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Committee & Speaker Biographies

Committee & Speaker Biographies

2020 PDA Europe Advanced Therapy Medicinal Products

24-25 June 2020, Brussels, Belgium

  • 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.

  • Chen Dayue

    Dayue Chen, PhD

    Genentech, A Member of the Roche Group

    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).

  • 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.

    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.

  • Fabio D'Agostino

    Fabio D'Agostino, EngD

    Claris Ventures

    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

    Richard Denk

    Skan AG
    Richard Denk is working at the company SKAN AG, headquartered in Allschwil in the position Senior Consultant Aseptic Processing & Containment. Richard founded 12 years ago the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2015. Richard is member of the PDA Ptc Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group. Richard has spent more than 20 years with the subject on Aseptic Processing and highly active / highly hazardous substances and has developed the containment pyramid.
  • Marco Fadda

    Marco Fadda

    Comecer

    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.

  • Falk Klar

    Falk Klar, PhD

    PDA Europe

    Falk Klar holds a PhD in Applied Physics and has more than 19 years of experience in Quality Assurance and Compliance. Before joining PDA Europe, he worked for the pharmaceutical, biopharmaceutical, and medical device industries, and in clinical research.

    Falk joined PDA Europe in 2015 as Senior Director Training & Education. He will develop and extend PDA Europe’s portfolio of training courses and workshops for the parenterals market. Recently, he was appointed General Manager and Vice President PDA Europe.

  • Andre Raposo

    R. André 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. 

  • Petter Bjorquist

    Petter Bjorquist, PhD

    Verigraft AB

    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.

  • Steve Bloor

    Steve Bloor, PhD

    Videregen

    Dr Steve Bloor has over 25 years’ experience in the medical device and regenerative medicine industry.

    He has worked in US multinationals (J&J, Covidien/Medtronic) and UK start-up companies, with specific expertise in leadership roles, strategic R&D, clinical compliance and regulation.

  • Francesco Cicirello

    Francesco Cicirello, MSc

    Therapeutic Goods Administration

    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).

  • Markus Gershater

    Markus Gershater, PhD

    Synthace

    I am very enthusiastic about how engineering biology will change the world. Coming from a biochemistry background, I am fascinated by how best to address biological complexity so that we can robustly engineer biology and biological processes. Robust methods, flexible automation, sophisticated experimental design and data analysis is what I focus on.

  • Jacob Halatek

    Jacob Halatek, PhD

    Microsoft Research Cambridge

    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

    Michael J Hantman, PhD

    Charles River Laboratories

    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

    Julian Hitchcock, JD

    Bristows LLP

    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.

  • Bruce Levine

    Bruce L. Levine, PhD

    University of Pennsylvania

    Dr. Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, is Founding Director of the Clinical Cell and Vaccine Production Facility at the University of Pennsylvania. He received a B.A. (Biology) from Penn and Ph.D. (Immunology and Infectious Diseases) from Johns Hopkins. First-in-human clinical trials include the first use of a lentiviral vector and first infusions of gene edited cells. Dr. Levine has overseen the production of 3,000 cellular products administered to >1,200 patients since 1996. He is co-inventor of the first FDA approved gene therapy (Kymriah), chimeric antigen receptor T cells for leukemia and lymphoma. Dr. Levine is co-inventor on 26 issued US patents and co-author of >180 manuscripts and book chapters with a Google Scholar citation h-index of 83. He is a Co-Founder of Tmunity Therapeutics, a spinout of the University of Pennsylvania. Dr. Levine has received the William Osler Patient Oriented Research Award, the Wallace Coulter Award for Healthcare Innovation, will serve as President Elect of the International Society for Cell and Gene Therapy (2020-2022). He has written for Scientific American and Wired and has been interviewed by the NY Times, Wall Street Journal, Washington Post, NPR, BBC, Time, National Geographic, Bloomberg, and Forbes.

  • Gareth McCathie

    Gareth McCathie, PhD

    Oxford Biomedica

    With a background in molecular & cellular biology and an interest in technology, working in the computer-aided biology field has been a natural fit for my skills. I have previously worked in analytical assay development, and have used VBA and ImageJ macro programming to automate routine analysis tasks for speed, throughput and reproducibility.

    Since 2017, I have been part of Oxford Biomedica’s Analytical Automation Team working to increase efficiencies within our bioscience labs in both research and GMP regulated environments. A significant focus of my work at OXB has been to design & implement compliant automated systems.

  • Tim Menzen

    Tim Menzen, PhD

    Coriolis

    Dr. Tim Menzen is Chief Technology Officer of Coriolis Pharma, a science-driven contract research organization located in Munich, Germany for formulation development, lyophilization, and analytics of biopharmaceuticals).

    Tim is a pharmacist by training and received his PhD in the group of Prof. Dr. Wolfgang Frieß at the LMU in Munich, Germany. Tim received the Carl-Wilhelm-Scheele award of the German pharmaceutical society (DPhG) for the outstanding achievements during his PhD thesis. His research focused on temperature-induced unfolding, aggregation and interaction of mAbs, which resulted in three publications.

    In 2014, Tim joined Coriolis Pharma. He was leading formulation development projects for biologics for 3 years and was involved in the implementation of novel technologies.

    In his current role as CTO of Coriolis, he is involved in internal research projects at Coriolis and in scientific relations, including collaborations with partners from industry and academia. Tim is past chair of the AAPS Biopharmaceutical Product Attributes and Biological Consequences (PABC) Community.

  • Christiane Niederlaender

    Christiane Niederlaender, PhD

    AMBR Consulting Ltd

    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

    Marthi Pretorius, PhD

    Novartis

    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).

  • Giulietta Roel

    Giulietta Roël, PhD

    COD.ON

    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.

  • Ahmad Sediq

    Ahmad Sediq, PhD

    LONZA

    Ahmad Sediq is a pharmacist with a PhD degree in pharmaceutical technology from Leiden University, the group of Prof.Dr. Wim Jiskoot. He has worked for 2 years as formulation scientist in Janssen Vaccines in the Netherlands. He was responsible for late stage development of AAV-vector based vaccine products, among others, for Ebola and HIV. Ahmad joined Lonza Drug Product Services in May 2018. He is Principal Scientist/Group Leader in the Formulation Development group, where his team is responsible for early and late stage formulation development of various biologics formats.

  • Philippe Willemsen

    Philippe Willemsen, PhD

    Novadip Biosciences

    Philippe Willemsen received his PhD from the Laboratory of Molecular and Cellular Biology of the University of Liege (Belgium). He has more than 15 years’ experience in Life Sciences, from R&D to manufacturing with a strong expertise in cell biology and cell therapy.

    He gained his first industrial experience on a collaborative project at CilBiotech with GSK Bio for large scale cell culture. He joined Cardio3 Biosciences in 2005 (former name for Celyad) for the company’s product development and contributed as Production Manager for all manufacturing activities. In 2011, he joined Promethera Biosciences where he was in charge of the Pilot Plant and Manufacturing activities and was actively involved in process development.

    He joined the Bioprocess team of Novadip Biosciences in 2019 to develop and optimize the manufacturing processes to bring them to industrialization.