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
| Time | Activity |
|---|---|
| 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 Merck |
| 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 Merck |
| 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
| Time | Activity |
|---|---|
| 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 Pfizer |
| 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 AbbVie |