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Tuesday, June 28 • 4:00pm - 5:15pm
#268: Emerging Biopharma Therapeutic Modalities: Scientific and Policy Implications

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will examine three emerging scientific platforms with potential to drive the next wave of therapeutic innovation. Participants will be presented with how to evaluate new platforms, recognize the hurdles and consider what regulatory pathways and policies are needed to bring these new therapies to patients.

Learning Objectives

Discuss three emerging therapeutic modalities and what aspects make them particularly useful as new therapies; Define the characteristics of each modality that present the most significant near-term challenges and inflection points for greater therapeutic utilization; Recognize what policies are needed to ensure development and delivery of these innovations as new therapeutics.

Chair

Adam Hacker, PhD

Speaker

Microbiome: What Is It and Why Do We Need to Prepare for It?
Adam Hacker, PhD

Regenerative Medicine: How Adaptive Biomedical Innovation Can Support Development of Cell and GeneTherapy Products
Anne-Virginie L. Eggimann, MS

Responding to Global Health Emergencies: A Regulatory Perspective
Luciana Borio, MD



Chair
avatar for Adam Hacker

Adam Hacker

Vice President, Head of Vaccines & Microbiome, Global Regulatory Affairs, Janssen Pharmaceuticals (johnson & Johnson)
Adam Hacker was appointed VP Head of Vaccines & microbiome for Global Regulatory Affairs at Janssen Pharmaceuticals (Johnson & Johnson company) in June 2015. As Head of Vaccines he is responsible for driving regulatory strategy with a focus on the accelerated development of Janssen’s Ebola vaccine. Adam is also responsible for coordinating regulatory activities for all microbiome projects and establishing policy positions and working closely... Read More →

Speakers
avatar for Luciana Borio

Luciana Borio

Acting Chief Scientist, Office of the Chief Scientist, OC, FDA
Dr. Luciana Borio is FDA’s acting chief scientist. In this capacity, she is responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts. | | The Office of the Chief Scientist works closely with FDA’s product centers, providing strategic leadership and support for FDA’s regulatory science and innovation initiatives. | | Dr. Borio received her M.D. from the George Washington University, and... Read More →
avatar for Anne-Virginie Eggimann

Anne-Virginie Eggimann

Vice President, Regulatory Science, bluebird bio, Inc.
Anne-Virginie joined bluebird bio in 2011 to lead global regulatory strategy and create innovative pathways to accelerate the development of bluebird bio’s gene therapy products. Previously, AV was an Executive Director at Voisin Consulting, leading rare diseases, oncology, and advanced therapies projects. AV holds a Master of Science from the UCLA School of Public Health, and a B.S. in Chemical Engineering from the California Institute of... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA