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Committee & Speaker Biographies

Committee & Speaker Biographies

2019 PDA Europe BioManufacturing

03-04 September 2019, Munich/Germany

  • Michael R. De Felippis, PhD

    Eli Lilly and Company

    Michael R. De Felippis, PhD joined the Lilly Research Laboratories of Eli Lilly and Company in 1990 after completing his doctoral studies in biochemistry at The Ohio State University.  He is currently a Senior Research Fellow working in the Bioproduct Research and Development division.  His work is focused on development of protein and peptide biopharmaceutical products with particular emphasis on characterizing physicochemical properties, defining delivery options, developing control strategies, executing technology transfers and preparing data packages to support worldwide product licensing applications and post-launch registrations.  Dr. De Felippis has lectured and published manuscripts, review articles and book chapters on the subjects of protein and peptide structural characterization, comparability, analytical testing and formulation design/delivery strategies.

  • Walid El Azab

    Walid El Azab

    STERIS

    Walid is Technical Services Manager for the Life Sciences Division at STERIS. He currently provides technical support related to cleaning chemistries, disinfectants and sterility assurance products and their application and validation. His areas of expertise include both upstream and downstream biopharmaceutical operation and validation. Walid has held various positions including Project Manager, Inspection Readiness Manager, Quality and Regulatory Manager, and Qualified Person (QP). Walid’s responsibilities and experience have also included handling deviations and complaints, releasing raw materials and drug products, conducting external audits of suppliers, and leading customer and regulatory (FDA, EMA, and other) audits. Walid earned a master’s degree in Industrial Pharmaceutical Sciences from the University of Liège, Belgium and is a certified Lean Six Sigma green belt. Walid also gives Industrial Pharmaceutical Sciences Master courses at the University of Liège (Belgium). Finally, Walid is an active member of the PDA, and is Secretary of the Belgium Qualified Person (UPIP-VAPI) association.

  • Steffen Gross

    Steffen Gross, PhD

    Paul-Ehrlich-Institut

    Steffen Gross has extensive experience in Molecular and Cell Biology.

    Dr. Gross joined the Paul-Ehrlich Institute in 2005 and became Head of the Section monoclonal and polyclonal antibodies in 2012. He is involved in the assessment of the quality and preclinical issues for marketing authorization applications, scientific advice and clinical trial applications. Until 2012, Dr. Gross was laboratory head of the section monoclonal and polyclonal antibodies and involved in testing of immunoglobulins, immune sera and monoclonal antibodies as well as in planning and performing research projects. Due to his experience, he also often supports inspections as an expert for certain products.

    Before joining the Paul-Ehrlich Institute, he worked in the Netherlands as well as at the National Institute of Health in Bethesda/USA.

  • Susanne Jörg

    Susanne Jörg, PhD

    LONZA

    Susanne Jörg joined Lonza, Switzerland, in 2006 as Head of Pharmaceutical Development, Drug Product Services. Her team is responsible for formulation and process development for customers' projects and related analytical testing, manufacturing of preclinical drug product supplies, process transfer to the GMP manufacturing site, and primary packaging and device functionality testing.

    Prior to joining Lonza, Susanne worked for 10 years in leadership roles at Novartis, most recently as Group Head Early Phase Pharmaceutical Development. She was involved into the development of Cosentyx as well as several product IND/IMPD submissions of monoclonal antibodies, recombinant protein, fusion proteins, bioconjugates, antibody fragments, nanobodies, and antibody-drug-conjugates for parenterals for various administration routes. Susanne studied pharmacy and holds a Ph.D from the Ludwig Maximillians University, Munich, Germany. In collaboration with Merck KGaA, Darmstadt (DE), she developed liquid high-concentration mAb formulations, and supported the registration filing of Erbitux®. 

  • Félix Alejandro Montero Julian

    Félix Alejandro Montero Julian, PhD

    BioMérieux
    Félix is a Scientific Director of the Healthcare Business of BioMérieux. Félix has over 25 years of experience in industrial and clinical diagnostics and previously served as the Chemunex R&D Director in BioMérieux. Félix graduated from the Autonomous Metropolitan University in Mexico as Industrial Biochemistry Engineer and obtained a PhD in Immunology from the Aix Marseille II University in France. Felix is a member of different scientific organizations (PDA, ISAC) and served as an expert in a panel for the Development of Compendial Rapid Sterility Tests for the USP.  Félix has been and continues to be extensively involved in the implementation and acceptance of rapid and alternative microbiological methods. He is a prominent speaker at congresses and conferences and a regular contributor to BioMérieux whitepapers.
  • Elisabeth Vachette

    Elisabeth Vachette

    Sartorius Stedim Biotech

    Elisabeth Vachette is a Product Manager for Single Use Fluid Management Technologies at Sartorius Stedim Biotech based in Aubagne, France. With a Biotechnology Engineer graduation of the ENSAIA of Nancy and 15 years of experience, Mrs. Vachette supports the biopharmaceutical industry on a world-wide basis, in particular in process design, validation, training and implementation of single-use fluid management technologies.

    Since joining Sartorius Stedim Biotech in 2000, she has been responsible for quality, production, engineering and now product management providing a broad view of the functionalities of single-use solutions development, qualification and manufacturing.

  • Martijn Van der Plas

    Martijn Van der Plas, PhD

    Dutch Medicines Evaluation Board

    Dr. R.M. van der Plas is senior assessor for biological products at the Medicines Evaluation Board, and previously RIVM where he started working as assessor in 2000. His fields of attention include biosimilars, monoclonal antibodies, recombinant proteins and plasma-derived products in general.

    He obtained a Ph.D. degree in 1999, with the thesis ‘Structure and Function  of Human von Willebrand Factor’. He obtained a ‘doctorandus’ (M.Sc) degree in 1994 with a major in Molecular Pharmacology.

  • Arne von Bonin

    Arne von Bonin, PhD

    Vaxxilon

    Arne has more than 15 years of industrial experience in Inflammation & Immunology Research. He has a thorough background in preclinical development of small molecule, antibody and vaccine related therapeutics. His spectrum of activities includes target & lead identification, optimization and the support of advanced clinical development programs.

    Before joining Vaxxilon in 2016, Arne was the CSO and a board member of AFFiRiS, Vienna and worked from 2003 until 2012 in different R&D related functions at Bayer Healthcare AG (before Schering AG, Berlin).

    Arne holds a PhD in Biology (Max-Planck Institute for Immunobiology, Freiburg, Germany). His long-standing interest is Immunology with a specific focus on T cell mediated immune regulation.

  • Florence Wauters

    Florence Wauters, PhD

    MSD

    Florence Wauters has over 15 years of experience in the biopharmaceutical industry with a focus on pharmaceutical process development, Regulatory Affairs and project management. Prior to joining MSD in 2016, Florence held various positions in the area of drug product development and development technologies within GSK.

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    Janmeet Anant, PhD

    MilliporeSigma - Merck KGaA

    Janmeet Anant serves as a Regulatory Advocate for the Process Solutions business area of Merck KGaA. In this role, Janmeet consults and inform global marketing and sales about new quality/regulatory trends and developments in biopharmaceutical manufacturing. He also coordinates processes with internal functions for the commenting/drafting of guidelines, regulations and standards. Over the last few years, Janmeet has been focused on supporting the areas of aseptic processing and single-use technologies. Janmeet is a voting member of the ASTM and ASME-BPE standard setting organizations.

    Janmeet has 20 years of experience as a supplier for the biopharmaceutical industry, starting in a technical applications role focused on chromatography, and moving through sales, marketing and most recently regulatory support. Janmeet has a Bachelor’s of Science degree in Chemistry and a Ph.D. in Pharmacology.

  • Adithya Balasubramanian

    Adithya Balasubramanian

    LONZA
    Adi joined Lonza's Drug Product Services in 2016 and currently working on formulation development of protein therapeutics for early and late stage programs. Prior to joining Lonza, he was working in Late Stage Pharmaceutical Development at Genentech Inc, USA and in Protein Chemistry Sciences at Regeneron Pharmaceuticals, USA. He holds a Master's degree in Biochemistry & Molecular biology from the University of Southern California in Los Angeles and an undergraduate degree in Engineering from Anna University, India, majoring in Industrial Biotechnology.
  • Giovanna Campanella

    Giovanna Campanella, PhD

    GSK Vaccines
    Giovanna Campanella is currently Senior Manager at GSK Vaccines in Technical Research and Development. In her current role she is responsible for Secondary Manufacturing process development and transfer for vaccine candidates at different stages of development - from the pre-clinical stage to life cycle management. She holds a Master of Science in Biology and Pharmaceutical Industrial Technologies and a PhD in Biology and Biotechnology. She has over 10 years’ working experience in biotechnological manufacturing covering scientific and management roles in R&D, QC and Quality.
  • Barbara Capecchi

    Barbara Capecchi, PhD

    GSK Vaccines

    Barbara holds a masters degree in Biological Sciences from the University of Pisa and a PhD in Molecular and Cell Biology from the University of Padova, Italy.

    Barbara started working at GSK Vaccines, formerly Chiron Vaccines in 1997, and spent 13 years in Pre-Clinical Research, focusing her research on the selection and functional characterization of bacterial and viral antigens, and the development of serological assays. In 2011, she joined the Analytical and Research Development team at GSK Vaccines in Italy leading efforts to develop and validate immunoassays and cell-based assays for measuring safety and potency attributes to support release and stability testing for clinical and commercial vaccines, with a focus on the replacement of in vivo with in vitro assays.

  • Gwenael Cirefice

    Gwenael Cirefice, PharmD

    EDQM

    Dr. Cirefice is Scientific Officer in the European Pharmacopoiea department at the European Directorate for the Quality of Medicines and HealthCare (EDQM), at the Council of Europe.

    G. Cirefice is responsible for the Ph. Eur. group of experts 15 elaborating monographs on vaccines for human use and the working party on host cell proteins.

    He holds a Doctorate in Pharmacy from the University of Strasbourg, France.

    G. Cirefice joined the vaccine industry in 2007 as a regulatory affairs manager before joining the Quality of Medicines department of the European Medicines Agency in 2010, with responsibilities in the field of human vaccines.

    He joined the EDQM in May 2014.

  • Andrew Clutterbuck

    Andrew Clutterbuck

    Merck KGaA

    Andrew Clutterbuck is the Head of Merck’s Manufacturing Sciences & Technology (MSAT) group for Europe, Middle East & Africa regions. With 18 years biomanufacturing experience from process development through to cGMP manufacturing, Andrew joined Merck in 2011 after working for contract manufacturing orgainsations in the UK in several development and manufacturing roles developing, scaling and manufacturing biopharmaceuticals. Andrew holds a degree in Molecular & Cellular Biology from the University of Huddersfield, UK.

  • Marcello Colao

    Marcello Colao, MS

    GSK Vaccines

    Marcello Colao currently holds the position of Director Regulatory & Technical Lifecycle within the Global Quality organization of GSK Vaccines aimed at sustaining and leveraging the successful lifecycle management of GSK vaccines from both a regulatory and technical perspective.

    Marcello joined GSK Vaccines in 2012 as Director Quality & Regulatory Compliance to lead the Regulatory Conformance Transformation of the company. Prior to that, he worked for Pfizer where he held positions of increasing responsibilities within the Global Quality Operations organization.

    Marcello holds a Master Science degree in Chemistry and has 20+ years experience in the pharmaceutical industry with an extensive knowledge of pharmaceutical operations, Quality Systems as well as Regulatory Compliance matters.

  • Indu Conley

    Indu Conley

    DPS

    Indu Conley, Department Manager, Process Engineering, DPS Group, Boston, MA USA office, has more than 18 years of experience in the biopharmaceutical industry with significant experience in large-scale mammalian cell culture processes. Recent experience has involved projects in novel therapeutics, and challenges in design and development of personalized vaccines and medicines. Indu’s design experience includes all stages of biologic process unit operations, including, harvest, TFF systems, chromatography, and filtration systems. She is one of DPS’ leading subject matter experts on Oligonucleotides and Peptides. Indu began her career on the owner side of the business and gained significant experience as a lead engineer for a biologics manufacturing facility; this experience brings valuable operational and plant experience to her design approach. Indu is an active member of ASME BPE (American Society of Mechanical Engineers Bioprocess Equipment) in which she serves on the standards committee for design and is also a member of AIChe and ISPE Boston.

  • Sandrine Dessoy

    Sandrine Dessoy

    GSK Vaccines

    Sandrine holds a Chemical Engineering degree and a Master in Biotechnology, both from the Université Libre de Bruxelles. Sandrine worked for 10 years for Solvay Enzymes and was in charge of the scale-up of the enzyme production processes. She joined the R&D Department of SmithKline Beecham, now GSK Vaccines, gained experience in development and scale-up of Drug Substance processes, process modelling, evaluation of new technologies and now fostering innovation in Technical R&D.

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    Caroline Duignan, PhD

    GSK

    After graduating from the National University of Ireland, Galway in 2005 Caroline worked as a QC Microbiologist within Allergan and Pfizer before returning to academia. She received a M.Sc. in Molecular Ecology from Queens University, Belfast in 2011 and then moved to Southampton where she completed a Ph.D. and worked as a research fellow at the University of Southampton.

    In 2018 she returned to industry and currently works as an Analytical Scientist focused on working within the Microbiology Modernisation program in the Method Innovation Team within GSK Research & Development. In her current role she works closely with QC Microbiologists across the Biopharm, Cell & Gene Therapy and Small Molecules division of GSK. She also participates in a cross-industry forum focused on sharing experience with new emerging technologies within the QC Microbiology field and looking at how best to implement these new technologies within the QC Pharmaceutical Microbiology field.

  • Annick Gillet

    Annick Gillet

    Sterigenics

    Annick Gillet has a biochemistry background and began her career at Sterigenics up to 10 years ago as Quality Manager for one of the biggest EO Sterigenics plant located in Belgium. She acted as the main contact during customers and regulatory inspections (FDA, European Authorities …etc.). Annick also gained ten years of experience in Medical Device industry (wound dressings) in R&D, Quality, and consultancy. She also worked for about two years as SME in sterilization at Allergan (Pharmaceutical industry) in a site manufacturing terminally sterilized hormonal Intra Uterine device. As a Technical Director for 3 years, Annick currently leads ethylene oxide sterilization projects in different Sterigenics plants and is supporting the plants as technical expert with pharmaceutical project responsibilities.

  • Uwe Gottschalk

    Uwe Gottschalk, PhD

    Lonza

    Uwe Gottschalk has been Chief Scientific Officer (CSO) at Lonza since July 2017.

    Between 2014 and 2017, he served as a Chief Technology Officer where he established and led the global Research and Technology organisation of Lonza Pharma/Biotech.

    Uwe earned his M.Sc and PhD in Chemistry at the University of Münster, Germany and Nottingham, UK, delivering his dissertation on drug targeting with monoclonal antibodies. He has written extensively in the areas of downstream processing, industrial biotechnology and somatic gene therapy.

    In academia, Dr. Gottschalk is currently Head Lecturer at the University of Duisburg-Essen (Germany) and also lectured at the Ecole Polytechnique Fédérale de Lausanne (EPFL) in Lausanne (Switzerland).

    Dr. Gottschalk sits on the editorial advisory boards of Pharmaceutical Bioprocessing, Genetic Engineering News and BioPharm International. He is honorary member of the Society for BioChromatography and Nanoseparations, member of the Management Pool at the Institute of Marketing, University of St. Gallen (HSG) and member of the American Chemical Society (ACS).

  • Cornelia Haas

    Cornelia Haas, PhD

    VTU Engineering

    Cornelia has worked on USP process development of perfusion systems at the University of Natural Resources and Life Sciences in Vienna prior to joining the manufacturing science and technology (MS&T) team of VTU Engineering in 2017.

    For the past several years she has focused on the topic of microbial and particulate contamination control strategies for several multinational companies. She developed and supported the establishment of these procedures in the area of biopharmaceutical drug substance and drug product manufacture, whereby she gained extensive knowledge on the topic of microbial and particulate control.

  • Josselyn Haas Durr

    Josselyn Haas Durr

    Merck KGaA

    Josselyn Haas Durr is a Biomanufacturing Engineer Manager active in the Merck EMEA Life Sciences MSAT group (Manufacturing Sciences & Technology). His main activities are the development of biopharmaceutical processes, process optimization, implementation, scale up and troubleshooting, focusing mainly on the clinical and commercial scale areas especially for the Tangential Flow Filtration. Josselyn is also carrying out investigations on process deviations. He has joined Merck (formerly Millipore) in 2006 and has held different pharma downstream processing expert positions. Josselyn holds a Master Degree in Biotechnology Engineering from the “Ecole Nationale Supérieure de Technologie des Biomolecules” (ENSTBB) de Bordeaux (France). 

  • Armin Hauk

    Armin Hauk, PhD

    Sartorius Stedim
    After his PhD, Armin started his career at Ciba-Geigy in 1995. He was responsible for the GLP & GMP lab for organic analysis, migration studies, E&L investigations, development of GMP QC methods and stability testing. After 2010 Armin worked as consultant and Qualified Person (QP) for Intertek. Since 2016 Armin has a position at Sartorius-Stedim Biotech as Principal Scientist. Armin is lecturer and trainer in E&L conferences and seminars and he is member of PDA, ELSIE and the BPOG supplier group. Armin is delegate of the German BfArM in the Pharmacopeia expert group of the European Directorate for the Quality of Medicines (EDQM).
  • Dolores Hernan

    Dolores Hernan Perez de la Ossa, PhD

    European Medicines Agency

    Dolores Hernan Perez de la Ossa, PhD Quality Specialist and Quality Working Party Core Team Scientific Secretary, European Medicines Agency, Amsterdam, NL

    Dolores obtained a Pharmacy degree and a European PhD in Pharmaceutical Technology from the Complutense University, Madrid, Spain conducting research stays at USA Virginia Commonwealth University-School of Medicine and the Institute of Biomolecular Chemistry of the Italian National Research Council.

    She joined the Quality Office of the European Medicines Agency in London in 2010, first in the biologicals section and then moved to the small molecules team. Since then she has been Product Team Leader/Quality Specialist for numerous medicinal products applications and supported the development of several scientific guidelines. Since 2012 she also acts as Scientific Secretary of the Quality Working Party Core Team (QWP CT) and provides scientific support to the EMA PAT team (coordinated EMA-FDA joint QbD pilot from 2012 until its closure in 2017). She represents EMA at the IPRP nanomedicines working group, ICH Q13 EWG on Continuous Manufacturing and ASTM E55.

  • Wilhelm Herok

    Wilhelm Herok

    AGES

    Wilhelm Herok joined the Federal Office for Safety in Health Care in October 2017 as a member of the Clinical Trials Unit. His background is in biotechnology. In his current role as clinical trial assessor he is performing quality assessments for biotech and advanced therapy products in clinical trials and contributing to national and EMA scientific advices.

    Prior to joining the Austrian national competent authority Wilhelm Herok was working in the pharmaceutical industry for several years mainly focusing on the quality management of gene therapy medicinal products in clinical trials.

  • Marcel Hoefnagel

    Marcel Hoefnagel, PhD

    Dutch Medicines Evaluation Board

    Marcel Hoefnagel is a Senior Assessor of Biopharmaceuticals for the Medicines Evaluation Board (MEB). Graduated as a biochemist, he obtained his PhD in Plant Molecular Biology. After several research positions he joined the MEB in 2002 where he specialised in vaccines, allergens, biosimilars, immunogenicity , and cell-based medicinal products. He has extensive experience in regulatory, GMP and legal aspects of biopharmaceuticals. He was part of assessment teams of two PRIME/accelerated access procedures.

    2012 he has focussed on ATMPs and was involved in EMA market applications procedures and scientific advices for cell and gene therapeutics and participates in drafting EMA regulatory guidance. In collaboration with Charlotte de Wolf, PhD student in immunology, he published several papers on potency tests as applied for cell-based products (T-cells, DCs and MSCs).

    His current research includes development of in vitro immunogenicity assays to replace in vivo potency testing of vaccines (IMI project VAC2VAC). In a collaboration with Utrecht University a Ph.D. student, Coen Stalpers, studies the immunogenicity of DTaP vaccine components in cell-based assays.

    Further he is involved in the development of an European and Global Substance Registration System (collaboration with FDA).

  • Michael Hust

    Michael Hust, Prof.

    Technical University Braunschweig

    Michael studied biology at the Carl von Ossietzky Universität in Oldenburg, Germany, from 1993-1999. He received his PhD from the Leibniz Universität in Hannover, Germany, in 2002. Since end of 2002 he is working as group leader at the Technische Universität Braunschweig, Germany. In 2011, he finished his professorial dissertation (Habilitation, venia legendi for Biotechnology) and was appointed as Privatdozent (PD). In 2014 he was appointed as professor for biotechnology.

    He published more than 130 articles and filed seven patents in the field of antibody engineering and phage display He is working on the development of human and human-like antibodies for proteome research, diagnostics and therapy with a focus on pathogens and toxins. Another field of work is the identification of biomarkers of pathogens using ORFeome phage display. He co-founded two biotech companies, the mAb-Factory GmbH in 2007 and the YUMAB GmbH (www.yumab.com) in 2012.

  • Klaus Kaiser

    Klaus Kaiser, PhD

    Bayer

    Dr. Klaus Kaiser is Head of Downstream within Biological Development at Bayer in Wuppertal, Germany. He also serves as lead of several strategic projects in the field of protein purification.

    He received a Diploma degree in Technical Biology from University of Stuttgart with the focus on Biochemical Engineering and a Doctor degree in Biochemistry from the Ludwig-Maximilians-University in Munich where his research activities focused on the control of class II gene transcription.

    After joining Bayer in 1997 Klaus worked several years in Technology Development to support biotechnological processes as well as blood plasma fractionation with focus on cell culture perfusion and virus safety topics. Until now he held different roles in process development and clinical manufacturing. His recent responsibility focuses on early and late stage development and process transfer from clinical scale to commercial production. Klaus shares a broad knowledge and experience in process characterization and production of different bulk drug substance modalities like antibodies and antibody drug conjugates.

    Specific interests cover downstream processing platform technologies, single-use applications and continuous manufacturing. Klaus also served as member in the DECHEMA expert committee “Bioprocess Technology” and in the “Qualification of scale down models for bioprocess” Point Share within the cross industry collaboration BPDG.
  • Amin Khan

    Amin Khan, PhD

    GSK Vaccines

    M. Amin Khan, Ph.D. leads the R&D Acceleration Team at GSK Vaccines. The team’s mandate is to enable the reduction of vaccine product development times, and to seek and integrate new approaches and tools to realize this ambition. He was Head of Global Technical Research and Development at GSK Vaccines from 2015 until his appointment to his current position in 2019.

    He joined GSK as part of the company’s acquisition of Novartis Vaccines in March 2015.  At Novartis Vaccines Dr. Khan held the position of Global Head of Technical Development, and Global Head of Technical Development and Manufacturing Sciences & Technology (2011-2015). Prior to joining the vaccines industry Dr. Khan spent more than 20 years working on small molecule drug, and biotherapeutic product, process and analytical development; Trinity Biosystems, Inc (2008-2010), Eli Lilly and Company (1998-2008), West Pharmaceutical Services (1993-1998), and Enzytech, Inc (1989-1993).  He holds a Ph.D., in Pharmaceutical Sciences from the University of Nottingham, U.K.

  • Zoltan Kis

    Zoltán Kis, PhD

    Imperial College London

    Dr. Zoltán Kis is a Research Associate in the Future Vaccines Manufacturing Hub at the Centre for Process Systems Engineering, Department of Chemical Engineering, Imperial College London. Zoltán is modelling vaccine production processes for assisting the application of QbD principles and for supporting the techno-economically feasible implementation of emerging vaccine platform technologies.

    He obtained his Ph.D. in Bioengineering from Imperial College London, UK, holds an M.Sc. in Applied Biotechnology and a B.Eng. in Chemical with Biochemical Engineering. Zoltán has co-authored over 20 scientific and technical publications and presented at over 20 international conferences.

  • Nanna Aaby Kruse

    Nanna Kruse, MSc

    Danish Medicines Agency

    Nanna Aaby Kruse obtained a Master of Science in Pharmacy at the Danish University of Pharmaceutical Science in 1993 and started her work life in the field of malaria vaccine research at the State Serum Institute in Copenhagen.

    In 1995, she joined the Danish Medicines Agency, where she is the Team Manager of the biological team in the pharmaceutical Quality Unit. Over the years, she has been the lead Quality/CMC Assessor for the Danish Rapporteur-team in the evaluation of a number of Marketing Authorisation Applications in the Centralized Procedure. She joined CHMP’s Biological Working Group (BWP) at EMA in 2002 and in 2014, she was elected by CHMP to be the BWP Vice-chair. In addition, Nanna is the Danish representative in the Committee for Advanced Therapies (CAT) and member of Biosimilar Working Party (BMWP) and EMA PAT/QbD team. Finally, she is representing BWP/EU in ICHs Expert Working Group for ICH Q12, where she is acting as Regulatory Chair.

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    Morcos Loka

    Minapharm

    Morcos Loka is Training Manager & GMP Advisor at Minapharm. He has 20 years of experience in the pharmaceutical & biopharmaceutical industry. Before his current role, Morcos served as Production Pharmacist, Technical Coordinator, QA Assistant Manager and Site GMP Auditor & GMP Training Manager. He has experience in manufacturing of sterile and non-sterile medicinal products, handling of regulatory & customer audits, auditing suppliers and contract manufacturers, GMP consultation, internal auditing, training, quality risk management, establishing quality management system, quality metrics and design of pharmaceutical and biopharmaceutical manufacturing facilities.

    Morcos has B.Sc. in Pharmaceutical Sciences and two postgraduate diplomas in Total Quality Management (TQM) and Train the Trainer (TOT). He also has four professional certificates: ASQ Certified Manager of Quality / Organizational Excellence (CMQ/OE), ASQ Certified Quality Auditor (CQA), ASQ Certified Pharmaceutical GMP Professional (CPGP) and ISPE Certified Pharmaceutical Industry Professional (CPIP).

  • Juha Mattila

    Juha Mattila

    Steris Finland
    Juha Mattila is Director, Sterilization Technologies, and responsible for STERIS Finn-Aqua steam and low temperature sterilization and biodecontamination technologies. He has B. Sc. with Hons in HVAC and process engineering, and M. Eng. in Business Informatics, both from Helsinki University of Applied Sciences. He joined STERIS in 2000 and has nearly 20 years of experience with pharmaceutical and research process equipment and applications, including several years in R&D, engineering and product management. He has led several new product development projects, worked on many customer projects in Europe, North America and Asia, is an active conference presenter, and contributes to industry articles in professional journals. Juha is a member of PDA, ISPE and Finnish Biosafety Network and a member of two ISO and CEN standard work groups, representing Finland.
  • Mic McGoldrick

    Mic McGoldrick

    MSD

    Mic currently is an Associate Director of Global CMC Policy at Merck Sharp and Dohme, Corp.  His background in the life sciences started with degrees in Microbiology, Chemistry, and Medical Technology and has experience with Vaccine and Biologics in the Pharmaceutical field for the last 28 years.  For 15 years Mic worked in Regulatory Affairs on INDs, new product filings, and post approval submissions globally.  For a large portion of this time he led the evaluation of worldwide guidances and the expansion of vaccines into the Emerging Markets.  For the last four years Mic has been working on CMC Policy for Vaccines and Biologics, advocating for harmonization and greater access of vaccines to patients.

  • Jose Menezes

    Jose C. Menezes, Prof. Dr.

    4Tune Engineering
    Prof. Jose C. Menezes is director since 2007 of a Program in Pharmaceutical Engineering covering QbD and PAT at the Technical University of Lisbon. He has published extensively on the above subjects. He is founder and partner of 4Tune Engineering Ltd a decade ago, working in the areas of Manufacturing Sciences applied to BioPharmaceutical Engineering.
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    John O'Hara, PhD

    UCB
    Dr. John O’Hara is Head of Biological Characterisation Sciences at UCB, based in Slough, UK. He has responsibility for characterisation activities for novel biological entities, with a particular focus on supporting manufacturing operations and regulatory filings throughout the development and commercial lifecycles. Dr. O’Hara previously worked for GlaxoSmithKline in the UK and Schering Plough in New Jersey, USA
  • Kavita Ramalingam Iyer

    Kavita Ramalingam Iyer, PhD

    MSD

    Dr. Ramalingam Iyer received her Ph.D in Biotechnology from Anna University, India and completed post-doctoral fellowship at University of Minnesota, USA focusing on antibody engineering and synthetic biology prior to joining MSD in 2008.

    Kavita has more than 8 years of Pharmaceutical industry experience leading CMC development, manufacturing, establishment of GMP facilities, technology transfer, talent development and strategic initiatives and performed site audits. She is a certified lean six sigma black belt.

    Currently, Dr. Kavita Ramalingam Iyer is the Regulatory Lead for investigational and marketed vaccine and biologics products within Global Regulatory Affairs and Clinical Supply (GRACS) Organization. Her current responsibilities include managing product dossier life cycles; developing, shaping and implementing CMC regulatory strategies in compliance with global regulations, developing regulatory documentation to support worldwide registration, lead regulatory CMC representative on matrix teams and mentors early development and cross-functional teams. She has given several conference talks and published multiple position papers in collaboration with industry experts addressing emerging regulations and guidance documents covering product development, registration and post-approval changes.

  • Fritz Roeder

    Fritz Roeder

    Merck KGaA

    Fritz Roeder is currently Senior Manager Validation, Qualification & Engineering at Merck KGaA in Darmstadt.

    Fritz is a recognized expert in the pharmaceutical industry. He has extensive experience in pharmaceutical media supply, GMP environments and the processing of solid, semi-solid and liquid (sterile) dosage forms. He is member of the EDQM Working Group “Water”, the ISPE DACH Expert Group “Water & Steam" and an active volunteer within PDA.

    Fritz has contributed to several audit projects (FDA, ANVISA, German RP, Russia, and others) and is experienced in GMP consulting in various technical questions, water treatment & TOC measurement design and has been a responsible operator of GMP equipment.

  • Michiel Rook

    Michiel Rook

    Global Consepts – Europe B.V.
    Michiel Rook is a biopharmaceutical consultant and an independent expert in aseptic filtration. He has 30+ years experience in liquid aseptic manufacturing processes and facilities. As a freelance consultant he is mainly involved in (management) of CQV projects or tech transfer projects of liquid aseptic products and plants. His CV includes large molecule, small molecule, vaccines, ATMP and personalised medicine manufacturers. 
  • Jochen Schmidt-Nawrot

    Jochen Schmidt-Nawrot

    CRB

    Jochen brings more than 20 years of experience to his role as Process Utilities Lead at CRB. He is an expert in the field of high purity water systems for the pharmaceutical industry. His deep knowledge and application of industry regulations, cGMPs and best practices has made him valuable in the design and delivery of process utilities. Jochen has vast experience in the design and dimensioning of complete systems for generation, storage and distribution of Purified Water, Water for Injection and Pure Steam. 

    Prior to CRB, Jochen worked for innovative and leading ultrapure water system manufacturers in different markets, such as BWT (Christ) and Hager+Elsässer. 

    He takes great pride in understanding the needs of an end user and combining it with his deep design knowledge to develop the optimal water system design, qualitatively and economically. He has written well-recognized publications and presented at several conferences and trainings. He has actively supported the approval of membrane technologies for production of WFI by the EDQM.

  • Mathias Siebner

    Mathias Siebner, PhD

    Sartorius Stedim Biotech GmbH

    Mathias has 23 years of experience in biopharmaceutical filtration technology. He is the Process Expert Separation Technologies in the European sales organisation of Sartorius Stedim Biotech. He has led different technical teams in Europe and Asia. He has a strong validation and regulatory background due to his 5 year experience of managing customer’s validation studies. He is an internal and external trainer for separation technologies e.g. for filter integrity testing, optimization of filtration processes and GMP related topics. 

  • Vivek Thakare

    Vivek Thakare, PhD

    Novartis

    Vivek Thakare is a Drug Product Leader at Novartis in Schaftenau, Austria. He is responsible for the late stage pharmaceutical development of the biologics drug product entailing technology transfer to manufacturing sites and supporting the validation and post-validation LCM activities. He has over 9 years of research experience focusing on the development of wide range of therapeutics and diagnostics. He is a pharmaceutical scientist by training and holds a PhD in Chemical Sciences from University of Bourgogne, Dijon in France.

  • Per Vase

    Per Vase, PhD

    NNE

    Per Vase is an acknowledged data analysis expert with more than 30 years of experience. His focus is on applying Six Sigma in good manufacturing practice (cGMP) environments, combining compliance and process optimization efforts to ensure both high quality and low costs. Per Vase holds a Ph.D. in materials science from the Technical University of Denmark and an M.Sc. in experimental physics from Aarhus University.

  • Welin, Mats

    Mats Welin

    Swedish Medical Products Agency

    Mats Welin holds a position as a Senior expert at the Medical Products Agency in Sweden, working with quality assessment of human and veterinary biologics, and normative work within this field with a focus on vaccines and monoclonal antibodies. He is a pharmacist by training and has been employed at the agency since 1988.

    Since 1996, Mats has been the Swedish delegate of CHMPs sub group on biologics, the Biologics working party (BWP), and he chaired the EMA-Industry workshop on making use of prior knowledge in regulatory submissions held in November 2017.

    He is also a member of EMEA PAT team dealing with QbD related topics since 2003 as one of the BWP representatives to cover biological aspects in the field. He was a delegate of the Quality implementation working group (Q-IWG) of the ICH during its existence to work with introduction of the Q8-Q10 concepts. He is frequent speaker at conferences on Quality by Design, process validation, setting of specifications and on general aspects in relation to biological medicinal products.

  • Klaus Wormuth

    Klaus Wormuth, PhD

    Sartorius Stedim Biotech GmbH

    Dr. Klaus Wormuth has a Ph.D. in Chemical Engineering from the University of Washington and 30 years of R&D experience in a variety of fields, primarily in medical devices and most recently single-use technologies. He is currently Lead Scientist, a global specialist for particles topics at Sartorius Stedim Biotech GmbH.