The Evolving Regulatory Framework for Novel Medicines in the EU

Back Bay Life Science Report

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.

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Thank you for joining us.