TERMIS Industry Symposium
Coordination of research and industrial organisations is the critical process in realising the potential of regenerative medicine. The Industry Symposium facilitates this by working to indentify the small ideas, as well as blockbusters, that can be taken forward. The aim being to pinpoint collaborations, big and small, that can make a difference.
This year the European and Northern American TERMIS Industry Committees will collaborate at the TERMIS-WC 12’ to develop a full day Industry symposium in Vienna.
The day is based on 4 sessions, providing an initial baseline around commercial development of therapies from academia, through a regulatory insight provided by both EMEA-CAT and FDA-CBER, then understanding how to build collaborations.
Importantly the day will finish with an interactive poster session and brainstorming workshop.
By working through the sessions the Industry Symposium will give academia and industry the opportunity to learn from their successes/failures throughout the commercialization process, whilst enabling identification of new partnerships and comment on cutting edge developments. At the end of the day all delegates should have an increased awareness of all aspects of the value chain, their position within it and how to move forwards in delivering commercially viable advanced therapies to patients/market.
Agenda
Friday Sept 7th, 2012
9:00 – 10:30 am
Session 1: Commercialization of Regenerative Products: The Academe/Industry Partnership
Prof. Dr. Hartmut Ehrlich (Baxter, Head RD Baxter Bioscience; Vienna, Austria)
Alain Vertes (London Business School , Sloan Fellow; London, UK)
“Commercialization of Regenerative Products: The Academia/Industry Partnership”
Arshad Ahmed (Scientia Advisors, Partner & co-founder; Boston, USA)
“Commercializing regenerative medicine therapeutics and sustaining a successful business”
Art J Coury (Consultant; former Vice President R&D Biomaterials, Genzyme; Boston, USA)
“Translating academic concepts to commercial medical products – A complex Academic/industrial partnership”
Rainer Knaus (Cell Medica, Senior Vice President & Head of European Operations; London, UK)
“Commercializing T cell Immunotherapies”
Peter Ghosh (Mesoblast, Senior Vice President, Orthopedic Research Programs; Melbourne, Australia)
“Successful translation of academic research using combinations of mesenchymal stromal cells with pharmaceutical agents for clinical applications in regenerative medicine”
11:00 am – 12:30 pm
Session 2: The Regulatory Imperative: International Perspective
Lucia D’Apote (European Medicines Agency [EMEA], Committee for Advanced Therapies [CAT], Scientific Administrator; London, UK)
Lecture on the European regulatory environment of regenerative medicine
Celia Witten (FDA’s Center for Biologics Evaluation and Research [CBER], Director of the Office of Cellular, Tissue and Gene Therapy, Washington, USA)
Lecture on the US regulatory environment of regenerative medicine
Roundtable with the US and European regulatory officers and
Alison Wilson (CellData Services, Principal Consultant; York, UK)
Tim Bertram (Tengion, Executive Vice President Science & Technology, Chief Scientific Officer; Winston-Salem, USA)
Maria-Pascual Martinez (TiGenix, Vice President of Regulatory Affairs; Spain & Belgium)
Robert Mays (Athersys, Senior Director of Regenerative Medicine; Cleveland, USA)
2:00 pm – 3:30 pm
Session 3: Making collaborations work
Chris Mason (University College London, Professor of Regenerative Medicine Bioprocessing; London, UK)
“Establishing a multibillion-dollar cell therapy industry requires a simple ABC approach – Academics, Businesspeople & Clinicians working together to integrate basic discovery, clinical translation and commercialization into a seamless process”
Michael Fehlings (Professor of Neurosurgery; Toronto, Canada) (Krembil Chair in Neural Repair and Regeneration
McLaughlin Scholar in Molecular Medicine
Director, University of Toronto Neuroscience Program
Co-Director, University of Toronto Spinal Program, University of Toronto
Medical Director, Krembil Neuroscience Center
Head, Spine and Spinal Cord Injury Program, Toronto Western Hospital, University Health Network)
“Translational Research in Spinal cord Injury: From Molecule to Man”
Simon Ellison (NHS Blood and Transplant, Specialist Services Commercial Manager; Watford, UK)
“Utilising economies of scope to use the NHS as a cell therapy development and delivery partner”
Charlie Campion (Baxter / Apatech, Senior Project Leader; London, UK)
“Academic - Industry Partnership – The Apatech story”
John Campbell (Miltenyi Biotec, Manager, Clinical Science & Technical Group; Guildford, UK)
“Technological advances in graft manipulation and cellular therapies – removing the bottlenecks”
4:00 pm – 5:30 pm
Session 4: Next academia-industry partnership (session open to abstract submission)
Leslie Wolfe (Genzyme, a Sanofi company, Vice President Technology Development ; Boston, USA)
“Production of Cell Therapies from Clinical Trial to Commercial Distribution”
Jonathan Mansbridge (Histogen, Chief Scientific Officer; San Diego, USA)
“Commercial Applications of Cell Conditioned Medium”
Andrew J Marshall (Healionics, Director and Chief Technology Officer; Seattle, USA)
“An Infection Control Solution for Catheter Exit Sites: Translation from Mice to Device”
Brian Horsburgh (Azellon, Director; Bristol, UK)
“Financing Regenerative Medicine: Azellon Ltd, an asset centric business model working in public:private partnership”
Rui Sousa (Stemmatters, CEO; Guimaraes, Portugal)
“Challenges in Translational Research: What role for SMEs?”
Michael Sittinger (Charité-Universitätsmedizin / CellServe; Berlin, Germany)
“Cardiac derived cells for the treatment of heart diseases - Current efforts to translate research into a marketable therapy”
Moritz Goeldner (Fraunhofer Research Institution for Marine Biotechnology; Lübeck, Germany)
“Translation from research to GMP-compliant manufacturing: Constructing a business model for a new stem cell source”