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Committee & Speaker Biographies

Committee & Speaker Biographies

2019 PDA Europe Advanced Therapy Medicinal Products

04-05 June 2019, Vilnius, Lithuania

  • Manuel Carrondo

    Manuel Carrondo, PhD

    ibet - Instituto de Biologia Experimental e Tecnológica

    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.

    His key areas of research interest are Animal Cell Technology and its application for human and animal health. Therapeutic and diagnostic recombinant proteins, including fusion proteins; virus like particles and pseudo viruses as vaccination agents and viruses (retro-, adeno-, lenti-) as deliverables for gene therapy; cell therapies and stem cells. cGMP pilot plant scale-up and production development of biopharmaceuticals.

    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.

  • Chen Dayue

    Dayue Chen, PhD

    Eli Lilly and Company

    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 is currently a research fellow in Bioproduct Research and Development Division at Eli Lilly and Company. His current responsibilities include managing CM&C activities for gene therapy development, supervising microbiology support for drug product formulation development, and overseeing molecular analytical characterization of cell substrates.

    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).

  • Kreil Thomas

    Thomas R. Kreil, PhD

    Takeda

    Beyond his work at Takeda, Thomas is Chairman of the Plasma Protein Therapeutics Association’s (PPTA) Pathogen Safety Steering Committee, a Steering Committee member of the Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) as coordinated by the Massachusetts Institute of Technology (MIT), and an Associate Professor at the Institute of Virology, Medical University of Vienna.

    Dr. Kreil obtained a PhD in Biochemistry from the University of Vienna, Austria, and spent several years on post-doctoral research at the same institution focusing on antiviral immunology and specifically, the role of antiviral antibodies. He then joined Shire (Immuno/Baxter/Baxalta), working in the area of pathogen safety of biopharmaceuticals, as well as research on virus vaccines. Dr. Kreil is well-published and has been a frequent international lecturer on the safety of biological medicinal products versus viruses and prions as well as antiviral defense, with particular emphasis on the role of virus antibodies/IVIG.

  • Margarida Menezes Ferreira

    Margarida Menezes Ferreira, PhD

    INFARMED

    Margarida Menezes Ferreira graduated in Biology at the Faculty of Sciences of the University of Lisbon. She received her PhD degree in Medical Biochemistry at the Aix-Marseille II University in France 1981 and did a post-graduate research in molecular endocrinology at the National Institutes of Health USA until 1984. She published several research papers in peer-reviewed journals amongst which two of them were selected for the Year Book of Endocrinology.

    Since 1996, she has been part of INFARMED, the Portuguese regulatory authority for medicines and health products having developed the strategic plan for the installation of the Biologics, Biotechnology and Microbiology Departments of the National Laboratory for the Control of Medicines and Health Products and coordinated its implementation and directed until 2001.

    Since 1999 to the present she has been the INFARMED appointed member of the Biologics Working Party at the European Medicines Agency (EMA). She has participated in the drafting of European guidance and scientific advice on biological medicinal products including cell based therapies. Initially as guest member and since 2007 as a permanent member of the Cell based Products Working Party she participated in the construction of the regulatory framework and quality guidance for cell based medicinal products. Presently and since its start in 2009 she is the alternate member representing Portugal in the Committee for Advanced Therapies.

    She also collaborates as guest professor with the Faculty of Pharmacy from the University of Lisbon coordinating a chair on Advanced Therapy Medicinal Products. She is also lecturing on Regulatory aspects related to Biotechnology and Advanced Therapy Medicinal Products in several post-graduate courses from Universities of Coimbra and Aveiro and at the Instituto Superior Técnico /University of Lisbon in the PhD program MIT-Portugal. Margarida is a long standing member of the PDA Europe ATMPs scientific programs committee and a frequent speaker.

  • Paula Alves

    Paula Alves, PhD

    iBET

    Paula Alves is the CEO of iBET, the Head of the Animal Cell Technology Unit at iBET and Professor at NOVA University of Lisbon (ITQB and FCT).

    She received her Ph.D. at Biochemical Engineering from the NOVA University of Lisbon, in 2001, and her B.S in Biochemistry from the Sciences Faculty of the University of Lisbon, in 1991.

    Working in Animal Cell Technology since 1990, her PhD contributed to the establishment of 3D in vitro models of Brain Cells for metabolic trafficking studies.

    She did part of her PhD studies at the NMR Center-Sintef, Trondheim Hospital, Norway and at the NMR Laboratory of the Chemistry Department of Bremen University. Professor Alves' research integrates cell metabolism understanding with biochemical engineering for the improvement of bioprocesses’ efficiency, also focusing on the development of new tools and technologies for pre-clinical research.

    Professor Paula Alves is currently the Chairperson of the ESACT (European Society for Animal Cell Technology) and Member of the IMI (Innovative Medicines Initiative) Scientific Council and of EURL-ECVAM (EU Reference Laboratory for Alternatives to Animal Testing).

    She was a member of the Advisory Board of Horizon 2020 Societal Challenge 1 - European Commission, between 2013 and 2018. She has published over 230 papers, 32 book chapters and supervised 35 PhD students, 18 post-docs and several master theses.

    In 2009, she received the Scientific Merit Award from NOVA University of Lisbon and in 2017, she was recognized as one of the 100 Top Portuguese Women in Science.

  • Isabelle Bekeredjian-Ding

    Isabelle Bekeredjian-Ding, PhD

    Paul-Ehrlich-Institut

    Isabelle Bekeredjian-Ding is the Head of the Microbiology Division at Paul-Ehrlich-Institut. She is a Medical Microbiologist and Immunologist, and Associate Professor at the University of Bonn, Germany.

    Isabelle received her Medical School training at the University of Heidelberg, Padova (Italy) and Mt. Sinai in New York, and the clinical training in Munich and Heidelberg.

    After a PhD equivalent in T cell biology and a postdoc in dendritic cell biology, her research interest focused on immune recognition of infectious pathogens and microbiological methods.

    Before joining PEI, she headed the microbiological diagnostics unit at the University Hospital in Bonn as deputy director of the Institute of Medical Microbiology, Immunology and Parasitology.

  • Ulrich Blaschke

    Ulrich Blaschke, PhD

    CureVac

    Ulrich Blaschke is VP of Technical Development at CureVac AG, a company focusing on mRNA as medicinal products. In this position, he is responsible for drug substance and drug product process development, development of analytical methods as well as advancing the mRNA technology for production of mRNA at industrial scale.

    Furthermore, he is interested in the specific aspects of mRNA manufacturing and controls within the evolving global regulatory framework for this new class of therapeutic molecules.

    Before entering the mRNA area, Ulrich was working for different pharmaceutical companies as Cinfa Biotech, Boehringer Ingelheim and Stada Arzneimittel in Germany and in the US.

    For 15 years, he worked on all aspects of biosimilars development with a strong focus on CMC.

    Ulrich studied chemistry and biochemistry at the Westfälische-Wilhelms University in Münster, Germany. After his PhD studies, he joined Rockefeller University, New York as a postdoctoral fellow working in the field of synthetic protein chemistry.

  • Johannes Bluemel

    Johannes Blümel, PhD

    Paul-Ehrlich-Institut

    Dr. Johannes Blümel is leading the virus safety section at the Paul-Ehrlich-Institut, Langen. He is dealing with assessment of virus safety and TSE safety of blood products and recombinant DNA products. He participates in the EMA-Biologics Working Party (BWP) and EDQM TSE-certification procedure as a national expert. Further, he is working in several research projects on virus inactivation and virus removal.

    Prior to joining the Paul-Ehrlich-Institut in 1998, Johannes worked at the University Hospital, University of Bonn (1993-1998). He performed basic research on virus replication and received a five years training in medical virology and virus diagnostics.

    He completed his Diploma in Biology (molecular genetics, microbiology, biophysics and physical chemistry) the University of Freiburg, Germany and received his Ph.D. degree at the Department of Virology, University of Freiburg, Germany. In 2010, he received teaching credential in Medical Virology from the University Frankfurt.

  • Christopher Bravery

    Christopher Bravery, PhD

    Advanced Biologicals Ltd

    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.

  • Paul Carter

    Paul Carter, PhD

    GSK

    Paul Carter leads the Cell and Gene Therapy - Product Development - Downstream Vector Process Development team at GSK and is based at Stevenage in the UK.

    He has been part of the CGT platform since 2015 and has 30 years’ experience working in the pharmaceutical industry across a wide variety of therapeutic modalities.

  • Rosa Catera

    Rosa Catera, PhD

    Novartis

    Rosa holds a Ph.D. in Applied Genetics from The Institute of Molecular Genetics of the National Research Council (University of Pavia, Italy).

    She did her Postdoctoral fellowship on Chronic Lymphocytic Leukemia (CLL) at The Feinstein Institute for Medical Research in New York, in the Immunology laboratory of Nicholas Chiorazzi and Kanti Rai.

    Rosa joined Novartis in 2012 as Regulatory CMC Associate Manager, in the Oncology Franchise, and moved to the Cell and Gene Therapies Unit within Novartis in 2014.

    Rosa is an active member of the Kymriah team that brought this new therapy to the market in a number of countries.

  • Giovanni De Grandis

    Giovanni De Grandis, PhD

    University College London

    Giovanni is an associate researcher at the Science, Technology, Engineering and Public Policy department (STEaPP), UCL.

    He works within the the Future Targeted Manufacturing Healthcare Hub, a large EPSRC funded project aiming at promoting innovative biomanufacturing solutions to enable broader patients' access and more economically sustainable targeted and personalised therapies.

    His role within the Hub is to analyse the evolving regulatory frameworks and trends for innovative therapies, as well as contributing to the Hub’s engagement with the policy community.

    Giovanni has a background in philosophy (Ethics and Political Philosophy), but in recent years his work has focused on medical ethics, on the social consequences and governance of digital and healthcare technologies and on transdisciplinary and translational research.

    Giovanni has a MA in Philosophy, Politics and Economics of Health (UCL) and a PhD in Philosophy (University of Turin).

  • Marc Eloit

    Marc Eloit, PhD

    Pathoquest

    Marc Eloit is Professor of Virology at the Veterinary School of Maisons-Alfort and the head of the Pathogen Discovery laboratory at Institut Pasteur Paris, which is using Next Generation Sequencing as a routine method for discovering new viruses in human patients and animal reservoirs.

    He has been a member of the Virus Safety Committee, French Agency of Medicinal Products (1992-2012).

    He has served as a consultant to many companies on the field of virus safety of biologicals.

    He founded in 2010 Pathoquest, a spin-out of Institut Pasteur dedicated to the identification of pathogens using untargeted Next Generation Sequencing.

    He has been its CSO till the end of 2016 and acts currently as a scientific advisor for the company.

  • Raquel Fortunato

    Raquel Fortunato, PhD

    GenIbet

    Raquel Fortunato is the CEO of GenIbet Biopharmaceuticals, a Portuguese CDMO offering highly specialized microbial, cell culture and viral GMP manufacturing services and process development to research groups, biotech and pharma companies.

    Raquel is a Chemical Engineer from Instituto Superior Técnico (Lisbon – Portugal) with a specialization in Biotechnology, a PhD in Biochemical Engineering from the NOVA University of Lisbon and Post-graduate education in General Management (NOVA University of Lisbon).

    Prior to joining GenIbet in 2006 as a Project Manager, she was the responsible for the launch of the Quality Control laboratory of a water treatment company.

    Raquel was GenIbet operations director from 2011 to 2015 and has expertise in Technology Transfer Processes, Project Management, Budget implementation, Technical Support to Process Operations, Client Interface, Quality Assurance and Team Coordination.

  • Alistair Gibb

    Alistair Gibb, PhD

    MHRA

    Alistair Gibb is a principal pharmacopoeial scientist and manager within the Inspection, Enforcement and Standards Division of the Medicines and Healthcare products Regulatory Agency. His focus as a leader within the team is ensuring that British Pharmacopoeia standards, and their delivery, continue to support the quality of medicines in a changing pharmaceutical landscape.

    His current activity in this area includes the public consultation and implementation of the MHRA strategy for pharmacopoeial standards for biological medicines.

    Alistair has been a part of the MHRA for over 10 year, including roles in the Information Management and Licensing Divisions.

  • Akseli Hemminki

    Akseli Hemminki, MD, PhD

    University of Helsinki/Finland

    Dr. Hemmini is a Professor of Oncology. Following an award-winning PhD in cancer genetics, Dr Hemminki completed his MD and then moved to the US to learn about gene therapy and oncolytic viruses.

    He has been involved in a dozen clinical trials in the US and Europe. He has also pioneered patient-by-patient use of oncolytic virus therapies under the EU Advanced Therapy Directive. 290 cancer patients refractory to routine treatments were safely treated with signs of efficacy seen.

    In 2008, Hemminki co-founded his first University spin-out company, Oncos Therapeutics Ltd (currently Targovax ASA, Norway), and in 2013 his second, TILT Biotherapeutics Ltd. Hemminki has published more than 280 peer-reviewed manuscripts on cancer research and oncolytic viruses, many of them in the best journals of the field. He has also filed 11 patent applications. 

  • Barbara Kraus

    Barbara Kraus, PhD

    Takeda

    With more than 20 years of experience in the biopharmaceutical industry Barbara´s particular expertise lies in the field of cell line & cell culture medium development, the development of upstream and separation processes, scale up and process transfer to clinical pilot plants and industrial manufacturing plants for recombinant proteins, viral vaccines and vectors as AAV.

    Currently, Barbara holds the position "Director, Head of Gene Therapy Tech & Sciences”.

    She earned her PhD in Biotechnology at the University of Natural Resources and Life Sciences, Vienna, Austria.

  • Romaldas Maciulaitis

    Romaldas Mačiulaitis, MD, PharmD

    Lithuanian University of Health Sciences, EMA/CAT Member

    Romaldas Mačiulaitis completed his MD and PharmD studies more than 20 years ago and after PhD studies in clinical pharmacology, became involved in drug regulatory and scientific appraisals at the national (Lithuanian) and international (European) levels, in particular as a national scientific expert for several of the European Medicines Agency, EMA Scientific Committees - Committee for Human Medicinal Products, CHMP (for last 12 years), the Committee for Advanced Therapies, CAT (since the very beginning of this Committee - for last 8 years), and Scientific Advice Working Party (for last 2 years).

    In 2009, he initiated the new experimental pharmacology research direction in his University in Kaunas - on Regenerative Pharmacology, applying cell preparations with the focus on PK/PD of cell therapies in renal and cartilage injuries. He has published more than 40 papers in reputable journals.

  • Jennifer Moody

    Jennifer Moody, PhD

    BlueRock Therapeutics

    Jennifer Moody is a cell therapy, business operations professional with 23 years of experience with stem cells, 13 of those years in industry commercializing products spanning from stem cell reagents to cell-based therapeutics.

    She obtained a BSc in Genetics from York University (Toronto), a PhD in Genetics from UBC (Vancouver), and pursued postdoctoral studies at the Lund Stem Cell Centre in Lund, Sweden.

    She transitioned to industry in 2006, joining STEMCELL Technologies in Vancouver as an R&D scientist where she led commercial development of the TeSR product line. This was followed by almost 6 years at the Centre for the Commercialization of Regenerative Medicine (CCRM) in Toronto, immersed in operations, alliance management and business development responsibilities.

    She is currently the Senior Director of Research Operations at BlueRock Therapeutics in Toronto, fulfilling a dream to be part of building a regenerative cell therapy company to treat intractable diseases. She is a member of ISSCR, ISCT, serves on the ISCT Business Model and Investment subcommittee and is a member of the Rotman Business School Healthcare and Life Sciences Leadership Network.

  • Sean Palecek

    Sean Palecek, PhD

    University of Wisconsin

    Sean Palecek is the Milton J. and Maude Shoemaker Professor and Vilas Distinguished Achievement Professor in the Department of Chemical & Biological Engineering at the University of Wisconsin – Madison.

    Sean’s lab studies how human pluripotent stem cells (hPSCs) sense and respond to microenvironmental cues in making fate choices, with a focus on differentiation to cardiovascular lineages.

    Sean’s lab has generated novel mechanistic insight and developed protocols for differentiation of hPSCs to cardiovascular and neurovascular cell types. They strive to engineer fully-defined, animal component-free differentiation platforms, compatible with biomanufacturing of cells for in vitro and in vivo applications.  

    Sean’s recent awards include the Cozzarelli Prize of the National Academy of Sciences and the Biotechnology Progress Excellence in Research Publication Award for his work on cardiovascular cell manufacturing from hPSCs.

    Sean is the Associate Director for Research for the National Science Foundation funded Center for Cell Manufacturing Technologies and the Associate Director for Research for ForwardBio Institute.

  • Andre Raposo

    R. Andre Raposo, PhD

    Oxford Biomedica

    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. 

  • Jasbir Rattu

    Jasbir Rattu, PhD

    CeutiQus

    Dr Jasbir Rattu is a Consultant Industrial Pharmacist Qualified Person (QP) collaborating with biopharmaceutical companies, universities, hospitals and charities, to successfully develop and commercialise innovative advanced therapy medicinal products (ATMPs) and regenerative medicines for unmet medical need. He has a special interest in ophthalmology and glaucoma.

    He is the managing director of CeutiQus, which provides strategic consultancy to develop biopharmaceutical products (especially ATMPs and regenerative medicines) and processes (QbD), businesses and also provides Qualified Person (QP) services and education for successful commercialisation. He teaches the fundamentals of Pharmaceutical Biotechnology, regenerative medicines and ATMPs in industry and academia via The BioPharmaceutiQals Academy™.

  • Kai Sohn

    Kai Sohn, PhD

    Fraunhofer Institute for Interfacial Engineering and Biotechnology

    Kai Sohn is Head of the Functional Genomics Group and Head of the IVD Business Unit at the Fraunhofer IGB in Stuttgart. He has founded Noscendo, a company dedicated for the development of Next Generation Diagnostics for infectious diseases.

    Kai studied Biology at the University of Heidelberg and received his PhD at the Biochemiezentrum Heidelberg in 1997.

    His expertise comprises the fields of molecular microbiology as well as molecular diagnostics, with a special focus on implementing high throughput sequencing technologies into clinical diagnostics and process controls for the production of cell therapeutics.

  • Martin Wisher

    Martin Wisher, PhD

    Merck BioReliance

    Dr Wisher has more than 34 years’ experience in biosafety testing, validation and regulatory affairs. He has worked for BioReliance, UK, for 29 years, since the company was founded in Stirling in 1990, acting as Scientific Director since 1993.

    Martin has extensive experience in the technical, scientific, quality and regulatory aspects of biological product quality control and manufacture. 

    Prior to joining BioReliance, Dr Wisher worked for Inveresk Research as Manager of Immunology, responsible for biosafety services.

    He obtained a PhD in membrane biochemistry from the National Institute for Medical Research, London, and prior to moving to the contract research industry was involved in research on membrane receptors, monoclonal antibodies and recombinant vaccines.

    Martin is a member of the PDA Regulatory Affairs & Quality Advisory Board (RAQAB), a member of the Alliance for Regenerative Medicine (ARM) European Regulatory Affairs Committee, Deputy Chairperson of the Animal Cell Technology Industrial Platform (ACTIP) and member of Biophorum Cell & Gene Therapy Regulatory Strategy Working Group.

  • Andrea Zobel

    Andrea Zobel, PhD

    PAREXEL

    Andrea Zobel initially joined PAREXEL in 2004 as Clinical Logistics Manager - Head of Clinical Trial Supply in the newly-founded PAREXEL Clinical Logistics Services. In her initial years with the company, Andrea significantly contributed to building up the Clinical Trial Supply services, including the expansion of a global depot network.

    By the time she moved on from PAREXEL, Andrea had reached the position of Director, Clinical Logistics Services Europe (EMEA), leading Clinical Trial Supply, Ancillary Supply and Laboratory Logistics Services. In her subsequent role at Marken Ltd, she went on to hold the position of Vice President, Global Clinical Trial Distribution and was heavily involved in developing clinical distribution services, including establishing a global depot network and growing the clinical distribution business.

    She then went on to rejoin PAREXEL for a second time in 2015 in the capacity of Global Senior Director Portfolio Management. 2016 Andrea has taken on the responsibility for the definition and implementation of new product and services for PAREXEL’s Clinical Trial Supplies and Logistics business globally.

    Andrea holds a diploma in Biochemistry from the Freie Universität Berlin and a PhD from the Max-Planck Institute for Molecular Genetics.

    Her scientific career includes 12 years’ research in gene technology, pharmacology and preclinical development, both in academic research and in biotech companies.

    Andrea is a passionate lecturer and trainer for pharmacology, regulations and clinical trial logistics at the PAREXEL Academy and training institutes and is also an active member of the ISPE (International Society for Pharmaceutical Engineering).