2023 Presentations
Day 1 - January 24, 2023
Plenary Lecture
Ronald T. Piervincenzi, Ph.D., United States Pharmacopeia (USP)
Session 3: Product Forumulation and Process Development
Dr. Mauricio Futran, Indiependent Industry Consultant and Dr. Martin Eastgate, Bristol-Myers Squibb
Plenary Lecture
CDR James Coburn, Food & Drug Administration (FDA)
Session 1: Early Development & Evaluation
Allen Templeton PhD, Merck and Dr. Annette Bak PhD, AstraZeneca
Session 2: Clinical Development and Evaluation
Dr. Martin S. Zand, University of Rochester Medical Center
Session 3: Solid Lipid Nanoparticles
Steve Byrn, Purdue University
Session 3: Excipients need to be considered in supply chain resiliency
Dr. Krizia M. Karry
Session 3: Process Engineering Perspective
Dipl. Ing. Richard Steiner
Day 2 - January 25, 2023
Creative Connections: FDA-wide Programs for Advancing Regulatory Science
Dr. Tina Morrison, Food & Drug Administration (FDA)
Session 5: FDA-Industry Collaborations Opportunities
Presentation by Dr. Steven Colvill, Duke-Margolis Center for Health Policy
Day 1 Recap
Dr. Gintaras “Rex” Reklaitis, Purdue University
Looking Forward with Purpose: FDA Oncology Initiatives
Dr. Nicholas Richardson, Food & Drug Administration (FDA)
Knowledge Management for Medicine: Increasing Transparency with CDEK
Dr. Michael Kinch, Long Island University
Session 5: FDA-Industry Collaborations Opportunities
Presentation by Dr. Thomas O’Connor, Food & Drug Administration (FDA)
Knowledge center in solid dose formulation, manufacturing, and regulatory compliance
Girish Patel, CMIC CMO USA Corporation
Session 4: Industry Perspective – What does Industry need to accelerate drug product and process development?
Dr. Bikash Chaterjee and Dr. Richard Steiner, Pharmatech Associates
Session 4: Industry Perspective – What does Industry need to accelerate drug product and process development?
Eyal H. Barash, J.D.
Day 3 - January 26, 2023
Day 2 Recap: Short presentations from attendees based on Section 6 outcomes
Dr. Frank Gupton, Virginia Commonwealth University
