Pharmaceutical & BioScience Society, PBSS

Symposium

[Free Online Symposium] Pediatric Drug Development: Regulatory and Clinical Considerations and Clinical Pharmacology Approaches

Speakers: Richard Vesely, Allucent; Bhanu Bejgum, Amgen; Manoj Chiney, Gilead; Salil Pendse, Allucent; Catherine Sherwin, Allucent; Ikram Elayan, FDA; Rainer Strotmann, Merck KGaA; Andrew Mulberg, Neurogene Inc
Organizers: Neha Bhise (Allucent), Richard Vesely (Allucent), Lauren Lohmer (Taiho Oncology), Betty Hussey (Allucent), Katy Moore (Allucent), Snow Ge (BridgeBio Pharma)
Date: 2023-04-03- 03/31/2023
Time: 8:30-13:30 Pacific Time
Registration fee: 0
Location: Online via Zoom
Major Sponsor:
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2023-03-31 (it will close sooner if the seating cap is reached)

About the Topic

Pediatric medicines are vital to the health and well-being of children. It is crucial to create a thoughtful plan to support efficient pediatric drug development to ensure safe and effective medicines for children. This workshop will cover the current regulatory perspectives, nonclinical and clinical strategies, and model-based approaches that can help accelerate pediatric drug development. Following completion of the workshop, the participants will have a deeper understanding of the regulatory perspectives of EMA and FDA in pediatric drug development, clinical study design considerations and strategies, and quantitative tools and real-world evidence that would help accelerate pediatric drug development.

About the Speakers

Day 1: Regulatory and Clinical Considerations in Pediatric Drug Development

PST	EST	Topic	Presenter
8:30-8:40 am	11:30-11:40 am	Welcome remarks	Snow Ge, BridgeBio Pharma
Regulatory Considerations: PIP and PSP to Advance Pediatric Development
8:40-9:20 am	11:40-12:20 pm	Pediatric drug development overview-past, present and future	Richard Vesely, MD, Vice President, Regulatory Affairs, Allucent
Non-clinical and Clinical Considerations in Pediatric Trials
9:20-10:00 am	12:20-1:00 pm	Juvenile animal studies in support of pediatric drug development: a regulatory perspective	Ikram Elayan, PhD, Pharmacology/Toxicology Supervisor, DPT-N, Office of Neuroscience, CDER-FDA
10:00-10:40 am	1:00-1:40 pm	Design and operational considerations for pediatric trials	Catherine Sherwin, PhD, MPharm, DABCP, FCP, CPI, Prof. VC Research (Pediatrics), Wright State University; VP, Clin Pharm, Allucent
10:40 -11:20 am	1:40-2:20 pm	Oral pediatric formulation development: drivers and industry trends	Bhanu Bejgum, PhD, Process, Development Sr. Scientist, Pivotal Drug Product Technologies, Amgen
11:20-12:20 pm	2:20-3:20 pm	Panel discussion and wrap up	All speakers

Day 2: Clinical Pharmacology Elements and Extrapolation Approaches

PST	EST	Topic	Presenter
8:30-8:40 am	11:30-11:40 am	Welcome remarks	Snow Ge, BridgeBio Pharma
Extrapolation Strategy to Enhance Efficiency of Pediatric Drug Development: Role of MIDD (PBPK, PopPK) approaches
8:40-9:20 am	11:40-12:20 pm	Challenges in Pediatric Drug Development: Regulatory Challenges, Role of Extrapolation, Ethical Considerations and Benefit Risk Calculus	Andrew Mulberg, MD, Senior Vice President, Regulatory Affairs at Neurogene Inc
9:20-10:00 am	12:20-1:00 pm	Quantitative approaches to support dose selection in pediatrics	Manoj Chiney, PhD, Director, Clinical Pharmacology, Gilead
10:00-10:40 am	1:00-1:40 pm	PBPK modeling to support dose selection in pediatric development	Salil Pendse, MS, Associate Director QSP, Allucent
10:40 -11:20 am	1:40-2:20 pm	Clin Pharm aspects in the development of an age-appropriate formulation	Rainer Strotmann, MD, Senior Scientific Director, Quantitative Pharmacology, Merck Healthcare KGaA
11:20-12:20 pm	2:20-3:20 pm	Panel discussion and wrap up	All speakers

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