Biopharma companies looking to establish a footprint in Europe face country-specific decision-making processes. The health technology assessments (HTAs) in France and Germany, for example, look very different.Does this regional level of thinking make it easier or potentially more difficult to get medicines to market and into the hands of patients who need them?In this episode of Back Bay’s Life Science podcast, Pete Bak is joined by Alexander Natz, Secretary-General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Europe’s principal trade body for companies working in the field of pharma, biotech, and medtech. Based in Brussels, EUCOPE provides expertise across a number of strategic issues such as regulatory paths and pricing and market access.Topics in this podcast include:
A brief overview of EU HTAs as they pertain to novel technologies, including cell and gene therapies
The differences and nuances between cell and gene therapies and best practices for companies during early clinical development
Where medication approval could be denied in the absence of specific data
The right time to start talking to EU payors
How the regulatory framework will continue to evolve
Impact on drug indication choice and strategy and examples of where the regulatory process has gone well or faltered
For questions on regulatory and market access, reach out to Back Bay Life Science Advisors and check-in with EUCOPE at www.eucope.org.Follow EUCOPE on LinkedIn www.linkedin.com/company/eucope and on Twitter: @EUCOPE.Make sure to subscribe to The Life Science Report podcast, follow Back Bay Life Science Advisors on LinkedIn and sign up for our industry newsletter.Thank you for joining us.