The University of Iowa PGSRM planning committee is proud and honored to announce Dr. Rakesh Awasthi, Dr. Devalina Law, Dr. Hamid Ghandehari, Dr. Atul Saluja, and Lindsey Floryance as our PGSRM 2024 speakers!
Title of the talk: Chimeric Antigen Receptor T-cell Therapy: An Overview of Clinical Development Journey of Tisagenlecleucel and Recent Advances
Biography:
Dr. Rakesh Awasthi is an Associate Director in the Pharmacokinetic (PK) Sciences department (Oncology Therapeutic Area) at Novartis (East Hanover, NJ). Joining Novartis in 2015, he has been instrumental in providing scientific and strategic directions to oncology drug development projects. Rakesh has also been appointed as the Scientific Leader in PK Sciences for Cell Therapy, where he spearheads the development of PKS strategy for chimeric antigen receptor (CAR) T-cell therapy projects at Novartis.
Link to Dr. Awasthi's full Biography
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Title of the talk: Oral Delivery of BCS IV Compound: 50+% Drug Loaded Formulations of Redispersal Amorphous Nanoparticles
Biography:
Dr. Devalina Law received her B. Pharm and M. Pharm from Jadavpur University, Kolkata India, and Ph.D. from University of Minnesota. After graduating from Dr. Grant’s Lab she joined Pharmaceutical Research & Development at Abbott Laboratories, now AbbVie Inc. supporting discovery in candidate nomination and development in formulation characterization. Then moved to Global Pharmaceutical Operations supporting on-market products and new product launches. In 2016 she moved back to R&D where her team is responsible for Phase 1-Phase 3 oral solid dosage form development.
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Title of the talk: Approaches for Spatiotemporal Drug Delivery
Biography:
Dr. Hamid Ghandehari is Professor and George S. and Dolores Doré Eccles Presidential Endowed Chair in the Department of Molecular Pharmaceutics, Professor of Biomedical Engineering, and Director of Utah Center for Nanomedicine at The University of Utah. His research focuses on the design of polymeric biomaterials for localized drug delivery and understanding the relationship between physicochemical properties of inorganic nanoparticles with their toxicity.
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Title of the talk: Biologics Combination Products Necessitate Integrated Development Combining Molecule, Formulation, Process and Device Design
Biography:
Dr. Atul Saluja currently heads the Injectables MSAT platform within Sanofi’s Manufacturing & Supply (M&S) organization. His organization, spread over 10+ commercial production sites in 5 countries in EU and North America, ensures drug product industrialization, technology transfer, validation/PPQ, pre-approval inspections, and dossier support for Sanofi’s commercial and launch-ready programs.
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Title of the talk: The Role of AI/ML in Model-Informed Drug Development
Biography:
Lindsey Floryance is a Business Development Specialist at Pumas-AI Inc., where she supports drug development activities (pharmacometrics and regulatory strategy), clinical trial design, client relationship management, and software/product development (especially those coded using R or Julia). Lindsey received her B.A. in Chemistry and M.S. in Pharmaceutical Sciences from the University of Iowa. She recently obtained an M.S. in Pharmacometrics from the University of Maryland Baltimore. In addition to pharmacometrics and clinical pharmacology, Lindsey's interests include radiopharmaceutical development, rare diseases, and patient advocacy.
Link to Lindsey's full Biography
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