EU Market Access 2021: What’s in Store for Orphan Drugs and ATMPs?

Life Sciences, Pharmaceutical Regulation, Commercialization & HEOR, Cell and Gene Therapy,
  • Wednesday, January 13, 2021

2021 has the potential to be a record year for orphan drugs and advanced therapy medicinal products (ATMPs) in Europe. With the hope of a world in which COVID-19 is a manageable disease comes the promise of ground-breaking new therapies and innovative approaches to digital healthcare. However, these will enter into an access environment under turmoil and change: a new EU Pharmaceutical Strategy, potential changes to orphan drug legislation and continual evolution of health technology assessment (HTA) processes and digital healthcare. The global population is now on the edge of a major shift in healthcare access, delivery and engagement. It is time to adapt or crash.

In this webinar, the featured speakers will bring a fresh, forward-looking perspective to the changing regulatory environment in Europe for orphan drugs and ATMPs and the key access trends expected in 2021. Through a mix of case examples and direct experiences, they will highlight insights into likely changes as a result of a greater number of ATMPs seeking commercialisation, the EU Pharmaceutical Strategy and associated changes to the orphan drug legislation. Importantly, the webinar panelists will recommend key considerations for manufacturers to optimise preparation of future orphan drug and ATMP launches.

Join this webinar to gain valuable insights into changes to the regulatory landscape expected in the coming year, and advice on how sponsors can optimise their commercialisation strategy for orphan drugs and ATMPs in Europe.


Alexander Natz_EUCOPE

Alexander Natz, EUCOPE Secretary General

Alexander Natz is Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and works as a lawyer for the law firm Novacos, in Dusseldorf. From 2008 to 2013, he was head of the German Pharmaceutical Industry Association’s (BPI) Brussels office. Before this, he worked as a lawyer at Sträter Law Firm in Germany, with a special focus on managed entry agreements, licensing, and pharmaceuticals. Alexander also worked in the field of competition law with the European Commission and in the pharmaceutical industry. As a research assistant at Duke University (USA), he has experience with international pharmaceutical law. His doctorate was supervised by a former judge at the European Court of Justice, Prof. Dr. Dr. Ulrich Everling.

Message Presenter
Sophie Schmitz, Partners4Access

Sophie Schmitz, Managing Partner, Partners4Access

Sophie is Managing Partner at Partners4Access (P4A), a global consultancy that is 100% focused on orphan drug access. P4A support the biotechnology and pharmaceutical industry along their launch journey to help secure successful price, reimbursement and access for orphan drugs. The company has solid partnerships with clients supporting their strategy and operations to effectively ensure launch success.

Sophie has worked in a range of disease therapy areas and has industry experience in both medical device and pharmaceutical industries. As such, she has developed a solid appreciation of strategic challenges and opportunities facing companies. Through her time in industry, she worked on several key product launches in both strategic planning and implementation. She has worked in global, regional and local teams which gives her a strong appreciation of real-life challenges in modern day healthcare organizations.

Sophie has enjoyed a successful 20-year commercial career within consultancy and industry. Prior to setting up Partners4Access, she worked at Alliance, PriceSpective, BMS, ConvaTec, SSL International and Smith & Nephew. In this time, Sophie has been involved in several product launches, organizational changes and acquisitions.

Message Presenter

Who Should Attend?

This webinar is essential for those working to commercialise orphan drugs, cell and gene therapies in small, medium and large biotech/pharma companies, with relevant areas of interest including:

  • Market Access
  • Payer Strategy/Value Strategy
  • Strategic Pricing
  • Patient Advocacy
  • Public Policy/Governmental Affairs
  • Commercial Operations

What You Will Learn

This webinar will help address the following in the context of commercialising orphan drugs and ATMPs in Europe:

  • Key market access trends likely to occur in 2021
  • Implications of the new EU Pharmaceutical Strategy for industry
  • Key considerations for manufacturers to optimise their market access strategy and implementation plans

Xtalks Partner


We are global experts in access for orphan drugs, cell and gene therapies, making a difference to those involved in rare diseases. At P4A, we believe in striking an equilibrium in the orphan drug, cell, and gene therapy world. That means helping drive access to the most appropriate treatments for patients and physicians, and a fair return on investment for manufacturers at an affordable proposition for payers. At P4A, we believe that as experts in access for orphan drugs, cell and gene therapies, we truly understand the complexity and challenges of the market access environment. We are passionate and take pride in partnering with our clients who trust us to help navigate some of the toughest challenges faced in gaining patients access to innovative treatments and therapies. Our motto is: Enlightened. Thinking. Applied.

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