TUESDAY, OCTOBER 8

IQ CMC Leadership Group Meetings

start times vary - contact the IQ Secretariat lead
Faegre Drinker Biddle & Reath LLP, Washington, DC
IQ membership required to attend Leadership Group (LG) meetings

• Analytical Leadership Group (ALG) 9:00-5:00 PM ET
• Biologics CMC Leadership Group (BIO LG) 9:00-5:00 PM ET
• Drug Product Leadership Group (DPLG) 9:00-5:00 PM ET
• Drug Substance Leadership Group (DSLG) 1:00-5:00 PM ET
• Quality Leadership Group - GMP QA  (TBD)
• Quality Leadership Group - GLP QA & GMP QA (TBD)

WEDNESDAY, OCTOBER 9

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

9:00 AM – 5:00 PM ET 
National Press Club, Washington, DC
Open to the public

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:

• Risk assessment and process to decipher these latest regulatory developments and challenges; what are the root of the challenge(s)?
• Case studies, guidance, applications, and potential solutions presented by WG leads.
• Learn ways to participate in cross-functional WGs to solve these problems. 
• The potential for future industry collaboration opportunities and/or concerted health authority engagement

IQ Life Science Leadership Group Meetings

start times vary - contact the IQ Secretariat lead
Faegre Drinker Biddle & Reath LLP, Washington, DC
IQ membership is required to attend Leadership Group (LG) meetings.

• 3Rs Translational and Predictive Sciences Leadership Group (3Rs TPS LG) TBD
• Clinical Pharmacology Leadership (CPLG) 9:00-5:00 PM ET
• Quality Leadership Group - GLP QA (TBD)
• Quality Leadership Group - GLP QA & GMP QA (TBD)

Welcome Reception

6:00 PM – 7:30 PM ET 
Faegre Drinker Biddle & Reath LLP, Washington, DC
Open to the public

THURSDAY, OCTOBER 10

IQ Symposium
Artificial Intelligence: Unlocking the Future of Drug Discovery & Development

8:45 AM – 5:00 PM ET
National Press Club, Washington, DC
Open to the public

Biopharmaceutical companies, patient communities, and regulators have been increasingly exploring artificial intelligence (AI) to streamline, improve, and participate in drug discovery and development. The emergence of generative AI applications has catapulted the importance of AI in popular imagination and provides an immediate impetus to widely and deeply explore the role of AI in drug discovery and development. This symposium will explore established applications, challenges and gaps, areas of growth, and enablers for maximizing impact while ensuring equity and inclusion in the use of AI.

Attendees can expect to learn:

• Hear real-world examples of AI in drug discovery, both successes and challenges
• Discover how stakeholders see the future of AI in this field
• Learn ways to empower your team to use AI effectively and fairly
• Find out where you can make the biggest difference with AI

FRIDAY, OCTOBER 11

IQ Board of Directors Meeting

Contact IQ Secretariat for details.
Open to Board members and LG leaders