Featured Speakers


Plenary Speakers

Opening Plenary Speaker


Siddhartha Mukherjee, M.D.

Oncologist and Cancer Researcher

Pulitzer Prize-winning Science Writer

Siddhartha Mukherjee is a pioneering physician, oncologist, and author who has redefined our public discourse on human health, medicine and science. A profoundly influential voice in the scientific community, he is best known for his books, The Emperor of All Maladies: A Biography of Cancer, which earned him the 2011 Pulitzer Prize, and The Gene: An Intimate History which won international awards and was recognized by The Washington Post and The New York Times as one of the most influential books of 2016.

Dr. Mukherjee’s achievements as a writer and educator build upon his career as a renowned medical scholar. His groundbreaking studies into the composition and behavior of cancer cells have pushed the boundaries of modern medicine. His innovative research signals a paradigm shift in cancer pathology and has enabled the development of treatments that reach beyond current pharmaceutical models toward new biological and cellular therapies.

Closing Plenary Speaker


Kathrin Jansen, Ph.D.

Senior Vice President and Head of Vaccine Research and Development

Pfizer Inc.

Kathrin U. Jansen, Ph.D., is the Senior Vice President and Head of Vaccine Research and Development (VRD) at Pfizer Inc, and a member of Pfizer’s Worldwide Research, Development and Medical leadership team. With over 28 years of pharmaceutical experience in Vaccine R&D. Dr. Jansen leads a fully integrated, global vaccines research and development organization, with responsibilities ranging from discovery to registration and post-marketing commitments. She manages a clinical vaccines portfolio that includes vaccines to prevent or treat diseases of significant unmet medical need such as those caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Streptococcus pneumoniae, Clostridioides difficile, Respiratory syncytial virus, Group B streptococcus, and Lyme disease. In collaboration with BioNTech, Dr. Jansen led the development of the BNT162b2 vaccine candidate against coronavirus disease 2019 (Covid-19). The vaccine was issued the first emergency use authorization (EUA) by the U.S. Food and Drug Administration – less than 11 months after the he SARS-CoV-2 genetic sequence was released and the first-ever authorized vaccine utilizing an mRNA platform.


Keynote Speakers



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




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 – 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




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




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




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