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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 SpeakersDay 1: Regulatory and Clinical Considerations in Pediatric Drug Development
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PST
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EST
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Topic
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Presenter
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8:30-8:40 am
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11:30-11:40 am
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Welcome remarks
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Snow Ge, BridgeBio Pharma
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Regulatory Considerations: PIP and PSP to Advance Pediatric Development
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8:40-9:20 am
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11:40-12:20 pm
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Pediatric drug development overview-past, present and future
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Richard Vesely, MD, Vice President, Regulatory Affairs, Allucent
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Non-clinical and Clinical Considerations in Pediatric Trials
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9:20-10:00 am
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12:20-1:00 pm
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Juvenile animal studies in support of pediatric drug development: a regulatory perspective
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Ikram Elayan, PhD, Pharmacology/Toxicology Supervisor, DPT-N, Office of Neuroscience, CDER-FDA
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10:00-10:40 am
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1:00-1:40 pm
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Design and operational considerations for pediatric trials
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Catherine Sherwin, PhD, MPharm, DABCP, FCP, CPI, Prof. VC Research (Pediatrics), Wright State University; VP, Clin Pharm, Allucent
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10:40 -11:20 am
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1:40-2:20 pm
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Oral pediatric formulation development: drivers and industry trends
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Bhanu Bejgum, PhD, Process, Development Sr. Scientist, Pivotal Drug Product Technologies, Amgen
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11:20-12:20 pm
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2:20-3:20 pm
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Panel discussion and wrap up
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All speakers
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Day 2: Clinical Pharmacology Elements and Extrapolation Approaches
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PST
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EST
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Topic
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Presenter
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8:30-8:40 am
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11:30-11:40 am
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Welcome remarks
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Snow Ge, BridgeBio Pharma
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Extrapolation Strategy to Enhance Efficiency of Pediatric Drug Development: Role of MIDD (PBPK, PopPK) approaches
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8:40-9:20 am
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11:40-12:20 pm
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Challenges in Pediatric Drug Development: Regulatory Challenges, Role of Extrapolation, Ethical Considerations and Benefit Risk Calculus
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Andrew Mulberg, MD, Senior Vice President, Regulatory Affairs at Neurogene Inc
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9:20-10:00 am
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12:20-1:00 pm
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Quantitative approaches to support dose selection in pediatrics
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Manoj Chiney, PhD, Director, Clinical Pharmacology, Gilead
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10:00-10:40 am
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1:00-1:40 pm
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PBPK modeling to support dose selection in pediatric development
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Salil Pendse, MS, Associate Director QSP, Allucent
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10:40 -11:20 am
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1:40-2:20 pm
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Clin Pharm aspects in the development of an age-appropriate formulation
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Rainer Strotmann, MD, Senior Scientific Director, Quantitative Pharmacology, Merck Healthcare KGaA
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11:20-12:20 pm
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2:20-3:20 pm
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Panel discussion and wrap up
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All speakers
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