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Short Course: October 4
Conference: October 5-6

The Biosimilars Price Competition and Innovation Act (BCPIA) 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 but barriers still exist to a robust biosimilars market. The current ongoing challenges are legal complications to the launch of a biosimilar, the persistence of misinformation and disparagement, and delays in the creation of policies that increase patient access. 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.

The development of biosimilars has been maintained by the prospect of cost savings to patients and possible improvement over the competition. To improve their market share, stakeholders are now focusing on streamlining biosimilars development, meeting ongoing manufacturing challenges, , addressing pricing issues, and educating prescriber and patients on the benefits of biosimilars. At the DIA 2021 Biosimilars Conference, manufacturers, regulators, payers, prescribers, and patients will come together to discuss factors that influence biosimilar development and access 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

At the end of this conference participants should be able to:
  • 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 impact of the approval of the first interchangeable biosimilar from a scientific and policy perspective
  • 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 opportunities for product differentiation and utilization of regulatory flexibility
  • Describe the status of biosimilar product development, availability, and uptake in the US

Program Committee

  • Hillel P Cohen, PhD
    Hillel P Cohen, PhD Executive Director, Scientific Affairs
    Sandoz Inc., United States
  • Tiffany  Fletcher, MA
    Tiffany Fletcher, MA Head of Global Access Policy
    Viatris, United States
  • Leah  Christl, PhD
    Leah Christl, PhD Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
    Amgen, United States
  • Emanuela  Lacana, PhD
    Emanuela Lacana, PhD Deputy Director, OTBB, OND, CDER
    FDA, United States
  • Julie  Marechal-Jamil, MSc
    Julie Marechal-Jamil, MSc Director, Biosimilar Policy and Science
    Medicines For Europe, Belgium
  • Stanton  Mehr
    Stanton Mehr Director of Content
    Biosimilars Review and Report, United States
  • Cecil J. Nick, MS
    Cecil J. Nick, MS FTOPRA, Vice President (Technical)
    Parexel Consulting, United Kingdom
  • Juliana Marguerite Reed, MS
    Juliana Marguerite Reed, MS Executive Director
    The Biosimilars Forum, United States
  • Laura D. Wingate
    Laura D. Wingate Executive Vice President, Education, Support, and Advocacy
    Crohn's & Colitis Foundation, United States
  • Sarah  Yim, MD
    Sarah Yim, MD Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER
    FDA, United States
  • Representative Invited
    Representative Invited United States
  • Lu-Ning  Cui, MD, PhD
    Lu-Ning Cui, MD, PhD Senior Clinical Evaluator, HPFB
    Health Canada, Canada
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