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Tuesday, June 20 • 2:00pm - 3:15pm
#251: Defining the Science of Patient Input to Enhance Drug Development and Approval: Regulatory

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-529-L04-P; CME 1.25; IACET 1.25; RN 1.25

Presenters will discuss how patient input and real world evidence can be used to meet the "adequate and well-controlled studies" standard. The panel will discuss the meaning of the science of patient input, and provide examples of successfully using patient input (e.g., in making trial endpoint decisions; weighing benefit/risk; modifying study protocols based on patient input, etc.) within the regulatory context to enhance drug development and approval by incorporating the patient voice. Gaps and challenges with suggested solutions will be discussed, and differences among US and non-US regulatory agencies may be considered.

Learning Objectives

Define the science of patient input; Describe the challenges and solutions to successfully incorporating the patient voice into drug development.

Chair

Bennett Levitan, MD, PhD

Speaker

The Voice of the Patient: Setting the Therapeutic Context for Regulatory Decision Making
James E. Valentine, JD, MHS

Incorporating Patient Preferences in Benefit-Risk Assessments: Interpreting ICH M4E (R2)
Lesley Wise, PhD, MSc

Advancing the Science of Patient Inputs in the Regulatory Setting
Telba Irony, PhD


Moderators
avatar for Bennett Levitan

Bennett Levitan

Senior Director, Benefit-Risk Assessment, Global R&D Epidemiology, Janssen Research & Development, LLC
Bennett Levitan, MD-PhD is Senior Director, Global R&D Epidemiology at Janssen R&D. He introduced state of the art patient-focused benefit-risk assessment to Janssen and his team has led numerous clinical teams in benefit-risk assessments and patient preference studies. He co-led... Read More →

Speakers
avatar for Telba Irony

Telba Irony

Deputy Director, Office of Biostatistics and Epidemiology, CBER, FDA
Telba is Deputy Director of the Office of Biostatistics and Epidemiology at CBER. She joined FDA to implement the use of Bayesian statistics for the regulation of medical devices and led the Decision Analysis initiative including Bayesian statistics, benefit-risk determinations, and... Read More →
avatar for James Valentine

James Valentine

Director, Hyman, Phelps & McNamara, PC, United States
James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central... Read More →
avatar for Lesley Wise

Lesley Wise

Managing Director, Wise Pharmacovigilance and Risk Management Ltd
Lesley Wise has more than 15 years of experience in pharmacovigilance both in medicines regulation at the MHRA, and in the pharmaceutical industry as vice-president and global head of Risk Management Centre of Excellence and Pharmacoepidemiology where she worked closely with colleagues... Read More →

Tuesday June 20, 2017 2:00pm - 3:15pm CDT
N226 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  04: PatientEngagement, Forum