TERMIS-EU Industry Day
After past exaggerated expectations and discouragements, the Tissue Engineering and Regenerative medicine (TERM) development cycle seems to have reached, over the last few years, the enlightenment phase as suggested by increasing numbers of clinical trials and recent market approvals of Regenerative Medicine solutions in both Europe (i.e. Glybera & Holoclar® from Chiesi Pharma and Strimvelis® from GSK) and Japan (i.e. Remestemcel-L from Mesoblast®). TERM commercial growth is expected to be propelled in the billions USD range, notably by genetically modified T cells, potential blockbusters for therapy of cancers.
The successful commercial translation of TERM research is governed by a number of major drivers: i) Bringing to the market, therapeutic solutions for disease conditions with very high medico-social burden and no effective or sustainable treatment, ii) Fully validated manufacturing capabilities, iii) Reimbursement of Regenerative Medicine solutions, showing high and demonstrable medico-economic benefits versus standard of care, iv) early and strong partnership with regulatory bodies, v) Dense collaborations between Centers of Excellence and Industry collaborations, vi) Robust and well-inspired clinical development strategy and evaluation.
The focus of this TERMIS-EU 2017 Industrial Day Symposium will be on the clinical translation of TERM solutions. Invited speakers will educate the attendees on clinical evaluation roadmap and clinical development strategy, on the prerequisites to clinical evaluation, and the planning of clinical trials in the field of Regenerative Medicine. Following on, real cases of Regenerative Medicine clinical evaluation will be presented and discussed.
Abstract submissions related to clinical translation of cell therapy and TERM solutions are welcomes.
Tentative Program of the Industrial Day Symposium
|28th of June 2017|
|9:10 AM- 10:40 AM||Clinical evaluation & translation: what, when, where and how?
– Session 1
|Invited Speaker 1- 15 min||Alain Vertes, NxR Technologies, Switzerland|
|Invited Speaker 2- 15 min||Fatima Boumares- NAMSA, France|
|Invited Speaker 3- 15 min||Ursula Schlichtiger, US Consulting, Germany|
|Oral presentation selected-1 -12 min|
|Oral presentation selected-2- 12 min|
|11:10 AM-12:40 AM||Clinical evaluation of TERM products: real cases and experience to date – Session 2|
|Invited Speaker 4- 15 min||Paul Kemp, Intercytex, United Kingdom|
|Invited Speaker 5- 15 min||Etienne Sokal, Promothera, Belgium|
|Invited Speaker 6- 15 min||Vincent Ronfard, UNT System College of Pharmacy, Fort Worth Texas, US|
|Oral presentation selected-3- 12 min|
|Oral presentation selected-4-12 min|
|17:50 PM-19:20 PM||Clinical evaluation of TERM products: real cases and experience to date – Session 3|
|Invited Speaker 7- 15 min||Jonathan Appleby, GSK, United Kingdom|
|Invited Speaker 8- 15 min||TiGenix, Belgium, to be confirmed,|
|Oral presentation selected-5- 12 min|
|Oral presentation selected-6- 12 min|
|Oral presentation selected-7- 12 min|
|Alain Vertès, NxR Biotechnologies|
|Andreas Emmendörffer, NAMSA|
Dr. Andreas Emmendörffer has more than 20 years' experience in regulatory affairs of medical devices, pharmaceuticals, cell-based health care products and combination products, and in Quality Management Systems according to cGMP and ISO 13485. He has 15 years' experience in applied research on immunotoxicological effects of chemicals, drugs and biologicals, and has authored several Biological Safety Evaluation Plans, Risk assessments (ISO 14971, ISO 22442), Gap Analyses. He has successfully managed several audits by Competent Authorities, Notified Bodies for cGMP and ISO compliance, regulatory Compliance (FDA/EMA/Swissmedic/PEI/BfArM), Qualified Person and Technical Responsible Person (FvP) as well as Supplier Qualification and GDP. He has a strong expertise on Biocompatibility, and has prepared biological risk assessments (cardiovascular, orthopedic and neurosurgical devices); performed and managed biological testing, reviewed and approved protocols and reports; and has training and experience in immunotoxicology, autoimmune diseases, inflammatory response in different organ systems (lung, skin, bone, brain, GIT).In addition, he holds a Ph.D. from Medical School Hannover, Germany and has authored more than 40 peer-reviewed publications.
|Daniela Marino, Cutiss AG|
Daniela Marino is the CEO of CUTISS AG, a spin-off of the University of Zurich that develops personalized skin grafts for the treatment of skin defects. Daniela Marino received her M.Sc. in Biotechnologies from the University of Milan in 2005 and her Ph.D. from the Institute of Pharmacological Sciences of ETH Zurich in 2009. During her postdoctoral studies at the Tissue Biology Research Unit in Zurich, and afterwards at the Wyss Translational Center Zruich, she specialized in tissue engineering of skin, project management, product development, clinical trials and regulatory affairs. Her professional mission is to finally provide a real solution to patients suffering from skin defects.
|Paul Kemp, Intercytex|
|Etienne Sokal, Promothera|
Short Bio.Etienne Sokal is Chief Innovation and Scientific Officer of Promothera Biosciences, a clinical stage pharmaceutical company that develops therapies for the treatment of liver diseases with no effective therapeutic cure. He is also Professor in the faculty of Medicine of the Catholic University of Louvain, Belgium.
|Vincent Ronfard, UNT System College of Pharmacy|
Short Bio.Vincent Ronfard is cell biologist who is passionate about developing products that help people heal. Vincent Ronfard has more than 28 years of experience in the field of Regenerative Medicine. He started his career at the Blood Transfusion Center (Lille, France) where he developed a fibrin substrate to transplant human keratinocytes. He studied the fate of keratinocyte stem cells in Pr. Yann Barrandon’s lab in Paris for 5 years. He then moved to Biopredic International where he developed the use of human and animal hepatocytes to for drug testing and screening. In 1997, he developed a new generation of tissue engineered products while senior scientist at Organogenesis Inc. In 2000, Dr. Ronfard served as director of research at Modex Therapeutics which was an early pioneer in the field of tissue regeneration, there he was co-inventor of Allox a cell therapy treatment for chronic wounds. In 2003, he joined L'Oreal (U.S.A. and Paris) where he served as associate Vice President/director of reconstructed skin worldwide. In this role, he led the global research on skin engineering covering US, China and Europe. Next, Dr. Ronfard returned to Organogenesis as VP R&D to build a pipeline and a research team. From 2010 to 2015 he was Vice-President of Research and Development at Smith & Nephew Biotherapeutics where led the development of biologics for the treatment of wounds. He is one of the founder of HairClone a company aiming at treating hair loss using autologous cellular therapy. He is adjunct Professor at the College of Pharmacy at UNT (Fort Worth, USA) and invited Professor at Claude Bernard University (Lyon, France). Vincent Ronfard holds a PhD in Cell Biology from the University of Compiegne, France and a graduate degree of Engineering in Agriculture from the University of Lille.
|Marie Paule Richard, TiGenix|
Short Bio.Dr. Marie Paule Richard has spent more than twenty five years in senior executive positions in pharmaceutical and biotechnology companies. She has held international management positions at Bristol Myers Squibb, Sanofi, GlaxoSmithKline, Sanofi Pasteur and Crucell. Prior to joining TiGenix, Dr. Richard was Chief Medical Officer at AiCuris GmbH, Germany. She has gained global and extensive experience of clinical development strategy and operations across all phases of development, regulatory affairs and pharmacovigilance, involving numerous anti infective and immunomodulatory drugs and biologicals, as well as the life cycle management of marketed products. She has obtained several drug approvals and international license renewals in both Europe and the United States. Dr. Richard holds a medical degree from the University of Nancy, France, and, among other qualifications, a certification in Clinical Immunology.