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Biosimilars Market Access

Biosimilars Market Access
Media Partners
Partners
Cocktail Reception Sponsor
Wednesday, February 25, 2015
8:00 am -
8:30 am

Registration and Morning Coffee

8:30 am -
8:45 am

Chairperson’s Welcome and Opening Remarks

Serge Messerlian
Vice President, Commercial Head - Biosimilars
Baxter Healthcare Corp.
8:45 am -
9:30 am

The Biosimilars Market - Current Status and Future Projections

  • Understand how the global pharmaceutical market is becoming more specialized and precise
  • Identify what the experience on biosimilars has been so far and assess what role generics and biosimilars play in the future
  • Identify which therapeutic areas have been explored and which were most successful for gaining approval and acceptance
Douglas M. Long
Vice President, Industry Relations
IMS Health, Inc.
*Mr. Long is presenting remotely. He is still be able to take questions from the audience.
9:30 am -
10:15 am

Examine Market Dynamics for Biosimilars in the US to Foster Confidence and Uptake

  • Identify which fundamental lessons were learned from the European experience that apply to the US and which do not
  • Define which elements of the U.S. framework will uniquely shape the U.S. market
  • Understand what the critical outstanding questions are that be must addressed as an industry in order to best encourage biosimilars in the U.S.
Michael Castagna
Vice President
Global Commercial Lead, Biosimilars Business
Amgen
10:15 am -
10:45 am

Networking and Refreshment Break

10:45 am -
11:30 am

Review the Latest Updates on FDA and Regulatory Guidances for a Clear Understanding of the Biosimilars Approval Pathway

  • Assess and discuss the emerging application and approval pathway
  • Understand how the purple book will impact biosimilars speed to market
  • Address the latest updates on nomenclature, substitution, and interchangeability
Thomas Sullivan Thomas Sullivan
President, Rockpointe Corporation
Editor, Policy and Medicine
Co-founder, Association of Clinical Researchers and Educators
11:30 am -
12:15 pm

Discuss Payer Considerations for Biosimilars Entering the US Market

As biosimilars, or lower-priced biologics, come to market within the year, how will payers evaluate these drugs beyond price?

  • Discuss what payers are looking for in terms of services when they are deciding which biosimilars to put on formulary
  • Learn what might influence them to choose one manufacturer over another for the treatment of the same indication
  • Analyze the parameters that could determine market access beyond price
Andrew Mulcahy
Associate Policy Researcher
RAND
12:15 pm -
1:30 pm

Luncheon

1:30 pm -
2:15 pm

Beyond the Formulary Decision: Discuss Potential Operational Barriers to Biosimilars Access and Uptake

  • Identify key “operational” barriers that could limit patient access to Biosimilars
  • Address the role various stakeholders need to play to reduce these barriers
Moderator:
Gina Kampfer
Global Biosimilars Lead, Payer Insights & Access
Pfizer Inc.
Panelists:
April Kunze
Director, Formulary Development and Pipeline
Prime Therapeutics
Joan O'Rourke
Vice President
CVS/Specialty
2:15 pm -
3:00 pm

Explore Provider Considerations on Biosimilars Adoption and Usage

For many drugs such as specialty oncology drugs, hospital systems hold a lot of power over which drugs get to patients because they are administered right at the hospital. Hear a unique perspective on:

  • How many biosimilars hospitals and institutions may plan to include on formulary?
  • How are decisions made which products are included on the formulary, especially when there are different products for the same indication?
  • What are the barriers to the adoption and usage of biosimilars in practice?
Edward Li, PharmD, BCOP
Associate Director of Pharmacy, UNE College of Pharmacy
Manager Oncology Pharmacy, NCCN
3:00 pm -
3:30 pm

Networking and Refreshment Break

3:30 pm -
4:15 pm

Identify Various Strategies to Encourage Biosimilars Acceptance by Physicians and Patients

  • Leverage co-payment assistance resources and programs for patients who might otherwise not be able to afford biologics treatments
  • Build physician confidence through education, experience, and by providing transparency on labeling and appropriate patient types
  • Understand how the entrance of the biosimilars era can improve accessibility and affordability for patients
Raj Kannan Raj Kannan
Vice President
Global Commercial Head
Biosimilars Unit
EMD Serono

Facilitated Roundtable Discussions:

4:15 pm -
5:00 pm

1. Discuss Effects of the ACA and the Changing Health Care Landscape on Biosimilar Uptake

Facilitated by:
Joseph P. Fuhr Jr., PhD
Professor, Economics
Widener University

2. Discuss the FDA's Call for Comments on Biosimilars Interchangeability and Implications for Biosimilars Manufacturers

Facilitated by:
Sarfaraz K. Niazi Sarfaraz K. Niazi, PhD
Executive Chairperson and Chief Executive Officer
Therapeutic Proteins International

3. Global Regulation and Monoclonal Antibodies: The Next Big Thing

Facilitated by:
Thomas Sullivan Thomas Sullivan
President, Rockpointe Corporation
Editor, Policy and Medicine
Co-founder, Association of Clinical Researchers and Educators
5:00 pm -
6:00 pm

Close of Day One / Cocktail and Networking Reception

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