6 Cedarbrook Drive, Cranbury, NJ 08512, USA cfpc.jstar@jstar-research.com

Program Schedule

Day-1 : Thursday, October 13, 2022
06:00 - 08:00 Breakfast
08:00 - 08:10 Opening Speech by Chairman, Dr. San Kiang, J-Star / Porton
Workshop: CMC Development Strategies
08:10 - 08:15 Introduction by Moderator, Dr. Jian Wang, J-Star Research
08:15 - 09:20 Combined In-Silico & Experimental Approach for Solid Form Screen & Selection, Drs. Yuriy Abramov and Shanming Kuang, J-Star Research
09:20 - 10:25 Enabling Technologies for Tox/FIH Formulation, Dr. San Kiang, J-Star / Porton
10:25 - 10:55 Coffee/Tea Break
10:55 - 12:00 Simulation Aided Process/Product Development, Scale-up, Tech-Transfer, and Regulatory Submission, Dr. Nima Yazdanpanah, Procegence
12:00 - 13:00 Lunch
Session 1: Smarter Solid Form & Pre-Formulation Studie
13:00 – 13:05 Introduction by Moderator, Dr. Shanming Kuang , J-Star / Porton
13:05 – 13:40 Reducing or Managing Complexity-New Realities with Emerging Chemical Space for Small Molecule Developability, Dr. Ahmad Sheikh, AbbVie
13:40 – 14:15 Five Degrees of Separation: Characterization and Temperature Stability Profiles for the Polymorphs of PD-0118057 (Molecule XXIII), Mr. Brian Samas, Pfizer
14:15 – 14:50 Novel Analytical Methods and Insights into Amorphous Solid Dispersions, Dr. Simon Bates, Rigaku
14:50 – 15:10 Coffee/Tea Break
15:10 – 15:45 Digitally Enabled Workflows: Accelerating the Molecule to Medicine Journey, Dr. Bob Docherty, WVH Consulting
Session 2: Physical Property Based Crystallization Process Dev
15:45 – 15:50 Introduction by Moderator, Dr. Nima Yazdanpanah, Procegence
15:50 – 16:25 A New Stereo-Purification Approach Enabled by Continuous Flow-Crystallization, Dr. Michal Achmatowicz, Mirati Therapeutics
16:25 – 17:00 Simulation Aided Solvent Selection for Robust Impurity Rejection By Crystallization, Dr. Yuriy Abramov, J-Star Research
17:00 – 17:05 Announcements by Chairman on Day-1 Evening and Day-2 Activities
17:05 – 18:00 Open Social Time
18:00 – 19:00 Cocktail Social Hour
19:00 – 21:00 Gala Dinner
See you next day!
Day-2: Friday, October 14, 2022
06:00 - 08:00 Breakfast
Session 2: Physical Property Based Crystallization Process Dev
08:00 – 08:05 Introduction by Moderator, Dr. Nima Yazdanpanah, Procegence
08:05 – 08:40 A Digital Mechanistic Workflow for Predicting Solvent-Mediated Crystal Morphology, Prof. Kevin Roberts, University of Leeds
08:40 – 09:15 Intelligent Cloud-Based Algorithms For Reducing Risk in Crystallization Process Development, Dr. Mike Bellucci, XtalPi
Session 3: Particle Engineering & DS-DP Co-Processing
09:15 – 09:20 Introduction by Moderator, Dr. San Kiang, J-Star / Porton
09:20 – 09:55 Control, Is It Achievable in Amorphous or Poorly Crystalline Peptide Isolations?, Dr. Jeremy M. Merritt, Eli Lilly
09:55 – 10:15 Coffee/Tea Break
10:15 – 10:50 Particle Engineering by Spray Drying: Process Dev., Scale-Up, and Technology Transfer, Dr. Nima Yazdanpanah, Procegence
10:50 – 11:25 Amorphous or Crystalline and Other Enabling API Particle Attributes Tracked by PAT, Mr. Richard Becker, BlazeMetrics
11:25 – 12:00 Spherical Cocrystallization of Pharmaceuticals, Prof. Calvin Sun, University of Minnesota
Topical Panel Discusison
13:00 – 13:05 Introduction by Chairman, Dr. San Kiang, J-Star / Porton
13:05 – 13:40 Challenges and Solutions of Developing Amorphous Solids as Drug Substance
Moderator: Prof. Calvin Sun, University of Minnesota
13:40 – 14:15 Bottlenecks and Breakthroughs of Computational Solutions for API Isolation and Formulation
Moderator: Prof. Kevin Roberts, University of Leeds
14:15 – 14:50 Early Formulation Challenges and Solutions –Discovery to Phase I
Moderator: Dr. San Kiang, J-Star / Porton
14:50 – 15:00 Closing Remarks by Chairman, Dr. San Kiang, J-Star / Porton
15:00 – 15:30 Coffee/Tea Break & Bus Ride for Lab Tour
Lab Tours of DS-DP R&D
15:30 – 16:00 Sneak Peek of Integrated DS-DP Facility with GMP DP Delivery Capability
16:00 – 17:00 DS & DP R&D Demo Stations: from material sciences to DS/DP Processes
17:00 – 17:20 Bus Ride Returning to Hotel
See you in 2023
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