Evidence Generation

Focus Area Working Group

The mission of the Evidence Generation Focus Area Working Group (FAWG) is to educate the MAPS membership on contemporary practices for data generation strategies, including the design, implementation, and communication of new evidenceand educate the MAPs membership how real-world (RW) evidence may be utilized to support product value; including labeling changes.

Activities: 

To reach our goals, the Evidence Generation FAWG will execute on two key objectives.  First, through educational programs and communications, we will increase understanding of requirements for Evidence Generation in the context of Medical Affairs strategic planning & execution of evidence generation plans.  Second, we will explore applications of real-world evidence across stakeholders within Medical Affairs, with the purpose of increasing the acceptance of real-world evidence for regulatory purposes.    

As part of this plan, we will organiza host of Evidence Generation activities including workshops for MAPS meetings in the North America, with longer term plans and aspirations of conducting Evidence Generation workshops in APAC (Asia Pacific – China/Japan), and EMEA (Europe, Middle East, Asia) regions.  

We will develop original content for webinars, podcasts, eLearning courses, and white papers. In addition, the working group will periodically contribute cogent and timely content on the Evidence Generation sector for the MAPS publication, Elevate magazine. Most importantly, we will provide a supportive resource for all Medical Affairs professionals seeking advice and direction on data generation and regulatory strategies. ​ 

Strategic Objectives

#1 Enhance foundational knowledge, standards and technical skills for evidence generation:

  • Develop understanding of standards and guidance for evidence generation.
  • Support planning & execution of evidence generation strategy in Medical Affairs.

#2 Increase opportunities for evidence generation:

  • Explore applications of real-world evidence across Regions.
  • Increase transparency and acceptance of real-world evidence.

Latest Podcast Episode

Description: MAPS speaks with Kent Summers, HEOR Lead at AlphaGroup and Steve Camper, VP of Medical Affairs at Blue Earth Diagnostics, about building Health Economics and Outcomes Research capabilities within Medical Affairs.

Members

Ann Harty

Ann Harty

VP, Deputy Head Global Value Evidence

Co-Lead

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Damian Largier

Damian Largier

VP, Medical Affairs International Developed Markets

Co-Lead

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Kevin Baruzzi

Kevin Baruzzi

Vice President, Chief of Staff, Advisory
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Neil Belson

Neil Belson

Life Sciences Attorney
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Scott Flanders

Scott Flanders

Executive Director, Medical Communications & Operations
Cerise James

Cerise James

Regional Medical Director
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Esther Liu

Esther Liu

Advisor, Integrated Evidence Generation
Eli Lilly
Rahul Mandlik

Rahul Mandlik

General Manager, Medical Affairs
Marko Mychaskiw

Marko Mychaskiw

Director GHEOR
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Daniel Bin Ng

Daniel Bin Ng

Senior Director, Head of HEOR International Markets and Greater China, Astellas Pharma Global Development
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Bhavik Pandya

Bhavik Pandya

Director, HEOR Oncology, Medical Affairs US
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Sreeram Ramagopalan

Sreeram Ramagopalan

Global Head, RWE
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Debra Schaumberg

Debra Schaumberg

Vice President, Epidemiology and Head, Strategic and Scientific Affairs
Phil Wakefield

Phil Wakefield

Global Medical Strategy and Value Lead
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Sue Wood

Sue Wood

International Medical Affairs Franchise Lead

FAWG Overview

Resources Related to Evidence Generation

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