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.
Program Now Available!
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Short Course or Primer
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Oct 05, 2020
Short Course: Current Biosimilar Policies: An Interactive Boot Camp for US Market Success
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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
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Hillel P Cohen, PhD • Executive Director, Scientific Affairs
Sandoz Inc., United States -
Cecil J. Nick, MS • FTOPRA, Vice President (Technical)
Parexel Consulting, United Kingdom -
Julie Marechal-Jamil, MSc • Director, Biosimilar Policy and Science
Medicines For Europe, Belgium -
Jian Wang, MD, PhD • Division Manager, Clinical Review Division – Heamatology/Oncology
Health Canada, Canada -
Leah Christl, PhD • Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Amgen, United States -
Laura McKinley, PhD • Director, Global Regulatory Policy and Intelligence
Pfizer Inc, United States -
Sarah Yim, MD • Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER
FDA, United States -
Tiffany Fletcher, MA • Head of Global Access Policy
Viatris, United States -
Anna Welch, MA • Chief Editor, Biosimilar Development
Life Science Connect, United States -
Laura D. Wingate • Executive Vice President, Education, Support, and Advocacy
Crohn's & Colitis Foundation, United States
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Registration Questions?
Preconference Short Courses
Short Course 1: Current Biosimilar Policies: An Interactive Boot Camp for US Market Success