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
Webinar: Early Access Programs in Europe: ‘A Friend or Foe?’
In the EU, Early Access Programs enable patients to access therapies pre-commercialisation for diseases with high unmet need. Known as Expanded Access Programs in the US, these initiatives allow for orphan drugs to be made available to patients with rare diseases before they have been formally approved by regulators. While these programs can offer numerous benefits to patients, physicians and manufacturers, decisions made during their set-up can have downstream implications for access and commercialisation potential after marketing authorisation. For example, decisions made around the patient eligibility criteria to access an in-development drug via an Early Access Program sets stakeholder expectations around the unmet need within the disease. This in turn could influence payer decisions around the patient population that they are willing to reimburse when the product finally launches commercially. In this webinar, featured speakers will bring multi-disciplinary perspectives to the benefits and pitfalls of Early Access Programs in Europe.
If you missed the event, you can download the webinar here.
P4A’s 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.
The P4A webinar series uncovered such myths – from clinical evidence to commercial concerns – and put forth the readiness of key markets to adopt and integrate gene therapies.
We gained expert insights from a cross-section of stakeholders from the medical community, patients to industry and payers.
Webinar 3: Innovative Access Agreements – A US & EU Perspective
In the last of the three webinar series on cell and gene therapy, P4A alongwith the MKO Group explored 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.