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Tuesday, June 28 • 4:00pm - 5:15pm
#260: A Risk-Benefit Approach to Planning Early Clinical Development

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Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-598-L04-P; CME 1.25; IACET 1.25; RN 1.25

Presentations will examine different but overlapping aspects of assuring safety and evaluating activity in early clinical development activities to enable rational clinical development, followed by an interactive discussion of potential future directions.

Learning Objectives

Discuss different aspects of including safety in early phase drug development processes; Identify aspects to be considered for risk assessments during a first-in-human study; Describe a dose selection process for cell and gene therapies to increase likelihood of efficacy; Explain recommended standards for operating an early phase CPU with staff training programs.


Howard Greenberg, MD


Structured Risk Assessment and Risk Mitigation in First-in-Human Studies
Thijs Van Iersel, MD

Dose Finding for Cell and Gene Therapies: Is Safety the Main Driver?
Gopalan Narayanan, MD, FFPM, FRCP

Site Training as a Critical Key to Safety
Donna W. Dorozinsky

avatar for Howard Greenberg

Howard Greenberg

Medical Safety Officer, Janssen Pharmaceuticals, Inc.
Dr. Greenberg is a Medical Safety Officer for Janssen Pharmaceuticals R&D, and Adjunct Associate Professor in the Department of Pharmacology & Experimental Therapeutics of Thomas Jefferson University. He is a Clinical Pharmacologist with education and experience in chemical engineering, business, and clinical research. He's been an Investigator of more than 130 early phase clinical trials from ~30 sponsors, and authored 50+ papers, and has been... Read More →

avatar for Donna Dorozinsky

Donna Dorozinsky

President, Just In Time GCP
Donna is a business consultant who has over 25 years of experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management. She encourages strategic thinking and implementation of solutions not only for today, but for the future. Her vast experiences dealing with a broad range of research organizations provides her with the knowledge to assist research... Read More →
avatar for Thijs Van Iersel

Thijs Van Iersel

Senior Director of Science, Early Development Services, PRA Health Sciences
Dr van Iersel is an MD with > 20 years of experience in clinical development. He is trained in Clinical Pharmacology in the UK and the Netherlands. Currently he is a Senior Director of Science at PRA. Previously he worked as Resident at Urology, and as Principal Investigator, Medical Director and Manager at Clinical Pharmacology Units of PBR and Xendo. He led the phase 1-2 clinical development of suggamadex at Organon, the Netherlands and... Read More →
avatar for Gopalan Narayanan

Gopalan Narayanan

Biologics and Advanced Therapies Expert, NDA Group
Trained in Internal Medicine. Currently providing strategic support and advice to Biotech/Pharma companies on regulatory science primarily in Biotechnology, Cell and Gene Therapy. Previously Head of Biotechnology Unit, MHRA, UK and Expert Medical Assessor; Member of Committee for Advanced Therapies (EMA/CAT), Scientific Advice Working Party (CHMP/SAWP), EMA Gene Therapy Working Party and Biosimilar Working Party. Member of Scientific Editorial... Read More →

Tuesday June 28, 2016 4:00pm - 5:15pm
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA