Oncology Therapy Development Workshop:
Pivotal Steps and Avoiding Pitfalls for Start-ups
March 30 & 31, 2021

Session Recordings:

Links to recordings will be added below as they become available.

Day One:

• 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

Day Two:

• 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

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