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