Keynote Speakers
DISCOVERY & BASIC RESEARCH
Engineering Better Biologics: Does Nature Know Best?
Anne De Groot, M.D., Epivax
Understanding of Bionanoscale Interactions as the Route to Systemic Targeted Therapeutics: Time for (Cautious) Optimism
Kenneth Dawson, Ph.D., University College Dublin
Building Targeted Protein Degradation Community
Milka Kostic, Ph.D., Dana-Farber Cancer Institute
Creating Living Drugs With Synthetic Compounds
Matthias Stephan, M.D., Ph.D., Fred Hutchinson Cancer Research Center
TRAIL-Coated Leukocytes that Target Circulating Tumor Cells in Concert with Fluid Forces
Michael King, Ph.D., Vanderbilt University
Testing Thousands of Chemically Distinct Nanoparticles in vivo Using DNA Barcodes
James Dahlman, Ph.D., Georgia Tech, Emory Medical School
PRECLINICAL DEVELOPMENT
Human Organs-on-Chips: From Experimental Models to Clinical Mimicry
Donald Ingber, M.D., Ph.D., Wyss Institute for Biologically Inspired Engineering at Harvard University
Innovations in Biological Modalities - Meeting Challenges in Translation and Development to Unlock Opportunity for Patients
Justin Sheer, Ph.D., Janssen
Nonclinical Safety Assessment for GalNAc-conjugated Antisense Oligonucleotides
Tae-won Kim, Ph.D., Ionis
Computational Systems Biology Approach for Enhancing Preclinical-to-Clinical Translation
Doug Lauffenburger, Ph.D., MIT
How to Fulfil Requirements of FDA Guidance on Diversity of Clinical Trial Population? Perhaps by Translational Modelling
Amin Rostami, Ph.D., University of Manchester, Certara
BIOANALYTICS
Bioanalytics – Chemical
Patrick Bennett, M.S., PPD Development
Reproducibility for Complicated NGS Analyses: Keeping Clouds in Bottles
Dave Shivak, Sangamo
Bioanalytics – Biomolecular
Dan Spellman, Merck
Towards the Implementation of Patient Centric Blood Sampling and Analysis as a Routine: Working as a Community
Neil Spooner, Ph.D., CChem, FRSC, Spooner Bioanalytical Solutions
Bioanalytics – Chemical
Chad Briscoe, Ph.D., BioAgilytix Labs
Evolving Best Practices in Bioanalytics - A Backstreet View of the “Fit for Purpose” Picture
Nancy Sajjadi, M.Sc., Sajjadi Consulting
CLINICAL PHARMACOLOGY
Drug Efficacy, Safety and Dosing Information for All Patients Regardless of Personal Disease and Characteristic Frequency
Bob Powell
Clinical Pharmacology
Amita Joshi, Ph.D., Genentech, Inc.
An Update on the Use of Physiologically Based Pharmacokinetic Modeling of Transporters: Predicting DDI, Non-Linearity and Target Tissue Exposure From in vitro to in vivo
Yuichi Sugiyama, Ph.D.
Pharmacokinetics and Pharmacodynamics of Non-Intravenous Delivery Routes for Biologics
Donald E. Mager, Pharm.D., Ph.D., FAAPS, University at Buffalo, SUNY
MANUFACTURING & ANALYTICAL CHARACTERIZATION
Tentative Title: Immune Stimulating Antibody Conjugates – Manufacturing and Analytical Considerations
Nathan Ihle, Ph.D., Bolt Biotherapeutics
Tentative Title: Novel Delivery systems, the Needs and Challenges of Leveraging Advanced Analytical Tools
Justin Pennington, Ph.D., Merck Research Laboratories
Tentative Title: Lessons Learned from the Commercialization of Continuous Manufacturing and Process Analytical Technology: How Can We Enable the New Modalities?
Morrey Atkinson, Ph.D., Vertex Pharmaceuticals
Tentative Title: Challenges in Analytical Control Strategy for Gene Therapies: Limited Time and Product
Van Hoang, Ph.D., Sparx Therapeutics
Tentative Title: Advances in Manufacturing Tools and Technologies to Meet the Challenges of Tomorrows Medicines
Ganapathy Mohan, Ph.D., Merck & Co. Inc.
Tentative Title: Advances in Process Control, Modeling and Analytics in Pharmaceutical Manufacturing – A Regulatory Perspective
Stelios Tsinontides, Ph.D., OPX/CDER, FDA, Invited
FORMULATION & DELIVERY
Critical Roles of Excipients in the Development of Generic Drug Products
Robert Lionberger, Ph.D., Office of Research and Standards, US Food & Drug Administration, Invited
Lessons Learned Developing the Pharmacologically Active Excipient, rHuPH20 Hyaluronidase to Facilitate Large-Volume Subcutaneous Administration of Other Biologic Therapies
Michael J. LaBarre, Ph.D., Halozyme
Development of Long Acting Injectables
Rene Holm, Ph.D., University of Southern Denmark
Nanotechnology and Biotechnology: New Hopes and Realities
Maria Jose Alonso, University of Southern California
Living in the World of RNA Therapeutics
Muthiah Manoharan
New Materials for the Delivery of Cells, RNA, and Genome Editing Tool
Dan Anderson, Ph.D., MIT