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

 

Pharma Crystallization Summit

 

October 13-14, 2022, Princeton, New Jersey

 

Day-1 : Thursday, October 13, 2022
06:45 - 07:45 Breakfast
07:45 - 08:00 Last-minute Registration
08:00 - 08:10 Opening Speech by Chairman, Dr. Qi Gao, J-Star / Porton
Workshop: CMC Development Strategies
08:10 - 08:15 Introduction by Moderator, Dr. Qi Gao, 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. Jian Wang, J-Star Research
15:50 – 16:25 A New Stereo-Amplification 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? Using Next Generation PAT to Track API Particle Attributes for Enhanced Downstream Processability, 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
Host: Dr. Kaushalendra Chaturvedi
16:00 – 17:00 DS & DP R&D Demo Stations: from material sciences to DS/DP Processes
Hosts: Drs. Harsh Shah and Kaushalendra Chaturvedi
17:00 – 17:20 Bus Ride Returning to Hotel
See you in 2023

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The Pharma Crystallization Summit (PCS) is held annually to bring together developers of new medicines with crystallization challenges and the crystallization experts (solution providers) in the industry and academia. PCS programs are designed to stimulate in-depth discussions on common and/or leading bottleneck issues related to crystallization of drug substance (DS) as well as the intermediates, the technologies and solutions that are available or underdevelopment. The discussions help new medicine developers to make educated and phase-appropriate decisions, and crystallization experts to understand better the critical needs for providing effective solutions.

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Past Keynote Presentations

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