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

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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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Cerise James

Cerise James

Regional Medical Director
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Rahul Mandlik

Rahul Mandlik

General Manager, Medical Affairs
Marko Mychaskiw

Marko Mychaskiw

Director GHEOR
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Sreeram Ramagopalan

Sreeram Ramagopalan

Global Head, RWE
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James Spalding

James Spalding

Senior Director HEOR Oncology
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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

Evidence Generation Updates

Evidence Generation Medical Affairs Podcast 3
The objective of this podcast is to discuss how the 21st Century Cures Act has led to new initiatives at FDA involving Real World Evidence.
HEOR Medical Affairs
This MAPS webinar details HEOR professional competencies included in the ISPOR Competency Framework, defining which are most relevant to Medical Affairs professionals.
This Powerpoint offers a comprehensive overview of Real World Evidence (RWE) and its evolving use in the biopharmaceutical industry.
AlphaGroup HEOR
MAPS explores Health Economics and Outcomes Research (HEOR): Why a Medical Affairs organization needs an HEOR function and how to build this capability.
Data Visualization OD Featured
In this Medical Affairs webinar, founder and CEO of Killer Visual Strategies, Amy Balliett, helps you master data visualization best practices.
RWE 2 Featured
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
Cerise James, MD, moderates this podcast in which Neil Belson, JD, discusses Real World Evidence and its impact to the biopharmaceutical industry.
REW Regulatory Featured
Real-World Evidence can show safety and effectiveness per FDA’s “totality of evidence approach” for evaluating regulatory submissions.
Sumegi Featured
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.
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