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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
Enabling Technologies for Tox/FIH Formulation
Dr. San Kiang,
J-Star Research
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
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
Digitally Enabled Workflows: Accelerating the Molecule to Medicine Journey
Dr. Bob Docherty ,
West View House Consulting
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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
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
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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
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
Richard Becker, BlazeMetrics
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Topical Panel Discussions
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Challenges and Solutions of Developing Amorphous Solids as Drug Substance
Gaps and Opportunities in Computational Design and Optimization of Pharmaceutical Crystallization
Early Formulation Challenges and Solutions – Discovery to Phase I
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