2022 Program Schedule
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. Yuriy Abramov, J-Star Research |
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 |
Screen, Evaluation and Selection of Amorphous Solid Dispersion Dr. Shanming Kuang, J-Star Research |
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. Jian Wang, J-Star Research |
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 Discussion | |
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 Panelists: Dr. Jeremy Merritt , Dr. Simon Bates , Dr. Veeran Kadajji |
13:40 – 14:15 | Gaps and Opportunities in Computational Design and Optimization of Pharmaceutical Crystallization Moderator: Prof. Kevin Roberts, University of Leeds Panelists: Dr. Yuriy Abramov, Dr. Nima Yazdanpanah Dr. Luca Iuzzolino |
14:15 – 14:50 | Early Formulation Challenges and Solutions –Discovery to Phase I Moderator: Dr. Vivian Bi, Aclaris Therapeutics Panelists: Dr. Ahmad Sheikh, Prof. Calvin Sun, Dr. John Grosso |
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 |