Webinar Series – Gene Therapy

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In hour-long, quarterly broadcasted industry-stakeholder discussions, P4A experts tackle complex subjects such as gene therapy and emerging technologies to help shape industry-wide conversations

P4A is hosting a three-part webinar series on Gene Therapy

Gene Therapy is emerging as the new frontier of human medicine with the potential to cure hard-to-treat rare diseases. The human genome project’s conclusion in 2003 followed by the first gene therapy approval in Europe (2012) and the US (2017) were key milestones.

However, very little is known about this approach to treatment, creating myths and expectations.

During the P4A webinar series, we will uncover these myths – from clinical evidence to commercial concerns and put forth the readiness of key markets to adopt and integrate gene therapies.

We will gain expert insights from a cross-section of stakeholders from the medical community, patients to industry and payers.

Webinar 3: Innovative Access Agreements for cell and gene therapy – A US and EU Perspective

In the last of the three webinar series on cell and gene therapy, P4A alongwith the MKO Group will explore the role of access agreements in patient access. Payers are increasingly concerned over the high cost of cell and gene therapies accompanied by deep uncertainty in clinical data.

Market access tools are being developed to address these concerns that would eventually provide a platform to share imminent and long-term risks. Innovative (IAA) or alternative access agreements could hold the answer.

Of the five EU countries, Italy (AIFA) and England (NICE) have been at  the  forefront in the application of such tools, often where providing an IAA has become the only realistic way to negotiate expensive oncology drugs. Some interesting, although limited, examples of this approach can be found also in France and some Spanish regions. Germany, on the other hand, has always  remained  shy  of  testing this approach, in particular after the introduction of AMNOG in 2011 although select examples do exist within innovative sick funds.

In the US,  IAAs  experienced  a  different  direction. Interest  in  these  types of agreements has been very high for years. Some examples  can  be  found  among commercial payers, and pilot programs have been intensifying.

The webinar will explore these in greater detail from both EU and US perspective.

Key topics to be discussed at the webinar are:

  • What are the available mechanisms to pay for gene therapy?
  • What is the impact of financial agreements in the UK and Germany?
  • Lessons learnt from Italy’s experience
  • Why have IAAs struggled to be implemented in the US?
  • What is the role of outcome-based agreements as IAAs?
  • Why are Gene/Cell therapies increasing interest in IAAs and what are the remaining complexities and risks associated with IAAs for these therapies?

Please use the registration form on the right to join us at the third webinar .

Date: January 15, 2019 | 17:00
Duration: 60 min


Sophie Schmitz
Managing Partner, Partners 4 Access


Sophie is a leading expert on orphan drugs, cell and gene therapy. She is heavily involved in advising orphan drug clients on price and market access strategies, with the ultimate goal of optimizing their launch. In a 20-year career span, Sophie has worked in various pharmaceutical therapy areas and medical devices focusing on key product launches in both strategic planning & implementation.

Gianluigi Casadei
Center of Health Economics Angelo and Angela Valenti, Italy


Camilla Gomiero 

Senior Consultant, MKO Group


Camilla is a value strategy consultant helping develop commercialization strategies for the biopharmaceutical industry. She has focused her career on development of pricing and market access strategies as well as asset valuations and business development support. She has over 9 years of experience across a wide range of therapeutic areas in both the hospital and retail settings, with a particular focus on orphan drugs.

Past webinars

Webinar 2: U.S. Lessons Learnt from Kymriah & Luxturna

In the second of three webinars, P4A is focussing on the US environment for gene therapies. Single application cell and gene therapies in the US face health insurance challenges driven by a short-term focus, disconnection between price reporting and outcomes value, and complex distribution models. To mitigate these challenges, health insurers and gene therapy companies are exploring different payment models to help improve access and spread costs.

If you missed the event, you can download the webinar here.

Webinar 1: Gene-therapy a revolution or evolution of healthcare?

In the first of three webinars held in November 2017, P4A provided historical context, understanding of what gene therapy is; its clinical and environmental challenges and whether it has the potential to truly revolutionise the healthcare environment.

If you missed the event, you can download the webinar here.

If you missed the events, you can download the webinars below

Webinar 2: U.S. Lessons Learnt from Kymriah & Luxturna?

Download webinar

Webinar 1: Gene-therapy a revolution or evolution of healthcare?

Download webinar

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