Title

Advanced Therapies Summit
Wednesday
March
14
The Advanced Therapies Summit is a gathering of top executives and policy makers leading the evolution of the ATMP framework in Europe and key member states. This year’s program will feature roundtable discussions and networking opportunities.
Amsterdam, The Netherlands

The Advanced Therapies Summit is a multi-stakeholder, interactive forum that seeks to exchange views and make recommendations on how best to advance the ATMP sector in Europe. The conference brings together the top executives, public policy makers and other members of the advanced therapies community to highlight the major achievements and explore the main challenges experienced along the path from discovery to delivery of transformative – and even potentially curative – therapies. This year’s program will feature interactive discussions and networking opportunities with policy makers leading the evolution of the ATMP framework in Europe and executives from leading companies in the ATMP sector.

8:00-9:00am      |   Breakfast and Registration

9:00-9:30am      |   Welcome and State of the Industry Remarks
Speaker: Janet Lambert, CEO, Alliance for Regenerative Medicine

9:30-10:15am    |   Plenary Session: Clinical and Commercial Momentum 
How can the European ATMP sector take advantage of recent successes to support further investment and growth?
Moderator: Timothy Schroeder, CEO, CTI Clinical Trial & Consulting Services
Speakers: Luca Alberici, Ph.D., Chief Business Officer, MolMed S.p.A.
Keith Thompson, CEO, Cell and Gene Therapy Catapult

10:15-11:00am  |   Comparability for Cell and Gene Therapies: Key Aspects for Consideration in Regulatory Guidance 
Moderator: Jacqueline Barry, Ph.D., Chief Clinical Officer, Cell and Gene Therapy Catapult

11:00-11:15am  |   Morning Break

11:15-12:45pm  |   EMA and EUnetHTA Collaboration on Evidence Generation
Moderator: Paolo Morgese, EU Director, Market Access & Member Relations, Alliance for Regenerative Medicine
Speakers: Chantal Guilhaume, Scientific Project Manager, EUnetHTA JA3, HAS
Ana Hidalgo-Simon, M.D., Ph.D., Head of Specialised Scientific Disciplines Department, Human Medicines Research & Development Support Division, European Medicines Agency
Sven Kili, M.D., VP, Head of Cell & Gene Therapy Development, GSK
Jane Moseley, M.D., Senior Scientific Officer, Scientific Advice Office, European Medicines Agency

12:45-2:00pm    |   Networking Lunch

2:00-2:30pm      |   Improvement to the Regulatory Landscape in Europe: Gaps and Next Steps 
Moderator: Annie Hubert, Senior Director, European Section and Public Policy, Alliance for Regenerative Medicine
Speakers: Ana Hidalgo-Simon, M.D., Ph.D., Head of Specialised Scientific Disciplines Department, Human Medicines Research & Development Support Division, European Medicines Agency
Anneli Torronen, Policy Officer, Unit B5, European Commission

2:30-3:15pm      |   Progress and Solutions in Addressing ATMP Manufacturing Requirements: The Evolution of Standards and Other Key Performance Metrics
Moderator: Morrie Ruffin, Co-Founder and Senior Advisor, Alliance for Regenerative Medicine
Speakers: Emmanuelle Charton, Ph.D., Head of Division, European Pharmacopoeia Department, European Directorate for the Quality of Medicines and HealthCare
Miguel Forte, M.D., Ph.D., CEO, Zelluna
Jack Price, Ph.D., Head, Division of Advanced Therapies, National Institute for Biological Standards & Control
Marc Turner, Ph.D., Medical Director, Scottish National Blood Transfusion Service

3:15-3:30pm      |   Afternoon Break

3:30-4:45pm      |   Health Technology Assessment, Pricing and Funding of ATMPs in Germany
Moderator: Doug Danison, Vice President, Access, Value & Evidence Strategy, bluebird bio
Speakers: Rimma Berenstein, Ph.D., Scientific Advisor, Gemeinsamer Bundesausschuss, Pharmaceuticals Department, Federal Joint Committee

4:45-5:00pm      |   Closing Remarks

5:00-6:00pm      |   Networking Reception

Venue
Hilton Amsterdam
Apollolaan 138
1077 BG Amsterdam, The Netherlands

Who Attends?
Senior representatives from the advanced therapy sector including C-level executives, big pharma, policy makers, regulatory and translational experts, investors and patient advocates

Registration Rates
ARM Member: €750
Non-Member: 
€995

Questions?
Chelsey Hathaway
Senior Manager, Patient Engagement & Events
chathaway@alliancerm.org