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Committee & Speaker Biographies

Committee & Speaker Biographies

2019 PDA Europe Parenteral Packaging

19-20 March 2019, Venice, Italy

  • Roger Asselta

    Roger P. Asselta, BS

    Genesis Packaging Technologies

    Roger has nearly thirty years working in the area field of injectable drug packaging.  He has held managenment 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. 

  • Daniela P. Boso

    Daniela P. Boso, PhD

    University of Padova
    Daniela P. Boso, is Associate Professor of Mechanics of Solids and Structures at the Department of Civil, Environmental and Architectural Engineering of the University of Padova. She is member of the Scientific and Internationalization Committee of the Department, faculty member of the Ph.D. School in Civil and Environmental Engineering Sciences of University of Padova and elected member of the Academic Scientific Committee for Structural, Transportation and Geotechnical Engineering Area.
    Her research interests are homogenisation of non-linear composites, contact mechanics in coupled thermo-electromechanical field, fracture mechanics, artificial neural networks (ANNs) in hierarchical modeling, ANNs models for parameter identification and medical application of multifunctional nano-particles for biomedical imaging and therapy, multiphase porous media modeling applied to tumor growth, diabetic foot and bioinspired scaffolds. Daniela P. Boso serves in the editorial board of Mathematical Problems in Engineering, is reviewer for several ISI journals and is author of more than 160 scientific publications in international journals, books and conference proceedings.
    Daniela holds a degree "magna cum laude" in Civil Engineering from Padova University and a Ph.D. in Structural Mechanics from Bologna University.
  • Anthony Bucci

    Anthony Bucci, PhD

    West
    Anthony Bucci received his BS in Chemical Engineering from Manhattan College, and then pursued his Ph.D. in Chemical Engineering from Drexel University. His thesis work focused on elucidating and characterizing small gas molecule transport pathways in proteins using molecular dynamics simulations and high-performance computing. After graduating, he worked for the United States Department of Agriculture as a Research Chemical Engineer, investigating and simulating novel processing methods for bovine milk. Anthony joined West Pharmaceutical Services and the Scientific Insights Lab in 2018 as a Senior Research Engineer, focusing on big data applications in pharma.
  • Soren Dahl

    Søren Dahl , PhD

    Novo Nordisk A/S
    Søren Dahl currently serves as a specialist within Filling and Isolator Technology and process and production support in Novo Nordisk. Søren has 20 years experience with the Pharmaceutical and Vaccine Industry covering all the steps in production. A part of this experience has been gained through engineering projects for full facilities.
    His current responsibilities also covers development of CCI methods, validation and strategy within Novo Nordisk Product Segments.
    He received his Ph.D in Thermodynamic Modelling at the Technical University of Denmark.
    Prior to his employment at Novo Nordisk he worked within process development and project management in the company FLSmidth.
  • Timothy Dutill

    Timothy Dutill

    Lyophilization Technology
    Tim has been a part of Lyophilization Technology since January 2011.  He is involved in managing client projects including product and process development, clinical manufacturing, validation, and troubleshooting.  Focused activities include lyophilization process improvements and technology transfer as well as understanding the control of heat transfer inside the lyophilizer through shelf temperature mapping and sublimation studies.  More recently he has undertaken various studies to evaluate the preparation of pre-filled syringes and cartridges with lyophilized products.  His career began in 2006 in the vaccine field as a Product Development Scientist at the Infectious Disease Research Institute.  Tim’s educational background consists of a B.S. in Chemical Engineering from Pennsylvania State University.  He has been published in the Journal of Colloids and Surfaces B: Biointerfaces, Pharmaceutical Development and Technology and Biopharm International.  His professional memberships include the International Society of Lyophilization - Freeze-Drying (ISL-FD), International Society of Pharmaceutical Engineers (ISPE), and the Parenteral Drug Association (PDA).
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    Yonghua Gao

    CNPPA
    YongHua Gao is Deputy Secretary-General at the China National Pharmaceutical Packaging Association. Graduated from West China Medical University, pharmacy chemistry is the major profession. 8 years work experience of pharmaceutical research, producing, and quality management in pharmaceutical factory. Since 2002, working in China National Pharmaceutical Packaging Association, responsible for the technology and research project on Pharmaceutical Packaging. 
  • Silvio Gianoli

    Silvio Gianoli, PhD

    Sealed Air Corporation
    Dr. Silvio Gianoli is a Principal Application Expert with Sealed Air at the European Innovation and Development Center located in Passirana di Rho, Italy.  His current role within the I&D organization is Technical Support for the European market and this includes non-PVC IV films development and market introduction within the Medical Applications business unit.  Other job experiences during his nearly 20-year career with Sealed Air R&D have included development of materials for new markets for Sealed Air (Medical packaging films, IV Ports, Films for ostomy bags) development of new test methods, and many product development initiatives related to Medical and Pharmaceutical packaging and films for new applications. Dr. Gianoli received a Degree in Food Science and Technology specialized in Packaging Materials from the Università degli Studi of Milan.
  • Massimo Guglielmi

    Massimo Guglielmi, Prof.

    University of Padova
    Massimo holds a degree in Chemical Engineering from the University of Padova.  Since 2000 Massimo is a Professor of Materials Science and Technology.  His teaching activity focuses on the fields of Materials Science and Engineering of Ceramics. He has been a member of the Academic Senate of the University of Padova and is currently Head of the Department of Industrial Engineering at University of Padova. Massimo is also Chairman of the Technical Committee 12 “Pharma Packaging” of the International Commission on Glass. His main topics of research have been surface phenomena in glasses due to chemically or physically induced modifications; synthesis of glasses and ceramics by chemical routes through sol-gel method, their characterization and application; deposition of thin inorganic coatings by the sol-gel method, their characterization and application. The research activity of the last years was aimed to exploit the possibility to apply the sol-gel techniques to the synthesis of nanocomposite and nanostructured materials.
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    Jonas Olsen Hede

    Novo Nordisk A/S
    Jonas holds a bachelors degree in Chemical Engineering and he is currently enrolled in the masters program for Chemical and Biochemical Engineering at the Technical University of Denmark.(DTU) 
    He has been working as a student assistant at Novo Nordisk A/S for 2.5 years. He has been a part of the CCIT (Container Closure Integrity Testing) development as part of his studies, in a cooperation between Novo Nordisk A/S and DTU. 
     
  • Kyle Hoff

    Kyle Hoff

    Corning

    Kyle is the applications engineering manager for glass parenteral packaging in the Pharmaceutical Technologies division of Corning Incorporated. Prior to this role, he spent nearly 7 years as a researcher in the Corning’s materials reliability group, specializing in characterizing glass performance. Hoff has led work to develop test methods for porous microcracked honeycomb ceramics, advance understanding of glass damage introduction mechanism, refine fatigue failure risk calculations for glass sheets, and generate technical marketing data to support the early development stages of the business. Prior to Corning, he was the project manager and principle investigator for material and product development of low-cost body and transparent armor solutions. Hoff holds both a B.S. and M.S. in ceramic science and engineering from the Pennsylvania State University. 

  • Robert Hormes

    Robert Hormes, PhD

    Novartis Pharma
    Robert is the Group Head Packaging Technology in Device Development and Commercialization at Novartis Pharma. He holds a degree in biochemistry from the University Bayreuth and a Ph.D. from the University Heidelberg, where he graduated in 1998. He joined Novartis in Basel in 2016. Before he worked with SCHOTT Pharmaceutical Packaging where he served in several leading functions in Product Management, Product Development for sterile primary packaging products and global Technical Customer Support. He has 18 years of experience in packaging products and devices for pharmaceutical and biotech applications.
  • Ronald Iacocca

    Ronald Iacocca, PhD

    Eli Lilly and Company

    Ronald received his B. S., M.S. and Ph.D. in Materials Engineering from Rensselaer Polytechnic Institute (RPI). For nine years prior to joining Lilly, he was a faculty member in the Department of Engineering Science and Mechanics at The Pennsylvania State University. Currently, as the senior-most technical engineer in Lilly, he manages projects ranging from packaging and device development to packaging/drug interactions. He has authored/co-authored over 70 journal articles, book chapters, and review articles, and has been granted 4 patents. In 2005, he was selected as one of ninety world-wide experts by the Bill and Melinda Gates Foundation to participate in the road-mapping initiative for the development of a world-wide malaria vaccine. Dr. Iacocca also served as an adjunct professor in the Department of Industrial and Physical Pharmacy at Purdue University from 2006-2009, and is a reviewer for a number of scientific journals. From 2010-2015, he was elected to the USP to serve on the Physical Analysis Expert Committee.

  • 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.

  • 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.
  • Yusuf Oni

    Yusuf Oni, PhD

    Bristol-Myers Squibb
    Dr. Yusuf Oni is a Principal Engineer at Bristol-Myers Squibb Company where he is involved in all aspects of primary packaging & device development in the parenteral product development space. Prior to joining BMS, Yusuf was a Senior Engineer with the Materials Science and Technology group at BD Medical. There, he led the design and development of material solutions for various medical products and packaging applications. Yusuf is also involved in academic instruction. He was a visiting professor at the African University of Science and Technology (Nigeria) and the University of New Haven. He currently serves as an Adjunct Faculty in the Biomedical Engineering department at New Jersey Institute of Technology. Yusuf received his Bachelors of Science degree in Chemical Engineering from New Mexico Institute of Mining and Technology and a PhD in Mechanical and Aerospace Engineering (with a concentration in Materials Science) from Princeton University.
  • Elizabeth Pavlik

    Elizabeth Pavlik, PhD

    MSD
    Dr. Pavlik, who goes by Jane, is Director Engineering at Merck & Co, Inc.  She has been with Merck since 2016, and works on drug product process design & development projects, new product introductions and development strategies for Biologics and Vaccines.  Previously Dr. Pavlik spent 14 years at Amgen in a similar role.  She earned her PhD in Molecular Genetics and Microbiology, from Rutgers University in New Brunswick, New Jersey, USA.
  • Volker Rupertus

    Volker Rupertus, Prof. Dr. rer. nat.

    SCHOTT

    Volker Rupertus is active as Senior Principal Expert at the Business Unit Pharmaceutical Systems of the SCHOTT AG, Mainz, Germany.

    He began his industrial career in 1995 joining the R&D department of SCHOTT. From 2000 to 2010 he headed the R&D-division “Process Development & Characterization” serving all Business Units of SCHOTT.

    In 2010, he joined the Pharmaceutical Systems business unit as head of global quality. Rupertus, who graduated from the University of Kaiserslautern with a degree in technical physics and a PhD in glass surface science, frequently gives lectures in materials analysis and was made a honorary professor by the Technical University of Clausthal.

  • Rahul Thakar

    Rahul Thakar, PhD

    Datwyler
    Rahul Thakar is a Technical Key Account Manager with Datwyler and has over 10 years of product development experience in pharmaceutical and chemical sciences. In his current role, Rahul consults with pharmaceutical and medical device companies on parenteral packaging solutions to develop safe and efficacious drug-delivery systems. He holds global responsibility for several key clients, where he is responsible for technical projects from the ideation to the commercialization stage. Within Datwyler, he is also leading strategic collaborations with external partners for product portfolio expansion and product innovation. Rahul was awarded his Ph.D. degree in Material Science and Analytical Chemistry from Indiana University, Bloomington where his graduate research was focused on design and microfabrication of bioanalytical devices for electroanalytical measurements.
  • Fabian Thygs

    Fabian Thygs, PhD

    Janssen J&J
    Fabian Thygs holds a Diplom degree (Dipl.-Ing.) in Biochemical Engineering from TU Dortmund University in Germany and obtained his PhD at the Laboratory of Plant and Process Design. Since middle of 2016, he is operational at Janssen R&D and currently works as a Manufacturing Science and Technology (MST) Scientist in the Clinical Supply Chain, where he leads continuous improvement (CI) and technology projects as well as functions as a Product Owner for liquid products in the Fill Finish Pilot Plant (F2P2), DPDS Schaffhausen. His responsibilities extend from the introduction of new equipment and technology tools, to the product/process/technology support and ownership in the parenteral production plant.
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    Susumu Uchiyama, Prof.

    Osaka University
    Susumu Uchiyama has been studying solution properties and structures of proteins for 20 years using various biophysical methods such as analytical ultracentrifugation and mass spectrometry. Factors that govern biophysical properties have been revealed based on the results from these methods. So far, he has more than 150 publications in international journals. Recent scope of his study focuses on the rational formulation developments of therapeutic proteins and quantitative analysis of protein aggregates. Especially how materials of container closure system affect stabilities of antibody dugs is one of his recent research interests.
  • Anthony Vico

    Anthony Vico

    OMPI - Stevanato Group
    Anthony Vico is with US Customer Technical Service at Ompi of America, Stevanato Group. He moved to the U.S. to support SG Ompi’s growth in glass primary packaging. In his previous role, he had been working for five years as the Technical & Quality Assurance Front End team at SG Ompi in Italy. He gained an abundance of experience in glass container technology for pharmaceutical use, supporting design, development, and manufacturing of ready-to-fill glass containers (syringes, cartridges, vials, special containers). He is an expert on technical and quality support (including regulatory and compliance) to pharmaceutical companies from early-stage development to life-cycle management, dealing with parenteral medicines in drug delivery systems based on pre-filled glass containers. He received both his M.S. in mechanical engineering, thermodynamics and heat transfer, Cum Laude, in 2011 and his B.S. in mechanical engineering, Cum Laude, in 2009 from the University of Padua, Italy.
  • Daniel Wagner

    Daniel Wagner, PhD

    Sanofi

    Daniel is a Pharmacist by training and Head of Packaging & Process Optimization for Sanofi's Pharmaceutical Sciences Operations unit (PSO) in Frankfurt, Germany.

    He has contributed to numerous patent applications in the field of injectables and injection devices and has been a committee member and speaker for PDA Europe's conferences for several years.

  • Klaus Wuchner

    Klaus Wuchner, PhD

    Janssen J&J
    Klaus Wuchner is leading a small team of specialists responsible for particle characterization and container closure integrity testing within the global Pharmaceutical Development and Manufacturing Sciences organization at Janssen R&D, Schaffhausen, Switzerland. The analytical development organization provides highly specialized and unique support mainly for sterile biological products from early clinical phases to marketed finished products. Klaus has over 15 years’ experience in the pharmaceutical industry and worked on various products from small molecule APIs to finished biotech products. Prior to joining the pharmaceutical world, he headed the organic residue analysis department in a water laboratory in France. He holds a Ph.D in Analytical Chemistry of the “Institut National Polytechnique of Toulouse”, France
  • Martin Zueger

    Martin Zueger, Dipl. Ing.

    pinPlus ag
    Martin is CEO of the engineering service pinPlus ag, which he founded in 2004. He is a Structural analyst, often working on nonlinear analysis with different material models for
    pharmaceutical, medical, consumer or automotive industry, such as rubber, TPE, silicone, general thermoplasts, reinforced plastics with consideration of anisotropic mechanical properties due to glass fibers. From 1995 – 2004 Martin was professor for strength of materials and finite element simulation at the University of applied science in Bern and analyst and project leader for engineering and consulting projects of Intec (Technology Institute of the University of applied science, Bern)