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.
9:00-9:30am | Welcome and State of the Industry Remarks
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?
Timothy Schroeder, CEO, CTI Clinical Trial & Consulting Services (moderator)
Luca Alberici, Ph.D., Chief Business Officer, MolMed S.p.A.
Miguel Mulet, Ph.D., Director, Strategy and Corporate Development, TiGenix
Keith Thompson, CEO, Cell and Gene Therapy Catapult
Andreas Weiler, Ph.D., Global Business Unit Head, Emerging Technologies, Lonza
10:15-11:00am | Comparability for Cell and Gene Therapies: Key Aspects for Consideration in Regulatory Guidance
Jacqueline Barry, Ph.D., Chief Clinical Officer, Cell and Gene Therapy Catapult (moderator)
David Hodl, VP, Business Development, Cell Therapy, Invetech
Karin Hoogendoorn, Pharm.D., Head of Chemistry, Manufacturing and Controls (CMC), Immunicum AB
Gopalan Narayanan, M.D., Vice President, Disruptive Biologics, Voisin Consulting Life Sciences
Ajan Reginald, CEO, Celixir
Paula Salmikangas, Ph.D., Director of Biopharmaceuticals and ATMP, NDA Advisory Board
11:00-11:15am | Morning Break
11:15-12:45pm | EMA and EUnetHTA Collaboration on Evidence Generation
Paolo Morgese, EU Director, Market Access & Member Relations, Alliance for Regenerative Medicine (moderator)
Didier Caizergues, M.D., Head of Regulatory Affairs Department, Genethon
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
Ioana Siska, Ph.D., Policy Officer, DG SANTE – Unit B4 Health Technology Assessment Team, European Commission
12:45-2:00pm | Networking Lunch
2:00-2:30pm | Improvement to the Regulatory Landscape in Europe: Gaps and Next Steps
Annie Hubert, Senior Director, European Section and Public Policy, Alliance for Regenerative Medicine (moderator)
Ana Hidalgo-Simon, M.D., Ph.D., Head of Specialised Scientific Disciplines Department, Human Medicines Research & Development Support Division, European Medicines Agency
Anneli Torronen, M.D., Ph.D., 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
Morrie Ruffin, Co-Founder and Senior Advisor, Alliance for Regenerative Medicine (moderator)
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, M.D., 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
Doug Danison, Vice President, Access, Value & Evidence Strategy, bluebird bio (moderator)
Luca Alberici, Ph.D., Chief Business Officer, MolMed S.p.A.
Rimma Berenstein, Ph.D., Scientific Advisor, Gemeinsamer Bundesausschuss (G-BA), Pharmaceuticals Department, Federal Joint Committee
André Berger, Ph.D., Medicinal Major Policy Issues, Paul-Ehrlich-Institut – Federal Institute for Vaccines and Biomedicines
Susanne Teupen, Patient Representative Spokesperson, Gemeinsamer Bundesausschuss (G-BA)
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
Held in Conjunction with:
[[{“type”:”media”,”view_mode”:”media_large”,”fid”:”2582″,”attributes”:{“alt”:””,”class”:”media-image”,”height”:”136″,”typeof”:”foaf:Image”,”width”:”220″}}]]
For those interested in attending BIO-Europe Spring, enter “ARM2018” in the comments section when registering to receive €200 off.
