U.S. Market access strategy at the clinical stage for all companies considering a launch: A three-part series

The complexity of the U.S. market access landscape means that proving safety and efficacy is no longer a guarantee of commercial success. This three-part series will provide you with the basics of government and commercial payer rules, walk through hypotheticals that bring those rules to life, and prepare you for the market’s evolving focus on value-delivery.

At the end of the series, you will understand why your market access strategy can and should start before the initiation of your Phase IIIs, have identified early-stage steps to de-risk those variables with the potential to constrain market access later, and why you should be prepared for investors to ask you these same questions. This series will benefit any company new to the U.S. market, or looking to launch in the U.S.

Hogan Lovells is a proud sponsor of The Demy-Colton Virtual Salon Series.


Part One | Wednesday, 20 April – 11:00AM-12:15PM (ET), including Q&A

The Foundation: The Basics of Market Access and Why They Matter Before Phase IIIs

This first session will provide a foundation in the government and commercial payer landscape in relation to coverage, reimbursement, and pricing, and how those considerations can have a real-time impact on commercialization strategy. While there are a number of straightforward business considerations relevant to commercialization, the focus of this discussion will be legal and policy considerations, which typically are less readily known to biotechs at this earlier stage of drug development.


  • Alice Valder Curran, Partner, Hogan Lovells
  • Kave Niksefat, General Manager, Inflammation Business Unit, Amgen
  • Beth Roberts, Partner, Hogan Lovells

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Part two | Wednesday, 4 May – 11:00AM-12:15PM (ET), including Q&A

Making It Real: What Does an Early-Stage Market Access Strategy Look Like?

Using the foundations covered in Part 1, Part 2 will walk through a series of hypotheticals that demonstrate why and how developers can create a market access strategy early in the clinical development process, including strategies for clinical trial design, likely investor inquiries, and competitive positioning.


  • Alice Valder Curran, Partner, Hogan Lovells
  • Tess Cameron, Principal, Strategic Finance, RA Capital Management
  • Adrienne Ellman, Partner, Hogan Lovells
  • Lynn Mehler, Partner, Hogan Lovells

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Part three | Wednesday, 18 May – 11:00AM-12:15PM (ET), including Q&A

Future-Proofing: How to Prepare a Value-Based Market Access Strategy

Market access considerations continue to evolve in the highly dynamic U.S. market. With an increasing focus on value delivery, Part 3 will discuss the different ways to measure and demonstrate value, the interplay between FDA and CMS on such value propositions, and strategies for payer engagement.


  • Alice Valder Curran, Partner, Hogan Lovells
  • Peter Rubin, Executive Director, No Patient Left Behind (NPLB)
  • Lowell Zeta, Partner, Hogan Lovells
  • Michael Rothrock, President, Allegheny Strategic Partners LLC

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