2018 Center for Biologics Evaluation and Research Science Symposium Agenda
Center for Biologics Evaluation and Research
Food and Drug Administration
June 25-26, 2018
Agenda
June 26, 2018
Opening Remarks
Carolyn Wilson, PhD
Associate Director for Research
Center for Biologics Evaluation & Research
Food & Drug Administration
June 25, 2018
Opening Remarks
RADM Denise Hinton
Chief Scientist
Food and Drug Administration
Session 1: Emerging and Re-Emerging Infectious Diseases
Session 2: Harnessing diverse types of data in regulatory decision-making
Session 3: Immunogenicity and Immunotherapy
June 26, 2018
Opening Remarks
Carolyn Wilson, PhD
Associate Director for Research
Center for Biologics Evaluation & Research
Food & Drug Administration
Session 4: New approaches to improve biologics and treatments
Session 5: Microbiome in Human Disease
Session 6: Advances in Regenerative Medicine
Session 1: Emerging and Re-Emerging Infectious Diseases
Pandemic Preparedness: Challenges and Opportunities
Anthony Fauci, MD
Director, National Institute of Allergy and Infectious Diseases
National Institutes of Health
Blood Safety and Availability: Regulatory and Scientific challenges for Emerging and Re-emerging Infectious Diseases
John Hobson, PhD
Deputy Director & Principal Investigator
Office of Blood Research & Review
Center for Biologics Evaluation & Research
Food & Drug Administration
Benefit–Risk Assessment to Support Management of Transfusion-Transmission Risk of Infectious Diseases
Hong Yang, PhD
Principal Investigator
Office of Biostatistics and Epidemiology
Center for Biologics Evaluation & Research
Food & Drug Administration
The Host Response to Pertussis Vaccination and Infection
Tod Merkel, PhD
Principal Investigator
Office of Vaccines Research & Review
Center for Biologics Evaluation & Research
Food & Drug Administration
Session 2: Harnessing diverse types of data in regulatory decision-making
Honest Learning for the Healthcare System: Large-Scale Evidence from Real-World Data
David Madigan, PhD
Executive Vice President and Dean of Faculty of Arts and Sciences,
Professor of Statistics
Columbia University
Steven Goodman, MD, MHS, PhD
Associate Dean & Professor
Stanford University
A Roadmap for Supporting the Decision-Making Process in Post-Market Safety Surveillance
Taxiarchis Botsis, MSc, PhD
Investigator
Johns Hopkins University
FDA’s Monitoring of Guillain Barré Syndrome Following Influenza Vaccines Using CMS Data
Richard Forshee, PhD
Associate Director for Research
Office of Biostatistics and Epidemiology
Center for Biologics Evaluation & Research
Food & Drug Administration
Session 3: Immunogenicity and Immunotherapy
Do Differences Make a Difference: Human Immune Responsiveness and Single-Cell Variations
John Tsang, PhD
Chief, Systems Genomics and Bioinformatics Unit, Laboratory of Immune System Biology
Co-Director, NIH Center for Human Immunology (CHI)
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Pre-existing Immunity Shapes Neutralizing Antibody Responses to Influenza Vaccines
Carol Weiss, MD, PhD
Laboratory Chief & Principal Investigator
Office of Vaccines Research & Review
Center for Biologics Evaluation & Research
Food & Drug Administration
Predicting Immune Responses to Therapeutic Proteins: The Promise of Safer Drugs and Improved Clinical Outcomes
Zuben Sauna, PhD
Principal Investigator
Office of Tissues and Advanced Therapies
Center for Biologics Evaluation & Research
Food & Drug Administration
Development of Safe and Effective Cancer Vaccines and Cellular Immunotherapy Products
Raj Puri, MD, PhD
Division Director & Principal Investigator
Office of Tissues and Advanced Therapies
Center for Biologics Evaluation & Research
Food & Drug Administration
June 26, 2018
Opening Remarks
Carolyn Wilson, PhD
Associate Director for Research
Center for Biologics Evaluation & Research
Food & Drug Administration
Session 4: New approaches to improve biologics and treatments
Aviv Regev, PhD
Chair of the Faculty & Director of the Klarman Cell Observatory and Cell Circuits Program,
Co-Director of the Cell Atlas Project
Broad Institute
Advances in Biomedicine are Bearing Fruit: Innovative New Therapies Enter the Clinic and Biotechnology Pipeline
Chava Kimchi-Sarfaty, PhD
Acting Deputy Associate Director for Research
Office of Tissues and Advanced Therapies
Center for Biologics Evaluation & Research
Food & Drug Administration
High-throughput Sequencing for Adventitious Virus Detection to Enhance Safety of Biologics
Arifa Khan, PhD
Principal Investigator
Office of Vaccines Research & Review
Center for Biologics Evaluation & Research
Food & Drug Administration
New Approaches to Improve Stored Cellular Blood Components
CD Atreya, PhD
Associate Director for Research & Principal Investigator
Office of Blood Research & Review
Center for Biologics Evaluation & Research
Food & Drug Administration
Historical Perceptive
Immune Globulin Intravenous and Hepatitis C Virus Transmission: The Critical Role of CBER's Research
Lawrence Bachorik, PhD
Former FDA Associate Commissioner for Communications
Session 5: Microbiome in Human Disease
The human microbiome and the relationship with health and disease
Vincent Young, MD, PhD
Professor
Department of Internal Medicine/Infectious Diseases Division
Department of Microbiology and Immunology
University of Michigan
Interactions Between the Immune System, the Microbiome, and Clostridium difficile
Paul Carlson, PhD
Principal Investigator
Office of Vaccines Research & Review
Center for Biologics Evaluation & Research
Food & Drug Administration
Bioinformatics of Microbiome: Challenges and Solutions at FDA
Vahan Simonyan, PhD
Lead Scientist & Project Director
High-Performance Integrated Virtual Environment
Center for Biologics Evaluation & Research
Food & Drug Administration
Session 6: Advances in Regenerative Medicine
3D Printing Technologies for Tissue Engineering
Jordan S. Miller, PhD
Assistant Professor
Department of Bioengineering
Rice University
Developing Strategies to Improve Characterization of Cell-based Regenerative Medicine Products
Steven Bauer, PhD
Laboratory Chief & Principal Investigator
Office of Tissues and Advanced Therapies
Center for Biologics Evaluation & Research
Food & Drug Administration
Combining Next Generation and Classical Methods to Reverse Engineer Neural Induction
Malcolm Moos, MD, PhD
Principal Investigator
Office of Tissues and Advanced Therapies
Center for Biologics Evaluation & Research
Food & Drug Administration
Practical Microscale Technologies in the Assessment of Regenerative Medicine Advanced Therapeutic Products
Kyung Sung, PhD
Principal Investigator
Office of Tissues and Advanced Therapies
Center for Biologics Evaluation & Research
Food & Drug Administration