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Committee & Speaker Biographies

Committee & Presenter Biographies

2022 PDA Parenteral Packaging Conference

02-03 June 2022

  • Bettine Boltres

    Bettine Boltres, PhD

    West Pharmaceutical Services

    As Principal Scientific Affairs, Dr. Bettine Boltres is supporting the scientific exchange between West and the pharmaceutical industry. This is complementing work as Product Manager for Schott Pharmaceutical Tubing, where she provided scientific consulting for glass primary packaging.

    Since 2015 Bettine is an active member of the USP Packaging and Distribution Expert Committee as well as the ISO TC76/WG 4 on elastomers. Additionally, in 2018 joined the European Pharmacopoeia Commission Group of Experts 16 (elastomers and plastics) and the GLS Working Party (glass).

    Since January 2019 she is also a member of the PDA Board of Directors, actively supporting the role of PDA in the global pharma world. She is active in the PDA Glass Handling Task Force and co-chairing the European PDA Interest Group Packaging Science as well as the Pharmacopeia Interest Group.
    In 2015 she published the book "When Glass Meets Pharma".

    She is a frequent speaker at industry conferences and has chaired and moderated several conferences for the PDA and other formats. This is adding to numerous trainings and publications that she has provided.

    Dr. Boltres is a (bio)chemist by training, with a diploma in chemistry and a PhD in biochemistry.

  • Roman Mathaes

    Roman Mathaes, PhD

    LONZA

    Roman Mathaes is Head of Pharmaceutical Services at Lonza DPS. In this role, he is responsible for primary packaging development and testing as well as device testing, tox and technical batch drug product manufacturing and the Lonza DPS lab automation group.

    In his previous role at Lonza DPS, he was a Sr. Group leader in the Analytical Department performing drug product stability studies and leading the Lonza particle core facility.

    Before his assignment Roman, worked within the Roche/Genetech network Basel/San Francisco.

    Roman is a pharmacist by training and holds a PhD in pharmaceutical technology.

    Roman is a adjunct member of the Pharmaceutical Department University Basel and authored 30 research papers in the field of Biotech Drug Product Development.

  • Roger Asselta

    Roger P. Asselta, BS

    Auxilium Packaging Advisors

    Roger has nearly thirty years working in the area field of injectable drug packaging.  He has held management and executive positions in production quality and technical development. He joined Genesis Packaging Technologies in 2006 as Vice President of Technical Affairs and Senior Advisor.  Roger teaches courses on pharmaceutical packaging including courses on pharmaceutical glass quality and vial sealing and integrity. He is the 2017 recipient of the PDA’s Packaging Science Award. He is also a member of the American Society for Quality and American Society for Testing and Materials.  Roger has written and presented on several aspects of pharmaceutical container/closure systems, including glass technology and container closure integrity. Roger has three patents for parenteral packaging systems.  He holds a B.S. in Biology from Maine’s Nasson College and received a graduate certificate in quality management from Pennsylvania State University.

  • Derek Duncan

    Derek I. Duncan, PhD

    Lighthouse Instruments

    Dr. Duncan began his career at the Dutch Institute for Atomic & Molecular Physics. He then moved into industry and has been based at the LIGHTHOUSE office in Amsterdam since 2003, responsible for developing applications for pharmaceutical process monitoring and finished product inspection. A member of PDA since 2004, Dr. Duncan has been a regular contributor to PDA conferences and Interest Groups and was the recipient of the 2015 PDA Europe Service Appreciation Award and the 2020 PDA Edward Smith Packaging Science Award. He holds a degree in Physics and Mathematics from Louisiana State University and a Ph.D. in Atomic & Molecular Physics from the University of Virginia.

  • Robert Guidos

    Robert Guidos, J.D.

    Corning
    Robert (Bob) Guidos, J.D. serves as executive director of pharmaceutical regulatory affairs and strategic alliance for Corning Incorporated where he supports efforts to streamline adoption of Corning’s Valor® Glass pharmaceutical packaging technology, among other things.  As a health policy executive with 25+ years experience with the U.S. Food and Drug Administration (FDA), U.S. Congress and the private sector, Bob has successfully led strategic initiatives by mobilizing multidisciplinary teams of experts in medicine, science, public health, law, regulation, and government and public relations.  Bob joined Corning in 2017 after serving as senior advisor to the director of FDA’s Center for Drug Evaluation and Research (CDER) and as CDER’s associate director for legislative affairs. Bob received his juris doctor degree from the University of Pittsburgh School of Law and bachelors in chemistry and business from Gannon University in Erie, Pennsylvania. 
  • Bram Jongen

    Bram Jongen

    Datwyler

    After his Masters in Polymer Chemistry at the University of Louvain, Belgium, Bram Jongen acquired a Ph.D. in Water Soluble Polymers used for advanced drug administration. Bram started as Technical Support Manager for Datwyler about 14 years ago, supporting customers in a vast area, from Western European countries to countries like India, Korea, and South Africa. Thereafter, he headed the Global Product Introduction & Support team, a global team of highly experienced and educated people, having each their own expertise in the world of pharmaceutical closures. Bram himself acquired profound Extractables & Leachables expertise. His team managed customer projects of technical nature and supported Datwyler’s product and portfolio management. Since end of 2012, he has been acting as Head of R&D, leading a group that focuses on developing new rubber and new coating materials.

  • Philippe Lauwers

    Philippe Lauwers

    Terumo

    Philippe Lauwers has been active in the medical device and pharmaceutical packaging sector for the last ten years with growing responsibilities in business development and technical roles. He is currently Director of Technology and Development at Terumo in Belgium.

    Philippe graduated in Biotechnology from the University in Ghent, Belgium and worked as a scientific researcher at the Catholic University of Leuven.

    Upon obtaining an additional degree in Biomedical Engineering at the Catholic University of Leuven he moved from an academic to an industrial environment.

    Philippe also serves as expert in ISO technical committees TC76 and TC84.

  • Robert Ovadia

    Robert Ovadia

    Gilead

    Robert Ovadia has been with Gilead for over a year and heads the parenteral packaging group. He is responsible for leading the design and selection of parenteral container closure systems, managing extractables and leachables teams, and driving manufacturing readiness at filling sites. Prior to joining Gilead, Robert spent eight years at Genentech specializing in drug product engineering. Robert graduated from the University of California, Davis with a B.S. in Biochemistry and Molecular Biology.

  • Galen Shi

    Galen Shi, PhD

    Eli Lilly and Company

    Dr. Galen Shi has been with Eli Lilly and Company since 2004 and is currently the Leader of Autoinjector Systems Engineering.  He is responsible for the design and integration of primary container closure systems and injection devices.  Galen has over 23 years of experience in the biomedical and pharmaceutical fields.  He held leadership roles (director and group leader) in a variety of areas including formulation development and process engineering for small and large molecule drugs.  His current responsibilities include leading a team on system design and development of prefilled syringes and autoinjectors for delivery of bioproducts. 

  • Folker Steden

    Folker Steden, PhD

    SCHOTT AG

    Folker Steden graduated as a Chemist from the Rheinische Friedrich-Wilhelms University in Bonn, Germany. He completed his PhD doctoral thesis in Inorganic Chemistry at Bonn and New Brunswick, Canada before joining SCHOTT for technical and pharmaceutical tubing applications.

    Since 2012, he has been leading the Product Management Team of the tubing division of SCHOTT. With his excellent scientific background and intercultural skills, he is working between customers and local R&D units, focusing on future customer needs.

    Folker presents frequently in international conferences on subjects related to special glass for technical and pharmaceutical applications.

  • Anniina Kujala

    Anniina Kujala

    UPM Raflatac

    Anniina Kujala is the Pharmaceutical Product Manager in EMEIA for UPM Raflatac and is responsible for the product management of labeling laminates for pharma and healthcare end uses. Before joining UPM Raflatac, Anniina spent several years working for various global packaging companies in pulp, paper, and cardboard industries. Anniina has a master’s degree in Business Administration and graduated with distinction in 2017.

  • Tudor Agape-Comsa

    Tudor Agape-Comsa

    BD

    Tudor is a R&D Engineer with BD since August 2019, working as CIFRE PhD student as part of LAMCOS at INSA Lyon. His work is focused on understanding the scientific fundamentals of the lubricated rubber-glass contact and applying his skills to modeling this contact as found in BD’s pre-filled syringes.

    Tudor holds a MEng degree from Imperial College London in Aeronautics, with his Master thesis on turbulent fluid phenomena. He is passionate about bridging different scientific domains, therefore joining BD to work on new applications.

  • Lottie Andersson

    Lottie Andersson

    UPM

    Lottie Andersson is Business Development Manager at UPM Raflatac for the Pharmaceutical & Healthcare labelling end-use segment. Lottie has worked in the labelling industry for the majority of her career holding various positions. She focuses on developing and establishing partnerships, collaboration, and business opportunities for sustainable labelling solutions specifically pre-tested for the versatile parenteral packaging types and application requirements.

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    Ugljesa Babic

    SCHOTT

    Ugljesa Babic is Junior Project Manager and former Product Engineer at SCHOTT AG, working on glass syringes topic with a strong focus on siliconization. Previous work experience as an R&D associate in polymer membrane engineering for automotive applications and diagnostic solutions in fuel cell development. He holds a bachelors degree in mechanical engineering, masters degree in power engineering and a doctorate in electrochemistry from ETHZ.

  • Guido Dietrich

    Guido Dietrich

    CEPI

    Dr. Guido Dietrich is a microbiologist and performed his studies at the University of Würzburg, Germany. Dr. Dietrich has more than 20 years of Experience in the Pharmaceutical, Biopharmaceutical and Vaccine Industry at Companies like GlaxoSmithKline, Novartis, Merck Sharp & Dohme and Lonza in a variety of Senior Management roles: Quality, Manufacturing, Engineering, R&D and Site Head.
    Dr. Dietrich is currently supporting the Coalition for Epidemic Preparedness Innovations (CEPI) and the Bill & Melinda Gates Foundation (BMGF) in setting up manufacturing solutions for Vaccines and Therapeutics against COVID-19.

  • Liang Fang

    Liang Fang, PhD

    West Pharmaceuticals, Inc.

    Dr. Liang Fang earned his B.S degree in Chemistry from Peking University in the year of 1997. He earned his Ph.D. degree in the field of Materials Chemistry from University of Wisconsin at Madison in 2003. After working for two years as in the field of Nano-mechanics and Nano-electronics at Lawrence Berkeley National Lab, Dr. Fang joined Arkema Inc. in 2005 first as a Material Scientist focused on surface analysis of semiconductors and polymeric materials, and later worked as a Research Scientist focused on fluoropolymer based materials, films and coatings. Dr. Fang joined West Pharmaceutical Services in 2015 as a Senior Research Scientist and since then focused his research on Parenteral Packaging materials and drug delivering devices/components, and their interfacial interaction with Biologics. He was then promoted to Principal Research Scientist position at the same company in Feb 2017. Dr. Fang has first-authored peer reviewed and highly-referred articles in well-known scientific journals such as Surface Science, Langmuir, The Journal of Chemical Physics, and Journal of Pharmaceutical Sciences. Dr. Fang has also given numerous scientific presentations at national meetings such as MRS, ACS and APS national meetings. Dr. Fang was also an invited speaker at 244th American Chemical Society National Meeting.

  • Ryan Forrey

    Ryan Forrey

    BD

    Ryan A. Forrey is currently Associate Director, Market Development and Training for the hazardous drug solutions platform at Becton Dickinson and Company (BD). Previously, he was Director of Pharmacy at Emory University Hospital Midtown in Atlanta where he was responsible for the distributive and clinical operations for the inpatient facility as well as the Winship Cancer Institute infusion center pharmacies.  He served on the 2015-2020 cycle of the United States Pharmacopeial Convention (USP) Compounding Expert Committee, the group charged with creating compounding standards for sterile, nonsterile, and hazardous drugs.  In his role at BD, he is a member of the Spanish Association for Standardization (UNE) closed system technical standardization committee, and the Product Quality Research Institute vial transfer device working group.  Earlier in his career, he served in a leadership role as Associate Director of Pharmacy at The Ohio State University James Cancer Hospital in Columbus, Ohio, where he oversaw design and construction of new and highly automated cancer hospital inpatient pharmacy as well as several outpatient infusion center pharmacies. 

    He received his Doctor of Pharmacy from the University of Arizona, and MS in Health-System Pharmacy Administration from The Ohio State University and completed a combined PGY1/PGY2 Residency in Health-System Pharmacy Administration from The Ohio State University Wexner Medical Center.  He was awarded the status of Fellow of the American Society of Health-System Pharmacists in 2014 and achieved Board Certification in Sterile Compounding in 2019. He provides graduate course lectures at The Ohio State University College of Pharmacy on the topics of pharmacy management and sterile compounding facility design.   He is a prolific speaker on the topics of sterile compounding facility design, USP Chapter <797>, USP Chapter <800>, and oncology pharmacy operations.

  • Alicia Gallagher

    Alicia Gallagher

    Corning Incorporated

    Alicia Gallagher, Product Development Scientist in Corning Pharmaceutical Technologies, has 10 years’ experience in glass mechanical reliability. Alicia joined Corning in 2011 and has worked in both research and development. Alicia is a subject matter expert in fractography. Alicia holds a bachelor’s degree in Biology from Houghton College.

  • Silvia Gallina

    Silvia Gallina

    Stevanato Group

    Silvia Gallina is currently part of Product Management team for syringe platform at Stevanato Group. After her master’s degree in Pharmaceutical Chemistry and Technology from University of Padova (Italy), she joined Stevanato Group in 2018 as Technical and Quality support Specialist. She managed relation with Key Accounts from different market areas, building a deep knowledge of pharmaceutical industry needs and expectations.

  • Sebastian Gerner

    Sebastian Gerner

    Ypsomed AG

    Sebastian Gerner is President of the Alliance to Zero, and Innovation & Business  Development Manager with Ypsomed Delivery Systems. He is driving the  transition of Ypsomed from a linear take – make – waste economy towards a  circular economy. Mr Gerner is a mechanical engineer with more than 10 years of medical device experience in various medical and pharmaceutical companies.

  • Jack Gill

    Jack Gill

    Pfizer

    Jack started his career in US Navy as a Nuclear Operator on Board submarines. He obtained his Bachelor of Science Degree in Mechanical Engineering from the University of Illinois at Chicago and has worked as a Nuclear Plant design engineer for five years. Thereafter Jack began 25 years working at multiple Pharma and Medical Device manufacturers and obtained his Masters of Business Administration from the University of Illinois. For the last 8 years, he has been with initially Hospira which was purchased five years ago by Pfizer. He spent his time in Supplier Quality Roles. He is also currently Co-Chair of the PDA TR43 Revision Task Force.

  • Rainer Gl&#246;ckler

    Rainer Glöckler

    Swissfillon - a Ten23 Health Company

    Rainer Glöckler is currently Head of New Technologies and member of the executive team at Swissfillon AG, a wholly-owned subsidiary of Ten23 Health.
    He is responsible to facilitate and ensure process fit and manufacturability for production of the swissfillon facility, Visp.
    His responsibilities also include building new filling modules in Visp. Rainer was previously CTO and Head of Production at Swissfillon AG.
    After completing his studies in biotechnology, he held various positions at Lonza AG, including Plant manager large scale. Rainer has more than 20 years’ experience in Pharma.

  • Anja Gottschalk

    Anja Gottschalk

    Borealis

    Anja Gottschalk joined Borealis in June 2016 as Application Development Engineer Healthcare, responsible for the European and Asian market. She already has more than 20 years of experience in the plastics industry in application development, technical service and material management in Automotive, Packaging and Healthcare based on her degree in plastics engineering. She is based in her home office near Frankfurt, Germany.

  • Ulla Grauschopf

    Ulla Grauschopf, PhD

    F. Hoffmann-La Roche Ltd

    Ulla Grauschopf is a biochemist by education and joined the pharmaceutical industry 15 years ago after a few years performing basic research at the Swiss Federal Institute of Technology, ETH Zurich. She spent over 10 years in Pharmaceutical Development before she took over a leadership role in Device Development Roche. Since 2019 she has headed both Device and Packaging Development at Roche Pharma in Basel. Dr. Grauschopf has a strong track record of leading cross-functional and global teams with extensive experience at the interfaces between early stage research, technical development, and commercial manufacturing. She has an excellent scientific background in biophysical protein characterization and drug product sciences with peer-reviewed publications and patents.

  • Arne Kloke

    Arne Kloke, PhD

    SCHOTT

    Arne Kloke is a Committee Member of the Alliance to Zero and Manager for Strategic Innovation at SCHOTT Pharmaceutical Systems. Within both organization, he is working towards service models enabling a simultaneous match of environmental responsibility and financial viability. He is a scientist by training and well experienced in realizing new primary packaging and processing solutions with partners throughout the injectables industry.

  • Diana L&#246;ber

    Diana Loeber

    SCHOTT

    Diana started her career in the medical device industry prior she joined SCHOTT in Summer 2018. In her role as Global Product Manager for bulk vials, she is responsible for the product strategy, including the identification of new market opportunities and the development and launch of innovative products.

  • Martin Mueri

    Martin Mueri

    Roche

    Martin Müri is a Principal Device Engineer with 16 years of experience in the pharmaceutical and medical device industry. Currently he co-leads the Smart Device and Packaging Technology Center at Roche with the goal to develop connected device and packaging solutions to improve patient experience and creating new value for clinical and commercial teams. In parallel, he is a device team leader for molecule projects. Martin has been deeply involved in many auto injector and patch pump projects, and has led the development and commercialization of related training devices.

    Prior working at Roche Pharma, Martin was a Device Engineer at Roche Diabetes Care. He was part of the development team of the Accu-Check Insight insulin pump and was involved in development projects for infusion sets and devices for continuous glucose monitoring.

  • Sven Pohle

    Sven Pohle, PhD

    SCHOTT

    Sven Pohle is Global Product Management for Glass Prefilled Syringes at SCHOTT Pharmaceutical Systems, where he is responsible for portfolio management and launching product innovations. Prior to that, Sven worked for over ten years in various R&D positions in dental industry. He holds a PhD in Polymer Chemistry from Technical University of Braunschweig, Germany.

  • Marco Povolo

    Marco Povolo, PhD

    Stevanato Group

    Marco Povolo is currently part of the SG Lab Analytics team at Stevanato Group.

    He obtained a Master’s degree in Mechanical Engineering and a Ph.D. in Mechanics and Advanced Engineering Sciences at the University of Bologna (Italy).

    He joined Stevanato Group as Senior Research Analyst in SG Lab Analytics after years of experience in the research field and publications. He specializes in the characterization of the mechanical, physical, and functional performances of container closure systems and drug delivery devices.

  • Coralie Richard

    Coralie A. Richard, PhD

    Eli Lilly and Company

    Coralie Richard is the Director of Packaging Systems in Delivery and Device Connected Solutions at Eli Lilly and Company, Indianapolis, U.S.

    A native from France, she came to the U.S. to pursue her PhD in Organic Chemistry at the Georgia Institute of Technology. After working as a R&D scientist in a material company, she joined the primary packaging system team at Eli Lilly, supporting container closure systems development activities and container related research projects. Her contributions were recognized with two Eli Lilly Top 100 Innovator Awards. In her current role she provides technical and organizational leadership in the areas of primary packaging/container closure development, secondary packaging, shipping and distribution, surface science, and several related DDCS laboratories. Her global team support clinical and commercial development activities across all business units.