2024 Agenda
Workshop Agenda - Day 1 (January 9, 2024):
8:30 – 9:45
Registration and Breakfast
9:45 – 10:05
Introductions and Review of goals, roles, and expectations, Vadim Gurvich, NIPTE
10:05 – 10:40
PLENARY TALK: Scientific Challenges in the Development of Complex Injectables
Robert Lionberger, Director, Office of Research and Standards, Office of Generic Drugs, FDA
10:40 - 11:15
PLENARY TALK: The Race to End Drug Shortages through Partnership & Patient-Centric Design
Laura Bray, Founder, Angels for Change
11:15 – 1:15
SESSION 1: Patient-centric discussion on injectable drug products
(Moderator: Robin Bogner, University of Connecticut/NIPTE)
11:15 – 11:35
Presentation of issues: Identify scientific, technological, and regulatory issues that need to be resolved, Parag Kolhe, Pfizer
11:35 – 12:35
Discussion: Breakthrough strategies for overcoming barriers
Glenn Wright, PDA; Hailing Zhang, FDA; Pieter Muntendam, SQ Innovation
12:35– 1:15
Lunch Break
1:15 – 3:15
SESSION 2: Injectable drug device combinations (Moderator: Eric Munson, Purdue/NIPTE)
1:15 – 1:35
Session Chair presentation: Manuel Sanchez-Felix, Halozyme Therapeutics
State-of-the-art in injectable device drug combinations, development and evaluation including methods to accelerate.
Barriers to accelerating combination product development and evaluation.
Main opportunities for accelerating product development and evaluation.
1:35 – 1:55
Panel Discussions
Manuel Sanchez-Felix, Halozyme Therapeutics; Galen Shi, Lilly; Eric Munson, Purdue/NIPTE
1:55 – 2:25
Breakout groups (by barrier): Breakthrough strategies for overcoming barriers
2:25 – 2:35
Break
2:35 – 2:55
Reports by breakout groups
2:55 – 3:15
Open forum discussion
3:15 – 3:30
Break
3:30 – 5:30
SESSION 3: Injectables with Complex Formulations and Assessment
(Moderator: Xiuling Lu, University of Connecticut/NIPTE)
3:30 – 3:50
Summary presentation: Annette Bak, AstraZeneca and Robert Lionberger, FDA
State-of-the-art formulation development for complex injectables and their quality evaluations.
Barriers to accelerating Product Formulation and Process Development.
3:50 – 4:10
Panel Discussions (Yan Wang, FDA; Annette Bak, AstraZeneca, Xiuling Lu, University of Connecticut/NIPTE)
4:10 – 4:40
Small group discussions: Breakthrough strategies for overcoming barriers
4:40 – 4:50
Break
4:50 – 5:10
Reports by small groups
5:10 – 5:30
Open forum discussion
Workshop Agenda - Day 2 (January 10, 2024):
7:45 – 8:15
Registration and Breakfast
8:15 – 8:30
Day 1 recap, Fernando Muzzio, Rutgers University/NIPTE - short presentations from attendees based on Section 1, 2 and 3 outcomes
8:30 - 9:00
Keynote 1 Continuous manufacturing of complex Injectables, PAT and AI Antony Costa, DIANT Pharma
9:00 – 9:30
Keynote 2: Advancing Freeze Drying through Technical Innovation: A Review of Current Efforts, Emily Gong, PSI
9:30 – 9:45
Q&A (Diane Burgess and Robin Bogner, University of Connecticut/NIPTE)
9:45 – 10:00
Break
10:00 – 12:00
Session 4: Advanced manufacturing in injectable products (Moderator: Diane Burgess)
10:00 – 10:20
Session Chair presentation: (Sujatha Sonti, GSK)
Main opportunities for Product Formulation and Manufacturing Process: AI-based prediction, advanced/continuous manufacturing, in-line controlling systems, scale-up process, modular GMP operations, etc.
Presentation by a large-scale manufacturer (Susan Clemmons, GSK)
Presentation by a small-scale manufacturer (Joe Bagan, 503B outsourcing facility)
10:20 – 10:40
Panel Discussion
10:40 – 11:10
Small group discussions: Breakthrough strategies for overcoming barriers
11:10 – 11:20
Break
11:20 – 11:40
Reports by small groups
11:40 - 12:00
Open forum discussion
12:00 – 1:00
Lunch
1:00 – 3:00
Session 5: Advanced modeling and analytical tools (Moderator: Bodhi Chaudhuri, University of Connecticut/NIPTE)
1:00 – 1:20
Session Chair presentation: (Michael Tian, FDA and Yongchao Su, Merck)
Main agency-based opportunities for accelerating evaluation. Breakthrough Therapy Designation, Emerging Technologies Team
1:20 – 1:40
Panel Discussions (Yongchao Su, Merck; Francis Kwofie, GSK; Michael Tian FDA; Steven Castleberry, Genentech)
1:40 – 2:10
Breakout groups (by barrier): Breakthrough strategies for overcoming given barriers
2:10 – 2:20
Break
2:20 – 2:40
Reports by breakout groups
2:40 – 3:10
Open forum discussion
3:10 – 3:30
Break
3:30 – 5:30
Session 6: Pathfinding – Small group breakouts, brainstorming, whiteboarding (Moderator: Alina Alexeenko and Nate Milton Purdue University/NIPTE)
Workshop Agenda - Day 3 (January 11, 2024):
8:15 – 8:45
Registration and Breakfast
8:45 – 9:00
Day 2 recap (Eric Munson, Purdue University/NIPTE)
Short presentations from attendees based on Section 4-6 outcomes
9:00 - 9:30
Keynote 3: Addressing supply chain vulnerabilities with innovative solutions Michael Levy, USP
9:30-10:00
Keynote 4: Innovation through Advanced Manufacturing: Learning from the Future Xiaoming Xu, FDA
10:00-10:15
Break
10:15-12:15
Session 7: Policy and Regulatory Perspective
(Moderator: Stephen Colvill, Duke Margolis Center for Health Policy)
10:15 – 10:55
Panel Discussions (Xiaoming Xu, FDA; Michael Levy, USP; Stephen Colvill)
Regulatory barriers to accelerating Industry Product and Process Development
10:55 – 11:25
Small group discussions: Breakthrough strategies for overcoming barriers
11: 25- 11:35
Break
11:35 – 11:55
Reports by breakout groups
11:55 – 12:15
Selection of a Workshop Report Development Committee
12:15 - 1:00
Lunch
1:00
WORKSHOP ADJOURNS – Thank you! General Audience departure
CLOSED SESSION
1:00 – 3:00
Organizing Committee - Development Committee Discussion & Report Session
