The Archbow Consulting team was pleased to participate in the 19th Annual regulanet® conference in Badenweiler, Germany last week. It was a fantastic opportunity to connect in person with the other members and partners, learn more about the collective capabilities of the regulanet® network, and share the Archbow story with a diverse, international group.
regulanet® is a network of independent regulatory and market access agencies with representation in over 90 countries throughout the world. Founded in 2001 by Dr. Jürgen Regenold, regulanet® offers services to a wide variety of international healthcare and pharmaceutical clients. The members of the network provide advice and assistance on international projects and marketing authorization procedures.
The meeting was full of vital information on the changing pharmaceutical landscape, including these five essential takeaways:
1. Cell/Gene therapy is dramatically altering the foundations of global healthcare
The science behind Cell/Gene therapy, specifically CAR-T, is no longer futuristic, but is now “currentistic.”
Advances in personalized medicine will fundamentally change healthcare, provide new hope to previously impossible-to-treat diseases, and dramatically alter the supply chain and patient services chain across the globe.
Before we know it, the weeks it takes to produce an autologous medical cure/treatment, will morph into days (allogenic/off the shelf) or even a single day (CRISPR on call).
2. Many European countries are including Real World Evidence in Health Technology Assessments (HTAs)
While the UK leads the way, the rest of the big five EU countries are catching up with France in second place.
RWE embedded into HTAs provides the Regulatory Authorities with additional data to effectively evaluate medicinal products.
3. Early Access Programs enable access to life-saving medicines, yet a lack of robust data plagues these applications
4. Brexit has caused and will continue to cause confusion and problems for pharma companies
We all know that Brexit affects logistical issues (e.g., an additional layer of complexities for importation/exportation), but it also will result in the duplication of qualified persons, pharmacovigilance, and general data collection.
EU regulations for new products will no longer apply automatically to UK products although the UK government is committed to be aligned as closely as possible with the EU
Brexit affects both pharmaceutical and medical devices.
The EMA is moving its headquarters to Amsterdam from London. That alone isn’t an issue, but the agency has lost 30% of its operating revenue, 30% of its staffing, and potentially, 30% of new drug approvals.
As summarized by a notable British expert, “Brexit is a bloody mess.”
5. regulanet® members and partners can help navigate the complexities of these important challenges
regulanet® members can support all aspects of development, regulatory, and market access in their respective countries
Contact Archbow if your company needs global market access or regulatory assistance. We can put you in touch with the right global partners to help develop solutions that meet your needs.