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ISMPP U: RWE Communication Challenges – Building Acceptance Through Transparency, Stakeholder Outreach and Health System Adoption


This webinar will educate on the opportunities and challenges of using Real World Evidence (RWE) in medical communications and publication planning. Multiple stakeholder perspectives including that of publication professionals, journal editors, RWE writers and consultants will be discussed. The presentation will also include how RWE is being used to enhance Health Technology Assessment submissions and approvals.

At the end of this session, participants should be able to:

  • Know how to incorporate RWE planning and stakeholder outreach into medical affairs and publication planning teams.
  • Understand how RWE is used by payers and other key stakeholders.
  • Understand how the FDA is investing in research studies that will help determine how RWE can be used for regulatory evaluation and efficacy.
  • Know how RWE is being used to enhance health technology submissions and approvals. 
Approved for 1 ISMPP CMPPTM recertification credit.


  • Tom Drake, MA, ISMPP CMPP, Director, Global Outcomes Group, Inc. - Moderator

    Tom Drake has been involved in medical communications for over thirty years. His first job in the health-care industry was with the international division of Rorer Pharmaceuticals, where he spent three years working in Europe. In 1990 Tom founded and launched the healthcare trade publication, Product Management Today (PMT). As PMT’s editorial director, he worked with several founders of International Society for Pharmacoeconomics and Outcomes Research (ISPOR) along with journal publishers and continuing medical education experts. Tom has been involved in most areas of medical communications including global publication planning, continuing medical education (CME), Health Economics and Outcomes Research (HEOR), Real-World Evidence (RWE), thought-leader development and digital and web-based communications. Tom has supported communication projects in all major therapy areas and supported orphan drug programs.
    He has been an active member of ISMPP since 2008. He was chair of the ISMPP-U committee in 2015 and last year moved to the Advocacy and Outreach committee. Tom is also a member of AMWA and ISPOR.
    In 2015 Tom launched the Global Outcomes Group, an independent healthcare communications agency supporting HEOR/RWE/PRO and Medical Communications for the bio/pharma and medical device industries.

  • Rob Matheis, PhD, President & CEO, ISMPP

    Rob Matheis has a long tenure within scientific and medical communications and has been an integral part of ISMPP for more than a decade. He joined ISMPP in July of 2019 from his role as the Executive Director and Head of Global Scientific Communications at Celgene Corporation. Previously, he was Senior Director of Evidence Based Medical Communications at Sanofi. Rob began his ISMPP journey as inaugural Chair of the ISMPP Credentialing Board of Trustees, with oversight of examination development and establishment of credentialing criteria. He also served as the 7th President of the ISMPP Board of Trustees. During his tenure, Rob was an influential champion for transitioning ISMPP governance to a permanent board-appointed President and CEO. Most recently, Rob has been Chair of the ISMPP Global Transparency and Trends Committee and a Workstream Lead for the ISMPP Authorship Selection Best Practices Task Force. His professional interests include establishing the value proposition for medical affairs and enriching the role of medical publication professionals to include medical communication capabilities. Dr. Matheis is a licensed clinical psychologist with specializations in behavioral statistics, neuropsychology, and organizational psychology. He is well-published with an extensive bibliography covering brain and spinal cord injury, multiple sclerosis, and alternative medicine. Outside of work, Rob enjoys spending time with his family, staying active, and volunteering with various community organizations.

  • Laura Happe, PharmD, MPH, Editor-in-Chief, Journal of Managed Care and Specialty Pharmacy; Associate Professor and Director of Online Masters, University of Florida

    Laura Happe is an editor, professor and author who specializes in using data to aid in decision making. Laura leads an online Master’s degree program with approximately 150 students and 50 graduates annually at the University of Florida, School of Pharmacy, Department of Pharmaceutical Outcomes & Policy. Laura is also the Editor-in-Chief of the Journal of Managed Care and Specialty Pharmacy (JMCP), the official peer-reviewed journal of the Academy of Managed Care Pharmacy with a circulation of over 25,000 people.

    Previously, Laura was the Chief Pharmacy Officer of Humana, where she was responsible for advancing the clinical pharmacy acumen and integrating pharmacy into the company’s integrated care delivery model. During her time at Humana, she also enhanced the company’s research program, contributing to more than 70 peer-reviewed published manuscripts. Laura earned her Doctorate of Pharmacy degree from Creighton University and is a licensed pharmacist in both Florida and Arizona. She also holds a Master’s of Public Health degree with an emphasis in epidemiology from the University of South Florida and is fellowship trained in pharmacoeconomics and outcomes research. Laura’s first book, If You Give an Ox an Oxy, is an educational resource for parents to teach their adolescents about the hazards of opioid use.

  • Lucinda Orsini, DPM, MPH, Vice President, Value and Outcomes Research, COMPASS Pathways plc

    Lucinda Orsini is currently vice president for value and outcomes research at COMPASS Pathways, a mental healthcare company dedicated to accelerating patient access to evidence-based innovation in mental health. Lucinda has previously worked at ISPOR – the professional society for health economics and outcomes research as Associate Chief Science Officer where she led the real world evidence transparency initiative as well as the ISPOR’s health technology assessment and patient councils and roundtables. Prior to ISPOR, Lucinda led the HEOR team at Parexel and spent over a decade at Bristol Myers-Squibb in world wide HEOR working mostly in oncology and started her career in HEOR at The Medstat Group – currently Truven Health Analytics. She is a graduate of Temple University School of Podiatric Medicine and Harvard’s School Public Health.

  • Jonathan Kowalski, MS, PharmD, Chief Practice Officer (Value Demonstration), and EVP, Head of BresMed US

    Jonathan Kowalski is responsible for accelerating the expansion of BresMed’s presence and scope of services in the US to help clients succeed in early pipeline value strategy and evidence planning, economic modelling and statistical analysis, health technology assessment, new product payer engagement and launch excellence, and post-approval product differentiation. Building on BresMed’s global capabilities in early-phase and pre-HTA evidence generation planning, qualitative research, clinical evidence reviews, and value communications, he also leads BresMed’s global Value Demonstration practice.

    Jonathan joined BresMed in September 2020 following more than 20 years at Alllergan (Irvine, California) where he held several US and Global HEOR, market access, and health-policy leadership roles including: VP and Head, US Health Outcomes and Value; VP, US HEOR and Global HEOR Initiatives; and increasing roles of responsibility leading global HEOR and strategy for key franchises including: ophthalmology, urology, medical dermatology, and facial aesthetics.

    Jonathan earned his B.S. in Pharmacy and Doctor of Pharmacy degrees from the University of Wisconsin-Madison, and a M.S. in Pharmaceutical Sciences with an emphasis in pharmaceutical economics, policy, and outcomes research from the University of Arizona.

December 15, 2021
Wed 11:00 AM EST

Duration 1H 0M

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