Don't Wait Until It's Too Late: Target Product Profiles and Avoiding Common Clinical Trial Mistakes

Event description

Presenters: Mark Levi, PhD and Elizabeth Mannick, MD

This webinar will discuss the importance of creating Target Product Profiles (TPPs) early in the product development stage and will provide several example profiles. The presentation will also include clinical trial design considerations at each phase of clinical development and will present examples of common mistakes at each phase, from real-world examples. Mitigation of issues and reduction of development time will also be discussed.

Dr. Mark Levi is a Director of Regulatory Affairs at RTI International with 20 years' experience in medicinal chemistry, pharm/tox, and CMC with a 9-year tenure at the FDA in NCTR and CBER. He has also consulted and worked at a late-stage biotech.

Dr. Elizabeth Mannick is a Director of Regulatory Affairs at RTI international as well as a pediatric gastroenterologist who was a clinical reviewer at FDA/CDER and a safety physician and regulatory affairs specialist for multinational, public, pharmaceutical companies.

Webinar presented on May 22, 2024 to an invited audience.

This video is provided for educational purposes only.

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Chapters

00:00
Welcome
01:26
What is a Target Product Profile (TPP)? and Why is it important?
03:00
Product TPP for Asthma
05:17
Product TPP for Pulmonary Arterial Hypertension (PAH)
07:07
Clinical Trial Design Considerations
07:15
Trial Considerations
10:44
Issues Encountered at Phase Ia (First in Human)
12:23
Biologics Anaphylaxis
14:40
Issues Encountered at Phase Ib
19:12
Phase II Clinical Trial Planning
24:40
Clinical Trial Pitfalls
24:58
"Don't wait until it's too late": Phase 2 Pitfall Examples
31:37
Phase III Clinical Trial Planning
33:37
"Don't wait until it's too late": Phase 3 Pitfall Examples
36:00
In Summary
37:07
Q&A
This research was, in part, funded by the National Institutes of Health (NIH) Agreement OT2 HL157844-01. The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the NIH.