2025 Pharma Conference Agenda

Agenda-At-A-Glance Day 1

ActivityTimeDescription
Exhibitor Check-in8:15 A.M. - 9:45 A.M.
General Check-in9:15 A.M. - 9:45 A.M.Coffee and Doughnuts, Provided
Day 1 Welcome9:45 A.M. - 10:15 A.M.Welcome, Jack Pender, ECU Eastern Region Pharma Center
General Session 110:15 A.M. - 11:00 A.M.The State of Pharma in NC-2025, Mark Phillips, NC Biotechnology Center
Networking Break11:00 A.M. - 11:30 A.M.
Breakout Session 111:30 A.M. - 12:15 P.M.Session Topics
  • Drug Development Process, Jennifer Harrell, CMP Pharma
  • How do I Develop a Dissolution Method?, Ken Boda, Agilent
  • Case Studies on Postapproval Changes, Jessica Grant,
    United Therapeutics
  • Toxicological Risk Assessment to Prevent Cross Contamination, Wendy Haines
Networking Lunch12:15 P.M. - 1:15 P.M.Lunch Provided
Breakout Session 21:15 P.M. - 2:00 P.M. Session Topics
  • Introduction to Method Validation, Kimberly Lupo, Portrett Pharmaceuticals
  • Nitrosamine Impurities, Waleed Saleh, Catalent
  • Introduction to Sterile Manufacturing, Racheal Beerer, Thermo Fisher
  • Developing Strategies for High Potent API Processing for Oral Solid Dosage Forms, Kyle Fugit, Catalent
Networking Break2:00 P.M. - 2:30 P.M.
Breakout Session 32:30 P.M. - 3:15 P.M.Session Topics
  • Stability Programs 101, Tim Klock, Microbac Laboratories
  • Q14: Analytical Procedure Development, Catharine Layton, Waters
  • Finding Manufacturing Pharma Knowledge, Michael DeHart, CMP Pharma
  • Rapid formulation development for oral solid dosage forms: replacing excipient compatibility, Kenneth Waterman, FreeThink Technologies
Networking Break3:15 P.M. - 3:45 P.M.
General Session 23:45 P.M - 4:30 P.M. FDA Reorganization, Daveta Bailey, FDA, Invited
Welcome Reception4:30 P.M. - 6:30 P.M. Hor d’oeuvres and Libations

Agenda-At-A-Glance Day 2

ActivityTimeDescription
General Check-in9:15 A.M. - 9:45 A.M.Coffee and Doughnuts, Provided
Day 2 Welcome9:45 A.M. - 10:00 A.M.Welcome, Jack Pender, ECU Eastern Region Pharma Center
General Session 310:00 A.M. - 10:45 A.M.Hot Topics and Facility Preparation, Daveta Bailey, FDA, Invited
Networking Break10:45 A.M. - 11:15 A.M.
Breakout Session 411:15 A.M. - 12:00 P.M.Session Topics
  • Empower Integration Tips, Melanie Richards, Waters Corp.
  • Lab Managers Anonymous: Discusssion Session, Christopher Williams, Alcami
  • Speed to patients. How to accelerate your drug approval, Victor Sanchez, PharmaBioServ.
  • CQV Framework of a MGF Facility: A Bird's Eye View from Construction to Commercialization - Carman Ezzard, Sequence
Networking Lunch12:00 P.M. - 1:00 P.M.Lunch Provided
Breakout Session 51:00 P.M. - 1:45 P.M. Session Topics
  • HPLC Theory for the Pharma Analyst, John Glennon, Novo Nordisk
  • HPLC Theory: Biomolecule Separations, Jack Bloom, FUJIFILM Diosynth Biotechnologies
  • Solving Formulation and Process Challenges during Pharmaceutical Product Development, Brad Gold, Piramal Pharma Solutions
  • Impact of Nitrosamines on Manufacturing, Marc Bonner, BioCryst
Networking Break1:45 P.M. - 2:15 P.M.
Breakout Session 62:15 P.M. - 3:00 P.M.Session Topics
  • How it Works: Behind the Covers of An HPLC, Thiru Dongala, Agilent
  • icIEF and CE-SDS, Nolan Dean, Thermo Fisher Scientific
  • Excipient Engineering for Improved Performance, Joe Zeleznik, IMCD
  • Alcami’s Approach to Tackling Oral Solid Dose Challenges from Formulation Development to Process Validation. Bobby Sciscento, Alcami
Networking Break3:00 P.M. - 3:15 P.M.
General Session 43:15 P.M - 3:30 P.M. Advanced Modeling from Highly Accelerated Stability Testing (ASAP) to Determine Drug Product Shelf-life, Kenneth Waterman, FreeThink Technologies
Conference Wrap up and Discussion4:30 P.M. - 6:30 P.M. Close Out, Jack Pender, ECU Eastern Region Pharma Center

2024 Programming (PDF)

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