A tentative agenda for "Pediatric Formulation Development: Challenges of Today and Strategies for Tomorrow" is available below for the convenience of workshop attendees.

This two-day workshop is scheduled for June 18-19, 2019. It will be held at the University of Maryland School of Pharmacy, located at 20 N. Pine Street in Baltimore, Md.

This two-day workshop will consist of sequential sessions to allow for maximum participation. The workshop will be divided to four main sessions: formulation, analytical, clinical, and regulatory and industry feedback. Each session will be initiated with a series of short framing presentations, followed by a facilitated break-out session. Interactive case studies will be used where appropriate. This workshop is intended to promote synergy and exchange in aspects of pediatric drug development. It is designed as a working session where participants discuss issues. All participants will be provided with pre-reading materials covering key topics for discussion prior to the workshop.

Download a printer-friendly agenda here.

Tuesday, June 18, 2019

7:45-8:30 a.m. Registration and Breakfast
Steve Hoag
University of Maryland School of Pharmacy
8:30-8:40 a.m. Introduction and Welcome
Steve Hoag
University of Maryland School of Pharmacy
8:40-8:55 a.m. Highlights of M-CERSI/EuPFI Workshop: Challenges and Strategies to Facilitate Formulation Development of Pediatric Drug Products (June 8-9, 2016 | College Park, MD)
Trupti Dixit
Navigant Pharma Consulting
8:55-9:15 a.m. Expectations for 2019 Workshop Outcomes
Arzu Selen
U.S. Food and Drug Administration
9:15-9:35 a.m. Formulation: Pediatric Patients Inspiring and Shaping Drug Development
Arzu Selen
U.S. Food and Drug Administration
9:35-9:45 a.m. Formulation: Industry Formulation Perspective
Karen Thompson
9:45-10:30 a.m. Formulation Break-Out 1: Excipients
Moderator: Darren Fegley (FDA)
10:30-10:45 a.m. Break and Networking
10:45-11:30 a.m. Formulation Break-Out 2: Acceptability
Moderator: Robert Ternik (Eli Lilly)
11:30 a.m. – 12:15 p.m. Formulation Break-Out 3: Devices
Moderator: Matthew Santangelo (Pfizer)
12:15-1:15 p.m. Group Photo, Lunch, and Networking
1:15-2:15 p.m. Formulation Summary and Panel Discussion
Moderator: Matthew Santangelo (Pfizer)
2:15-2:30 p.m. Analytical: Testing and Release Strategies for Mini-tablets
Asha Rajapakshe
2:30-2:45 p.m. Analytical: Considerations for In-Use Stability and Compatability with Vehicles
Ramesh Sood
U.S. Food and Drug Administration
2:45-3:30 p.m. Analytical Break-Out 1: Mini-tablets Specification
Moderators: Elizabeth Galella (Bristol-Myers Squibb), Asha Rajapakshe (Merck), and Biplob Mitra (Celgene)
3:30-3:45 p.m. Break and Networking
3:45-4:30 p.m. Analytical Break-Out 2: Dosing Vehicles
Moderators: Ramesh Sood (FDA), Steven Mount (Astra Zeneca), and Paul Seo (FDA)
4:30-4:45 p.m. Break and Networking
4:45-5:45 p.m. Analytical Summary and Panel Discussion
Moderator: Elizabeth Galella (Bristol-Myers Squibb)
5:45-7:45 p.m. Evening Reception and Poster Session

Wednesday, June 19, 2019

8:00-8:30 a.m. Breakfast
8:30-8:45 a.m. Summary of Day 1
Elizabeth Galella
Bristol-Myers Squibb
8:45-9:00 a.m. Perspectives on the Need for Improved Pediatric Formulations
Ann Zajicek
National Institutes of Health
9:00-9:15 a.m. Clinical: Clinical Considerations in Pediatric Drug Product Development from an Industry Perspective Jack Cook
9:15-9:30 a.m. Clinical: Value of Pharmacokinetics in Pediatric Clinical Trials
Hao Zhu
U.S. Food and Drug Administration
9:30-10:15 a.m. Clinical Break-Out 1: Pharmacokinetics
Moderators: Jian Wang (FDA) and Shailly Mehrotra (Otsuka Pharmaceutical)
10:15-10:30 a.m. Break
10:30-11:15 a.m. Clinical Break-Out 2: Study Design
Moderators: Jing Liu (Pfizer) and Hari Sachs (FDA)
11:15 – Noon Clinical Break-Out 3: Biostudies to Support Formulation
Moderators: Karen Thompson (Merck) and Elmika Fletcher (FDA)
Noon – 12:45 p.m. Lunch and Networking
12:45-1:45 p.m. Clinical Summary and Panel Discussion
Moderator: Jack Cook (Pfizer)
1:45-2:00 p.m. Regulatory and Industry: Building on Regulatory Experiences to Advance Pediatric Formulation Development
Erica Radden
U.S. Food and Drug Administration
2:00-2:15 p.m. Regulatory and Industry: Looking into the Future of Pediatric Development
Daniel Schaufelberger
Schaufelberger Consulting
2:15-3:00 p.m. Regulatory and Industry Break-Out 1: Regulatory Lessons Learned
Moderators: Erica Radden (FDA) and Mona Khurana (FDA)
3:00-3:15 p.m. Break and Networking
3:15-4:00 p.m. Regulatory and Industry Break-Out 2: Future Landscape
Moderators: David Tan (AbbVie) and Daniel Schaufelberger (Schaufelberger Consulting)
4:00-4:15 p.m. Break and Networking
4:15-5:15 p.m. Regulatory and Industry Summary and Panel Discussion
Moderator: David Tan (AbbVie)
5:15-5:30 p.m. Closing and Summary
David Tan