Title

Advanced Therapies Summit
Wednesday
April
06
The Advanced Therapies Summit is a gathering of top executives and clinical researchers from across Europe and the US. This year’s program will feature interactive roundtable discussions and networking opportunities.
Stockholm, Sweden

6th Annual Advanced Therapies Summit
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, clinical researchers, public policy makers and other members of the advanced therapies community to highlight the major achievements as well as 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 roundtable discussions and networking opportunities.

 

Agenda
Wednesday, April 6, 2016

8:30am | Registration, Breakfast & Networking

9:00am | Welcome & State of the Industry Remarks
Morrie Ruffin, Managing Director, Alliance for Regenerative Medicine
Alexander Vos, CEO, PharmaCell 

9:30am | Roundtable I: Industrialization of Cell Therapy
As more cell therapy products are approaching later stages of clinical development, how are both companies and major medical centers confronting the hurdle of scalability for these single patient treatments? This session will discuss where these types of therapies are being delivered, what manufacturing models are currently being utilized and which standardized platforms and methods have the potential to succeed.

Discussion Leaders
Sylvain Arnould, Ph.D., Head of Manufacturing, Cellectis 
Tomas Borgegård, Innovation Program Manager, Karolinska University Hospital
Dieter Hauwaerts, Vice President of Operations, Celyad 
Keith Thompson, CEO, Cell and Gene Therapy Catapult 
Giuliana Vallanti, Ph.D., Head of Development and Quality Control, MolMed 
Phil Vanek, Ph.D., General Manager, Cell Bioprocessing, GE Healthcare Life Sciences 

10:30am | Morning Break

10:45am | Roundtable II: ATMP Development & Regulatory Challenges
In this discussion, industry leaders and regulators will share their views on what the challenges are to develop ATMP, prepare and/or review clinical trial applications and regulatory submissions for ATMP. The role of regulators to provide guidance for ATMP development, the upcoming clinical trial regulation and how the regulatory landscape is adapting to the specific needs of advanced therapies will be discussed. Discussion leaders will exchange views on the possible improvements that could be further made to facilitate ATMP development.

Discussion Leaders
Jacqueline Barry, Ph.D., Head of Regulatory, Cell and Gene Therapy Catapult
Eduardo Bravo, CEO, TiGenix 
Anne-Virginie Eggimann, Vice President, Regulatory Science, bluebird bio 
Paula Salmikangas, Ph.D., Chair, Committee for Advanced Therapies (CAT), European Medicines Agency (EMA)  
Carmen Vieira, Pharm.D., Associate Director of Regulatory Affairs - EMEA, Janssen Research & Development 

11:45am | Roundtable III: Pharma’s Strategic Investment in Gene & Cell Therapy 
This discussion will address in-depth pharma’s strategic investment in ATMPs including specific areas of interest for pharma companies, such orphan diseases, oncology and other areas. Hear firsthand from leading pharma representatives on their expectations when working with smaller companies as well as the company decision-making process. This discussion will focus specifically on what smaller companies should be prepared for when meeting with prospective pharma company partners.

Discussion Leaders
Sven Kili, M.D., Gene Therapy Development Head, GlaxoSmithKline 
Edward Lanphier, CEO, Sangamo BioSciences
Mathieu Simon, M.D., Executive Vice President, Chief Operating Officer, Cellectis
Jeff Till, 
Ph.D., Director, External Innovation, EMD Serono

12:45pm | Networking Luncheon

2:00pm | Roundtable IV: Adaptive Pathways & Early Market Access
This discussion will provide an update on the pilot project for adaptive pathways and impart how this approach is working within the existing regulatory framework to provide earlier access to new treatments. Discussion leaders will share their early ATMP experiences across a variety of therapeutic areas and discuss whether and how HTA agencies and payers embrace this model and facilitate early market access for innovative products.

Discussion Leaders
Francis Arickx, Head of Directorate Pharmaceutical Policy, National Institute for Health and Disability Insurance 
Doug Danison, Head of Global Pricing, Reimbursement, Market Access, and Health Economics, bluebird bio 
Leeza Osipenko, Ph.D., Associate Director of Scientific Advice, National Institute for Health & Care Excellence (NICE) 
Yaron Ramati, Ph.D., Director of Regulatory Affairs, Pluristem Therapeutics
Constantinos Ziogas, M.D., Principal Administrator, European Medicines Agency (EMA) 

3:15pm | Afternoon Break

3:30pm | Roundtable V: ATMP Product Reimbursement
This session will explore payer views on advanced therapies including expectations of appropriate data and models for ATMP developers. Discussion leaders will explore what is possible to fund potentially curative treatments in Europe and overcoming barriers to access to patients.

Discussion Leaders
Francis Arickx, Head of Directorate Pharmaceutical Policy, National Institute for Health and Disability Insurance 
Matthew Durdy, Chief Business Officer, Cell and Gene Therapy Catapult 
Eric Faulkner, Vice President, Precision and Transformative Technology Solutions, Evidera
Alec Orphanidis, SVP, Global Commercial Operations, uniQure 
Leeza Osipenko, Ph.D., Associate Director of Scientific Advice, National Institute for Health & Care Excellence (NICE) 

4:45pm | Closing Discussion: Key Takeaways: Issues & Challenges for the Sector
This discussion will summarize the key takeaways from the day while examining the issues and challenges facing the sector in the coming year.

Discussion Leaders
Michael Hunt, Chief Financial Officer, ReNeuron Group 
Morrie Ruffin, Managing Director, Alliance for Regenerative Medicine
Alexander Vos, CEO, PharmaCell 

5:15pm | Networking Reception

Venue
Scandic Victoria Tower
Arne Beurlings Torg 3
164 40 Kista, Sweden

Cost of Attendance
ARM Members: 595
Non-members: 850

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