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Committee & Speaker Biographies

Committee & Speaker Biographies

2021 PDA Advanced Therapy Medicinal Products

23-24 June 2021, online

  • 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.

  • 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.

  • Irving Ford

    Irving Ford, MSc

    Bristol-Myers Squibb

    Irving Ford is currently the Head of CAR T QC Laboratories at BMS. Irving has over 28 years of QA/QC leadership experience, included consent decree remediation, in the pharmaceutical/biotechnology and cell and gene therapies industries.

    Irving is an active participant in various industry groups and has served on the numerous planning committee’s for industry related conferences. Irving is also an author/contributor for PDA Technical Reports, White Paper publications and various Standards setting committees.

  • Silvia Aldi

    Silvia Aldi, PhD

    SKAN

    A cell and gene therapy bioprocessing and translational research expert, Dr. Aldi has more than 10 years of expertise in R&D management.

    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. Dr. Aldi received her PhD in Molecular Medicine and earned her Master’s Degree, BS in Cell and Molecular Biology from University of Siena, Siena, Italy.

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

  • Stefano Baila

    Stefano Baila, PhD

    Anemocyte

    Stefano Baila received his PhD in 2007 based upon translational research and development of gene therapies for hemophilia at the Children’s Hospital of Philadelphia. Since that time, he has been actively involved in the process development and manufacturing of advanced therapeutic medicinal products through business development and strategic marketing roles at Areta International, a CDMO, and by leading field implementation and commercialization activities for the cell processing unit of Terumo BCT.

    Stefano also worked as Industrialization Manager at Celyad where he led process development and automation efforts for CAR-T. Now he serves as Director of Operation and Business Development for Anemocyte.

  • Paul W. Barone, PhD

    MIT

    Dr. Barone has been at the MIT Center for Biomedical Innovation since 2010. He currently is the Associate Director of two biopharmaceutical industry consortia housed at MIT: the Biomanufacturing Research Program (BioMAN) and the Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB). He manages sponsored projects and activities for both BioMAN and CAACB with topics ranging from analysis of media treatment options to risk assessment and risk control for adventitious agent contamination.

  • 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.

  • Francesco Cicirello

    Francesco Cicirello, PharmD, MSc

    EVELO BIOSCIENCES
    Francesco Cicirello is Director, Quality Assurance. Before joining EVELO BIOSCIENCES, Francesco worked in a Regulatory Agency. He was an Expert Inspector at the Therapeutic Good Administration (TGA) in Australia. He was elected to several roles in PIC/S including Chairperson of the Working Group revising the PIC/s Annex 2 and Deputy Chair of the Subcommittee on Harmonisation. Francesco represented PIC/S at the EMA IWG and was member of the PIC/S Coordinating Committee on the Human Blood, Tissues, Cells & ATMPs.
  • Richard Denk

    Richard Denk

    Skan AG

    Richard Denk has been with SKAN AG aas Senior Consultant Aseptic Processing & Containment for several years. Richard founded the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2015.

    He 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.

    Richard is also member of the PDA Advisory Board on ATMPs, a frequent speaker, and planning committee member.

  • 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.

  • Manel Juan

    Manel Juan, MD, PhD

    Centro de Díagnóstico Biomédico, University Hospital Barcelona

    Dr. Juan holds degrees and a PhD in Medicine and Surgery with the clinical specialty of Immunology. He currently serves as Head of Immunology Service with direct responsibilities of cell immunotherapy and cytometry coordination with three main approaches: DCs + TILs + CART. He is working with one approved product (ARI0001, CART19, Hospital Exemption).

    Beyond his clinical work, he is Assistant Professor with the Department of Medicine at the Medical School, Universitat de Barcelona (UB). Previously, he has been Assistant Professor of Immunology (1997- 2007) and coordinator in the Master’s class of autoimmune diseases. He has directed nine doctoral theses and co-directed five.

    Currently, he is working on four active projects and has completed 12 previous projects as Principal Investigator. Dr. Juan has published 122 articles in journals and 129 papers in total, he has been a frequent speaker in 77 national and 114 international congresses. Dr. Juan holds six patents (4 PCT).

  • Olga Kolaj-Robin

    Olga Kolaj-Robin, PhD

    EDQM

    Olga Kolaj-Robin graduated with a Master's Degree in Molecular Biotechnology from Gdansk University of Technology (Poland), and subsequently completed a PhD in Protein Biochemistry at the University of Limerick (Ireland).

    During her postdoctoral research at the University of Limerick and Institute of Genetics and Molecular and Cellular Biology (Illkirch, France), she focused on structure-function analysis of membrane proteins and large protein complexes, before joining the European Pharmacopoeia Department of the European Directorate for the Quality of Medicines and Healthcare in 2015.

    She currently works as Scientific Programme Manager coordinating the work of Groups of Experts and Working Parties in charge of elaboration of pharmacopoeial texts in the field of biopharmaceuticals, antibiotics, and gene therapy.

  • Kreil Thomas

    Thomas R. Kreil, PhD

    Takeda
    Beyond his work at Takeda, he 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.
  • Michael Maguire

    Michael Maguire, PhD

    Avectas

    Michael is CEO of Avectas which he co-founded in 2012. He is a capable and motivated business leader with demonstrated track record in both start-up biotechnology and established medical device companies.

    He has led Avectas’ funding and business collaboration activities. Michael works closely with the Avectas Board, shareholders, internal and external teams to grow Avectas.

    He holds a BSc. Eng (Biomedical Engineering) from Trinity College Dublin, M. EngSc (Biomedical Engineering) and PhD (Drug Delivery) from Maynooth University.

  • Tania Pereira

    Tania Pereira, PhD

    Univercells Technologies

    Tania D. Pereira Chilima is the Chief Technology Officer at Univercells Technologies where she focuses on driving innovation to execute our mission of making biologics globally available and affordable. She also oversees the direction of the technology portfolio and is responsible for continuously identifying new technologies that could complement our portfolio as well as the application of our systems to new modalities.

    Prior to this role, she was Product Manager for the NevoLine™ platform at Univercells, and previously worked as a post-doctorate researcher for the ULTRA grant sponsored by the Bill and Melinda Gates foundation, focused on designing manufacturing strategies for ultra-low-cost vaccine manufacture.

    Tania holds an engineering doctorate from the University College London in partnership with Pall Life Sciences entitled, Decisional Tools for Enabling Successful Manufacture and Commercialization of Cell Therapy Products, and is a frequent contributor to industry publications and journals.

  • Remington_Kathy_web

    Kathy Remington, PhD

    BioReliance

    Kathryn Martin Remington is a member of BioReliance’s Field Development Services group and provides U.S. clients with technical and regulatory support.

    Kathy came to BioReliance in 2010 from Catalent Pharma Solutions where she established their viral clearance program and managed it for 7 years. Prior to that, Kathy was the Section Head of the Viral Validation group for Bayer Healthcare. During her nearly 20 years in viral clearance, she has authored a number of publications on the viral safety of biopharmaceuticals. Kathy earned her M.S. and Ph.D. degrees in Microbiology from the University of Montana.

  • Anne Stokes

    Anne Stokes, PhD

    GSK

    Dr. Anne Stokes is a Virologist. She is a GlaxoSmithKline (GSK) Senior Fellow, a member of the Council of Fellows and currently the Director of TSE and Virus Control within GMP Operations, Biopharmaceutical Product Development and Supply in Pennsylvania USA.

    For the past 23 years, she has worked for GSK in the development and manufacture of Biopharmaceuticals and cell and gene therapy products. She has managed Cell Banking activities and is currently the Director of TSE and Virus Control, responsible for the oversight of TSE and virus safety of a clinical Biopharm GMP manufacturing facility.

    She received a Doctorate in Viral Immunology whilst at the Pirbright Institute Surrey, UK. As a Fogarty Fellow at the NIH she worked on a vaccine for human parainfluenza virus 3.

    She is currently a member of the PDA. She has 20 publications and has presented posters and talks at many scientific meetings. Anne is currently representing PhRMA on the Expert Working group for the update (revision 2) to ICHQ5A. She is committed to fostering scientific talent through the GSK Fellows Program.

  • 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 gene and cell-based products. Trained as a pharmacist and with an MSc in HTA, she also holds a PhD in Drug Innovation.

    Over the years, Renske conducted research at the University of California, San Francisco (UCSF), spent time at the Dutch Medicines Evaluation Board (CBG-MEB) and National Healthcare Institute (Zorginstituut Nederland).

    Renske strives to facilitate translation of gene and cell-based therapies by identifying and mitigating regulatory and HTA challenges to increase patient access. She believes insights from (past) challenges will not only benefit gene and call-based therapies now, but also future biomedical innovations.

  • Nicolas Theys

    Nicolas Theys, PhD

    Novadip Biosciences

    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.