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Day-1 :
Thursday, October 13, 2022
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| 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 |
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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
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| 09:20 - 10:25 |
Enabling Technologies for Tox/FIH Formulation,
Dr. San Kiang, J-Star / Porton
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| 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
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| 12:00 - 13:00 |
Lunch |
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Session 1:
Smarter Solid Form & Pre-Formulation Studie
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| 13:00 – 13:05 |
Introduction by Moderator,
Dr. Yuriy Abramov, J-Star Research
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| 13:05 – 13:40 |
Reducing or Managing Complexity-New Realities with Emerging Chemical Space for Small Molecule Developability,
Dr. Ahmad Sheikh, AbbVie
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| 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
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| 14:15 – 14:50 |
Novel Analytical Methods and Insights into Amorphous Solid Dispersions,
Dr. Simon Bates, Rigaku
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| 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
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Session 2:
Physical Property Based Crystallization Process Dev
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| 15:45 – 15:50 |
Introduction by Moderator,
Dr. Jian Wang, J-Star Research
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| 15:50 – 16:25 |
A New Stereo-Amplification Approach Enabled by Continuous Flow-Crystallization,
Dr. Michal Achmatowicz,
Mirati Therapeutics
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| 16:25 – 17:00 |
Simulation Aided Solvent Selection for Robust Impurity Rejection By Crystallization,
Dr.
Yuriy Abramov,
J-Star Research
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| 17:00 – 17:05 |
Announcements by Chairman on Day-1 Evening and Day-2 Activities
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| 17:05 – 18:00 |
Open Social Time |
| 18:00 – 19:00 |
Cocktail Social Hour |
| 19:00 – 21:00 |
Gala Dinner |
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See you next day!
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Day-2:
Friday, October 14, 2022
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| 06:00 - 08:00 |
Breakfast |
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Session 2:
Physical Property Based Crystallization Process Dev
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| 08:00 – 08:05 |
Introduction by Moderator, Dr.
Jian Wang, J-Star Research
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| 08:05 – 08:40 |
A Digital Mechanistic Workflow for Predicting Solvent-Mediated Crystal Morphology ,
Prof. Kevin Roberts,
University of Leeds
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| 08:40 – 09:15 |
Intelligent Cloud-Based Algorithms For Reducing Risk in Crystallization Process Development,
Dr. Mike Bellucci, XtalPi
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Session 3:
Particle Engineering & DS-DP Co-Processing
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| 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
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| 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
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| 10:50 – 11:25 |
Amorphous or Crystalline? Using Next Generation PAT to Track API Particle Attributes for Enhanced Downstream Processability,
Mr. Richard Becker, BlazeMetrics
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| 11:25 – 12:00 |
Spherical Cocrystallization of Pharmaceuticals,
Prof. Calvin Sun, University of Minnesota
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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
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| 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
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| 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
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| 14:50 – 15:00 |
Closing Remarks by Chairman,
Dr. San Kiang, J-Star / Porton
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| 15:00 – 15:30 |
Coffee/Tea Break & Bus Ride for Lab Tour
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Lab Tours of DS-DP R&D
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| 15:30 – 16:00 |
Sneak Peek of Integrated DS-DP Facility with GMP DP Delivery Capability
Host: Dr. Kaushalendra Chaturvedi
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| 16:00 – 17:00 |
DS & DP R&D Demo Stations: from material sciences to DS/DP Processes
Hosts: Drs. Harsh Shah and
Kaushalendra Chaturvedi
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| 17:00 – 17:20 |
Bus Ride Returning to Hotel
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| See you in 2023
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