News:

Termis-EU Congress, European Chapter Meeting of the Tissue Engineering and Regenerative Medicine International Society 2017
was granted 23 European CME credits (ECMEC) by the European Accreditation Council for Continuing Medical Education (EACCME).




Accepted Society Symposia:

























TERMIS-EU Industry Day

Personalised Therapies for Regenerative Medicine

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.


Program of the TERMIS-EU Industry Day Symposium

28th of June 2017


8:50 AM- 10:20 AM

Clinical evaluation roadmap and clinical development strategies

Session 1


Introduction Paul Kemp, CEO & CSO, Intercytex & CEO HairClone, UK


Clinical development strategy and operations

Marie Paule Richard, Chief Medical Officer, Tigenix, BE & SP



RM development strategies

Alain Vertes, Managing Director, NxR Biotechnologies, CH


 


 

10:50 PM-12:20 PM Planning of clinical trials in the field of Regenerative Medicine: real case scenario Session 2


Cell and non-cell therapies 

Vincent Ronfard, Professor, UNT, USA & CSO, HairClone, UK


Bio-engineered skin grafts

Daniela Marino, CEO, CUTISS AG, CH



Cell therapies for orphan diseases

Mustapha Najimi



 


 

17:15 PM-18:45 PM

Prerequisites to clinical evaluation

Session 3


Regulatory environment

Andreas Emmendörffer, Entrepreneur and CTI Coach,

Phalcon Consulting &  NAMSA (subcontractor),  CH


Immuno-oncology

Jonathan Souquet

Head of Biotech Process Science Technology & Innovation, Merck Serono, FR


Elastin Anthony Weiss
The University of Sydney, AU


Cell manufacturing Ruud Das, Scinus Cell Expansion, NL


 

Biographies Invited Speakers

Paul Kemp, Intercytex, CEO & CSO and HairClone, CEO UK

Paul is a recognised pioneer in the field of Regenerative Medicine and has over 25 years’ experience in the US and UK in the commercialisation of various Regenerative Medicine and Cell Therapy products in both public and private Companies. Over the years, he has built a successful track record in all aspects of the business, from carrying out translational research, in-licensing technologies from Universities and out-licensing products to a variety of HealthCare Companies, designing, obtaining regulatory approval and running clinical trials in the US, Canada, UK and Europe, designing, building and operating GMP facilities, founding biotech companies, and launching, marketing and selling cell based products in the US and UK. When at Organogenesis Inc he was the lead inventor on patents for the first multi-cell therapy approved by the FDA and was involved in all stages of the development of this product from the bench, through the clinical trail process, development of a licensing and marketing partnership and the eventual approval and launch in the US. This product has now treated approximately a million patients and is the largest selling manufactured cell therapy in the world. After Organogenesis, Paul returned to the UK and was the sole founder of Intercytex. He served as CEO for the first 5 years and under his leadership the company grew rapidly, attracted significant VC investment from Europe, the US and Asia. During this period Intercytex developed several products that reached the clinic, including the world's first cell therapy clinical trial to induce new hair formation. Paul has numerous patents and publications in the field and is invited to speak at International Conferences and sit on a variety of panels, grant funding bodies and regulatory committees. He is co-editor of the Journal of Regenerative Medicine, a co-Director of the Doctoral Training Centre in Regenerative Medicine at Manchester University and Industrial Director of Regener8.

   

Marie Paule Richard, Chief Medical Officer, Tigenix, BE & SP

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.

   

Alain Vertès, Managing Director, NxR Biotechnologies, CH

Dr. Alain Vertès is Managing Director at NxR Biotechnologies, a boutique consulting firm based in Basel, Switzerland, where he advises on strategy, business development (partnering, alliance management, in- and out-licensing, commercialisation), and investment. 
Dr. Vertès came to this role after extensive experience in the pharmaceutical and industrial biotechnology sectors, in Europe, North America, and Asia in different functions including research, manufacturing, partnering, and sales, in pharmaceuticals (Lilly, Pfizer, Roche), petrochemicals (Mitsubishi Chemical Corporation), public research (Institut Pasteur; RITE/Kyoto), contract research (Battelle Memorial Institute, PPD) and consulting (Australian Strategic Policy Institute). Focusing on innovation commercialization, he was a key player in the evaluation, selection, deal making, implementation, and alliance management of novel products and emerging technologies. For example, he championed radical innovation for bringing to patients disease-modifying, paradigm-changing therapeutics such as siRNA (Scrip Award 2008) and led in a scientific, strategic, and business manner Roche’s global cell therapeutics strategy and implementation team from 2007-2010. Dr. Vertès received an M.Sc. degree from the University of Illinois at Urbana-Champaign, a PhD from the University of Lille Flandres Artois, and is a Sloan Fellow from London Business School (MBA/M.Sc.).

   

Andreas Emmendörffer, Entrepreneur and CTI Coach, Phalcon Consulting &  NAMSA (subcontractor),  CH

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.

   
Jonathan Souquet, Head of Biotech Process Science Technology & Innovation at Merck Serono, FR

Jonathan Souquet is Head of Biotech Process Science Technology and Innovation at Merck KGaA. He previously held leadership process development positions at Boehringer Ingelheim as Head of Global Bioprocess Science and at Allergan as Head of Process Development. Jonathan Souquet received his M.Sc. in Biochemical Engineering from University College London and his Ph.D. from the  University of Birmingham department of Biochemical Engineering.

   

Vincent Ronfard, Professor, UNT, USA & CSO, HairClone, UK

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.

   

Daniela Marino, CEO, Cutiss AG, CH

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.