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Technical Program

October 13-14, 2022; Princeton, NJ, USA

Workshop: CMC Development Strategies
  • Combined In-Silico & Experimental Approach for Solid Form Screen & Selection
         Drs. Yuriy Abramov and Shanming Kuang, J-Star Research
  • Enabling Technologies for Tox/FIH Formulation
         Dr. San Kiang, J-Star / Porton
  • Simulation Aided Process/Product Development, Scale-up, Tech-Transfer, and Regulatory Submission
         Dr. Nima Yazdanpanah, Procegence
  • Session 1: Smarter Solid Form & Pre-Formulation Studies
  • Reducing or Managing Complexity-New Realities with Emerging Chemical Space for Small Molecule Developability
         Dr. Ahmad Sheikh, AbbVie
  • Five Degrees of Separation: Characterization and Temperature Stability Profiles for the Polymorphs of PD-0118057 (Molecule XXIII)
         Mr. Brian Samas, Pfizer
  • Novel Analytical Methods and Insights into Amorphous Solid Dispersions
         Dr. Simon Bates, Rigaku
  • Screen, Evaluation and Selection of Amorphous Solid Dispersion
         Dr. Shanming Kuang, J-Star Research
  • Session 2: Physical Property Based Crystallization Process Dev
  • A New Stereo-Amplification Approach Enabled by Continuous Flow-Crystallization
         Dr. Michal Achmatowicz, Mirati Therapeutics
  • Simulation Aided Solvent Selection for Robust Impurity Rejection By Crystallization
         Dr. Yuriy Abramov, J-Star Research
  • A Digital Mechanistic Workflow for Predicting Solvent-Mediated Crystal Morphology
         Prof. Kevin Roberts, University of Leeds
  • Intelligent Cloud-Based Algorithms For Reducing Risk in Crystallization Process Development
         Dr. Mike Bellucci, XtalPi
  • Session 3: Particle Engineering & DS-DP Co-Processing
  • Control, Is It Achievable in Amorphous or Poorly Crystalline Peptide Isolations?
         Dr. Jeremy M. Merritt, Eli Lilly
  • Particle Engineering by Spray Drying: Process Dev., Scale-Up, and Technology Transfer
         Dr. Nima Yazdanpanah, Procegence
  • Amorphous or Crystalline? Using Next Generation PAT to Track API Particle Attributes for Enhanced Downstream Processability
         Mr. Richard Becker, BlazeMetrics
  • Spherical Cocrystallization of Pharmaceuticals
         Prof. Calvin Sun, University of Minnesota
  • Topical Panel Discussions
  • 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
  • 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
  • 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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