IQ CMC Summit
Hot Topics in Pharmaceutical Innovation: Novel Modalities & Development Strategies

October 9, 2024
National Press Club, Washington, DC
** IN-PERSON ONLY **

Join us to explore CMC and regulatory aspects on various topics like artificial intelligence (AI)/machine learning (ML), data management, PFAS, Nitrosamine, MAPP, and novel modalities!  The experts among our working group leads will present current CMC and regulatory perspectives and share challenges faced by your peers.  If you have proposals, please reach out and we will form a track – bring your problems to us!

Through highlighted Working Group presentations, interactive Hot Topic Discussions led by each CMC Leadership Group, and breakout sessions attendees can expect to learn:

US Eastern Time Zone

8:00 AM – 8:55 AM

8:55 AM – 9:00 AM

9:00 AM – 9:40 AM
 

9:40 AM - 10:20 AM
 

10:20 AM – 10:55 AM
 

10:55 AM – 11:30 AM

11:30 AM – 12:05 PM

 

12:05 PM – 1:00 PM

1:00 PM – 1:35 PM

1:35 PM – 2:10 PM



 

2:10 PM – 2:45 PM

2:45 PM – 3:20 PM
 

3:20 PM – 3:30 PM

3:30 PM – 4:40 PM



 

4:40 PM – 4:55 PM

4:55 PM – 5:00 PM

DRAFT PROGRAM AGENDA

Continental Breakfast and Networking

Welcome

Industry Keynote Address: David Curran (GSK)
- Long-Acting Injectables 

Regulatory Keynote Address: Hongna Wang (FDA)
- MAPP 5019

MAPP Hot Topic Discussion
Biologics CMC and Drug Product Leadership Groups

Nanomaterial and Nanotechnology WG Presentation (DPLG)

Patient-centric specifications and Bayesian analysis in CMC Hot Topic Discussion
Statistics Leadership Group

Networking & Lunch

Next-Generation Data Analytics WG Presentation (ALG)

Artificial Intelligence, Machine Learning, and Automation Hot Topic Discussion
- Analytical Leadership Group
- Biologics CMC Leadership Group
- Quality Leadership Group

Nitrosamines WG Presentation (DSLG)

PFAS Hot Topic Discussion
Drug Substance Leadership Group

Break

Parallel Breakout Sessions (Tentative Topics Below - # and Topics to be Decided by Participant Interest at Event)
1. Titanium Dioxide
2. Analytical Platforms & Data Integrity
3. New Modalities

Debrief from Breakout Sessions 

Closing Remarks

 


REGISTRATION

This event is open to the public. IQ membership is not required.


VENUE

National Press Club
529 14th St NW Washington, DC 20045