Title

Advanced Therapies Summit
Wednesday
March
22
The Advanced Therapies Summit is a gathering of top executives and clinical researchers from across Europe and the U.S. This year’s program will feature roundtable discussions and networking opportunities.
Barcelona, Spain

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 Outline

8:30am       REGISTRATION, BREAKFAST AND NETWORKING

9:00am       WELCOME AND STATE OF THE INDUSTRY REMARKS

Discussion Leaders
Robert Preti, Ph.D., Chairman, Alliance for Regenerative Medicine (ARM); President, PCT, A Caladrius Company; SVP, Manufacturing and Technical Operations, Caladrius Biosciences
Keith Thompson, CEO, Cell & Gene Therapy Catapult
Albert Barberà, Ph.D., CEO, Biocat

9:30am       ROUNDTABLE I: FOSTERING REGULATORY DEVELOPMENT AND IMPROVING PATIENT ACCESS TO ATMPS IN EUROPE
Participants will explore and discuss possible regulatory improvements to encourage and facilitate development and accelerate patient access for ATMPs in Europe. This roundtable will provide an opportunity to report progress in the elaboration of an action plan by the EMA, the European Commission and Member States. Some of the recommendations made by ARM in its position paper will be discussed including those focused on hospital exemption or on GMO requirements.

Discussion Leaders
Jacqueline Barry, Ph.D., Chief Clinical Officer, Cell & Gene Therapy Catapult (Moderator)
Eduardo Bravo, CEO, TiGenix
Ana Hidalgo-Simon, M.D., Ph.D., Head of Specialsed Scientific Disciplines, European Medicines Agency (EMA)
Christiane Niederlaender, Ph.D., Senior Quality Assessor and Deputy Unit Manager, Biologicals Unit, Licensing Division, Medicines and Healthcare Products Regulatory Agency (MHRA)
Chris Sotirelis, Patient Expert, EURORDIS/UK Thalassemia Society
Michael Werner, Executive Director, Alliance for Regenerative Medicine

10:30am     ROUNDTABLE II: STRATEGIC COLLABORATIONS AND PARTNERING
Given the unique development challenges for gene and cell therapy, it is clear that strategic partnerships will play a significant role in moving beyond early clinical signals of efficacy toward versatile and robust models that can support treatment on a larger scale. This panel of executives will discuss the unique nature of deals in the ATMP sector including both transactions driven by access to technology platforms and research and development, and those driven more by a specific therapeutic focus. The panel will also consider the different types of funding sources and deal structures to support both earlier stage programs and commercialization.

Discussion Leaders
Morrie Ruffin, Managing Director, Alliance for Regenerative Medicine (Moderator)
Elena Kfoury, General Manager, Axiogenesis
Peter Nell, Ph.D., VP, Head Strategy and Business Development, Casebia Therapeutics
Alexandra Richardson, Ph.D., Head of Marketing and Business Development, Clayton Biotechnologies
John Tchelingerian, Ph.D., CEO, Promethera Biosciences

11:30am     MORNING BREAK

11:45am     ROUNDTABLE III: CAPITAL FORMATION AND THE INVESTOR’S ASSESSMENT OF ADVANCED THERAPIES
The remits and criteria for investment in advanced therapies will be addressed by a panel of lead investors. The optimal factors for investment and the importance of the business model, including the types of products and potential markets will be discussed as well as access to non-dilutive financing in the EU.

Discussion Leaders
Matthew Durdy, Chief Business Officer, Cell & Gene Therapy Catapult (Moderator)
Pete Finan, Ph.D., Venture Partner, Epidarex Capital
Genghis Lloyd-Harris, Ph.D., Partner, Abingworth
Dave McDonald, Head, Life Sciences Investment Banking, Lake Street Capital Markets
Christina Trojel-Hansen, Ph.D., Senior Investment Associate, Novo Seeds
Bram Vanparys, Ph.D., Investment Director, Healthcare, Merck Ventures

12:45pm     NETWORKING LUNCHEON

2:00pm       ROUNDTABLE IV: CHALLENGES AND OPPORTUNITIES FOR MARKET ACCESS AND REIMBURSEMENT OF ATMPS IN EUROPE
This roundtable will address the specific challenges for the value assessment of ATMPs and discuss whether the HTA processes in place in different Member States are fit for the evaluation and funding of transformative and potentially curative therapies. The opportunity of cross-border healthcare with patients’ traveling to a different EU country for treatment will also be evaluated.  

Discussion Leaders
Doug Danison, VP, Market Access, Value and Evidence Strategy, bluebird bio (Moderator)
Bertrand Alexandre, Global Marketing Director, Celyad
François Meyer, M.D., Advisor to the President, International Affairs, French National Authority for Health (HAS)
Bastien Mézerette, Pharm.D., Innovative Health Products Officer, Innovation and Clinical Research Office, French Ministry of Health, General Directorate for Healthcare Provision (DGOS)
Emilie Sam, Market Access for Innovative Health Products Pharmacist, Innovation and Clinical Research Office, French Ministry of Health, General Directorate for Healthcare Provision (DGOS)

3:15pm       AFTERNOON BREAK

3:30pm       ROUNDTABLE V: MANUFACTURING, INDUSTRIALIZATION AND INFRASTUCTURE 
As the first wave of approved cell-based and gene-based therapies enters the market, the commercial success of this initial portfolio of products will depend on the use of appropriate models and structures to deploy both autologous and allogeneic products. A panel of key opinion leaders will discuss manufacturing scales, economies of scope and learning, the development of standards and capital expenditures as well as available production capacity.

Discussion Leaders
Alexander Vos, CEO, PharmaCell (Moderator)
Nina Bauer, Ph.D., Senior Manager, Commercial Development Cell Therapy, Lonza
Boro Dropulić, Ph.D., Chief Science Officer and General Manager, Lentigen Technology, A Miltenyi Biotec Company
Madhusudan Peshwa, Ph.D., Chief Scientific Officer; EVP, Cellular Therapies, MaxCyte
Robert Preti, Ph.D., President, PCT, A Caladrius Company; SVP, Manufacturing and Technical Operations, Caladrius Biosciences
Kunihiko Suzuki, Vice Chairman, Forum for Innovative Regenerative Medicine (FIRM); Member, Board of Directors and Vice Chairman, MEDINET Co.

4:45pm       CLOSING DISCUSSION: KEY TAKEAWAYS FOR THE SECTOR

Discussion Leaders
Michael Hunt, Chief Financial Officer, ReNeuron Group
Alain Vertès, Ph.D., European Section Director, Alliance for Regenerative Medicine

5:00pm       NETWORKING RECEPTION

6:00pm       SUMMIT ENDS

Venue
AC Hotel Barcelona Forum
Paseo Taulat 278
08019 Barcelona Spain

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

Contact:
Chelsey Hathaway
Manager, Patient Advocacy & Events
chathaway@alliancerm.org