20th December 2019, 9am CET
In France, it takes 530 days between market authorisation and patients having access to a new medicine. It’s 374 days in Spain, 111 in the UK, and 106 in Germany. In this webinar we discuss the current access challenges to access to new, innovative oncology treatments in Europe, as well as reforming processes to make reimbursement pathways clearer and more efficient. The objective is to foster timely and appropriate access for those patients with unmet medical needs, and increased clarity and certainty around regulatory access decisions.
23rd of October 13.00-14.00 Eastern US
This webinar presents original research by Vital Transformation that will be peer review published in Therapeutic Innovation and Regulatory Science, showing the devastating impact on R&D, Investments, and patients that will be caused by reference pricing in the United States.
With the increasing use of new regulatory tools, like the FDA’s breakthrough therapy designation, there are increasing demands for European health technology assessors (HTAs) to make an accurate assessment of the long-term value and performance of CAR-T therapies from smaller datasets and shorter outcomes. This webinar will highlight our recent publication in the BMJ, sponsored by ZIN, which showcases a novel approach to harnessing RWE and develops a longitudinal data set that can be used for effectiveness measures, even in orphan conditions. As well, we will kickoff our new research project in Diffuse large B-cell lymphoma (DLBCL) and describe how we will leverage our methodology to measure the effectiveness of the various options for treatment, both in emerging CAR-T treatments, as well as existing chemotherapy regimes and bone-marrow transplants.
Do CAR-T – Chimeric antigen receptor T-cell – therapies have the potential to revolutionise cancer care? These therapies are disrupting traditional concepts of immuno-oncology, manufacturing, delivery and value across Europe. However, for many, there remain a number of open questions that need to be addressed. This session highlighted the transformative potential of these therapies, and sceptical voices who will focus on the unknown variables and where current challenges lie.
Duane Schulthess, managing Director of Vital Transformation, was invited as an expert by POLITICO to participate in “Health Care 2024,” a survey-driven series of online debates in which POLITICO will explore how the European Union can best tackle health policy. In this installment of Health Care 2024 POLITICO asks: Can the EU gain benefits from sharing health data without weakening privacy — and if so, how?
Podcast Better Science, Better Health: Erik Tambuyzer Negotiated the First EU Orphan Drug Legislation
Erik Tambuyzer is one of the world’s thought leaders in orphan drugs and rare disease indications. While he was Genzyme’s EU and International Senior Vice-President for Corporate Affairs, he was also the industry’s negotiation lead with the European Commission and Parliament on the Orphan Medicinal Products Regulation, introduced in the year 2000, working together with patients’ organisations and academics.
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