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Committee & Speaker Biographies

Committee & Speaker Biographies

2020 PDA Europe BioManufacturing 

22-23 September 2020, Dublin/Ireland 

  • Cristiana Campa

    Cristiana Campa, PhD

    GSK Vaccines

    Cristiana Campa is currently a Technical R&D Advisor and Fellow at GSK Vaccines, with 20 years’ experience in biologics and related analytical and development strategies, gained in different universities and companies. She joined Novartis Vaccines in 2006, focusing on development, validation and transfer of analytical methods for release and characterization of several vaccine products, first as senior manager and then as Head of Analytical Development, Italy. Since 2012, Cristiana has worked on Quality by Design (QbD) principles implementation for vaccines. After acquisition of Novartis Vaccines by GSK in 2015, she has been the Head of QbD Integration and, until June 2018, the Head of Science and Development Practices in Technical R&D, covering QbD implementation, Knowledge Management and Development roadmaps.

  • 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.

  • 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.
  • 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.

  • 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®. 

  • Sebastian Teitz

    Sebastian B. Teitz

    ASAHI Kasei Bioprocess Europe

    Sebastian Teitz graduated from University of Cologne with a diploma in Genomic Imprinting. He followed this with a PhD in the Analysis of O-glycosylated Proteins. Sebastian has previously worked at Fred Hutchinson Cancer Research Center (Seattle, WA), looking into Cytomegalovirus and its Role in Graft vs. Host Disease and Transplant Rejection; and at NewLab BioQuality / Charles River as the Project Manager of Virus Clearance Studies. Within Asahi his focus is on virus- & pathogen safety, supporting customers & internal entities technically and scientifically, and being liaison for authorities, CROs and industry consortiums of the biopharmaceuticals industry.

  • 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.

  • 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.

  • Matthias Angelmaier

    Matthias Angelmaier

    Syntegon Technology

    Matthias Angelmaier has a bachelor’s degree in industrial and mechanical engineering as well as a master’s degree in business development. He joined Robert Bosch GmbH, now Syntegon Technology in 2009.

    During his first 3 years, he was a project manager for handling complex customer projects. Since 2012, he is the globally responsible product manager for barrier systems and isolator technology. His expertise includes process engineering, sterilization, bio-decontamination, aseptic and high-potent Isolator applications, glove testing systems as well as topics related to advanced aseptic processing.

  • Magali Barbaroux

    Magali Barbaroux

    Sartorius Stedim
    Magali Barbaroux has over 25 years of experience in polymer science for healthcare applications. She belongs to the Sartorius Corporate Research and manages Advanced Polymers related research programs, with a strong focus on opportunities brought by the New Plastic Economy in biotech process.
  • Mirko Gabriele

    Mirko Gabriele

    Thermo Fisher Scientific

    Mirko joined Patheon, now part of Thermo Fisher Scientific, in 2008 and has held various positions, including Technology Transfer Project Manager, Technical Business Manager, Manager of Technology Transfer Responsibility and Global TT Sr. Manager for commercial unit for the Ferentino team. He also has experience in Quality Control and Research and Development, both in Finished Products and API companies.

    Mirko led the Parenteral Drug Association (PDA) Group issuing the Technical Report 65 on Risk Management during Technology Transfer and is currently leading the PDA Global Technology Transfer Interest Group. He is member of the PDA Regulatory Affairs and Quality Advisory Board since 2014. Mirko received a Master Degree in Chemical and Pharmaceutical Technologies in 2004 at the University of Rome and in 2012 and Executive MBA in Pharma Administration at the Luiss Business School of Rome. Mirko is Qualified Person for the Italian Health Authority since July 2014.
  • Marc Glogovsky

    Marc G. Glogovsky, MS, SM (NRCM)

    Valsource LLC

    Marc Glogovsky, MS, S.M. (NRCM) has over 20 years’ experience in the pharmaceutical industry, specializing in aseptic operations, contamination control, and risk-based environmental monitoring.  He has written a number of publications involving rapid microbiology, environmental monitoring, Mycoplasma and MALDI-TOF microbial identification.  Currently, he is a Senior Microbiology Consultant with ValSource, Inc. Prior to joining ValSource, he was responsible for managing the Environmental Monitoring Control division at Veltek Associates, Inc., and more than 10 years as a senior microbiology specialist at Merck KGaA. Marc earned his B.S. in Biology from Monmouth University and his M.S. in Microbiology from Rutgers University.

    Marc is actively involved with Parenteral Drug Association, where he serves on PDA’s Science Advisory Board, Education Advisory Board, chairs the Microbiology/EM Interest Group, is a faculty member at PDA-TRI and has contributed to a number of technical report committees and is currently co-chairing the Microbial Data Deviation technical report and a revision of the Environmental Monitoring (TR-13) technical teport.

  • Marc Hogreve

    Marc Hogreve

    Sartorius Stedim Biotech GmbH

    Marc Hogreve has been working for Sartorius since 2006, were he is today Senior Engineer for Integrity Testing Solutions. He earned his engineering degree at the “University of Applied Sciences and Arts” in Goettingen. Marc started his career as project leader in the field of development for lab equipment for cell culture and microbiology.

    As of 2011, he has been working as an engineer for integrity testing solutions with a focus on single-use systems for fluid management. As a subject matter expert in that area he is working on Sartorius’ global container closure integrity strategy for single-use systems. As part of task forces in several organizations like ASTM, BPSA or PDA he is supporting the creation of standards and best practices for the container closure integrity of single-use systems.

  • Michael Jahn

    Michael Jahn, PhD

    Lonza Drug Product Services
    Michael Jahn is heading the group Forensic Chemistry at Lonza’s Drug Product Services in Basel, Switzerland, since 2016. The group is supporting Lonza’s customers from the (bio )pharmaceutical industry in the following focus areas: excipient / surfactant analysis, extractables / leachables assessment, sub-visible and visible particle identification / spectroscopy / imaging, protein characterization by MS, trace analysis / structure elucidation. Before coming to Lonza, Michael worked for 11 years in the chemical and (bio )pharmaceutical  industry (Ciba Expert Services, Novartis), where he set up and led analytical laboratories specialized in trace analysis and structure elucidation. 
  • 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.

  • Peter Makowenskyj

    Peter J. Makowenskyj, MEng

    G-CON Manufacturing

    Peter Makowenskyj has over 13 years of experience in pharmaceutical and biopharmaceutical industries. Peter held various technical roles in process solutions for the biotech industry prior to moving into management positions in technical and sales roles. He has extensive knowledge of bioprocess manufacturing and helped design new facilities and retrofit existing facilities with single use technologies. Peter joined G-CON Manufacturing in 2016 where he now consults with clients in the design of their facilities utilizing G-CON’s pre-fabricated autonomous clean rooms.

    Peter received his Bachelor of Science in Chemical Engineering and a Minor in Biomedical Engineering from Cornell University. He received is M. Eng in Chemical Engineering from Cornell University.

  • Cilian McCabe

    Cilian McCabe, PhD

    Eli Lilly & Company

    Prior to joining Eli Lilly & Co. in 2007, Cillian graduated with a PhD in Molecular Medicine from NUI, Galway, Ireland and gained considerable experience in the areas of cell culture and gene therapy viral vector production platforms.  Since joining Eli Lilly & Co., Cillian has held a number of technical support roles in the US and Ireland supporting Process Development, Commercialization and Commercial Supply. In  Cillian’s current role, as a drug substance control strategy steward for multiple molecules he provides technical oversight to new product introductions and commercial supply.

  • Francesca Micoli

    Francesca Micoli, PhD

    GSK Vaccines
    Francesca Micoli graduated from the University of Florence in 2003 on industrial organic chemistry. She was awarded her PhD in Florence in 2006 on “Catalytic activity of mononuclear Ruthenium complexes containing different phosphinic ligands”. After a short stay at Boehringer-Ingelheim C.R.C she moved to Novartis Vaccines and Diagnostics, working on synthesis, purification and characterization of glycoconjugate vaccines. In 2007 she moved to Novartis Vaccines Institute for Global Health, now GSK Vaccines Institute for Global Health (GVGH), focusing her research on the development of effective and affordable vaccines for neglected diseases in impoverished communities. She has been Technology Platform Head at GVGH, working on two main technology platforms, glycoconjugation and Generalised Modules for Membrane Antigens (GMMA). From April 2020, she is Project Leader of the Shigella project and of the GMMA platform. Author of more than 40 scientific publications and several patent applications, she has many collaborations in place with academic and industrial partners.
     
  • Ragini Shivji

    Ragini Shivji, PhD

    European Medicines Agency
    Ragini Shivji is a pharmacist, with a Ph.D. from the University of Nottingham, UK. She worked for a number of years for the UK MHRA as a senior pharmaceutical assessor on a range of biotechnology / biological submissions. She has worked for the European Medicines Agency for eighteen years in the Quality Office, where her role as a principal quality specialist requires input into many aspects of biotechnology / biological applications with a focus on vaccines, particularly influenza and pandemic preparedness. 
  • Wim Van Molle

    Wim Van Molle, PhD

    Sciensano

    Dr Wim Van Molle is working at Sciensano (formal Scientific Institute of Public Health), Belgium, in the division of Quality of Vaccines and Blood Products, where he is responsible for vaccine batch release and evaluation of the quality part of registration and variation dossiers of vaccines and biologicals. Wim is also actively involved in scientific advice procedures at national and European level and participates as product expert in GMP inspections on the request of the Belgian (FAMHP) and European (EMA) medicines agency. Dr. Van Molle is a member of the Vaccine Core Group and observer at the Vaccine Working Party, both at the EMA, and is actively involved in European IMI projects.

    At Sciensano, he is manager of the unit for Cellular and Molecular Biology and Biochemistry, involved in quality release testing of vaccines and blood derived medicinal products.

    Wim works as auditor for the European Directorate for the Quality of Medicines & Healthcare (EDQM), Strasbourg, France where he is frequently asked to participate in mutual joined audits of European control laboratories. He is also in firm collaborations with the World Health Organization (WHO) as temporary advisor in the framework of the regulatory strengthening of regulatory authorities (NRA assessments) and the Global Learning Opportunities program on vaccine dossier evaluation.

    Dr Van Molle holds a Master in Biotechnology and obtained a PhD in Molecular Biology from the University of Ghent, Belgium and worked for over 10 year in the academic field, followed by a 2 year period at the Belgian regulatory authority before joining Sciensano.

  • John Walshe

    John Walshe

    Ward Automation
    John Walshe works in Business Development with Ward Automation, a high-quality developer and manufacturer of assembly machines, filling machines, test equipment and special purpose equipment for Pharmaceutical and Medical Device Industries. John has been a key member of the team for over 10 years and has vast knowledge of the robotics and automation industry, researching the latest technology trends and supplying automation solutions to the top 10 Medical Device and Pharmaceutical companies worldwide.
  • 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.

  • Qingyu Zeng

    Qingyu Zeng, PhD

    West Pharmaceutical Services, Inc.

    Dr. Qingyu Zeng has more than 20 years of extensive working experience in polymer material formulation development, product development, process development, and testing method development. He holds more than 10 granted patents. Throughout his career, Qingyu has served in various roles and responsibilities such as principal scientist, technology manager, and advanced technology platform team leader with various responsibilities to strategically lead many multi-discipline and cross-function team efforts to identify, evaluate, and develop cutting-edge materials, products, and core technologies for successful commercial implement and deployment. He joined West in February, 2016. Qingyu graduated with BS and MS from Donghua University in China and received his Ph.D. in Polymer Science with honor from North Carolina State University, and he also completed his EMBA from Ohio State University.