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Overview

October 5: Short Course
October 6-7: Forum


This year marks the 10th Anniversary of the Biosimilars Price Competition and Innovation Act (BPCIA), which created a biosimilars approval pathway in the US with the goal of increasing access to safe, effective, and cost effective biological treatment options for patients. To date, significant progress has been made in the science and regulation of biosimilar development and approval, and awareness and educational efforts are increasing prescriber and patient confidence and uptake. The challenges have been and continue to be complex, interrelated, and best addressed by stakeholder collaboration, not only within the US but across global regions.

To sustain the momentum, stakeholders are now looking forward – to streamlining biosimilars development, meeting ongoing manufacturing challenges as well as those posed by the COVID-19 pandemic, addressing pricing issues, and to discovering new targets for biosimilar development. At the DIA 2020 Biosimilars Conference, manufacturers, regulators, payers, prescribers, and patients will come together to envision the biosimilars landscape of the next 5 years and to share perspectives on what success and equilibrium will look like. They’ll apply the newest thinking and relevant learnings from global regions to build strategies for continuing the growth of the biosimilars market and bringing these important biologic therapies – and cost savings - to patients.


Who should attend?

Professionals involved in: Senior Level Professionals and Decision-makers involved in:

  • Biosimilar/Biologic Pharmaceutical Research
  • Biomedical Product Development and Manufacturing
  • Regulatory Affairs
  • Clinical and Nonclinical Research
  • Biostatistics and Data Management
  • Business Development
  • Marketing and Commercialization for biosimilars
  • Medical Communications/MSLs
  • Patient Advocacy/Patient Support Programs
  • Health and medical care across therapeutic disciplines
  • Health Education
  • Provision of prescription products
  • Development and management of prescription product formularies
  • Development and management of prescription benefit plans

Learning objectives

The aim of the course is to provide a common framework of language and clarify core concepts to promote collaboration amongst stakeholders. We will accomplish this through the following course objectives:

  • Discuss current developments in regulatory and scientific issues and their impact on development, manufacturing, access, and uptake of biosimilars and interchangeable products
  • Discuss imperative and progress in streamlining biosimilar development
  • Describe the US reimbursement and pricing landscape and its impact on market uptake and sustainability of biosimilars and interchangeable biological products
  • Examine current prescriber and patient confidence and patterns of biosimilar use, and education efforts that have been successful in increasing literacy on these products
  • Describe relevant international developments influencing patterns of biosimilar uptake globally
  • Discuss new product targets for biosimilar development
  • Explore the nature of the US biosimilars landscape in the next 5 years, and how equilibrium will be defined
  • Describe the status of biosimilar product development, availability, and uptake in the US

Program Committee

  • Hillel  Cohen, PhD
    Hillel Cohen, PhD Executive Director, Scientific Affairs
    Sandoz Inc., United States
  • Cecil J. Nick, MS
    Cecil J. Nick, MS FTOPRA, Vice President (Technical)
    Parexel Consulting, United Kingdom
  • Julie  Marechal-Jamil, MSc
    Julie Marechal-Jamil, MSc Director, Biosimilar Policy & Science
    Medicines For Europe, Belgium
  • Jian  Wang, MD, PhD
    Jian Wang, MD, PhD Division Manager, Clinical Review Division – Heamatology/Oncology
    Health Canada, Canada
  • Leah  Christl, PhD
    Leah Christl, PhD Executive Director, Global Regulatory and R&D Policy
    Amgen, United States
  • Laura  McKinley, PhD
    Laura McKinley, PhD Director, Global Regulatory Policy and Intelligence
    Pfizer Inc, United States
  • Sarah  Yim, MD
    Sarah Yim, MD Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER
    FDA, United States
  • Tiffany  Fletcher
    Tiffany Fletcher Head of Global Biosimilar Policy and Access
    Mylan, United States
  • Anna  Welch, MA
    Anna Welch, MA Chief Editor, Biosimilar Development
    Life Science Connect, United States
  • Laura D. Wingate
    Laura D. Wingate Senior Vice President, Education, Support, and Advocacy
    Crohn's & Colitis Foundation, United States
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