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.

Our objectives include 1.) Enabling broader use of real-world evidence to support product value worldwide; 2.) To develop a community of professionals within MAPS seeking to enhance their foundational knowledge and technical skills for evidence generation3) To establish opportunities to increase the integration of evidence generation into Medical Affairs strategy; and 4.) To provided direct and specific individual personal leadership development and career advancement skills. 

Activities: 

To reach our goals, the Evidence Generation FAWG will execute on 2 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. ​ 

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

Scott Flanders

Scott Flanders

VP, Medical Affairs

Co-Lead

Dendreon Pharm Logo
Ann Harty

Ann Harty

VP, Deputy Head Global Value Evidence

Co-Lead

Lundbeck Logo
Damian Largier

Damian Largier

VP, Medical Affairs International Developed Markets

Co-Lead

Pfizer logo
Phil Wakefield

Phil Wakefield

Global Medical Strategy and Value Lead
MEDiSTRAVA Logo

Bob Honinberg

Bob Honinberg

Consultant

MS & T Consulting LLC

Cerise James

Cerise James

Regional Medical Director
Ferring logo
Marko Mychaskiw

Marko Mychaskiw

Director GHEOR
Teva Logo
James Spalding

James Spalding

Senior Director HEOR Oncology
astellas.logo
Neil Belson

Neil Belson

Life Sciences Attorney
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Lianna Ishihara

Lianna Ishihara

Senior Director CORDS Market
Bristol Myers Squibb Logo

FAWG Overview

Evidence Generation Updates

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Essentials of Real World Evidence (RWE)

This Powerpoint offers a comprehensive overview of Real World Evidence (RWE) and its evolving use in the biopharmaceutical industry.
AlphaGroup HEOR
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Creating an HEOR Function Within Medical Affairs

MAPS explores Health Economics and Outcomes Research (HEOR): Why a Medical Affairs organization needs an HEOR function and how to build this capability.
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History of Real-World Evidence Prior to the 21st Century Cures Act

Medical Affairs thought leaders discuss the Pre-21st Century Cures Act uses of Real World Evidence (RWE) in regulatory decision-making.
RWE Regulatory Podcast Featured
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The Application of Real-World Evidence in Regulatory Decision Making

Cerise James, MD, moderates this podcast in which Neil Belson, JD, discusses Real World Evidence and its impact to the biopharmaceutical industry.
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The Future of Medical Affairs: A Conversation with Beat Sümegi, SVP Medical, Sanofi

MAPS speaks with Beat Sümegi, SVP Medical with Sanofi, about major areas of change and the need to help Medical Affairs professionals build new skills to succeed in this world of increased responsibility and opportunity.
GTH Evidence Dissemination Featured
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Global Town Hall: An Opportunity for Medical Affairs Strategic Leadership During the Pandemic and Beyond

This MAPS Global Town Hall focuses on the challenges arising from the global Covid-19 pandemic and the emerging opportunity for Medical Affairs to provide strategic leadership.