Pre-Approval Access – the Theory and the Practicality

Whilst clearly-defined routes exist in most countries to allow pre-approval access to medicines under development, how these regulations play out in the real world is often very different from the written legislation.

With the raised profile of pre-approval access (thanks in part to Right-to-Try and the 21st Century Cures Act) there has been a noticeable increase in the number of companies and independent consultants seeking to become involved in this field. In and of itself this is no bad thing – increased choice for pharmaceutical and biotech companies is surely welcome.

However, the specificities of pre-approval access require more insight than theoretical consultancy can provide, and without direct experience of practical implementation of many pre-approval access programs any consultancy is by its very nature theoretical. Additionally, every single access program has a unique dynamic, specific to a wide range of factors which impact pre-approval access.

This presents a number of issues for pharma and biotech companies seeking expert guidance on an aspect of their operations which has a clear risk of impacting their reputation and their asset in the crucial period in the run up to launch, if it is not handled correctly.

Recently we were approached by a client who had taken advice from a consultancy which had recommended opening their pre-approval access program in a number of Latin American countries, but not France, Germany or Italy, on the rationale that they could capture data and charge for access more easily in Latin America. Whilst it is theoretically possible to charge for access and capture data in some Latin American countries, in practical terms it is almost impossible to recover payment, and it is unlikely that any European HTA body would use any data which could be captured in those countries,

We are seeing more and more of this sort of theoretical consultancy being provided to clients and it should be a concern to any company considering pre-approval access to any of their assets.

There is a place for theoretical consultancy, but at Inceptua we would argue that it is not within pre-approval access. Academic interpretation of regulations without the experience in the practicalities of how to provide access to patients with high levels of unmet need or ability to contextualize through direct experience of working through those regulations poses big risks.

Contact:

Stuart Bell
stuart.bell@inceptua.com

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CEO and Board Member

Stefan Fraenkel

Stefan Fraenkel is the CEO of the Inceptua Group and is also on the Inceptua Board. He has extensive experience in the pharmaceutical industry. Before joining Inceptua, he held senior management positions at Sobi (Swedish Orphan Biovitrum), Sweden’s largest publicly listed specialty pharmaceutical company, leading Marketing & Sales and serving as Head of Corporate Development and Strategy.

Previously, Stefan worked at Pfizer and Wyeth in international commercial leadership roles across Europe and the USA, gaining deep insights into global pharmaceutical markets and strategies. Stefan has also spent part of his career in management consulting. Stefan holds a PhD in International Economics, an MBA, and a BSc in Engineering.

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Member of the Board

Chris Hasslinger

Chris Hasslinger is a Partner of Vesey Street Capital Partners and serves as a member of the Firm’s Investment Committee. He joined VSCP in 2023 and is responsible for sourcing and evaluating new investment opportunities and general portfolio company management. Mr. Hasslinger has nearly three decades of experience in healthcare and technology strategy and deal-making within the industry as well as in investment banking and private equity. He has extensive M&A experience, having closed over $20 billion in transaction value, and has established and structured a number of large commercial partnerships.

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Executive Vice Chairman

Alan Raffensperger

Alan Raffensperger has a robust leadership background in the pharmaceutical industry, having served as CEO of Inceptua and COO of Sobi (Swedish Orphan Biovitrum), along with significant international executive roles at Amgen, Roche, and Pharmacia.

He has also been CEO for venture capital-owned medical device companies, showcasing his versatility in healthcare leadership. Alan’s early career as an advanced life support paramedic provided a strong foundation in emergency healthcare.

He holds an MBA and a BA in Emergency Health Care Management.

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Blake Goodner

Blake Goodner is a founder member of the investment firm Bridger Capital. He previously worked as a healthcare analyst at Tiger Management and a healthcare investment banker at Morgan Stanley. He currently serves as an advisor and board member for a range of healthcare companies. Mr. Goodner has been a member of the Trinity College Board of Visitors and the Duke Annual Fund Executive Committee. He is a current advisory board member with The Duke Margolis-Center for Health Policy.

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Adam Feinstein

Adam Feinstein is the Managing Partner of Vesey Street Capital Partners. Mr. Feinstein has 30 years of investment experience exclusively in the healthcare services sector. Prior to founding Vesey Street Capital Partners in 2014, he was a Managing Director on Wall Street and a healthcare industry executive. He held the position of Senior Vice President of Corporate Development, Strategic Investments, and Office of the Chief Executive Officer at LabCorp. Before his tenure at LabCorp, he spent 14 years as the Managing Director in Equity Research at Lehman Brothers/Barclays Capital. Mr. Feinstein is the Chairman of VSCP’s investment committee. He is also actively involved in working with portfolio company executives and sourcing new investment opportunities. At the same time, he oversees all of the firm’s investment activities and employees.

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Larry Marsh

Larry is a General Partner of Vesey Street Capital Partners and serves as a member of the Firm’s Investment Committee. He joined VSCP in 2016, and currently sits on the Board of QualityMetric, Safecor Health, and HRGi. He is responsible for portfolio company management and for evaluating new investment opportunities. Prior to VSCP, Larry was EVP, New Market Development & Chief Strategy Officer at Fortune 10 AmerisourceBergen. Prior to that, Larry was the #1 ranked Healthcare Technology & Distribution analyst on Wall Street for over a decade, at Barclays, Lehman Brothers, Salomon Smith Barney, and Wheat First Butcher & Singer. Larry worked with Adam, Bryan, Dan, and Joe at Barclays and Lehman. Larry received a B.S. in Economics & Management as well as an M.B.A. from the University of Richmond, and an M.P.H. from Columbia University.

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Heyward Donigan

Heyward Donigan is a seasoned healthcare CEO, Board Member, and Private Equity Advisor with broad industry experience and a track record of profitable growth. From 2019 to 2023, Ms. Donigan served as Rite Aid’s president and chief executive officer, making her one of the few women CEOs of a Fortune 500 company. While at Rite Aid, Ms. Donigan led the company to through a major brand, merchandise and technology transformation, debt reduction/refinancing, while also leading the company through a pandemic. Ms.Donigan is currently a strategic advisor to Vesey Street Capital Partners, Arima Health, and a board member of OnMed.

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Doug Cook

Doug Cook is the Executive Chairman at Inceptua. Mr. Cook began his career driving the early success of Livingston Healthcare, leading to the purchase by UPS to become what is today UPS’s Global Healthcare business. After Livingston Healthcare, Mr. Cook moved to AmerisourceBergen (now called Cencora/COR) in 1998 and had an impressive career overseeing most of Cencora’s high growth, manufacturer-facing business. Mr. Cook ultimately served as the Executive Vice President, President Commercialization and Animal Health for COR.

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