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Tuesday, June 20 • 2:00pm - 3:15pm
#256: Post-Trial Access: Ensuring Patient Access Across the Development Spectrum

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Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-555-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000203; RN 1.25

Clinical trials are an important way many patients gain access to life saving treatment they might not otherwise be able to obtain. Once the trial ends for an individual patient, what happens during the time treatment stops and the investigational agent becomes approved? Sponsors of clinical trials for life threatening diseases need to plan proactively for the management of this transition and engage with downstream stakeholders to ensure continued access to beneficial treatments.

Learning Objectives

Define what is meant by post-trial access; Discuss the bioethical principles behind providing post-trial access; Describe the planning that should be undertaken in advance of initiating a trial for a life threatening disease.

Chair

Karla Childers, MS

Speaker

Development of a Common Ethical Framework for Post Trial Responsibilities
Rebecca Li, PhD

Post-Trial Access: Terminology and Ethical Concepts Matter
Luann E Van Campen, PhD, MA, MS

Panelist
Walter Straus


Speakers
avatar for Luann Van Campen

Luann Van Campen

Senior Advisor and Head of Bioethics, Eli Lilly and Company
Since 2008, Luann Van Campen, PhD, has been the head of Lilly Bioethics, and has served on external work groups. Prior to this role, she developed publications for neuroscience drugs and established Lilly publication policy. Before Lilly, she worked in hearing science at Vanderbi... Read More →
avatar for Karla Childers

Karla Childers

Senior Director, Strategic Projects, Office of the Chief Medical Officer, Johnson & Johnson
Karla Childers is a Senior Director of Strategic Projects in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibilities are the Clinical Trial Data Transparency Initiative and the Johnson & Johnson Bioethics Committee.
avatar for Rebecca Li

Rebecca Li

Executive Director, Harvard MRCT Clinical Trials Center, Brigham and Women's Hospital
Rebecca Li, PhD, has over 17 years of experience spanning the entire drug development process with experience in Biotech, Pharma and CRO environments. Dr. Li has served as the Executive Director of the Multi-regional Clinical Trial Center at Harvard since 2012. She is also a co-F... Read More →
avatar for Walter Straus

Walter Straus

Associate Vice President, Therapeutic Area Head, Clinical Safety and Risk Mgmt, Merck & Co., Inc.
Dr. Straus’ team oversees global clinical safety for investigational products as well as post-licensure safety monitoring and assessment for the Merck portfolio in vaccines and infectious disease therapeutics. He is trained as an internist, gastroenterologist, and epidemiologis... Read More →

Tuesday June 20, 2017 2:00pm - 3:15pm
N230b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  08: StratPlan-Exec-Partnershps, Session