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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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