Oncology Therapy Development Workshop:Pivotal Steps and Avoiding Pitfalls for Start-ups
March 30 & 31, 2021
The agenda may be updated if scheduling changes occur. The current version is Version 9, updated on March 26, 2021.
The speaker biographies document provides additional details about all the Workshop speakers.
Links to recordings will be added below as they become available.
- Oncology Center of Excellence Introduction – Marc Theoret and Overview and Guide to the Workshop – Jeffrey Summers
- Keynote: Innovation Mindset – Advancing Science to Therapies – Keith Marmer
- FDA Oncology Drug Development Overview – Past to Present – John Leighton
- Federal Resources for Innovative Cancer Startups: More than Just Funding! – Deepa Narayanan
- Best Practices for Venture Capital Fundraising: Learn How Early-stage VCs Think – Colleen Cuffaro & Christy Shaffer
- Funding Sources: Q&A Panel
- Building Your Network and Value to Obtain External Input Prior to Interacting with FDA – Julie Bullock
- Assembling the Best Team to Navigate Through Preclinical Development – Christopher Scull
- Consulting Companies and FDA Limitations: Q&A Panel
- CMC Considerations for CAR T Cell Product Development – Kimberly Schultz
- CMC Considerations for Oncolytic Viral Product Development – Bo Liang
- Preclinical Considerations for Cell and Gene Therapy Products, An FDA Perspective – Ying Huang
- FDA’s Clinical Regulatory Perspective: Designing First-In-Human Trial for Cellular and Gene Therapy Products – Peter Bross
- Welcome and Overview for Day Two – Jeffrey Summers
- Chemistry and Manufacturing Requirements for Early Clinical Development: What’s in there? Prove it. – Paresma Patel & Olen Stephens
- CMC Considerations for Biotechnology Product Development: A Regulatory Perspective – Wendy Weinberg & Kristen Nickens
- Getting to FIH for Small Molecules and Biologics – Whitney Helms
- Designing First-in-Human Trials for Small Molecules and Biologics – Martha Donoghue
- Planning for Co-development of Companion Diagnostics – Donna Roscoe
- Clinical Development of Radiopharmaceuticals as Theranostic Pairs and Dosimetry Considerations for Therapeutic Radiopharmaceuticals – Anthony Fotenos & Donika Plyku
- Getting the Best Dose: The Clinical Pharmacology Studies that Help Achieve this Goal – Brian Booth
- Panel Discussion with Jeffrey Summers & Marc Theoret
Continuing Education Credit
Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.
- has been pre-approved by RAPS as eligible for credits (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
- has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.
- has been pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
If you have questions regarding the content of the event or other CDER-specific information, please: