2024 API Agenda
Advanced Manufacturing Technologies: Overcoming Global Risk to the Pharmaceutical Supply Chain
Workshop Agenda - September 23, 2024:
START AT NOON
11:30-12:00
Registration and box lunch
12-12:15
Opening Remarks (Vadim Gurvich, NIPTE)
12:15-12:45
API: Achieving Pharmaceutical Independence (Stephen Schondelmeyer/Fernando Muzzio)
12:45-1:15
Keynote: TBD
1:15– 1:30
Q & A Session
1:30-2:00
Plenary Talk: Joe Hammel/Chad Hrdina/Sean Cease/Dawn O’Connell/Judy Staveley (ASPR)
2:00-2:15
Break
2:15 – 4:15
Session 1: Prioritization of Critical Active Pharmaceutical Ingredients
2:15 – 2:45
Session Chair Presentation (Stephen Schondelmeyer, Minnesota/NIPTE)
2:45 – 3:15
Panel Discussions: (Panel members TBD)
3:15 – 3:45
Small group discussions: Breakthrough strategies for overcoming barriers
3:45-4:00
Reports by small groups
4:00– 4:15
Open forum discussion
4:15-4:45
Break
4:45-6:45
Session 2: Feasible Alternative Pathways to Critical APIs and Excipients Using Domestically
Sourced Key Starting Materials
4:45 – 5:15
Session Chair presentation: (James Ferri, VCU/NIPTE)
5:15 – 5:45
Panel Discussions (Panel members TBD)
5:45 – 6:15
Small group discussions: Breakthrough strategies for overcoming barriers
6:15 – 6:30
Reports by breakout groups
6:30 – 6:45
Open forum discussion
6:45 – 8:15 p.m.
Cocktail reception & dinner
Workshop Agenda - September 24, 2024:
8:00-8:30
Registration and continental breakfast
8:30-9:00
Day 2 Opening Remarks and Day 1 recap (TBD)
9:00-11:00
Session 3: Technology Transfer and Commercial Implementation
9:00 – 9:30
Session Chair Presentation (Frank Gupton, VCU/NIPTE)
9:30 – 10:00
Panel Discussions (Panel members TBD)
10:00 – 10:30
Small group discussions: Breakthrough strategies for overcoming barriers
10:30-10:45
Reports by small groups
10:45 – 11:00
Open forum discussion
11:00-11:15
Break
11:15 –1:15
Session 4: Platform for Rapid Development, Scale-Up, Manufacturing, and Technology Transfer
11:15 – 11:45
Session Chair presentation: Fernando Muzzio (Rutgers/NIPTE)
11:45 – 12:15
Panel Discussion (TBD)
12:15 – 12:45
Small group discussions: Breakthrough strategies for overcoming barriers
12:45 – 1:00
Reports by small groups
1:00 - 1:15
Open forum discussion
1:15 – 2:00
Lunch
2:00 – 4:00
Session 5: Critical Excipients
2:00 – 2:30
Session Chair presentation (Krizia Kerry/BASF)
2:30 – 3:00
Panel Discussions (TBD)
3:00 – 3:30
Small group discussions: Breakthrough strategies for overcoming given barriers
3:30 – 3:45
Reports by breakout groups
3:45 – 4:00
Open forum discussion
4:00 – 4:15
Break
4:15 – 5:00
Concluding Thoughts and Next Steps: TBD
5:00
Meeting Adjourned
