Professor Jean-Hugues Trouvin graduated in Pharmacy and received his State Doctorate in Pharmacology from the University of Paris. He developed a carrier as Professor of Pharmacology and Pharmacokinetics in parallel with regulatory activities as experts for the Regulatory Agencies. In France, he was chairman of the French biotechnology working party from 1989 to 1993.
He was appointed as Director of the Directorate for Evaluation of Medicinal products and Biologics at the French medicine agency (AFSSAPS) from 2001 to July 2007. At the European level, he was the French representative of the biotechnology/pharmacy working party (BWP) from 1986 until 2001 when he was elected as Chairman of this Working Party and reelected for three new terms and he completed his mandate in February 2014. He was the French representative for the Committee for Advanced Therapy medicinal products (CAT) from its opening (2009) to Sept. 2012.
During his regulatory carrier, he has been involved in the drafting of many guidelines, concept papers for the development of biologicals and biotechnology-derived medicinal products (including monoclonal antibodies). He took part in the elaboration and finalization of the EU regulation and technical requirements for biologicals, biotechnology-derived products, biosimilars and lastly the advanced therapy medicinal products which consist of cell therapy, gene therapy and tissue engineering medicinal products. He also contributed to the ICH process, for the biological topics and guidelines from 1994 up to 2008.
After he left his regulatory activities in 2014, he returned full time to his academic position as professor and hospital pharmacist, at Paris Descartes University, school of Pharmacy, in the department of Health Product and Public Health, head of the Unit for Pharmaceutical Development and Innovation and at the Central Pharmacy of the Parisian Hospital Group (AP-HP), head of the Research and Development department.
He retired in October 2019 but maintained his activities at IABS (International Alliance for Biological Standardization) as chairman of the European affiliate and contributing in the organization and holding of meetings, workshops or webinars dedicated to technical and regulatory issues on biological/biotechnological medicinal products, including vaccines, recombinant proteins and cell and gene therapy products.
Aurelio ZERIAL is doctor in Biology (University of Trieste, Italy) and PhD in Biochemistry (1978 -Wesleyan University, USA). His research experience at the Battelle Institute (Switzerland) and Rhône-Poulenc (France) included immunology, anticancer- and antiviral- chemotherapy, with development of four drug candidates up to clinical trials. He is author of a hundred publications and abstracts. In 1991 he joined Rhône Poulenc Rorer and Chugai Rhône Poulenc as Regulatory Affairs Associate, then as Director at Aventis International, managing registration dossiers of chemical drugs and biomedicines. During the last twenty years he is a private consultant in drug development and regulatory affairs, first as director of BioProgetti then on his own. His main contributions to companies are in biomedicines, particularly in the areas of CMC (Chemistry, Manufacturing and Controls) and preclinical studies. Aurelio is involved also in teaching activity, first as Associate Director at ISFBM (Gustave Roussy, France) then with other institutions to perform professional training on pharmaceutical subjects.
Marion Orset: After studying pharmacy at Grenoble and Lyon Universities, I am now living in Normandy with my family. For 20 years, I have worked in many areas of the pharmaceutical industry : formulation, manufacturing, distribution, pharmacovigilance and quality assurance. These experiences in France and abroad have enabled me to develop a wide range of skills and a global knowledge of the pharmaceutical world. After having worked in international groups, in big French companies or smaller structures, I decided, 6 years ago, to set up my own business as a pharmaceutical affairs consultant and quality auditor. I can now bring my expertise to human-sized companies looking for versatile support. I like the diversity of the missions I am entrusted with, the richness of the exchanges and the new fields explored.
Florence Allouche: Founder and President of MYRPHARM ADVISORS, a consulting firm helping translational academic research by startup creation, valorization of innovation, business development, innovation management, funding, strategy and growth.
Member of the French National Academy of Pharmacy
Associate Professor at the University of Paris, School of Pharmacy - Pharmaceutical innovation & Entrepreneurship.
Pharmacist Doctor, specialist in Intellectual property, Innovation management, and Tech Transfer, Business development
MBA graduate from HEC Paris
Board member certified (Science Po / IFA)
I co-founded Sparingvision in 2016 with Prof. José Alain Sahel and Dr Thierry Léveillard, I was the president of the company till October 2020 when we finalized Series B. SparingVision is leading a step shift in how ocular diseases are treated, moving beyond single gene correction therapies. At the heart of this is SPVN06, a gene independent treatment for retinitis pigmentosa (RP), the most common inherited retinal disease affecting two million people worldwide. SparingVision has raised €130 M to date. SparingVision has been awarded from the EIC Accelerator program (H2020 SME instrument Phase 2
In 2000, after positions in the pharmaceutical and diagnostics industry, I created the Office of Tech Transfer, Licensing & Industrial Ventures of Greater Paris Hospitals Assistance Publique - Hôpitaux de Paris, which I managed and developed for 16 years.
Sourcing, scouting, innovations protection, patent filing and prosecution, industrial transfer, and licensing of innovation from AP-HP clinical departments. Over this period of time, more than 75 biotech, Medtech, and eHealth startups were created. Up to 2000 partnerships with biotech/Medtech companies on R&D programs. Development of drugs for orphan and neglected diseases. 1000 patent families filed, 300 license agreements signed, with € 25M of annual revenues.
* First prize Biotech in Catapult EIT Health startup Competition 2019
* Finalist of the International Galien Medstart'up Prize, New York, 2019
* Award of Mercure HEC des Entrepreneurs 2019
* Award of the HEC Trajectoires Au Féminin 2017
* Elected « Woman of the Year 2017 » by the French financial journal La Tribune.
* Member of the the Big Investment Plan Committee under the authority of the French Prime Minister (Comité de Surveillance des investissements d’avenir - Secrétariat General pour l’Investissement).
Tony Antoine AWAD (PhD) – CMC Advisor
Antoine (Tony) Awad joined Synlogic in December 2018 as Head of Technical Operations and is responsible for process sciences and manufacturing functions for the Company. Tony has over 15 years of experience in the biotechnology and pharmaceutical industry with substantial experience in the development and manufacturing of novel therapeutics from pre-IND studies through global commercialization. Prior to joining Synlogic, Tony was most recently at Abpro Therapeutics and served as Senior Vice President of CMC and Operations where he was responsible for the development of bi-specific antibodies for oncology and leading corporate operational functions. Prior to that he served as Senior Vice President of Technical Operations and Manufacturing at L.E.A.F. Pharmaceuticals focused on developing small molecules for oncology. Previously, Tony held positions of increasing responsibilities over a ten-year period at Merrimack Pharmaceuticals. As Head of Process Sciences & Manufacturing, Tony led CMC development, manufacturing and approval of ONIVYDE® for treatment of advanced pancreatic cancer and transitioned to Ipsen Bioscience to integrate and lead commercial manufacturing of ONIVYDE®. Tony has broad experience in partnerships, collaboration and M&A, most notably with Sanofi, Baxalta/Shire plc, Actavis Pharma/Teva Pharmaceutical Industries and Ipsen Bioscience. He is a graduate of Boston University and holds degree in biochemistry and molecular biology, and conducted graduate research at Boston University School of Dental Medicine.