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