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Omni Rancho Las Palmas Resort & Spa

2018 年 03 月 19 日 1:00 下午 - 2018 年 03 月 21 日 4:00 下午

41000 Bob Hope Drive, Rancho Mirage, CA 92270

Medical Affairs and Scientific Communications Forum

Medical Communication, MSL, and Medical Writing.

Session 3 Track 2A: The Trouble with IgG: Immunogenicity in the Clinical Deveopment of Biologics

Session Chair(s)

Darryl  L'Heureux, PhD, MPharm, MSc

Darryl L'Heureux, PhD, MPharm, MSc

Director, Clinical Science, Medical Writing, and Publications

Ambrx, Inc, United States

The use of protein therapeutics has increased dramatically over the past decades, since the introduction of the first recombinant protein therapeutic, human insulin, as replacement therapy more than 30 years ago. Recently approved recombinant protein therapeutics have been developed to treat a wide variety of clinical indications, including cancers, autoimmunity/inflammation, exposure to infectious agents, and genetic disorders. While proteins have a dynamic role in the body (catalyzing biochemical reactions, forming receptors and channels in membranes, providing intracellular/extracellular scaffolding, and transporting molecules), protein-based therapeutics have a tendency to trigger unwanted immune responses against themselves. This session will discuss immunogenicity, the safety and efficacy implications in clinical development, and the communication of risk to stakeholders.

Learning Objective :

At the conclusion of this session, participants should be able to:

  • Identify the use of therapeutic proteins in treatment, immunogenicity response, and regulatory requirements
  • Understand and assess risk-based approach for clinical development and communication to Health Authorities
  • Communicate clinical relevance and significance of immunogenicity to both patients and clinicians

Speaker(s)

Darryl  L'Heureux, PhD, MPharm, MSc

Speaker

Darryl L'Heureux, PhD, MPharm, MSc

Ambrx, Inc, United States

Director, Clinical Science, Medical Writing, and Publications

Lisa  Iacono Sheehan, PharmD

Speaker

Lisa Iacono Sheehan, PharmD

Bristol-Myers Squibb, United States

Director Global Regulatory Strategy

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