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Real World Evidence: What Does It Mean for Your Commercialization Plans?

WEBINAR DETAILS

Date: September 29, 2016

Featured Speakers:

To ensure successful commercialization, manufacturers need to understand the crucial role real world evidence (RWE) is now playing in product planning and determine best practices for evidence dissemination.

Join our featured speakers, Dr. Mike Eaddy and Patricia Wolfangel, both from Xcenda, for a complimentary webinar that explores the critical role and impact of RWE on product life-cycle management from concept through post-launch. Insights will be provided on use of RWE to demonstrate product value, as well as best practices to ensure decision-makers receive data in a timely and actionable format.

During this session, the speakers will address:

  • Industry challenges that necessitate new forms of evidence to demonstrate product value
  • New evaluation methods and data types impacting the landscape (ex. value-based frameworks)
  • Current perceptions of FDAMA section 114 and effect on market access strategy and formulary decisions
  • Case studies and best practices for successfully using RWE to maximize market access success

Keywords: Real World Evidence, Commercialization

      ABOUT OUR SPEAKERS

      Dr. Mike Eaddy

      Dr. Mike Eaddy, PharmD, PhD, Vice President, Real-World Evidence Generation, Xcenda


      Michael Eaddy, PharmD, PhD, joined Xcenda in 2001 and, as a Vice President, leads the Real World Evidence consulting practice. Under his leadership, his team helps manufacturers generate evidence-based insights, as well as apply data analytics, to support their products' clinical or economic value propositions.

      Dr. Eaddy previously led Xcenda's Strategic Market Insights team where he helped clients gain actionable insights from payers, providers, and patients. He also led more than 50 adherence-based quality and outcomes assessments and completed Markov and Semi-Markov models in oncology. He specializes in advanced statistical techniques with work that includes economic and retrospective analyses, studies assessing the control of unobserved heterogeneity with the use of frailty models, the effects of missing data on the statistical decisions of quality of life data, and the expanded use of the Cochran-Mantel-Haenszel statistic.

      Dr. Eaddy brings more than 15 years of experience evaluating, designing, and implementing retrospective analyses using SAS, STATA, and E-views and more than 10 years of experience in the manipulation of large public and private administrative databases. He also has extensive clinical experience in bone marrow transplantation and soft-tissue cancer treatments. Dr. Eaddy has focused much of his research in analyzing outcomes in cardiovascular, urological, and mental health disorders.

      He is an active author and speaker and a member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), which recognized his work with a best poster award in 2009. Included among his other awards is "best value proposition" as recognized by one of the three largest US pharmaceutical companies. Dr. Eaddy has presented symposia for ISPOR and the Academy of Managed Care Pharmacy, and his work has been published in numerous peer-reviewed journals, including the Journal of Managed Care Pharmacy and theJournal of Clinical Psychopharmacology.

      At the University of South Carolina, Dr. Eaddy obtained his BS in Pharmacy, his PharmD, and his PhD in Pharmaceutical and Health Outcomes Sciences.

      Patricia Wolfangel

      Patricia Wolfangel, Vice President, Market Access Consulting & Communications, Xcenda


      Patricia Wolfangel is Vice President and Agency Lead Strategist for Xcenda. In this role, she leads the Xcenda Market Access Consulting & Communications (MACC) practice.

      Ms. Wolfangel leverages the vast biopharmaceutical needs of clients with the suite of services offered by Xcenda, including health economics and outcomes research (HEOR), epidemiology, managed markets, stakeholder insights, reimbursement strategies, risk management, training, and field support.

      Prior to joining Xcenda, Ms. Wolfangel was a Partner and President of several market access consultancies.

      In 2015, she was acting Vice President, Payer Strategy at a large pharmaceutical manufacturer. In this role, she developed the company’s approach to channel and brand marketing strategy across the bio-pharma company portfolio, developing the governance of this function and leading it day to day.

      Her long-standing pharmaceutical industry experience, depth of knowledge, and span of contacts allow her to leverage her launch and brand experience.

      Ms. Wolfangel developed an interest in the use of pharmacoeconomic data in managed care decision making early in her career. She was a founding member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), where she developed the group’s first national and international congresses. She also served as the business editor for ISPOR’s journal and continues to build her practice around the foundational intersection of clinical and economic decision making.

      Ms. Wolfangel earned her Bachelor’s degree in Communications/Business from Purdue University. She completed graduate work in business and health administration at UCLA and UC Berkeley, CA, along with graduate work in art history. She is a frequent speaker and moderator at industry events including the Healthcare Businesswomen’s Association (HBA) and Academy of Managed Care Pharmacy (AMCP). She also enjoys mentoring young professionals to consider and embrace the field of market access.

      THIS PROGRAM IS INTENDED FOR

      Professionals from pharmaceutical, biotech, or medical device companies with responsibilities in:

      • HEOR
      • Epidemiology
      • Medical Affairs
      • Real World Evidence
      • Data Analytics
      • Market Access
      • Reimbursement CER
      • Data Management
      • Publication Planning
      • Informatics
      • Clinical Operations
      • Brand Management
      OUR XTALKS PARTNER FOR THIS EVENT

      Xcenda
       

      Xcenda is a strategic consulting firm with more than 20 years of experience applying real-world expertise in health economics and outcomes research, reimbursement, health policy, market research, and market access strategy. We support global pharmaceutical companies as well as emerging pre-commercialization phase firms with challenges such as developing an evidence package to optimize access in key global markets, predicting product performance, and identifying reimbursement strategies and programs to maximize patient access. From development through market maturity, Xcenda helps manufacturers identify, demonstrate, and deliver their brand’s value proposition to key healthcare stakeholders.

      Xcenda is backed by a wide breadth of healthcare knowledge and partnerships through its parent company, AmerisourceBergen Corporation (NYSE: ABC), a global leader in pharmaceutical sourcing and distribution. AmerisourceBergen drives innovative partnerships to improve product access and efficiency throughout the healthcare supply chain and enhance patient care. For more information on Xcenda, visit www.xcenda.com.

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