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 – 1:45 PM


1:45 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 Topic Keynote Address: Rising to the Challenge: In-Vitro Release of Long Acting Injectables 
David Curran (GSK)

Regulatory Topic Keynote Address: Allowable Content in Vials
Chandra Webb (Pfizer)

Content in Injectable Products (Vials) Hot Topic Discussion
BioCMC facilitator: Chandra Webb (Pfizer)
DPLG facilitator: David Tan (AbbVie)

Nanomaterial and Nanotechnology WG Presentation (DPLG)
Patrick Lim Soo (Pfizer)

Patient Centric Specifications and Bayesian Analysis in CMC Hot Topic Discussion (SLG)
Bayesian Analysis facilitator: Katherine Giacoletti (Merck)
Patient Centric Specifications facilitator: Stan Altan (JnJ)

Networking & Lunch

Next-Generation Data Analytics WG Presentation (ALG)
Brian Good (Eli Lilly)
Peter Tattersall (BMS)

IQ MLAC Update
Brian Good (Eli Lilly)

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

Nitrosamines WG Presentation (DSLG)
Frank Bernardoni (Merck) or Jared Evans (Gilead)

PFAS Hot Topic Discussion
Facilitator: Gemma Scotney (Pfizer)

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
4, Primary Stability Batch

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