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Committee & Speaker Biographies

Committee & Presenter Biographies

2022 PDA Advanced Thearpy Medicinal Products Conference

22-23 June 2022

  • Dayue Chen PhD

    Dayue Chen, PhD

    Genentech, Inc.

    Dayue Chen received his Ph.D. from Baylor College of Medicine and did his postdoctoral training in Northwestern University. Dr. Chen is currently a staff scientist and the Head of Cell Therapy and Engineering Development at Genentech. He is a trained virologist and molecular biologist with extensive experience in biopharmaceutical industry. He was a research fellow in the Bioproduct Research and Development Division at Eli Lilly and Company before joining Genentech in 2019.

    Dr. Chen has published 40+ research articles 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. He is an enthusiastic allurophile and amateur marathoner.

  • Richard Denk

    Richard Denk

    SKAN AG
    Richard Denk is working at the company SKAN AG, headquartered in Allschwil/Switzerland in the position Senior Consultant Aseptic Processing & Containment. Richard was member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is Member of the PDA Advisory Board for ATMPs, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group. Richard founded 11 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 2021 Richard has spent more than 30 years with the subject production of aseptic processing and highly active / highly hazardous substances and has developed the containment pyramid.
  • Manuel Carrondo

    Manuel Carrondo, PhD

    ibet - Instituto de Biologia Experimental e Tecnológica

    Manuel Carrondo, Professor of Chemical and Biochemical Engineering, Universidade Nova de Lisboa, has been involved in animal cell technology research since the mid-eighties, through a couple of sabbaticals at MIT’s Biotechnology Process Engineering Center.

    He created iBET in Oeiras in 1988 and GenIbet as a spin off in 1906 to carry out productions of cGMP biopharmaceuticals for phase I/II clinical trials for proteins, viruses for gene therapy and vaccines and cell therapy.

    Prof. Carrondo has published over 250 papers and supervised thirty-six Ph.D. students (thesis defended).

  • 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.

  • 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.

  • Renske ten Ham

    Renske ten Ham, PhD

    University Medical Center Utrecht

    Renske ten Ham is an assistant professor at the UMC Utrecht in the Netherlands and specializes in health economics & health technology assessment (HTA) of Regenerative Medecines. Trained as a pharmacist and with an MSc in HTA, she holds a PhD in Drug Innovation titled: “Development, market authorization and market access of gene- and cell-based therapies”.

    Over the years Renske conducted research at the University of California, San Francisco (UCSF), spend time at the Dutch Medicines Evaluation Board (CBG-MEB) and National Healthcare Institute (Zorginstituut Nederland) and collaborated with several research groups, amongst which the Center of Health Economics at the University of York.

    At the Julius Center Renske strives to increase translation of (academic) regenerative medicinal products, in particular gene and cell-based therapies towards implementation in healthcare services to facilitate patient access. In doing so her research focusses on payment models, development cost, (early) economic evaluations and business models. She aims to contribute to better understanding of the fit between (radical) innovative therapies and existing development frameworks. This is not only relevant for transformative therapies nearing market access but also for future biomedical innovations.

  • Silvia Aldi

    Silvia Aldi, PhD

    SKAN

    Silvia Aldi is a SME in Cell and Gene therapy/Advanced Therapy Medicinal Products (ATMPs) manufacturing.

    She has more than 10 years of expertise in R&D management and coordination of translational and pre-clinical multidisciplinary research projects. Dr Aldi received her PhD in Molecular Medicine and her Master Degree, M.Sc. in cell and molecular biology from University of Siena, Italy. As Research Coordinator at Karolinska Institutet, Stockholm, Sweden, she led the development of In Vitro Medical Device (IVD) to diagnosis of autoimmune diseases, such as rheumatoid arthritis and lupus erythematosus.

    As Assistant Professor at Karolinska Institutet, she coordinated International and Interdisciplinary Seventh Framework Programs (FP7, European Commission) focused on novel targets for cardiovascular diseases.

    After receiving her PhD, she was a research fellow at the Weill Cornell School of Medicine in NY, USA where she led pharmacological studies for the role of immune cells in heart failure.

  • 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, CEO of VERIGRAFT AB, a pioneering company within tissue engineering and advanced regenerative medicine for use in treatment of cardiovascular and other diseases. Currently board member of a South Korean biotechnology company (GemVax group), and of publicly listed Swedish company Phase Holographic Imaging.

  • Julien Camperi

    Julien Camperi

    Genentech/Roche

    Dr. Julien Camperi received his Ph.D. in Analytical Chemistry from the Paris Sciences et Lettres University, France.

    He is a Technical Development Scientist at Genentech (A member of Roche group) in South San Francisco, California. He provides technical support throughout the analytical development process, moving novel therapeutic molecules from research to clinical trials through collaboration with cross-disciplinary teams.

    He is currently working on the development of analytical methods for the biological and potency characterization of cell therapies.

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    Bertie John Daly

    Takeda

    Bertie Daly Head of Manufacturing Takeda BSC Biopharmaceutical science MSC Strategic Growth and Leadership (Michael Smurfit) UCD Over 20 years experience with Pharma/BioPharma working with manual, semi automated and fullt automated processes within the sterile core.

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    Emilie Gauthy, PhD

    Celyad

    Emilie Gauthy is a Bioengineer by training. She earned her PhD in 2013 at the De Duve Institute in Brussels where she focused on cancer immunology and specifically on the modulation of regulatory T cells function by micro-RNAs.

    Since then, she had diverse experiences in the pharmaceutical industry covering roles such as QC scientist, QA supervisor at GlaxoSmithKline’s Industrialization department for the development of new vaccines and CMC project manager for oncological sterile product manufacturing in a CDMO.

    She joined Celyad Oncology in 2018 within the Industrialization team to oversee CMOs & CROs work and act as the Raw and Starting Materials Site Matter Expert. She is currently leading a scientific team dedicated to the development and validation of next generation allogeneic CAR-T products, bringing product candidates from research to clinical manufacturing.

  • Marcel Hoefnagel

    Marcel Hoefnagel, PhD

    Dutch Medicines Evaluation Board

    Marcel Hoefnagel, Senior Assessor Biopharmaceuticals, Medicines Evaluation Board (CBG-MEB), The Netherlands.

    • Senior Assessor of Biopharmaceuticals for the Medicines Evaluation Board (MEB) and
    • Specialised in ATMPs, vaccines, allergens, biosimilars, immunogenicity assays -
    • Since 2012 involved in regulation of CGTP (cell and gene therapy products) and drafting of guidance for CGTP and in drafting of several guidance documents for ATMPs.
    • Co-organiser of EMA/FDA Work on support to quality development in early access approaches. This was the start of drafting Toolbox guidance to support quality data packages for products for an unmet medical need. This approach was also used to support accelerated development and assessment of COVID-19 vaccines. Dr. Hoefnagel published several papers on potency testing for cell-based products. Current research includes impact of regulation on quality and costs of CGTP and the development of in vitro assays to replace in vivo potency testing of vaccines (IMIproject VAC2VAC).

    As Chairman of the Substance Validation Group he is involved in development of an international Substance Registration System (with EMA in collaboration with FDA: EU-SRS and G-SRS).

  • Ian Johnston

    Ian Johnston, PhD

    Miltenyi Biotec

    Dr. Ian Johnston is currently project and development lead responsible for certain TCR T and CAR T cell gene therapies being prepared for clinical application. Since joining Miltenyi Biotec in 1999, Dr. Johnston has developed a number of reagents and procedures to improve the efficiency of genetic modification of primary cells such as human T and stem cells.

    A number of these procedures have been fully automated on a functionally closed cell processing platform – the CliniMACS® Prodigy. In addition, Dr. Johnston has lead development of numerous products for magnetic isolation of cells, molecules, organelles and for use in the field of HIV research. He has been Principle Investigator on a number of European consortium grants focused on the genetic modification of stem cells, most recently Cell-PID and SCIDNET.

    Prior to joining Miltenyi, he studied Natural Sciences at Cambridge University where he also completed a PhD studying immunopathological mechanisms in the CNS. This was followed by postdoctoral research at Würzburg University with Prof. Volker ter Meulen working with recombinant measles virus systems, supported by two fellowships from the Wellcome Trust and Alexander von Humboldt Foundation.

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    Ohad Karnieli, PhD

    Adva Biotechnology

    Dr Karnieli is the founder & CEO of Adva Biotechnology.

    He is a well-known international expert in cell therapy. Dr. Karnieli is the founder and former CEO of Atvio Biotech, a leading Innovation center for cell & gene therapy.

    Former VP of Technology & Manufacturing at Pluristem Therapeutics, and the former VP of the medical device at Goji solutions. Dr. Karnieli has served as the chair of the process & product development committee of the International Society for Cellular Therapies, an expert member in the ISO TC276 Biotechnology standard committee, and the former chair of the science and technology committee of the Alliance for Regenerative Medicine.

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    Christina Meissner

    AGES - Austrian Agency for Health and Food Safety

    Christina Meissner is an EU GMP inspector at the Austrian Agency for Health and Food safety since 2013.

    Prior she worked as a Quality Assessor for clinical trials and at the Department of Medical Virology at the Charite University Hospital in Berlin.

    Christina Meissner was involved in the drafting of the Eudralex Volume IV Part IV - GMP requirements for Advanced Therapy Medicinal Products and the Q&A on "the principles of GMP for the manufacturing of starting materials of biological origin used to transfer genetic material for the manufacturing of ATMP".

    Christina Meissner was the Chair of the PIC/S Drafting Group on Annex 2A and 2B published in May 2021.

  • Brian O'Mahony

    Brian O'Mahony

    Irish Haemophilia Society

    Brian O’Mahony has been the Chief Executive of the Irish Haemophilia Society since 2006. He represents the society on the statutory National Haemophilia Council, the statutory Hepatitis C Consultative Council and he is the Vice Chair of the Tender Commission established by the Irish Government for the Procurement of Factor Concentrates and haemophilia medications.

    He is a member of the Board of the Irish Blood Transfusion Service. He previously served as Chair of the Irish Haemophilia Society for 17 years from 1987 to 2003. He served as President of the European Haemophilia Consortium (EHC) for 8 years from 2011 to 2019 and as President of the World Federation of Hemophilia (WFH) for 10 years from 1994 to 2004.

    He is currently a member of the Coagulation Product Safety Supply and Access (CPSSA) committee of the WFH and of the Medical and Scientific Advisory Group (MASAG) of the EHC. His publications for WFH include Monographs on Advocacy, Developing Haemophilia Organisations, Economics and Health Technology Assessments and A Guidebook on National Tender Systems. He is the author or co-author of more than 60 peer reviewed journal articles, and he is an ad-hoc reviewer for the journal Haemophilia.

    He is a Fellow of the Academy of Clinical Science and Laboratory Medicine (Ireland) and a Fellow of the Institute of Biomedical Sciences (UK). He has post graduate qualifications in Management and in Occupational Health and Safety and is currently an assistant adjunct Professor in Health Service Management in Trinity College, Dublin. 

    Brian O’Mahony has severe Haemophilia B.