24-25 June 2020, Brussels, Belgium
Christopher founded Consulting on Advanced Biologicals Ltd at the end of 2009 in order to focus his activities within the Regenerative Medicine sector. CAB Ltd provides EU regulatory services to the regenerative medicine industry in addition to business and regulatory research and analysis to identify and focus on the real barriers to commercialisation of regenerative medicine.
Christopher has spent most of his career working in regenerative medicine: starting with a PhD in xenotranplantation immunology he first moved into industry in 1998 when he joined Imutran Ltd (A Novartis Pharma AG Co.) developing novel transgenic pigs to treat human organ failure. Following the closure of Imutran, Christopher moved to Intercytex and subsequently made the transition to regulatory affairs by joining the MHRA as a quality (CMC) assessor (biologicals and biotechnology unit).
During this time Christopher was involved with National implementation of the new Advanced Therapies Regulation and also involved through his participation in the CHMP’s cell products working party (CPWP) in implementation at the EMA level including drafting guidelines.
Dr. Dayue Chen received his Ph.D. in Virology from Baylor College of Medicine and did his postdoctoral training in Northwestern University.
He has extensive experience in bioprocess development and is a well-recognized industry expert in viral safety and adventitious agent control.
Dr. Chen was a research fellow in Bioproduct Research and Development Division at Eli Lilly and Company. His responsibilities included managing CM&C activities for gene therapy development, supervising microbiology support for drug product formulation development, and overseeing molecular analytical characterization of cell substrates.
In late 2019, he moved to Genentech/Roche to become Head of T-cell Engineering Process Development.
Dr. Chen has published 40+ papers in peer reviewed journals and currently serves on the editorial boards for the PDA Journal of Pharmaceutical Science and Technology, and the Journal of Biotechnology and Applied Biochemistry.
Dayue is also an adjunct professor in the School of Applied Life Sciences at Keck Graduate Institute (Claremont, California).
Dr. Carrondo holds a PhD in Environmental Engineering from the Imperial College of Science and Technology, and he is a full Professor of Chemical and Biochemical Engineering, Faculty of Sciences and Technology at the University of Lisbon.
Manuel is founder, earlier president and CEO (currently vice –president) of iBET – the Institute for Experimental and Technological Biology.
Dr. Carrondo has published over 230 papers in international journals; he is a member of the editorial board of Biotechnology and Bioengineering, Current Gene Therapy and Biotechnology Letters; referee of Biotechnology Progress, Cytotechnology, Applied Microbiology and Biotechnology, Enzyme and Microbial Biotechnology.
He is also a long standing member of the PDA Europe ATMPs scientific programs committee and frequently speaks at our events.
Dr. Fabio D’Agostino brings extensive experience in cell and gene therapy to this conference.
In 2013, he joined the Parenteral Drug Association (PDA) Cell and Gene Task Force with the aim of developing a manufacturing control strategy for cell and gene based medicinal products. His areas of expertise also include Lean Six Sigma, process development and optimization, business development and technology evaluation.
Fabio started his career at the medical device company Sorin Group (now LivaNova) after a BSc and a MSc with honors in Biomedical Engineering from the Polytechnic University of Turin (Italy). Later, he moved to Newcastle (UK) to take an Engineering Doctorate in Biopharmaceutical Process Development at Newcastle University.
Richard Denk has studied mechanical engineering and examined Experts of GMP, Qualification and Validation, Pharmaceutical Auditing, Pharmaceutical Engineering, Quality Control on the University of Applied Sciences in Albstadt/Sigmaringen Germany.
He is working at SKAN AG, headquartered in Allschwil, Switzerland in the position of Head of Containment.
Richard is an author at Maas & Peither GMP Publishing on containment and hygienic design and has published several PDA Scientific Documents for Preventing Cross Contamination.
He has spent more than 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid.
Marco Fadda, Biomed. Eng., began as researcher in a biomechanics laboratory, investigating bone cutting quality using robot held tools, followed by development of medical robotics together with customer training and OR support. Successively, he served as executive for top brands in the Medical Device Industry, with focus to understanding medical needs and transforming them into successful and remunerative global surgical solutions.
Since 2014, he is dedicated to the development of principles and solutions for managing cell manipulation, expansion and transformation in aseptic environments.
His main goal is the application of principles of Isolation Technology to ATMP development and production, with integration of all the necessary process tools and devices into a Grade A environment.
R. Andre Raposo is a Group Lead within Platform Research at Oxford Biomedica. He holds a PhD in HIV Immunology from the University of Oxford (UK) and has worked as postdoc at the University of California San Francisco (USA) and later at The George Washington University in Washington DC (USA). Prior to joining OXB, he has worked at GSK in the Cell & Gene Therapy Platform.
Andre has a particular interest in understanding the molecular pathways by which viruses evade the immune system and during his academic career, he has helped characterise host intrinsic factors used by cells to counteract HIV-1.
Petter holds a PhD in Biology/Biochemistry from Gothenburg University. He has 50 + publications in peer reviewed journals, several book chapters and patents.
Petter has spent ten years within AstraZeneca R&D in Cardiovascular Diseases, twelve years at Cellartis/Cellectis as VP Regenerative Medicine, where he was responsible for e.g. the major collaboration with Novo Nordisk on development of a human embryonic stem cell derived beta cell treatment for diabetes.
Also, he was responsible for development of human pluripotent stem cell derived cardiomyocytes and hepatocytes.
As of February 2014, Petter has been CEO of VERIGRAFT AB, a pioneering company within tissue engineering and advanced regenerative medicine for use in treatment of cardiovascular, neuronal and other diseases.
Francesco Cicirello is an Expert GMP Inspector within the Medical Devices & Product Quality, Manufacturing Quality Branch. Francesco has been with the Australian Therapeutic Goods Administration (TGA), since 2014.
Francesco is the Chairperson of the PIC/S Working Group on the revision of Annex 2 and is part of the Coordinating Committee of the Expert Circle on Human Blood, Tissues, and Cells & ATMPs. He is the Deputy Chair and EMA Inspector Working Group (IWG) liaison officer of the PIC/S Subcommittee of Harmonisation (SCH) and has contributed to the development of a number of guidance, annexes and chapter revisions.
Prior to joining the TGA, he worked in the biochemical industry for over 15 years in varied capacity including Production, Quality Assurance and Compliance Management roles.
Francesco has a degree in Chemistry and Pharmaceutical Technology, an MSc in Oncology Pharmacy and Pharmacology, and an MSc in Production of Cosmetic Products. Francesco is a registered pharmacist - General Pharmaceutical Council (GPhC-UK) and the Federal Office of Public Health (FOPH – CH).
Jacob Halatek obtained a PhD in Statistical and Biological Physics from the LMU Munich, Germany, in 2017. His main area of expertise is quantitative modelling of complex biological systems, specifically intracellular protein dynamics and self-organisation.
Following a one-year Postdoc at the LMU, Jacob joined Microsoft Research Cambridge as a Researcher in 2018 to work on Station B – a platform for programming biology.
His research aims to integrate state-of-the-art machine learning methods and mechanistic modelling approaches to facilitate predictive and quantitative modelling on an industrial scale.
Michael J. Hantman, Associate Director of Methods Development and Validation for Charles River, received his Ph.D. from Temple University School of Medicine working on genetic mapping and pathogenicity of Streptococcus mutans, the main cause of dental caries.
Postdoctoral fellowships at Harvard Medical School, Massachusetts General Hospital, and at the University of Washington focused on vaccine development and host-pathogen interactions, using recombinant, attenuated salmonella strains expressing heterologous genes to stimulate immune pathways.
Over the past 19 years, Michael and his team have developed and validated over 250 methods used for the detection/quantitation of adventitious agents in biopharmaceuticals as well as for characterization of substrates used in the production of biopharmaceuticals, including quantitative PCR assays for specific and broad-range targets, residual HCD/sizing, and copy number.
Julian Hitchcock is a regulatory life science lawyer at Bristows in London.
He has specialised in the law of genes, cells and tissues for many years.
Julian is a governance subcommittee member of the UK government’s Synthetic Biology Leadership Committee, and a co-author of the Nuffield Council on Bioethics report on genome editing in human reproduction.
Thierry Huss has worked at Transgene for over 20 years.
As an Industrial Partners manager / External manufacturing and CMC-CMO manager, Thierry managed Contract Manufacturing Organizations (CMOs) : selection and monitoring with regard to budget, deliverables, timelines, quality aspects and he was accountable for compliance to these criteria.
He was responsible for the management of CMOs located in Europe and in the US, for interactions with CMOs located in Asia and for the management of the transfer of aseptic Drug Substance and Drug Product manufacturing processes to commercial CMOs.
Thierry is now heading a manufacturing pilot unit that was recently implemented at Transgene. This unit will manufacture Phase I / Phase II batches of therapeutic vaccines and oncolytic viruses to feed the Transgene driven clinical trials in cancer immunotherapy.
Christiane has spent 12+ years in medicines, tissue, cell and gene therapy regulation, last with the MHRA, where she worked for 8 years until August 2019 assessing all groups of biological medicines.
Christiane was the UK representative at the EMA committee for advanced therapies (CAT) and the Rapporteur/ Co-Rapporteur/ CMC assessor for several ATMPs. She acted as the Rapporteur for the EMA gene therapy guideline and was drafting group member for many other CAT guidelines.
Prior to joining the MHRA, Christiane worked for the UK competent authority responsible for the European Tissues and Cells Directive as an assessor and inspector. She has a Ph.D. and research background in cell-signalling, cancer and stem cells and obtained a law degree in 2005.
Christiane has set up her own consultancy company in September 2019.
Marthi Pretorius is a subject matter expert, focused on innovative analytics, with broad knowledge in advanced therapy medicinal products (ATMP) such as CAR T and stem cell products, viral vectors (lentiviral, AAV, AV).
She is an analytical project lead as well as a viral safety specialist within the Novartis Cell and Gene Therapy group, focusing on innovative analytics, with broad knowledge in advanced therapy medicinal products (ATMP) such as CAR T and stem cell products, viral vectors (lentiviral, AAV, AV).
Marthi holds a PhD in Medical Virology from the University of Pretoria (RSA). She has worked as lecturer at the University of Pretoria University and research scientist at the National Institute for Communicable Diseases (RSA).
Dr. Giulietta Roël is Head of Product Development at CO.DON AG, Germany. She joined the company in 2015 and coordinated projects concerning manufacturing and quality of a cell-based ATMP for cartilage repair during a EU marketing authorization procedure. Currently, she is engaged in projects concerning further development of the company’s product for autologous chondrocyte transplantation.
Giulietta studied Biology at the University Utrecht and received her PhD degree at the Hubrecht Institute/University Utrecht in The Netherlands where she investigated cell fate decision mechanisms during embryonic development. She performed post-doctoral research projects in the field of developmental biology and translational medicine before joining CO.DON.
Nicolas became Chief Operating Officer of the company in 2015. Prior to joining Novadip, Nicolas was the head of the advanced-therapy medicinal products group for a contract development and research organization (Quality Assistance, BE) acting for major international biopharmaceutical companies. He began his career as Lead Researcher in experimental medicine.
Nicolas has more than 15 years of experience in developing and manufacturing stem cell technologies in both academic and industrial environment. Since 2008, Nicolas has been an invited lecturer in biochemistry and cellular physiology by several Universities.
He received his PhD in Life Sciences from the Université Catholique de Louvain (UCL) in Belgium and did postdoctoral studies at the Université Libre de Bruxelles, the University of Glasgow, and UCL.