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  1. Workshops, Meetings & Conferences (Biologics)

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

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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

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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

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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

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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

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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

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