She received her Doctor of Pharmacy degree and Certificate in Aging Studies from Virginia Commonwealth University School of Pharmacy. |
| Renu Lal, PharmD Division of Drug Information Office of Communications CDER, FDA |
Renu Lal joined the Food and Drug Administration in October 2002, where she has worked for the Division of Drug Information (DDI) in CDER’s Office of Communications. In DDI, Renu is also part of the Small Business Assistance Program. She is responsible for answering questions from the public regarding a wide range of topics, from drug safety to drug development. She also is active in maintaining and developing the Small Business Assistance Program, along with increasing its visibility and outreach. In addition to her time at FDA, Renu has spent time in industry, retail pharmacy, and hospital pharmacy. Renu received her Doctor of Pharmacy from the Medical University of South Carolina, and her Bachelor’s degree in Pharmacy from the University of Connecticut. |
| Kristina Lauritsen, PhD Product Jurisdiction Officer CDER, FDA |
Kristina Lauritsen, PhD is a Product Jurisdiction Officer in the FDA Center for Drug Evaluation and Research. In this role, she serves as CDER’s expert in matters related to intercenter product jurisdiction and works, as liaison to the Office of Combination Products and in consult with CDER new drug review staff,and the CDER Office of Compliance, to establish the regulatory identity of products as drugs, biologics, devices, or combination products, and to determine which FDA Center is most appropriate for reviewing a combination product. Prior to joining CDER in 2014, Dr. Lauritsen spent the previous seven years as a regulatory health scientist in the FDA’s Office of Combination Products, which resides in FDA’s Office of Medical Products and Tobacco. Her primary focus in OCP was in providing scientific input on matters of product classification (drug, device, biologic, or combination product), product assignment, and associated regulatory policy. She received her PhD from Georgetown University (tumor biology) and her BS from Shippensburg University (biology). Dr. Lauritsen has over 10 years of experience in regulatory science, having originally joined the FDA in 2003 as a premarket reviewer in the Center for Devices and Radiological Health, Office of Device Evaluation. |
| Julia Lee, PharmD Deputy Director Division of Filing Review ORO | OGD | CDER |FDA |
Dr. Julia Lee is the Deputy Director in the Division of Filing Review. She joined the Office of Generic Drugs in 2012 as a regulatory filing reviewer. Prior to working at the Agency, she was a retail pharmacist at Walgreens. She has also worked in the Chesapeake-Atlantic node of the Pediatric Emergency Care Applied Research Network as a clinical research assistant. She received her Doctorate of Pharmacy at the University of Maryland, Baltimore, School of Pharmacy and her Bachelor of Science in Chemistry at The George Washington University. |
| Sau (Larry) Lee, PhD Associate Director for Science Team Leader for Botanical Review Team Chair for OPQ Emerging Technology Team Immediate Office OPQ | CDER | FDA |
Sau (Larry) Lee is a Senior Biomedical Research Scientist (SBRS) and serves as the Associate Director for Science of the Office of Pharmaceutical Quality (OPQ), the Team Leader of the OPQ Botanical Review Team, and the chair of the OPQ Emerging Technology Team. Larry and his OPQ Scientific and Research Staff are leading the effort in advancing OPQ research and in manufacturing science, complex drug substances and products containing nanomaterials, as well as in developing the regulatory policy, scientific standards as well as computational and modeling tools supporting quality review and inspection in OPQ. Larry joined the Office of Generic Drugs (OGD) in 2005 as a chemical engineer. In 2012 – 2013, Larry was the peptide team leader which specializes in CMC reviews of ANDAs for complex drug substances and products, including inhalation products. As a member of the Office of Pharmaceutical Quality (OPQ) TAG Integrated Team-based Review Pilot, Larry led a team to evaluate OPQ’s vision for a team-based product and process/facility quality assessment approach. He also co-led the Risk Based Review Pilot which aimed to increase the review quality and efficiency of injectable products. In early 2013, Larry was promoted to Expert Regulatory Scientist in recognition of his expertise in evaluation of complex drug substances and products. Larry received a B.S. degree in Chemical Engineering from the University of Virginia with a minor in Materials Science and a Ph.D. in Chemical Engineering from Princeton University. |
| Benjamin Lim, PhD Acting Branch Chief Office of Lifecycle API Office on New Drug Product (ONDP) OPQ | CDER | FDA |
Benjamin Lim, Ph.D. is currently an acting branch chief in the Division of Lifecycle API in ONDP. He has been an ANDA reviewer in the former OGD before the OPQ reorganization. He received his PhD from University of Maryland Baltimore County (UMBC). |
| Robert Lionberger, PhD Director of the Office of Research and Standards Office of Generic Drugs |
Robert Lionberger, PhD serves as Director of the Office of Research and Standards within the Office of Generic Drugs. In this role, Dr. Lionberger leads OGD’s implementation of the GDUFA regulatory science commitments including internal research activities and external research grants and collaborations to ensure the therapeutic equivalence of generic drug products. In his 10 years as member of the OGD Science Staff, his accomplishments include the development of bioequivalence methods for complex and locally acting drugs, mathematical modeling of drug dissolution and absorption, and incorporation of pharmaceutical development information into the ANDA review process. He received his undergraduate degree from Stanford University in Chemical Engineering, and a PhD from Princeton University in Chemical Engineering, working on modeling the rheology of colloidal suspensions. After his PhD, he spent two years of post-doctoral research in Australia in the Department of Mathematics and Statistics at the University of Melbourne. Prior to joining the FDA, he was an Assistant Professor of Chemical Engineering at the University of Michigan. |
| Elaine Lippmann, JD Senior Regulatory Counsel Office of Regulatory Policy (ORP) | CDER |
Elaine Lippmann, J.D., serves as Regulatory Counsel in the Office of Regulatory Policy in FDA’s Center for Drug Evaluation and Research. Ms. Lippmann provides oversight and leadership in the development of regulations, policies, procedures and guidances that affect the drug approval process, and in the development of new legislation. Prior to joining the FDA in 2011, Ms. Lippmann was an attorney at Spiegel & McDiarmid, a law firm that represents municipalities in administrative law and regulatory matters. |
| Stanley Liu Consumer Safety Officer Premarket Programs Branch Division of Industry and Consumer Education Office of Communication and Education CDRH | FDA |
Stanley Liu is a Consumer Safety Officer in the Premarket Programs Branch, Division of Industry and Consumer Education (DICE), in CDRH’s Office of Communication and Education. During his 8-year FDA career, he has provided education and regulatory assistance to both industry and consumer stakeholders, with a specialization in design controls and premarket clinical study regulations. Mr. Liu has 13 years of prior experience in FDA-regulated corporate industry, having worked in Quality Assurance/Regulatory Affairs for both pharmaceutical and medical device companies. Mr. Liu received a Bachelor of Arts in History and Bachelor of Science Degree from Purdue University, and attended Indiana University School of Medicine. |
| Paul Loebach Director Drug Registration and Listing Staff Division of Industry and Consumer Education Office of Compliance CDER | FDA |
Paul Loebach serves as the Director for the Drug Registration and Listing Staff. He has over 25 years’ experience with FDA, specifically with Drug Registration and Listing. He holds a bachelors degree in Mathematics from the University of Maryland Baltimore County and a Certificate of Public health from Georgetown University. |
| Rik Lostritto, PhD Deputy Director Office of New Drug Quality Assessment CDER |
Richard (Rik) Lostritto, PhD, joined the FDA in 1995 and currently serves as Acting Deputy Office Director for Science & Policy and Acting Biopharmaceutics Lead in the Office of New Drug Quality Assessment (ONDQA). Previously, Rik served as Director, Division-I which includes CMC (chemistry, manufacturing, and controls) responsibility for oncology, hematology, cardio-renal, neurology, and psychiatric drug products. He had also served as CMC Team Leader successively collocated in the Divisions of Oncology Drug Products and Pulmonary and Allergy Drug Products. Before joining the Agency, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group which developed medical aerosol formulations after serving as Assistant / Associate Professor of Pharmacy at The University of Connecticut (1983-1992). He received his M.S. and PhD Degrees in Pharmaceutical Chemistry and Pharmaceutics from the University of Michigan and his BS Degree in Pharmacy from The University of Connecticut. |
| Damaris Maldonado, BS Drug Product Quality Reviewer Office of Lifecycle Drug Products OPQ, CDER, FDA |
Damaris Maldonado joined the Agency in 2000 as a Review Chemist in the Office of Generic Drugs after 15 years of manufacturing experience in Boehringer Mannheim and Johnson & Johnson. She has served as Team Leader as well as an active member of FDA initiatives related to Risk Assessment and Surveillance. She is a Certified Quality Engineer and Quality Auditor and holds a BS in Chemistry from the University of Puerto Rico. |
| Elias Mallis Director Division of Industry and Consumer Education Office of Communication and Education CDRH | FDA |
Elias Mallis is the Director of the Division of Industry and Consumer Education in CDRH’s Office of Communication and Education, a position he has held since August 2011. In this role, Mr. Mallis leads a division whose mission is to educate our industry and consumer stakeholders with understandable and accessible science-based regulatory information about medical devices and radiation-emitting electronic products. Mr. Mallis began his 23-year FDA career in 1994 in CDRH’s Office of Device Evaluation where he conducted regulatory review and developed policy for a diverse range of medical device programs, such as 510(k)s, IDEs, PMAs and HDEs. As as the Lead Electrical Engineer in the Gastroenterology and Renal Devices Branch, he reviewed medical products in the fields of hemodialysis, extracorporeal therapeutics, gastric motility and incontinence, and endometrial ablation. As Branch Chief of the Cardiac Electrophysiology and Monitoring Branch, responsible for cardiovascular disciplines such as cardiac ablation for treatment of atrial fibrillation and implanted heart failure diagnostics. Mr. Mallis also served in the ODE Front Office as a Policy Analyst where he contributed to various policy efforts such as the 510(k) Program Guidance and Pivotal Clinical Studies Guidance, device reclassifications and de novo requests. Mr. Mallis received a Bachelor of Science in Electrical Engineering at the University of Maryland at College Park. |
| David Mazyck Office of Compliance CDER | FDA |
David Mazyck has over 20 years of government regulatory experience. He is a Consumer Safety Officer with the Food and Drug Administration’s Office of Compliance, having worked for the FDA for over 11 years in the registration and listing compliance program. Prior to joining the FDA, he served as the Senior Task Leader for Zimmerman Associates on the Drug Registration Listing System government contract, and as the Insurance Billing Manager for Midlands Oncology Associates. Mr. Mazyck is a graduate of the University of South Carolina, where he earned a Bachelor of Science degree in Biology. |
| Mavis Mbi, PharmD, RPh Filing Reviewer Division of Filing Review (DFR) ORO | OGD CDER | FDA |
Dr. Mavis Mbi currently serves as a control correspondence reviewer in the Division of Filing Review (DFR) within the Office of Regulatory Operations (ORO). Prior to this role, Dr. Mbi served as a primary filing reviewer in DFR for 2 years, and served as a filing review specialist working on complex filing reviews. Dr. Mbi obtained her B.S in Medicinal Chemistry from Towson University in 2006, and her Doctor of Pharmacy from the University of Maryland in 2008. Prior to joining the FDA in 2014, Dr. Mbi worked in the community pharmacy as the pharmacist in charge responsible for dispensing medications, providing pharmaceutical care, and running the managerial affairs of the pharmacy. |
| Jean E. McCue Senior Regulatory Advisor Division of Imports, Exports, and Recalls Office of Drug Security, Integrity and Response (ODSIR) Office of Compliance CDER | FDA |
Jean McCue is a Senior Regulatory Advisor in the Division of Imports, Exports, and Recalls in FDA’s Center for Drug Evaluation and Research, Office of Compliance, Office of Drug Security, Integrity and Response. Ms. McCue’s work focuses on a wide range of policy and compliance issues concerning drug imports and exports. Prior to joining FDA, Ms. McCue was an attorney in private practice where she counseled clients on compliance with FDA, Federal Trade Commission, and Consumer Product Safety Commission regulatory requirements. Ms. McCue received a B.A., summa cum laude, from the University of Notre Dame, and a J.D. from the University of Virginia School of Law. |
| Marissa McNall, PharmD Controlled Correspondence Coordinator Office of Regulatory Operations Office of Generic Drugs (OGD) CDER, FDA |
Marissa McNall has been with the Office of Generic Drugs since 2014. She started in the Immediate Office, Communication Staff and is currently in the Office of Regulatory Operations, Immediate Office as a Controlled Correspondence Coordinator for OGD. She assures that controlled correspondences are routed to the appropriate office for review. Marissa has a Bachelor of Arts degree in Psychology and a Doctor of Pharmacy degree. |
| Lubna Merchant, PharMD Associate Director Division of Medication Error Prevention and Analysis (DMEPA) CDER, FDA |
Dr. Merchant currently serves as the Associate Director for the Division of Medication Error Prevention and Analysis (DMEPA). Dr. Merchant has worked in DMEPA since 2010. In her capacity as the Associate Director for DMEPA, she serves as expert/scientific advisor on medication errors associated with drug and biological products within the Office of Surveillance and Epidemiology, and other offices within the Center and outside agencies. Dr. Merchant provides support and technical expertise on safety recommendations regarding drug nomenclature, labels, labeling, packaging, and product design. As the Associate Director, she assists in the development of standards; processes, good pRACtices and analytic tools to foster a high quality science-based program to assess medication error related questions. She works with external stakeholders, regulators, and researchers to better understand the causes of errors and the effectiveness of interventions at preventing errors, and provides guidance to industry on drug development considerations from a medication errors perspective. Dr. Merchant graduated from Massachusetts College of Pharmacy and Health Sciences with Master of Science in Industrial Pharmacy and Doctorate of Pharmacy and completed a PGY1 Pharmacy PRACtice Residency. She has worked in a variety of health care settings including retail pharmacy, Industry and hospital pharmacy as an inpatient pharmacist and as clinical specialist. |
| John Metcalfe, PhD Senior Microbiology Reviewer Office of Pharmaceutical Science (OPS) CDER, FDA |
Dr. John Metcalfe holds a BA in biology from Merrimack College in Andover, MA, and a PhD in microbiology from the University of Rhode Island. John spent 14 years teaching college microbiology courses prior to beginning a career in CDER in 2003. At FDA, John works as a microbiologist where he performs a review of both sterile and non-sterile drug products providing an assessment of microbiological quality. He is an FDA Liaison to the USP Expert Committee on Pharmacy Compounding, and is a published author in the area of drug product microbiological quality. |
| Kristen Miller, PharmD Health Science Policy Analyst Office of Medical Policy (OMP) CDER | FDA |
Kristen Miller helps to lead FDA’s activities with Clinical Trials Transformation Initiative (CTTI), a public private partnership between FDA and Duke University that identifies and promotes practices to increase the quality and efficiency of clinical trials. She joined the FDA in 2002, and prior to her work with CTTI in the Office of Medical Policy, she worked on postmarketing safety activities under FDAAA and FDASIA, specifically Risk Evaluation and Mitigation Strategies (REMS). A pharmacist by training, Kristen received her PharmD from the University of Pittsburgh. |
| Judit Milstein Chief, Project Management Staff Division of Transplant and Ophthalmology Products Office of Antimicrobial Products CDER | FDA |
Ms. Judit Milstein was born and raised in Buenos Aires, Argentina, where she received her Degree in organic chemistry (Licensed) from the University of Buenos Aires. Judit immigrated to the United States in 1985 and became a US Citizen in 1986.Ms. Milstein joined the Center for Drug Evaluation and Research as a consumer safety officer in 1999 in the Division of Anesthetic, Critical Care and Addiction Drug Products. She joined the Division of Anti-Infective Drug Products in 2001 as a Regulatory Health Project Manager and she became a supervisor in the Division of Special Pathogen and Transplant Products in 2005, currently named Division of Transplant and Ophthalmology Products. |
| Alicia Mozzachio Acting Division Director, Office of Policy for Pharmaceutical Quality (OPPQ) OPQ, CDER, FDA |
Alicia has been with the FDA for 20 years in various job roles (investigator and compliance officer) and locations. She began her career as a junior level investigator with FDA shortly after graduating from Temple University School of Pharmacy in Philadelphia, PA. Alicia distinguished herself as a Drug Specialist within her organization before accepting a new position with CDER’s then known Foreign Inspection Team. In addition to her FDA roles and responsibilities, Alicia has deployed with the Public Health Service (PHS) to provide aid to victims impacted by disasters. |
| Charu Mullick, MD Senior Medical Officer Division of Anti-Viral Products (DAVP) OAP | OND | CDER | FDA |
Charu Mullick is a Senior Medical Officer in the Division of Antiviral Products, CDER at the Food and Drug Administration. She is a physician trained in Infectious Diseases and has worked at the FDA for 10 years. She provides expertise in all phases of antiviral clinical drug development and is responsible for the development of new products for the treatment and prevention of HIV infection, Ebola and Marburg infections, hepatitis B and C, influenza, and various herpes infections. She is actively involved with preparation of FDA regulatory guidance for industry related to developing antiviral drugs for various infections. She also serves in committees in CDER as well as with external stakeholders including other US government agencies. |
| Utpal Munshi, PhD Deputy Director Division of Bioequivalence 1 Office of Bioequivalence | OGD CDER | FDA |
Utpal M. Munshi, Ph.D., is the Deputy Director of the Division of Bioequivalence I in the Office of Bioequivalence, Office of Generic Drugs. He is responsible for providing technical and administrative oversight in the assessment of the bioequivalence section of Abbreviated New Drug Applications in the Division. Dr. Munshi received his Ph.D. in Biological Chemistry from the University of Michigan and then undertook post-doctoral training at the National Cancer Institute in Frederick in the field of virology before joining the Division in 2007. During his time in DBI, Dr. Munshi has had roles ranging from primary assessor to Acting Associate Director. He has been active in the development of Agency guidances and has been involved in numerous working groups. Dr. Munshi has received awards for his work at the Agency. |
| Eileen Navarro Medical Team Leader Division of Anti-Infective Products Office of Antimicrobial Products, Office of New Drugs, CDER, FDA |
Eileen Navarro Is a Medical Team Leader in the Division of Anti-Infective Products, Office of Antimicrobial Products, OND, CDER, FDA. She is a Fellow of the American College of Physicians and is board certified in Infectious Diseases. In addition to her clinical review responsibilities as team leader of a team of 5 primary review physicians, she has acted as a Cross- disciplinary team leader for several new molecular entity NDA submissions. She participates in reviewer training, guidance development, data standards development and represents the Division in public-private partnerships. |
| Diane Nell, Ph.D. Consumer Safety Officer Premarket Programs Branch Division of Industry and Consumer Education Office of Communication and Education Center for Devices and Radiological Health |
Diane Nell is a Consumer Safety Officer in the Premarket Programs Branch, Division of Industry and Consumer Education (DICE), in CDRH’s Office of Communication and Education (OCE). Her work consists primarily of helping external stakeholders locate and understand various regulatory resources and requirements established by FDA. Dr. Nell began her career with the FDA in 2000 and served as a lead reviewer in the Office of Device Evaluation (ODE) for 14 years. There she was responsible for the evaluation of premarket notifications (510(k)), investigational device exemptions (IDE), and premarket approval applications (PMA). Just prior to joining DICE, Dr. Nell worked in ODE’s PMA Staff, assisting in the processing and administrative reviews of PMA and Humanitarian Device Exemption (HDE) applications. In addition to her work in ODE, Dr. Nell conducted research on the thermal effects of high intensity focused ultrasound within the FDA’s Office of Science and Engineering Laboratories. Dr. Nell received a Doctorate Degree in Mechanical Engineering from The George Washington University. |
| Marc Neubauer, ASQ-CSQE, ASQ-CBA Medical Device Specialist Baltimore District Office Office of Regulatory Affairs |
Marc Neubauer serves as the Medical Device Specialist at the Baltimore District Office, in FDA’s Office of Regulatory Affairs. He has performed over 100 inspections and been involved in numerous high profile regulatory cases leading to warning letters and recalls. He speaks as a roundtable expert at FDA Inspections Summit Conference and serves as an instructor for the AAMI courses, Quality System Requirements and Industry Practice and Regulatory Requirements for Software Validation. Mr. Neubauer was a recipient of 2015 FDA Outstanding Service Award and 2016 Federal Executive Board Excellence in Federal Career Award. He is ASQ certified as a Biomedical Auditor and a Software Quality Engineer. Before working for the FDA, Mr. Neubauer taught college level chemistry and film courses at three local colleges in the Buffalo, NY area. He obtained his Bachelor of Science in Chemistry at the University of Buffalo and completed his PhD coursework in chemistry and chemical biology at the University of California at Irvine. |
| Jennifer H. Nguyen, PharmD Quality Assessment Lead (Acting) Office of Program and Regulatory Operations (OPRO) | OPQ |
Jennifer is currently a Quality Assessment Lead (acting) and a Regulatory Business Process Manager in the Office of Program and Regulatory Operations within the Office of Pharmaceutical Quality. Prior to joining the FDA, she was a pharmacy supervisor for a health department in the DC area where she managed policy and program compliance for county and state programs, and supported emergency preparedness planning. Jennifer is a pharmacist by training and received her Doctor of Pharmacy degree at the University of North Carolina at Chapel Hill. |
| Martha Nguyen, JD Director, Division of Policy Development Office of Generic Drug Policy OGD | CDER |
Martha Nguyen currently serves as the Director of the Division of Policy Development within the Office of Generic Drug Policy. Ms. Nguyen has worked at FDA since 2005 and served as a Senior Regulatory Counsel in CDER’s Office of Regulatory Policy before joining the Office of Generic Drugs. Previously, she worked at a Washington, DC, law firm providing strategic advice on implementation of the Medicare Prescription Drug, Improvement, and Modernization Act and emerging healthcare initiatives related to preventive health, disease management, and expanding coverage for the uninsured. She holds a JD degree from the Georgetown University Law Center and a BA from the University of Pennsylvania. |
| QuynhNhu Nguyen, MS Lieutenant Commander, USPHS Associate Director for Human Factors Division of Medication Error Prevention and Analysis CDER | FDA |
QuynhNhu Nguyen is an engineer officer currently stationed at the Food and Drug Administration (FDA). She has been with FDA for about 13 years. She has been working with evaluating human factors (HF) and use safety of medical products, originally, with the MedSun project in the Office of Surveillance and Biometrics, then with the Human Factors Premarket Evaluation Team in the Office of Device Evaluation within the Center for Devices and Radiological Health, and now with the Division of Medication Errors and Prevention Analysis (DMEPA) within the Center for Drug Evaluation and Research. Her regulatory review experience includes performing specialized biomedical engineering reviews and human factors reviews of a variety of premarket submissions including combination products (drug/device, biologic/device). In addition, she has participated in Agency guidance development efforts with specific focus on HF considerations for medical devices and combination products. She has led a number of HF-focus training and outreach efforts with internal FDA staff and external stakeholders. Currently, she serves as the Associate Director for Human Factors. In this capacity, she works with DMEPA management to develop policy and best practices for HF reviews to ensure clarity and consistency. She received her Bachelor in Biomedical Engineering from George Washington University in 2005, and Masters in Systems Engineering from Johns Hopkins University in 2013. She also received the Admiral Jerrold Michael Global Health Graduate Certificate from University of Maryland in 2010. |
| Thuy (Twee) Nguyen, BSN, MPH Division of Inspectional Assessment Office of Process and Facilities Office of Pharmaceutical Quality (OPQ), CDER |
Thuy Nguyen is a former Investigator with Kansas City District and CDER Compliance Officer/Division of International Drug Quality. Currently Ms. Nguyen works with the Division of Inspectional Assessment, Office of Process and Facilities (OPF), Office of Pharmaceutical Quality (OPQ). |
| Lucila B. Nwatu, MS, RAC Consumer Safety Officer/ Investigator Pharmaceutical Quality Division 4 Office of Regulatory Affairs (ORA) FDA |
Mrs. Lucila B. Nwatu is currently an Investigator/Consumer Safety Officer within Division 4 of Office of Pharmaceutical Quality Operations in the Office of Regulatory Affairs/FDA. Prior to her current position, Mrs. Nwatu was a Regulatory Project Manager in the Center of Biologics Evaluation and Research, Office of Biostatistics and Epidemiology. Mrs. Nwatu received her BS in Chemistry from The Pennsylvania State University (University Park) and her MS in Biomedical Sciences from Hood College (Frederick, MD). Mrs. Nwatu has had experience in pharmaceutical manufacturing and regulatory affairs before joining the FDA. |
| LCDR Soo Jin Park, PharmD, MS Regulatory Compliance Officer Drug Registration and Listing System Staff Office of Compliance | CDER | FDA |
LCDR Park is a Regulatory Compliance Officer with the U.S. Food and Drug Administration in the Office Compliance. She’s been with Drug Registration and Listing System staff for 9 years and is an expert in regulation and operation pertaining to establishment registration and drug listing for both domestic and foreign drug manufacturers. Since 2013, LCDR Park has been heavily involved in writing guidance and policy related to 503B outsourcing facilities. She continues to assist outsourcing facilities with registration as well as submission of biannual product reporting. |
| Donal Parks MBA, MPM Director Division of User Fee Management and Budget Formulation Office of Management (OM), CDER, FDA |
Donal directs the Division of User Fee Management and Budget Formulation at CDER’s Office of Management. This staff is responsible for collecting user fees under the Generic Drug User Fee Amendments (GDUFA), the Prescription Drug User Fee Amendments (PDUFA), and the Biosimilars User Fee Act (BsUFA), all of which were authorized or reauthorized in the FDA Safety and Innovation Act as signed by the President on July 9, 2012. Before joining the FDA as an operations research analyst in 2008, Donal worked for the District of Columbia Office of the Chief Financial Officer, on Capitol Hill for the Chief Administrative Officer of the House of Representatives, and for a private consulting firm specializing in public health-related outsourcing work. He earned graduate degrees in finance (MBA) and in public-sector financial management (MPM) from the University of Maryland at College Park in 1995, and an undergraduate degree in Foreign Service from Georgetown University in 1988. |
| Suhas Patankar, PhD Branch Chief (Acting) Division of Immediate Release Products (DIRP) II , Branch2, Office of Lifecycle Drug Products (OLDP), Office of Pharmaceutical Quality (OPQ), CDER , FDA |
Suhas Patankar, PhD has extensive experience in review and approval of Generic Drugs with Office of Generic Drugs (OGD) and the newly formed Office of Lifecycle Drug Products (OLDP)under Office of Pharmaceutical Quality (OPQ). Since joining FDA as a CMC reviewer in 2003, she has been involved with several committees and working groups in CDER, OPS and OGD including Good Review PRACtices working group, Stability working group, Inactive ingredients working group, PAT committee, and QbD for modified release products working group. As a Lead Chemist in Office of Generic Drugs she has provided guidance to International Regulatory Authorities as part of the faculty for CDER Forum and continues to do so as an Acting Branch Chief. She is actively involved in representing the Agency as a speaker in FDA-Industry meetings, workshops, and training events. Prior to joining OGD she has spent several years in pharmaceutical industry at Novartis Inc. and also in generics. |
| Bijal Patel, Pharm.D., BCPS Pharmacist, ORO/DFR CDER | FDA |
Bijal Patel is currently a Primary Filing Reviewer in the Division of Filing Review (DFR) within the Office of Regulatory Operations. Prior to working at the FDA, she worked as a research pharmacist at the National Institute of Allergy and Infectious Diseases (NIAID), NIH. She has also worked as a clinical pharmacist and an anticoagulation clinic pharmacist at Howard County General Hospital, Johns Hopkins Medicine. She received her Pharm. D. from Northeastern University, Boston, Massachusetts and completed her Post-Doctoral Pharmacy Practice Residency training from VA North Texas Health Care System, Dallas, Texas. After completing residency, Bijal obtained her Board certification as pharmacotherapy specialist (BCPS). |
| Hasmukh Patel, PhD Acting Director Division of Post-Marketing Activities 1 Office of Lifecycle Drug Products (OLDP) OPQ | CDER | FDA |
Dr. Hasmukh Patel is the Acting Director in the Division of Post-Marketing Activities 1 (for NDAs) in the Office of Lifecycle Drug Products (OLDP), OPQ, CDER. He is also the Branch Chief for Branch 2 of this Division. He is with the FDA for more than 20 years. He started as a review chemist in the Division of Medical Imaging and Surgical Products and then served as a Chemistry Team Leader and Deputy Division Director in the Office of New Drug Chemistry (ONDC) and as a Branch Chief in the Office of New Drug Quality Assessment (ONDQA). Dr. Patel has extensive technical, regulatory and managerial experience. His work experience includes review of Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and NDA supplements for a wide variety of dosage forms and drug products. He has also served on various technical committees at CDER. He has several years of industrial research and development experience in the area of natural products and organic synthesis and academic experience in the development of radiopharmaceuticals for medical imaging. He received his PhD degree in Organic Chemistry from the University of Georgia, Athens, Georgia and M.Sc. in chemistry from the Indian Institute of Technology, Bombay, India. |
| Kshitij A. Patkar, PhD Acting Director Review Chemist OPQ | OPF | DPA III | CDER | FDA |
Dr. Patkar received his PhD in Pharmaceutical Sciences from University of Maryland, Baltimore in 2002 with a focus on peptide synthesis and analysis. He did his post-doctoral work at NIDA, NIH and then worked as a researcher at the University of Kansas where he developed a bioanalytical program to assess metabolic fate of peptide drug candidates in biological matrices. After his tenure at the University of Kansas he worked as a principal investigator at Torrey Pines Institute for Molecular Studies. Dr. Patkar joined FDA in October 2012. Since then he has been involved in the review of complex drug substances and products ANDAs. Dr. Patkar is currently a Review Chemist in the Office of Process and Facilities (OPF) under the Office of Pharmaceutical Quality (OPQ) in CDER. |
| Vinayak B. Pawar, PhD Senior Review Microbiologist Division of Microbiological Assessments Office of Pharmaceutical Quality (OPQ), CDER, FDA |
Dr. Vinayak B. Pawar is a Senior Scientific & Regulatory Review Microbiologist with the Office of Pharmaceutical Quality, CDER, FDA. He serves as a Regulatory, Scientific and Technical consultant and provides guidance to industry regarding CDER, CBER cGMP issues and proper submission of new drug applications while training Pharmaceutical Inspectorate Candidates. Previously, as a Senior Director at Parkedale Pharmaceuticals & BioReliance Inc he directed day-to-day QA & QC operations while enforcing company-wide cGMP compliance for aseptic filling operations. Prior to serving the pharmaceutical industry he was the Chairman, Clinical Laboratory Sciences Department at University of Nevada and Director of Graduate Medical Technology Program at University of Maryland, School of Medicine. |
| Vasum Peiris, MD, MPH FAAP, FACC, FASE Chief Medical Officer – Pediatrics and Special Populations Center for Devices and Radiological Health |
As Chief Medical Officer for Pediatrics and Special Populations at the FDA, Center for Devices and Radiological Health, Dr. Peiris serves as the Center’s senior clinical expert on pediatrics and pediatric medical device issues. He provides clinical and executive leadership on Center policies associated with medical devices intended for use in the pediatric populations. He engages and develops Agency-wide and cross-Agency initiatives that serve pediatrics and special populations. He leads the Center’s outreach to facilitate the development of new and modified devices to address the needs of pediatrics and special populations, explains relevant Agency/Center activities, policies and decisions, and solicits feedback. He also leads the Center’s efforts with respect to the development, assessment, regulation, and safe use of pediatric medical devices. Prior to joining the FDA, Dr. Peiris was the Joon Park MD Endowed Chair for Medical Excellence and Associate Professor and Chief of Pediatric and Adult Congenital Cardiology at Texas Tech University Health Sciences Center (TTUHSC) School of Medicine, The Graduate School of Biomedical Sciences, and University Medical Center (UMC), with appointments in the Departments of Pediatrics and (adjunct) Internal Medicine. He was Medical Director of the Congenital Cardiovascular Imaging Laboratory and the Pediatric and Adult Congenital Cardiorespiratory Stress Laboratory at the University Medical Center. Dr. Peiris was one of the inaugural faculty helping to develop the School of Public Health. Dr. Peiris achieved his undergraduate degree at Yale University, his graduate degree at Yale School of Medicine Department of Epidemiology and Public Health, and medical degree at The University of Vermont College of Medicine. He completed residency at Yale School of Medicine/Yale-New Haven Hospital, and fellowship in Pediatric Cardiology and Cardiovascular Research at Children’s Hospital Boston/Harvard Medical School. Dr. Peiris is board certified in Pediatrics and Pediatric Cardiology by the American Board of Pediatrics, and is board certified in Adult Congenital Cardiology by the American Board of Internal Medicine. He is a Fellow of the American Academy of Pediatrics, the American College of Cardiology and the American Society of Echocardiography. |
| Gisa Perez, MBA Generics Branch Chief Division Of User Fee Management and Budget Formulation Office of Management, CDER, FDA |
Gisa Perez is the current Generics Branch Chief in the Division of User Fee Management and Budget Formulation at CDER’s Office of Management. This Branch is responsible for collecting user fees under the Generic Drug User Fee Amendments (GDUFA). Gisa has been working on GDUFA matters since its inception in 2012. She was part of the user fee implementation team and worked on various projects that contributed to GDUFA’s success. Prior to joining the Office of Management, Gisa Perez worked at the Office of New Drugs (OND) in the Program Management and Analysis Staff. She earned her BS in Computer Sciences in 2004 and an MBA in 2010, both from University of Maryland. |
| Frank W. Perrella, PhD Project Manager Office of Policy for Pharmaceutical Quality OPQ, CDER, FDA |
Frank Perrella received his Bachelor of Science degree in engineering from the New Jersey Institute of Technology and his PhD degree in Biomedical Science from Rutgers University. Following postdoctoral research at the McArdle Laboratory for Cancer Research of the University of Wisconsin, Frank was appointed Assistant Professor at the Wistar Institute of the University of Pennsylvania. He also worked for E.I. DuPont Pharmaceuticals as a Senior Research Biochemist, C.R. Bard as a Senior Research Scientist, Tillotson Healthcare Corporation as the Vice President of Research and Development. Thereafter, Frank joined the FDA and worked in the Center for Drug Evaluation and Research’s (CDER) Office of Compliance as an Interdisciplinary Scientist and a Compliance Officer. Currently, he is a Project Manager working in CDER’s Office of Pharmaceutical Quality (OPQ) in the Office of Policy for Pharmaceutical Quality (OPPQ). |
| LCDR Thomas A. Peter, ASQ CBA Lieutenant Commander, Public Health Service Supervisory Investigator Medical Device and Radiological Health Operations/Division 1 (East) Office of Regulatory Affairs, FDA |
LCDR Thomas A. Peter serves as a Medical Device Specialist in Division 1 of the Office of Regulatory Affairs (ORA) Office of Medical Device and Radiological Health Operations. He is also a commissioned engineer officer in the U.S. Public Health Service and is stationed in Detroit, Michigan. LCDR Peter has been performing medical device inspections since joining FDA in 2010 and has been involved in numerous high-profile cases resulting in Warning Letters and other regulatory actions. He is a former member of ORA’s Medical Device Foreign Inspection Cadre and helped develop ORA’s Medical Device Investigator Certification exam. LCDR Peter is an ASQ Certified Biomedical Auditor (CBA), Certified Quality Technician (CQT), and Certified Quality Improvement Associate (CQIA). He earned his Bachelor and Master of Science degrees in Biomedical Engineering from the University of Michigan. |
| Erika Pfeiler, PhD Microbiologist and Acting Quality Assessment Lead Division of Microbiology Assessment OPF | OPQ | CDER | FDA |
Dr. Erika Pfeiler is a microbiologist and acting Quality Assessment Lead in the FDA/CDER Division of Microbiology Assessment, where she performs and oversees reviews of the microbiological aspects of NDAs, ANDAs, and INDs. Her areas of particular interest include rapid microbiological testing methods, pharmacy compounding, and the microbiological aspects of nonsterile products. Prior to working at the FDA, Dr. Pfeiler received a B.S. from the University of Tennessee, and a Ph.D. from North Carolina State University. |
| J. Paul Phillips, MS Senior Regulatory Health Project Manager Immediate Office OND | CDER | FDA |
J. Paul Phillips is currently a Senior Regulatory Health Project Manager on the Regulatory Affairs Team in the Office of New Drugs (OND), Immediate Office. One of his primary responsibilities since February of 2017 is oversight of the expanded access program in OND. Mr. Phillips has been at the FDA since 2008, working in various roles including as a Team Leader and acting Chief, Project Management Staff in OND’s review Division for Dermatology and Dental Products. Prior to joining the FDA, Mr. Phillips worked for 3 years in academic labs and 6 years as a research associate in the biotech industry. Mr. Phillips received a Bachelor of Science degree in Biology from the University of Utah, a Master of Science in Bioscience and Regulatory Affairs from Johns Hopkins University, and a graduate certificate in Patient and Product Safety from the University of Southern California. |
| CDR Kimberly Piermatteo Commander, Public Health Service Consumer Safety Officer Premarket Programs Branch Division of Industry and Consumer Education Office of Communication and Education CDRH | FDA |
CDR Kimberly Piermatteo is an officer in the U.S. Public Health Service and serves as a Consumer Safety Officer in the Premarket Programs Branch, Division of Industry and Consumer Education (DICE) in CDRH’s Office of Communication and Education. She has been with the FDA in various capacities since 2006, including premarket reviewer within the Office of Device Evaluation; postmarket medical device analyst in the Office of Surveillance and Biometrics; and program analyst in the Office of Compliance. CDR Piermatteo received a Bachelor of Science in Engineering Science and Minors in Bioengineering and Mathematics from the Pennsylvania State University and a Master of Health Administration (MHA) from the University of Maryland. |
| Quallyna Porte, MBA Quality Assessment Lead (Acting) Division of Inspectional Assessment OPF | POQ | CDER | FDA |
Quallyna Porte received her B.S. in Biology from Saint Paul’s College and an MBA from the University of Maryland, University College. She has 18 years of pharmaceutical industry experience in various leadership roles in Quality organizations within clinical and commercial manufacturing operations. Quallyna joined the FDA in late 2014 as a Biologist/Interdisciplinary Scientist, immediately prior to the standup of the new Office of Pharmaceutical Quality. In this position, she was a facility reviewer in the Office of Process and Facilities where she conducted quality assessment (scientific and regulatory review) of pre-approval inspection information relating to manufacturing and regulatory submissions including INDs, BLAs, NDAs, DMFs, ANDAs, and their supplements. Currently, she is the Quality Assessment Lead (Acting) of Branch 2 in the Division of Inspectional Assessment, where in addition to conducting, she also oversees quality assessment (scientific and regulatory review) of pre-approval inspection information. She has cross contamination as an area of expertise and is involved in resolving a broad range of scientific multidisciplinary issues concerning the application of FDA’s regulatory authorities as described in statute, regulations, and guidance. |
| Miranda Raggio, MA Senior Regulatory Health Project Manager Office of New Drugs Regulatory Affairs Team CDRH, FDA |
Miranda Raggio holds a BA and MA from the University of MD and a BSN from Catholic University. Ms. Raggio is currently a Senior Regulatory Health Project Manager within FDA’s Center for Drug Evaluation & Research (CDER) where she serves as CDER’s Breakthrough Therapy Program Manager. As a member of the Office of New Drugs Regulatory Affairs Team is involved in regulatory and policy initiatives. Miranda’s prior professional experience includes educational program management for various national associations, adult and pediatric oncology research nursing at the Veteran’s Administration and the National Institutes of Health, and project management in CDER’s Divisions of Pulmonary, Allergy, and Rheumatology Products. |
| Leyla Rahjou-Esfandiary, PharmD Director Registration and Listing Compliance Program OC | CDER | FDA |
Leyla Rahjou-Esfandiary has been with FDA’s Office of Compliance for over 9 years. She is currently leading the registration and listing compliance program. She has also worked in the Office of Unapproved Drugs and Labeling Compliance and Office of Business Informatics. Prior to joining FDA, she has held different positions in retail and hospital pharmacy settings. Leyla has earned her Pham. D. from Tehran University, School of Medical Sciences in Iran. |
| Radhika Rajagopalan, PhD Quality Assessment Lead Division of Modified Release Products Office of Lifecycle Drug Products (OLDP), Office of Pharmaceutical Quality (OPQ), CDER , FDA |
Radhika Rajagopalan, PhD, has extensive experience in the review and approval of Generic Drugs with the Office of Generic Drugs (OGD), and now the Office of Lifecycle Drug Products, FDA. She has been a CMC reviewer, Special Assistant to the Deputy Director, and a Quality assessment lead. Radhika has chaired the Stability Work Group Chair since its inception in 2011. She has years of Pharma industry experience prior to joining the FDA. Under her stewardship, the stability work group has pursued implementing ICH stability guidances for the generic ANDA and DMF submissions, and has published the draft and final guidance for the stability testing of ANDAs in the Federal Register. In addition, Stability Q & A guidance on ANDAs: Stability Testing is also published in the Federal Register. During her FDA tenure she has chaired the CMC-Analytical methods technical committee 1999-2001 (AMTC), completed Excellence in Government Fellows Program for Leadership, published papers, and represented the Agency as a speaker in several national, international, and trade meetings. Dr. Rajagopalan continues to contribute to FDA-Industry workshops, training events, initiates regulatory research, and CMC policy implementation efforts such as draft and final guidance development initiatives, in addition to approving several generic drug applications. |
| Ramnarayan Randad, PhD Branch Chief, Branch II Division of lifecycle API, Office of New Drug Product (ONDP) | OPQ |
Ramnarayan Randad (Ram) is the Branch Chief, Branch II, Division of Lifecycle API in of the Office of New Drug Products (ONDP) in CDER’s recently reorganized Office of Pharmaceutical Quality (OPQ). Ram has served as a review chemist, Quality Assessment Lead, and Master Reviewer. Ram has served on number of working groups and has contributed immensely to development of scientific policies related to complex (Sevelamer, Colesevelam, peptides), sensitive, controversial (conjugated Estrogens), and critical (Mefloquine, and Amphetamine Aspartate) products, and has worked on number of review efficiency and enhancement projects such as QbR, Risked based reviews, and completeness assessment for DMFs. Ram has provided technical presentations to internal and external stake holders on wide ranging science and regulatory topics at number of workshops and conferences. He has also authored a chapter “FDA Regulation and Drug Reviews” in the 7th edition of Burger`s Medicinal Chemistry: Drug Discovery and Development. Prior to joining the FDA, Ram worked in the R&D department at NCI, Tibo Tec and Neogenesis, in various capacities as a Medicinal Chemist, Group Leader and Principle Investigator. Ram received his Ph.D. in Organic Chemistry from Poona University, India and post-doctoral research associate at Purdue University, West Lafayette, IN; and Virginia Commonwealth University, Richmond, VA. |
| Giuseppe Randazzo, MS (Acting) Director Office of Program and Regulatory Operations (OPRO) Office of Pharmaceutical Quality CDER , FDA |
Giuseppe Randazzo currently serves as acting Office Director, Office of Program and Regulatory Operations (OPRO), Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER). During his 12 year tenure at the FDA, he served as an OND regulatory project manager, followed by three years in compliance, and then moved back to OND as a regulatory scientist. As acting office director of OPRO, Giuseppe focuses on all processes associated with drug quality reviews for NDAs, BLAs and ANDAs in collaboration with OPQ functional office leadership. In addition, OPRO houses the quality management systems, and the learning and professional development staff within OPQ. Giuseppe earned his MS in Regulatory Science from Johns Hopkins University and his BS in Chemistry Education from Pennsylvania State University. |
| Andre Raw, PhD Acting Senior Science and Policy Advisor Office of Lifecycle Drug Products (OLDP) OPQ | CDER | FDA |
Andre Raw received his B.S. degree from the Massachusetts Institute of Technology and his Ph.D. degree in chemistry from the University of California at Berkeley. He was a Welch post-doctoral research fellow under Alfred G. Gilman at the University of Texas Southwestern Medical Center. He 2001, he joined the FDA as a reviewer within the Office of Generic Drugs (OGD). In his fourteen year tenure within FDA he has been promoted to FDA Agency Expert and to Chemistry Division Director. Currently he is Acting Senior Scientific and Policy Advisor in the Office of Life Cycle Drug Products (OLDP) in the Office of Pharmaceutical Quality (OPQ). Dr. Raw was involved in the development of several important FDA initiatives, including the Guidance on Pharmaceutical Solid Polymorphism in Abbreviated New Drug Applications (ANDAs), Regulations on Listing of Polymorph Patents in the “Orange Book”, and Question Based Review – Quality by Design (QbD) Initiative, QbD Example for Generic Modified Release Products, and Guidance for Industry: Pharmaceutical Solid Co-Crystals. He has also been active in addressing the scientific and regulatory issues raised in citizen petitions, in defining regulatory policy that impact ANDAs. He was instrumental in FDA’s recent approval of generic versions of complex active ingredients including Lovenox (enoxaparin sodium), Ferrlecit (sodium ferric gluconate complex in sucrose) and Copaxone (glatiramer acetate). More recently, Dr. Raw has been active in Risk Based Review and Quality Informatics Initiatives. |
| Jonathan Resnick Project Management Officer Office of Business Informatics Division of Data Management Services and Solutions Office of Strategic Programs | CDER | FDA |
Jonathan Resnick has been with FDA since January 2011. He is currently Project Management Officer with Office of Bioinformatics where he advises on eCTD and guidance as member of CDER’s Electronic Submissions Team. Mr. Resnick has been involved in a number of projects within CDER, working with stakeholders to identify and fulfill business objectives. Prior to joining FDA, Mr. Resnick spent 18 years working in IT project management supporting federal and private sector clients. |
| Alexandre J. S. Ribeiro, PhD Biological Scientist Staff Fellow Division of Applied Regulatory Science Office of Clinical Pharmacology CDER | FDA |
The work of Dr. Alexandre Ribeiro focuses on evaluating risk and toxicity of drugs with pluripotent stem cells. He joined the FDA in January 2017 and is leading a lab for studying drug toxicity with microengineered in vitro cellular systems made with human induced pluripotent stem cells. His goal is to test, validate and deploy stem cell-based cellular systems for predicting clinical toxicity of drugs and replacing traditional methods that are currently used to predict risk associated to drug use. Alongside with research, Dr. Ribeiro also developed several roles in education, such as lecturing of classes on cell mechanics at Stanford University and working with the Exploratorium Museum in San Francisco to make an interactive exhibit on cardiac cells differentiated from induced pluripotent stem cells. Dr. Ribeiro received a Ph.D. in Biomedical Engineering in 2010 from Carnegie Mellon University in Pittsburgh, where he studied the mechanics of the cell nucleus as a biomarker of cell differentiation. |
| Eric Richardson Branch Chief, Premarket Programs Branch (Acting) Division of Industry and Consumer Education Office of Communication and Education CDRH | FDA |
Eric Richardson is the Premarket and Small Business Determination Acting Branch Chief for the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH). In this role, Mr. Richardson leads his Branch in the development of medical device industry education on premarket and consumer issues. Since 2013 Mr. Richardson has been a Lead Reviewer for the Circulatory Support Devices Branch, Structural Heart Devices Branch and Implantable Electrophysiology Devices Branch in the Division of Cardiovascular Devices within the Center for Devices and Radiological Health (CDRH). Prior to the FDA, he worked as the Director of US Clinical Studies at a medical device company where he managed the US Clinical Studies Team and assisted with regulatory submissions. He has over 17 years of medical device industry experience. Mr. Richardson received a Bachelor of Science degree in Mechanical Engineering from Brigham Young University and a Masters of Science in Mechanical Engineering from the University of Utah. |
| Jason D. Rodriguez, PhD Laboratory Chief, Branch 1 Division of Pharmaceutical Analysis (DPA) Office of Testing and Research (OTR) | OPQ CDRH, FDA |
Jason Rodriguez is a Laboratory Chief for Branch I at the FDA Division of Pharmaceutical Analysis in St. Louis, MO. He has a Ph.D. in Chemistry from the University of Illinois Urbana-Champaign. As a Laboratory Chief at DPA, he leads a team of analysts that works on pharmaceutical science and research projects including dissolution, chromatography, inhalation, transdermal and mass spectrometry. Dr. Rodriguez also has extensive experience in rapid spectroscopic screening techniques using Raman and near infrared technologies. The work of his team has spanned the areas of improving raw material (excipient) identification, counterfeit medicine detection and screening of stockpiled medical countermeasures. |
| Niles Ron, PhD, MBA Branch Chief (Acting) Division of Post-Marketing Activities-II, Office of Lifecycle Drug Products (OLDP) OPQ | CDER | FDA |
Dr. Niles Ron is currently a Branch Chief in the Division of Post-Marketing Activities-II, which is responsible for post-marketing activities for generic drugs, including ANDA supplement review. Dr. Ron has been at the FDA since January 2011, starting as a CMC reviewer for ANDAs. Prior to joining the FDA, Dr. Ron held several positions of increasing responsibility in scientific management in the biopharmaceutical industry spanning over a period of 12+ years, relating to CMC activities including product and process development, and manufacturing. He received his PhD from Washington University in Saint Louis in Chemical Engineering and his MBA from Clark University in Worcester, Massachusetts. |
| B.J. Ryan Quality Assessment Lead (acting) Division of Inspectional Assessment OPF | OPQ | CDER | FDA |
B.J. Ryan, currently serves as Quality Assessment Lead (Acting) for the Division of Inspectional Assessment (DIA) in the Office of Process and Facilities. Previously he was an ORA Field Investigator, Drug specialist, in the GDUFA drug program for the Los-Angeles District Office. In DIA he is responsible for conducting and overseeing quality assessments of Pre-Approval inspection outcomes related to critical manufacturing facilities and regulatory submissions. Prior to joining the agency, Mr. Ryan worked in various roles in the pharmaceutical industry in Operations, Quality Control, Quality Assurance and most recently as a Compliance Officer for a global sterile injectable manufacturer. Mr. Ryan received his degree in Medical Biotechnology from the State University of New York. |
| Sanjay K. Sahoo, MS, MBA Team Lead (Acting) Regulatory Science Staff (RSS) OSE | CDER | FDA |
Sanjay K. Sahoo is a regulatory scientist informatics, Team Lead (Acting) at Regulatory Science Staff (RSS), OSE, Food and Drug Administration. Sanjay has a Bachelor of Science (BS) in Physics and Mathematics and Post Graduate Diploma in Industrial Pollution Management (PGDIPM) from Utkal University (India); a Master of Science (MS) in Computer Science from the Institute for Technology and Management (India) and a Master in Business Administration (MBA) from Carey Business School, Johns Hopkins University (Baltimore, Maryland). His research interests are in the fields of human drug safety and surveillance, health data science, advance analytics and data mining, natural language processing and machine learning techniques. He has over eighteen years of demonstrated achievements in healthcare science and technology across governments (i.e. FDA, NCI, NIAID, NHLBI) and pharmaceutical industries (i.e. MedImmune, AstraZeneca) focusing on healthcare informatics solutions to assess safety, efficacy and quality of all FDA regulated drugs, devices and biologics products. |
| Nashed Samaan, PhD Senior Chemist Reviewer Division of Immediate Release Products II OLDP | OPQ | CDER | FDA |
Nashed Samaan, Ph.D. is a senior reviewer in OLDP. His academic qualifications include a B.Sc. M. Sc., and a Ph.D. in chemistry. He joined FDA in 2000 and has been involved with the chemistry review function since. In addition to his review activities, he also served on a number of working groups, such as the Impurities in DS and DP working Group. He has been involved in the writing of Guidances, including the Guidance for Industry entitled “ANDAs: Impurities in Drug Substances” and “ANDAs: Impurities in Drug Products” published on 2010. He has received several honors and awards in recognition of his career. Before joining FDA, Nashed came to the USA and joined a private company dealing in research and development of diagnostic medical devices for early cancer detection called MonoGenTM. He also involved in the development of a drug of abuse screening device. This work resulted in the development and manufacturing of a fully integrated, easy-to-use, testing device called the “Genie Cup™”. |
| Regie Samuel, BS DRLS Staff OC | CDER | FDA |
Regie Samuel has worked with the FDA for 5 years. For 3 years, he worked as an FDA contractor supporting the eDRLS and CDER Direct systems on the software development team. He has been a part of the DRLS staff for over 2 years. He has his BS in Finance from the University of Maryland in College Park. |
| Vincent Sansone, PharmD, PMP Commander, USHPS Office Deputy Director Immediate Office Office of Regulatory Operations (ORO) | OGD CDER | FDA |
CDR Vincent Sansone of United States Public Health Service is the Deputy Director, Office of Regulatory Operations, Office of Generic Drugs (OGD). As Deputy Director, he co-leads the four divisions (Labeling, Filing, Quality Management Systems and Project Management) in efforts to meet program objectives and GDUFA II deliverables while ensuring high quality, effective generic medications are provided to the Nation. He previously spent five years serving in several project management positions within OGD including Supervisory Regulatory Project Manager. Prior to joining OGD, he spent several years as a pharmacist in the Bureau of Prisons and as a clinical pharmacist with the National Institute of Health. Vincent received a bachelor’s degree in biology from Towson University in 1999 and his Pharm.D. from the University MD School of Pharmacy in 2004. |
| Priya Shah, PharmD Associate Director for Operations Office of Regulatory Operations (ORO) | OGD CDER | FDA |
Priya Shah graduated from the University of Maryland School of Pharmacy in 2010. For the first 3 years of her pharmacy career, she worked at a national pharmacy retail chain. In 2013, she joined the Office of Generic Drugs (OGD) as a Regulatory Project Manager and subsequently as a Regulatory Project Manager Team Leader in the Division of Project Management. She currently is working as the Associate Director for Operations in the Office of Regulatory Operations in OGD. Her primary area of expertise is on the approval of generic medicines, tracking of reconsideration requests, and operational process enhancements ensuring success of the OGD mission. |
| Mohan Sapru, PhD Member Emerging Technology Team CMC Lead Application Technical Lead (ATL) Office of New Drug Products (ONDP) Office of Pharmaceutical Quality (OPQ) CDER | FDA |
Dr. Sapru currently serves as the Chemistry, Manufacturing and Controls (CMC) lead and application technical lead (ATL) in the Office of New Drug Product, Office of Pharmaceutical Quality (OPQ) FDA. He is a member of the FDA’s Emerging Technology Team (ETT), which is aimed to facilitate a promote innovative technologies to modernize all aspects of drug development. Dr. Sapru has extensive experience in leading and managing multi-office review teams and finalizing CMC review-based drug approval recommendations. Prior to joining the FDA, Dr. Sapru served as a faculty member in the CMRC Neurobiology Program at the Feinberg School of Medicine, Northwestern University in Chicago. His research focus in collaboration with the Northwestern University continues to involve: a) developing novel RNAi-based gene therapy for Parkinson’s disease and related neurodegenerative disorders, and b) studying molecular mechanisms mediating neurotoxin-triggered neuronal cell death. He is the holder of US patents, and author of several research publications in prestigious peer-reviewed journals. |
| Rakhi B. Shah, MS, PhD Quality Assessment Lead (Acting) Division of Process Assessment-I OPF | OPQ | CDER | FDA |
Dr. Rakhi B. Shah comes from Office of Process and Facilities (OPQ) where she is employed as a Quality Assessment Lead (Acting). Her interests includes dosage form design and development of conventional and biotech derived drugs, application of Quality by Design, Process Analytical Technology, use of Design of experiments, risk management, novel drug delivery systems. She has received numerous internal awards at FDA as well as various external awards. Prior to joining OPF, she worked as a team leader in Office of Generic Drugs (OGD) in the Chemistry division and as a lab scientist in research labs at FDA. She received her Ph.D. in Pharmaceutical Sciences from Texas Tech University. She has also earned M.S. in Bioprocess Tech and B.S. in Pharmaceutical Sciences from Mumbai University, India. She has co-authored 40+ publications and 8 book chapters and has presented her research findings in various international meetings. She has also been invited as a speaker at various national and international meetings. She serves as the reviewer for numerous journals. |
| Vibhakar Shah, PhD Consumer Safety Officer Office of Policy for Pharmaceutical Quality (OPPQ) Office of Pharmaceutical Quality (OPQ), CDER, FDA |
Dr. Vibhakar Shah is currently a Consumer Safety Officer with close to 20 years of drug regulatory experience in various capacities at CDER, USFDA. He has been a PAT (Process Analytical Technology) certified Review Chemist, Senior Policy Advisor and a Compliance Officer with substantial experience in assessing quality of pharmaceuticals both through application review (Chemistry, Manufacturing and Controls), and inspections of manufacturing facilities for GMP (Good Manufacturing PRACtice) compliance. Prior to USFDA, Dr. Shah was a Research Scientist at the University of California, San Francisco. He also has industry experience in the manufacture of bulk chemicals for pharmaceutical, food, flavor, and cosmetic industries. In addition to a PhD in Pharmaceutical Sciences from the University of Arizona, Dr. Shah holds a BSc. (Tech.) and a M.Sc. (Tech.) in Technology of Pharmaceuticals, Fine Chemicals and Chemical Engineering and a B. Sc. In Chemistry, Physics from India. |
| Balajee Shanmugam, PhD Branch Chief (Acting), Branch 3 Office of New Drug Products (ONDP) Office of Pharmaceutical Quality (OPQ), CDER |
Balajee (Bala) Shanmugam started his career at the FDA in 2003 as a Review Chemist in the Division of Special Pathogens. He later served as the CMC Lead for the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) program and subsequently as the CMC Lead for the Division of Transplant and Ophthalmic Products. Since 2015, Bala has been serving as the Branch Chief (Acting) in the Office of New Drug Products. His Branch is aligned with the Office of Antimicrobial Products. Bala’s professional experience includes careers at Roche Vitamins and Wyeth-Ayerst Pharmaceuticals working in the area of natural products. |
| Marjorie A Shapiro, PhD Chief, Laboratory of Molecular and Developmental Immunology Division of Monoclonal Antibodies CDER, FDA |
Dr. Marjorie Shapiro received her PhD in immunology in 1987 from the University of Pennsylvania where she studied molecular mechanisms underlying antibody diversity. Her current research continues towards understanding antibody repertoire development in natural and artificial systems and potential implications for therapeutic monoclonal antibodies. |
| Trueman W. Sharp, MD, MPH Deputy Director (Acting) Office of Bioequivalence OGD, CDER, FDA |
Trueman Sharp MD MPH is currently serving as the Deputy Director (Acting) in the Office of Bioequivalence in the Office of Generic Drugs. Prior to this, he was a clinical reviewer in the Division of Clinical Review in the Office of Bioequivalence. Dr. Sharp came to the FDA after a career in the U.S. Navy where he held a number of positions in clinical medicine and research, focusing on the development of drugs and diagnostics for tropical infectious diseases. He is a graduate of the University of Virginia School of Medicine and the University of Washington School of Public Health, and is board certified in General Preventive Medicine and Public Health. |
| Edward “Ted” Sherwood Director Office of Regulatory Operations (ORO) Office of Generic Drugs | CDER | FDA |
Ted Sherwood returned to the Office of Generic Drugs (OGD) to serve as the Director, Office of Regulatory Operations (ORO). ORO consists of four different divisions: the Division of Project Management, the Division of Filing Review, the Division of Labeling Review, and the Division of Quality Management Systems. Previously, he served as the Associate Director of Immediate Office Operations, Office of Pharmaceutical Science [now the Office of Pharmaceutical Quality (OPQ)]. Prior to joining OPQ in 1999, he spent a dozen years in OGD. He held various positions including, reviewing new submissions for determination of fileability, conducting program analyses, and coordinating congressional activities. Ted received his bachelor’s degree from the University of Maryland in 1992. |
| Martin Shimer Deputy Director Division of Legal and Regulatory Support Office of Generic Drug Policy |
Martin Shimer has worked for the Office of Generic Drugs for the past 15 years. He began his tenure in the Regulatory Support Branch, now known as the Division of Filing Review, where he worked as a filing reviewer for three years and then Branch Chief for ten years. Martin then served as Deputy Director for the Division of Labeling and Program Support prior to the reorganization of the Office of Generic Drugs. During the reorganization, Martin accepted a position as the Deputy Director of the Division of Legal and Regulatory Support in the Office of Generic Drug Policy. |
| Derek Smith, PhD Branch Chief, (Acting) Branch II, Division of Inspectional Assessment Office of Process and Facilities OPQ | CDER | FDA |
Derek Smith received his B.S. in Physics from Washington College (2003) and his Ph.D. in Chemical and Biochemical Engineering from University of Maryland, Baltimore County (2008). He completed a National Research Council (NRC) postdoctoral fellowship at National Institute of Standards and Technology (NIST) (2008-2010) prior to joining the FDA’s Office of Compliance. There, he spent 2 years in the Division of Good Manufacturing Practice Assessment as a compliance officer for pre-approval facility evaluations. Later, he joined Office of Generic Drugs (OGD) as a chemistry reviewer of ophthalmic, topical, and injectable drug products. In these positions, he was involved in several important FDA regulatory initiatives including Quality by Design, Process Analytical Technologies, and the Risk-Based Review of ANDAs. In the Office of Pharmaceutical Quality (OPQ), Derek served as Quality Assessment Lead (Acting) in the Office of Process and Facilities (OPF) Division of Process Assessment 3 focusing on the reviewing of the manufacturing process of liquid drug products while being a key contributor to the cross-functional training of process and facility reviewers in OPF. Currently, he is the Branch Chief (Acting) of Branch 2 in the Division of Inspectional Assessment where he continues to be involved in both cross-functional training and risk-based review initiatives. |
| Glen Smith, MS, MAS Acting Deputy Director, Office of Lifecycle Drug Products (OLDP), OPQ, FDA |
Glen Smith, M.S., MAS, Acting Deputy Director, Office of Lifecycle Drug Products (OLDP), OPQ, joined the FDA in 1991 as a review chemist with experience in quality assurance, systems/process validation, and current good manufacturing pRACtices (CGMP) compliance activities for the medical diagnostic industry. As a chemistry team leader, and later division director, Mr. Smith oversaw the chemistry, manufacturing, and controls (CMC) review and tentative approval of more than 80 abbreviated new drug applications (ANDAs) for the President’s Emergency Plan for AIDS Relief (PEPFAR) program. He also coordinated review issues for other PEPFAR applications, and helped coordinate efforts to conduct the first drug registration training in East Africa. Mr. Smith holds a Master’s Degree in Physical Chemistry from the University of Maryland, and a Master’s Degree in Management from The Johns Hopkins University. |
| Ángel Soler-García, PhD Microbiologist Urology and Lithotripsy Devices Branch Office of Device Evaluation CDRH | FDA |
Angel Soler-Garcia, PhD is Microbiologist in CDRH’s Office of Device Evaluation, responsible for the premarket review of medical devices in the field of urology and lithotripsy as well as serving as consultant on microbiology issues including sterilization and reprocessed medical devices, a role he has enjoyed since 2014. Prior to his FDA career, Dr. Soler-Garcia was a postdoctoral fellow at the National Cancer Institute (NCI) – National Institutes of Health (NIH), where he worked on the discovery of new genes with a role in prostate cancer and reproduction. In 2004, he joined the Children’s Research Institute where he served as a Principal Investigator conducting basic and clinical research related to the discovery of urinary biomarkers of HIV-associated renal disease. Dr. Soler-Garcia also served as an Assistant Research Professor of Pediatrics at George Washington University and served as a microbiologist in FDA’s Center for Food Safety and Applied Nutrition. Dr. Soler-Garcia received a Bachelor of Science in Microbial Technology and Master of Science in Biology with specialization in Microbiology and Molecular Biology from the University of Puerto Rico. He earned a Ph.D. in Microbiology and Immunology from the Uniformed Services University of the Health Sciences, with graduate focus on the molecular biology aspects of Neisseria gonorrhoeae pathogenesis using a novel mouse model of gonoccal infection. |
| Michael Spagnola, MD Medical Officer Division of Clinical Review OB | OGD | CDER | FDA |
Michael Spagnola MD currently serves as a medical officer in the Division of Clinical Review in the Office of Bioequivalence in the Office of Generic Drugs. Prior to this, he worked as a hospitalist and was an Assistant Clinical Professor of Medicine at George Washington University. He is a graduate of George Washington University School of Medicine and is board certified in internal medicine. |
| Marla Stevens-Riley, PhD Master Microbiology Reviewer Division of Microbiology Assessment Office of Process and Facilities Office of Pharmaceutical Quality | CDER | FDA |
Dr. Stevens-Riley is currently a master microbiology reviewer in the Division of Microbiology Assessment (DMA) in the Office of Process and Facilities (OPF) in the Office of Pharmaceutical Quality (OPQ) in CDER. Previously, she was a senior microbiology reviewer in the Office of Policy for Pharmaceutical Quality, and prior to the formation of the OPQ, she was a Team Leader in the Division of Microbiology in the Office of Pharmaceutical Science (OPS), and a Team Leader and senior microbiology reviewer in the Office of Generic Drugs (OGD) in CDER. She is a CDER liaison to the United States Pharmacopeia (USP) General Chapters-Microbiology Expert Committee and one of the co-leaders on the Parenteral Drug Association (PDA) Task Force rewriting the PDA Technical Report 27: Pharmaceutical Package Integrity. During her scientific career, she has co-authored over 15 peer-reviewed scientific publications. Dr. Stevens-Riley holds a B.S. in biology from the College of William and Mary and a Ph.D. in Microbiology from the University of Georgia, and she completed post-doctoral training in the Department of Microbiology and Immunology at the University of Texas Southwestern Medical Center in Dallas. |
| Kendra Stewart, PharmD Captain, USPHS Supervisory Pharmacist Orange Book Staff DLRS | OGDP | OGD CDER | FDA |
Captain Kendra Stewart is the Supervisor of the Orange Book Staff within the Office of Generic Drugs Policy (OGDP) at the Food and Drug Administration (FDA). She joined the FDA in 2003 as a Commissioned Officer in the US Public Health Service on the Orange Book Staff. She held that position until 2008, at which time she joined what was then known as the Labeling Review Branch within the Office of Genic Drugs (OGD). In 2013, after spending nearly five years as a labeling reviewer within that group, Captain Stewart returned to the Orange Book staff where currently she holds the position of Senior Supervisor Regulatory Affairs. In her work with the Orange Book she is involved extensively with various policy issues, drug product listings and patent and exclusivity matters. |
| Brenda Stodart, PharmD CAPT, USPHS Program Director CDER Small Business and Industry Assistance (CDER SBIA) DDI | OCOMM | CDER | FDA |
CAPT Brenda Stodart is currently the Program Director for the Center for Drug Evaluation and Research’s (CDER’s) Small Business and Industry Assistance (SBIA). Prior to her current position, CAPT Stodart was a Senior Regulatory Management Officer in the Office of Regulatory Policy (ORP). Before ORP, CAPT Stodart served as a Senior Health Promotion Officer in the Division of Drug Information for 9 years. CAPT Stodart received her BS in Pharmacy from Howard University and her PharmD from the University of Arkansas Medical Sciences. CAPT Stodart has had experience in hospital and retail pharmacy before joining the FDA. |
| Guoping Sun, PhD Branch Chief (Acting) Division of Immediate Release Products Office of Lifecycle Drug Products (OLDP) OPQ | CDER | FDA |
Dr. Guoping Sun currently serves as the Acting Branch Chief for the Division of Immediate Release Products within the Office of Lifecycle Drug Products (OLDP) at the Office of Pharmaceutical Quality (OPQ). He has occupied this position since 2015, prior to which he served as a Team Leader (2010 – 2014) and Review Chemist (2002 -2012) in the Office of Generic Drugs (OGD). Before coming to FDA, Dr. Sun was a Staff Fellow at the National Institutes of Health (NIH). From 1993-1988, Dr. Sun was employed as a Research Associate at the University of Tennessee. He received his PhD in organic chemistry from the University of Akron, Ohio in 1993. |
| Kimberley Swank, PharmD Safety Evaluator Office of Surveillance and Epidemiology (OSE) Division of Pharmacovigilance I CDER | FDA |
Dr. Swank obtained her PharmD from Nova Southeastern University College of Pharmacy in 2000. Following graduation, she completed a Pharmacy Practice Residency at University of Maryland Medical Center. Dr. Swank has 15 years of clinical pharmacy experience in various inpatient hospital settings. She has been at the FDA as a Safety Evaluator in the Division of Pharmacovigilance since 2014. |
| Karen Takahashi Senior Policy Advisor Division of Regulations, Guidance, and Standards Office of Policy for Pharmaceutical Quality (OPPQ) |
Karen Takahashi is a Senior Policy Advisor in CDER’s Office of Pharmaceutical Quality in the Office of Policy for Pharmaceutical Quality. Prior to January 2015, she spent fifteen years as a Compliance Officer and Senior Policy Advisor in CDER’s Office of Manufacturing and Product Quality. At the beginning of her FDA career, Karen was an Investigator with FDA’s New England District Office. She holds a Master of Science degree from Boston University, and a Bachelor of Science degree from the University of Wisconsin-Madison. |
| Maria Cecilia Tami, PhD Product Quality Team Leader Division of Biotechnology Review and Research 3 (DBRR3) Office of Biotechnology products (OBP) OPQ | CDER | FDA |
Dr. Maria Cecilia Tami received a M.Sc. in biology and a PhD in the field of molecular virology from University of Buenos Aires, Argentina. Dr. Tami joined the FDA as a post doctoral fellow at the Division of Emerging and Transfusion Transmitted Diseases, CBER/FDA and then became a product quality reviewer in the office of Biotechnology Products in CDER/FDA. She is currently a Product Quality Team Leader in the Division of Biologic Review and Research 3, in the Office of Biotechnology Products at the FDA. |
| Joseph Tartal Deputy Director Division of Industry and Consumer Education Office of Communication and Education CDRH | FDA |
Joseph Tartal is the Deputy Director of the Division of Industry and Consumer Education, in CDRH’s Office of Communication and Education. In this role, he directs the division’s effort to educate the medical device industry to understand its regulatory requirements and responsibilities with medical devices. Mr. Tartal also serve as an FDA Instructor for the Association for the Advancement of Medical Instrumentation (AAMI). Prior to his 12-year FDA career, Mr. Tartal served as a Quality Assurance Manager for small medical device manufacturers, primarily responsible for implementing and maintaining compliant quality management systems. Mr. Tartal has over 25 years of experience in the medical device industry, including premarket submissions. Mr. Tartal received a Bachelor of Science in Biology from Pennsylvania’s Slippery Rock University. |
| Douglas Throckmorton, MD Deputy Director for Regulatory Programs Office of the Center Director CDER, FDA |
Dr. Douglas Throckmorton is the Deputy Director for Regulatory Programs in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). In this role, he shares responsibility for overseeing the regulation of research, development, manufacture and marketing of prescription, over-the-counter and generic drugs in the U.S. From aspirin to cancer-treatments, CDER works to ensure that the benefits of approved drug products outweigh their known risks.Dr. Throckmorton has been at the FDA since 1997. He received his training in Internal Medicine and Nephrology from the University of Nebraska Medical School, Case Western Reserve University and Yale University. Prior to coming to the FDA he was a basic science researcher and academic physician at the Medical College of Georgia and the Veterans Administration Hospital in Augusta Georgia. |
| Maryll W. Toufanian, JD Division Director Office of Generic Drug Policy |
Most recently, Ms. Toufanian was an Associate Chief Counsel for Drugs in FDA’s Office of Chief Counsel focusing primarily on generic drug and biosimilar issues. Prior to joining FDA, she was in private pRACtice at Zuckerman Spaeder LLP, where she worked on a variety of FDA-related matters. |
| Katherine Tyner, PhD Associate Director for Science (Acting) SS | OPQ | CDER | FDA |
Dr. Katherine Tyner is the Associate Director of Science (acting) in the immediate office of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research at the United States Food and Drug Administration (FDA). As Associate Director, Dr. Tyner leads the OPQ Science Staff in coordinating the intersection between science, review, and policy in OPQ as well as facilitating interactions between other CDER offices and FDA Centers. She received her PhD in Chemistry from Cornell University and joined the Food and Drug Administration in 2007 as a chemist specializing in nanotechnology. While at the FDA, Dr. Tyner has investigated the quality, safety, and efficacy of drug products containing nanomaterials, and she currently leads the CDER nanotechnology working group and is active in other CDER and FDA nanotechnology initiatives. Dr. Tyner is the author of multiple book chapters and journal articles concerning the appropriate characterization and biological impact of nanoparticle therapeutics. |
| Kathleen Uhl, MD Director for the Office of Generic Drugs (OGD), CDER |
Kathleen Uhl, MD currently serves as the Director for the Office of Generic Drugs in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). This office is responsible for the review and approval of Abbreviated New Drug Applications (ANDAs) and is largely tasked with implementing the Generic Drug User Fee Amendments (GDUFA). Dr. Uhl began her career with FDA in 1998 as a medical officer in the Office of Clinical Pharmacology and has served in numerous positions at FDA, including the Assistant Commissioner for Women’s Health and the Director of FDA’s Office of Women’s Health and the Deputy Director of the Office of Medical Policy in the CDER. She received her undergraduate degree from Temple University and her medical degree from the Medical College of Pennsylvania, with subsequent fellowship training in medical research and clinical pharmacology at the Uniformed Services University. She retains faculty appointments as Professor in Family Medicine and Internal Medicine at the Uniformed Services University and is a retired officer of the US Public Health Service Commissioned Corps |
| Aileen I. Velez Cabassa Consumer Safety Officer Postmarket and Consumer Branch Division of Industry and Consumer Education Office of Communication and Education CDRH | FDA |
Aileen I. Velez Cabassa is a Consumer Safety Officer in the Postmarket and Consumer Branch, Division of Industry and Consumer Education (DICE), in CDRH’s Office of Communication and Education (OCE). In this role, she educates manufacturers to help them to learn and understand the regulations that govern medical devices and radiation-emitting products. Ms. Velez Cabassa has over 17 years of professional experience that includes: in the life science industry as a Quality Control Analyst for Cell Therapy products, in research laboratories at the Johns Hopkins University (JHU) and the Medical College of Virginia at Virginia Commonwealth University (VCU). She also proudly served in the US Navy as a Hospital Corpsman. Ms. Velez Cabassa received a Bachelor of Science in Biology from Virginia Commonwealth University (VCU) and a Master of Science in Biotechnology with a Regulatory Affairs concentration from Johns Hopkins University. |
| Ubrani Venkataram, PhD Branch Chief (Acting) Division of Process Assessment II OPF | OPQ | CDER | FDA |
Dr. Ubrani Venkataram came to the United States after completing his Ph.D. at the Indian Institute of Science, Bangalore, India. After completing his post-doctoral work, he worked in industry for several years. He has been with the Agency for more than 25 years and is currently an acting Branch Chief at the Office of Process and Facilities/OPQ/CDER/FDA |
| Alex Viehmann Branch Chief (Acting) Office of Surveillance (OS) Quality Intelligence Branch OPQ | CDER | FDA |
Alex Viehmann is currently the acting Branch Chief of the Quality Intelligence Branch within the Office of Surveillance. The Quality Intelligence Branch is responsible the site dossier program, CDER’s Quality Metrics implementation and OPQ statistical consults. Prior to joining the Quality Intelligence Branch, Alex worked as a statistician for the Office of Pharmaceutical Science’s Science and Research staff where he performed statistical reviews for ANDAs and NDAs, as well as managed research projects related to pharmaceutical manufacturing. He began is FDA career is 2009 working in the Office of Pharmaceutical Science’s Policy staff where developed guidance and standards related to sampling, test method evaluation and statistical quality control. Prior to joining the Agency, Alex worked as a project manager for a government contractor. He received his undergraduate degree in Economics and Statistics from the University of Maryland. |
| Jessica Voqui, PharmD. Regulatory Review Officer Study Endpoints and Labeling Development (SEALD) CDRH, FDA |
Dr. Voqui joined FDA as a Regulatory Review Officer for the Study Endpoints and Labeling Development (SEALD) – Study Endpoints Team in 2012. She earned a Doctor of Pharmacy degree at Virginia Commonwealth University, followed by a Master of Science in Pharmacy at the University of Florida (Pharmaceutical Outcomes and Policy program). Her professional interests include patient-reported outcomes, improving communications with stakeholders regarding clinical outcome assessments, and collaborative efforts for global harmonization of decisions and policies regarding clinical trials and study endpoints. |
| Marisa M. White, BS, CCRP Lead Consumer Safety Officer Division of Bioresearch Monitoring Office of Compliance CDRH | FDA |
Marisa White is the Research Misconduct and Complaints Lead Consumer Safety Officer for the Division of Bioresearch Monitoring (DBM) in the Office of Compliance at FDA’s Center for Devices and Radiological Health (CDRH). Marisa started at the FDA in the International Operations Branch under the Office of Regulatory Affairs (ORA), where she was involved in the coordination of FDA foreign inspections as the Bioresearch Monitoring (BIMO) Program Team Lead. Prior to FDA, Ms. White worked at the New York Blood Center as a Research Assistant before becoming a Clinical Research Program Coordinator at Johns Hopkins University in the Oncology Department, where she managed data and regulatory requirements for various multi-center protocols, with coordinating center responsibilities. She also served as a Senior Research Program Coordinator for the Leukemia Research Group with responsibilities for training and SOP writing/updates. After Johns Hopkins, she held several roles at a clinical research organization (Covance, Inc.), one of which was a Clinical Research Associate (CRA) involved the set-up and monitoring of clinical trials. Ms. White holds a Bachelor of Science in Biotechnology & Minor in Biochemistry from Rutgers University and a CCRP certification from the Society of Clinical Research Associates (SoCRA). |
| Tonya A. Wilbon Chief, Postmarket and Consumer Branch Division of Industry and Consumer Education Office of Communication and Education CDRH | FDA |
Tonya A. Wilbon is the Branch Chief for the Postmarket and Consumer Branch, Division of Industry and Consumer Education (DICE), in CDRH’s Office of Communication and Education. Tonya leads DICE’s efforts to educate and inform the medical device and radiation health industry on its FDA regulatory requirements for marketing medical devices and radiation-emitting products. In addition, she leads the division’s efforts to educate and inform consumers, health care professionals, and patients on issues with these medical devices and radiation-emitting products. Ms. Wilbon has been with FDA for over 18 years with more than 10 years of clinical laboratory experience. She initially began with the FDA as a Microbiology Scientific Reviewer for CDRH’s Office of In Vitro Diagnostics and Radiological Health (OIR) and served as the Quality System Specialist within OIR. Ms. Wilbon also currently serves as an FDA instructor for the Association for the Advancement of Medical Instrumentation (AAMI) new Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements, Integrating Risk Management into the Quality System Course, and Design Controls Course and assisted with updating the course ancillary document, The Quality System Compendium. She also serves on FDA’s Content Advisory Group and serves as an instructor for the FDA Basic Medical Device Course for FDA Investigators and Staff. Ms. Wilbon has previously served as a member of the Consensus Committee for Quality System and Laboratory Practices and the Subcommittee on Antimicrobial Susceptibility testing of Human Mycoplasmas for the Clinical and Laboratory Standards Institute (CLSI). Ms. Wilbon received a Bachelor of Science Degree in Microbiology from Howard University and is a certified Microbiologist by the American Society of Clinical Pathology (ASCP). |
| Willie Wilson III, PhD Chemist Division of Biotechnology Research and Review I Office of Biotechnology Products (OBP) OPQ | CDER | FDA |
Dr. Wilson serves as a Primary Product Quality Reviewer in the Office of Biotechnology Products (OBP) located in the Center for Drug Evaluation and Research (CDER). He is responsible for reviewing the Chemistry, Manufacturing and Controls (CMC) for therapeutic biologics throughout drug development. Dr. Wilson began his service with FDA in 2014. Prior to joining FDA, he conducted five years of post-doctoral training at the National Cancer Institute (NCI) on the campus of the National Institutes of Health, Bethesda, MD. Dr. Wilson received his Master’s degree in Biology from North Carolina Central University (Durham, NC), and his Doctoral degree in Genetics & Molecular Biology from the University of North Carolina at Chapel Hill, (Chapel Hill, NC). |
| Lieutenant Geoffrey Wu Associate Director for Science and Communication, Office of Lifecycle Drug Products (OLDP) Office of Pharmaceutical Quality (OPQ), CDER |
Geoffrey Wu, PhD, is a scientist officer in the United States Public Health Service. He is currently the Associate Director for Science and Communication in the Office of Lifecycle Drug Products, Office of Pharmaceutical Quality (OPQ), CDER. He is also a current member on the OPQ Emerging Technology Team (ETT). Geoff has been deeply involved, leading or co-leading regulatory review and research for controlled correspondences, ANDAs, and supplemental ANDAs in the past five years. Geoff has training and education in pharmacy, pharmaceutical science, protein chemistry, polymer chemistry, and process analytical technology. He received his PhD degree in Pharmaceutics and Pharmaceutical Chemistry from University of Utah, and BS in pharmacy and M.S. in pharmaceutics for Peking University, China. |
| Larisa Wu, PhD Special Assistant to OPQ Directors Office of Pharmaceutical Quality – Immediate Office (OPQIO), CDER, FDA |
Larisa Wu, Ph. D. serves as Special Assistant to the Office of Pharmaceutical Quality (OPQ) Directors in OPQ Immediate Office. Prior to this she was a product quality reviewer in the Peptide Team at Chemistry OGD/OPS and then in Science and Research Staff in the OPS IO. In this capacity, she performed primary and secondary review of ANDAs and DMFs for complex drug substances, as well as small molecules. Larisa was heavily involved in various initiatives within OPS which were pivotal for OPQ stand up, including integrated team based quality assessment, risk based review and CMC GDUFA hiring. Her contributions were recognized in various award ceremonies at agency, center, and office level. Larisa received her PhD degree in Bioengineering from University of Utah, followed by a postdoctoral fellowship in Pharmaceutical Sciences at University of Maryland, School of Pharmacy. She also holds a M.S. degree in Chemistry and a BS degree in Biomedical Engineering. |
| Yuliya Yasinskaya, MD Medical Team Leader DAIP | OAP | OND | CDER |
Dr. Yuliya Yasinskaya is a Medical Team Leader in the Division of Anti-Infective Products, Office of Antimicrobial Products, Center for Dug Evaluation and Research, Office of New Drugs. She obtained her Medical Degree from Khabarovsky State Medical University, Russia. She joined the FDA in 2005 as a Medical Officer after completion of her fellowship training as a pediatric infectious disease physician at NIH/Children’s National Medical Center. As a Medical Team Leader, she oversees a diverse application portfolio of products targeting various bacterial and fungal pathogens, agents of bioterrorism, as well as parasitic diseases (INDs, NDAs, BLAs) and is an active member of many Agency committees. |
| Johnny Young, MA Director (Acting) Division of Filing Review (DFR) ORO, OGD, CDER, FDA |
Acting Director, Division of Filing Review since September 2014. Acting Deputy Director, Division of Filing Review from August to September 2014. Regulatory Filing Reviewer in the Office of Generic Drugs/Division of Labeling and Program Support from May 2007 to August 2014. Prior to that, he was in retail pharmacy pRACtice for 18 years. He has a BS in Pharmacy from the University of MD; a BA in English Literature from the University of MD, Baltimore County; and a Liberal Arts Masters from St. John’s College in Annapolis. |
| Ingrid Zambrana Atlanta District Director Office of Regulatory Affairs FDA |
Ingrid Zambrana began her tenure as the District Director (DD) of the U.S. Food and Drug Administration Atlanta District Office and is part of ORA’s Senior Management Staff in April 2014. Prior to her current position, she was the ATL-DO Deputy District Director. She began her career with Food and Drug Administration as a Consumer Safety Officer in 2000 with the San Francisco District Office, based in the Fresno, CA resident post and relocated to Atlanta, GA in 2006. In this capacity, she conducted inspections or investigations in all program/product areas regulated by the FDA, including veterinary products, animal feeds, human foods, biologics, and clinical investigators. Prior to joining the FDA, she proudly served in the US Army in the military medical group, stationed domestically and abroad. Ms. Zambrana received a Bachelor of Science in Chemistry from Cameron University. |
| Chunchun Zhang, PhD CMC Lead (Acting) Office of New Drug Products (ONDP) OPQ | CDER | FDA |
Chunchun Zhang is a CMC lead (acting) in the Office of New Drug Products, OPQ/CDER at the Food and Drug Administration. She has been with the FDA since 2012. Prior to joining the FDA, she was as a principle scientist in Pfizer, working on drug discovery and development projects for 8 years. She obtained her PhD from University of Wisconsin-Milwaukee in 2004. |
| Huyi Zhang, PhD Acting Branch Chief in Division of Lifecycle API Office of New Drug Product, Office of Pharmaceutical Quality (OPQ), CDER, FDA |
Dr. Huyi Zhang received his PhD in Medicinal Chemistry and Bachelor of Pharmacy from Peking University Health Science Center (formerly Beijing Medical University). After his postdoctoral training in Organic Synthesis at Worcester Polytechnic Institute, he worked at Trimeris on Fuzeon and the follow-on fusion inhibitors. He led the API supporting group in Global Quality and Analytical Development in Technical Operation and Product Supply at legacy Wyeth, then Pfizer. In 2010, Dr. Zhang joined FDA’s Office of Generic Drug (OGD) as a Science Staff, and moved to the Drug Master File (DMF) review team in 2011, and currently serves as Acting Branch Chief in Division of Lifecycle API, Office of New Drug Product, Office of Pharmaceutical Quality (OPQ). |
| Banu Sizanli Zolnik, PhD Division of Biopharmaceutics, Office of New Drug Products (ONDP), Office of Product Quality (OPQ), CDER, FDA |
Banu Sizanli Zolnik is a biopharmaceutics reviewer in the Division of Biopharmaceutics, Office of New Drug Products within the Office of Product Quality (OPQ) at the FDA. Her responsibilities are to evaluate and review biopharmaceutics section of the New Drug Applications (NDAs) and drug component of the drug-device combination products. Upon the inception of the OQP in January 2015, Dr. Zolnik also evaluates and reviews the dissolution method for Abbreviated New Drug Applications (ANDAs). Previously, she was involved in various regulatory science policy projects related to nanotechnology, bioequivalence of generic drugs and drug product quality issues in the Science and Research Staff (SRS) of the Office of Pharmaceutical Science. Prior to joining SRS, Dr. Zolnik was a bioequivalence reviewer at the Office of Generic Drugs. Prior to joining FDA, she was a post-doctoral fellow in the Nanotechnology ChaRACterization Laboratory/NIH. Dr. Zolnik obtained her doctorate in Pharmaceutical Sciences from the University of Connecticut and a BS degree in Pharmacy from Istanbul University. |
| Susan Zuk, MS CDER Excipient Working Group Lead Office of Policy for Pharmaceutical Quality OPQ, CDER, FDA |
Susan holds a BS in Chemistry from SyRACuse University and a MS in Biotechnology from Johns Hopkins University. During her 16 years with the FDA, she has served as Chemistry Reviewer, Team Leader and Acting Deputy Director in the Office of Generic Drugs. She has served as Acting Branch Chief of the Division of Internal Policies and Procedures (DIPAP) in the OPQ Office of Policy for Pharmaceutical Quality (OPPQ). She is the current leader of the Excipient Working Group. In this role, she is responsible for overseeing the IID project. Susan has served on many FDA committees and working groups related to product safety and quality.. |