2023 Agenda
Workshop Agenda - Day 1 (January 24, 2023):
8:30 – 8:50
Introductions and Review of goals, roles, & expectations - Dr. Vadim Gurvich, NIPTE
8:50 – 9:25
Plenary Lecture - Dr. Ronald Piervincenzi, United Sates Pharmacopeia (USP)
9:25 – 10:00
Plenary Lecture - Dr. James Coburn, Food & Drug Administration (FDA)
10:00 – 10:15
Break
10:15 – 12:15
Session 1: Early Development and Evaluation - Dr. Allen Templeton, Merck and Dr. Annette Bak, AstraZeneca
10:15 – 10:35
Session Chair presentation:
State-of-the-art early development and evaluation including early chemistry, rapid formulation, and delivery system design for maximizing exposure of animals and humans, rapid manufacturing and control, preclinical toxicology consisting of (a) artificial organs; (b) chip tox technologies; (c) computational methods, and judicious scheduling of the entire preclinical landscape to reduce time to IND trials; (d) nanoparticles; and (e) small-scale continuous manufacturing of API and drug product.
Identification of barriers to accelerating early development and evaluation.
Identification of the main opportunities for accelerating early development and
evaluation.
10:35 – 10:55
Panel Discussions
10:55 – 11:25
Small group discussions: Breakthrough strategies for overcoming barriers
11:25 – 11:50
Reports by small groups
11:50– 12:15
Open forum discussion
12:15 – 1:15
Lunch
1:15 – 3:15
Session 2: Clinical Development and Evaluation - Dr. Martin Zand, University of Rochester Medical Center
1:15 – 1:45
Session Chair presentation:
State-of-the-art in Clinical development and evaluation including methods to accelerate clinical trials, adaptive trials, decentralized trials, recruitment, centralized versus local infrastructure, remote clinical trials
Barriers to accelerating Clinical development and evaluation.
Main opportunities for accelerating Clinical development and evaluation.
1:45 – 2:05
Panel Discussions
2:05 – 2:35
Breakout groups (by a barrier): Breakthrough strategies for overcoming barriers
2:35 – 3:00
Reports by breakout groups
3:00 - 3:20
Open forum discussion
3:20 – 3:30
Break
3:30 – 5:15
Session 3: Product Formulation and Process Development - Dr. Mauricio Futran, Independent Industry Consultant and Dr. Martin Eastgate, Bristol-Myers Squibb
3:30 – 3:50
Session Chair presentation:
State-of-the-art in Product Formulation and Process Development including solid dosage forms and injectables.
Barriers to accelerating Product Formulation and Process Development.
Main opportunities for Product Formulation and Manufacturing Process: formulation science database, AI-based prediction, advanced/continuous manufacturing, in-line controlling systems, scale-up process, modular GMP operations, etc.
3:50 – 4:05
Panel Discussions
4:05 – 4:35
Small group discussions: Breakthrough strategies for overcoming barriers
4:35 – 4:50
Break
4:50 – 5:20
Reports by small groups
5:20 - 5:50
Open forum discussion
6:00 – 8:30
Cocktail hour and dinner
Workshop Agenda - Day 2 (January 25, 2023):
8:00 – 9:00
Day 1 recap - Dr. Gintaras “Rex” Reklaitis, Purdue University
- Short presentations from attendees based on Section 3 outcomes
9:00 - 9:30
Knowledge Management for Medicine: Increasing Transparency with the CDEK
Knowledgebase - Dr. Michael Kinch, Long Island University
9:45 – 10:00
Break
10:00 – 12:00
Session 4: Industry Perspective – What does Industry need to accelerate drug product and process development? (Dr. Bikash Chaterjee and Dr. Richard Steiner, Pharmatech Associates
10:00 – 10:20
Session Chair presentation:
Barriers to accelerating Industry Product and Process Development
Main industry-based opportunities for accelerating Product and Process Development
10:20-10:40
Panel Discussion
10:40 – 11:10
Small group discussions: Breakthrough strategies for overcoming barriers
11:10 – 11:30
Reports by small groups
11:30 - 11:50
Open forum discussion
11:50 – 12:50
Lunch
1:20 – 3:30
Session 5: FDA-Industry Collaborations Opportunities - Dr. Thomas O’Connor, Food & Drug Administration (FDA)
1:20 – 1:35
Presentation by Dr. Thomas O’Connor, Food & Drug Administration (FDA)
1:35 – 2:05
Breakout groups (by a barrier): Breakthrough strategies for overcoming barriers
2:05 – 2:15
Break
2:15 – 2:45
Reports by breakout groups
2:45 – 2:55
Presentation by Stephen Colvill, Duke-Margolis Center for Health Policy
2:55 – 3:05
Presentation by Dr. Fernando Muzzio, Rutgers University
3:05 – 3:15
Open forum discussion
3:15 – 3:30
Break
3:30 – 5:30
Session 6 (evening) – Small group breakouts, brainstorming, whiteboarding
5:30 – 7:30
Cocktail hour and dinner
Workshop Agenda - Day 3 (January 26, 2023):
8:00 – 9:00
Day 2 recap - Dr. Frank Gupton, Virginia Commonwealth University
Short presentations from attendees based on Section 6 outcomes
9:00-noon
Session 7: Plenary discussion – Dr. Atul Dubey, United States Pharmacopeia (USP)
9:00 - 10:15
Selection of acceleration mechanisms to be included in Workshop Report
10:15 – 10:30
Break
10:30 – 11:30
Consensus on Workshop Report Outline and Publications
11:30 – 12:00
Selection of a Workshop Report Development Committee
Noon - 1:00
Lunch
1:00
GENERAL AUDIENCE DEPARTURE
