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Committee & Speaker Biographies

Committee & Speaker Biographies

2019 The Universe of Pre-filled Syringes & Injection Devices

22-23 October 2019, Gothenburg/Sweden

  • Mathias Romacker

    Mathias Romacker

    Pfizer

    Mathias Romacker is Senior Director, Device Strategy at Pfizer HQ in New York City. He joined Pfizer in March 2015.

    In this commercial role, he focuses on the front end of device technology. He works with multiple functions and sites across the organization to develop a device strategy for Pfizer pipeline and inline products.

    Previously, for a duration of 9 years, Mathias worked in the device area for Amgen in Thousand Oaks, California. Before joining Amgen, he held multiple sales and marketing positions with Becton Dickinson and Gerresheimer in Germany, South Africa, and New Jersey. Mathias holds a Masters equivalent degree in economics from the University of Freiburg/Germany.

  • Schoenknecht_Thomas

    Thomas P. Schönknecht, PhD

    LONZA

    Thomas Schoenknecht has over 20 years’ experience in the pharmaceutical industry in various leading roles such as project management, research & development and business development. Before joining LONZA in 2019 as Head of Research and Development of DrugProductServices, Thomas has been with SHL since 2013 as an Executive

    Director of Business Development, responsible for global Business Development, Key Account Management and new Technology Evaluation, Thomas has gained experience in various leading positions in product and business development at Schott Pharmaceutical Packing Division, Amgen Inc California and Gerresheimer’s Pharmaceutical Packing Division.

    Thomas has a Ph.D. in Biophysical Chemistry from the Max-Planck-Society and the University Goettingen, Germany and a Master’s degree in Chemistry from the University Goettingen.

  • Frank Bamberg

    Frank Bamberg, MBA

    CSL Behring

    Frank Bamberg has close to 20 years’ experience in the pharmaceutical industry in various leading roles such as in research & development, business development, and project management.

    Before joining CSL Behring in Bern CH as Associate Director for Medical Device and Primary Packaging, Frank has been with Hoffmann-La Roche since 2011 as Section Head Pre-Fillable Syringe responsible for the development of primary packaging and devices which will be in contact with the drug.

    Frank has gained experience in various positions at SCHOTT Pharmaceutical Packaging. He was also leading the global business development & customer service for Pre-Fillable Syringes.

    Frank holds an MBA in Industrial Engineering and Management from the University of Bern/Zürich and he is Plastics Engineer by training.

  • Theresa Bankston

    Theresa Bankston, PhD

    Becton Dickinson

    Theresa Bankston leads the WW Technical Services group for BD Medical – Pharmaceutical Systems that is responsible for providing technical support, solutions, and services around delivery systems for injectable drug therapies.

    She has over 20 years of combined experience in the pharmaceutical and medical device industries. Her areas of expertise include process chemistry and engineering development, analytical method development, and drug-container integration science.

    Theresa received her BS in Biochemistry from Florida State University and her doctorate in Chemical Engineering from the University of Virginia.

  • Markus Bauss

    Markus Bauss

    SHL Group
    Markus has over 10 years' experience in the area of pharmaceutical packaging in various leading roles such as global key account management, research & innovation and business development. Looking at upcoming new technologies such as smart phones, mobile apps and connectivity, Markus started his technology Start-Up company ConnectMeSmart GmbH in 2013. In 2015, SHL Group and ConnectMeSmart partnered up in the Joint Venture SHL Connect to investigate the market for connectivity, emerging technologies and explore their potential application within each of SHL Group’s companies. From 2004 to 2014, Markus was working for Schreiner MediPharm, a leading supplier of advanced labeling solutions. Working in the U.S. and Europe, Markus contributed with innovative products, such as Needle-Trap, a label integrated needle stick prevention solution. Markus studied process engineering at the Technical University of Clausthal and started his career in environmental & recycling technology at RWE in Germany in 1997, prior to moving to the pharmaceutical area.
  • Sherri Biondi, PhD

    AstraZeneca
    Prior to joining Medimmune/AstraZeneca, Sherri was an Associate Director in Device Development at Genentech and manages human factors activities for combination product development. In addition, Sherri has gained experience in development of inhalation products.
  • William Dierick

    William Dierick

    Terumo
    With extensive experience in the Medical and Pharma sector for more than 35 years, Mr. Dierick has held various positions in Terumo, covering quality assurance, manufacturing, product development & engineering, project management, marketing, corporate planning and business development. Mr. Dierick serves as expert of ISO/TC76, expert and convenor for ISO/TC84 and is an active member of Eucomed and volunteer of PDA
  • Olivia Henderson

    Olivia A. Henderson, PhD

    Amgen Inc.

    Dr. Olivia A. Henderson works in the Mechanical Engineering Methods Department at Amgen in Thousand Oaks, California, where she leads a group to qualify, validate, and transfer physical methods for combination products. Prior to joining Amgen, Olivia worked at Biogen for 13 years and has extensive experience in CCI, extractables/leachables, single use systems, parenteral filling operations, and contract manufacturing/analysis. Olivia earned a BS in Chemistry from Truman State University, and MS and PhD degrees in Pharmaceutical Science from the University of Missouri-Kansas City. Olivia is an active member of Parenteral Drug Association; she is the Pre-filled Syringes Interest Group Leader for North America and a member of the Biopharmaceutical Advisory Board.

  • Laurent Jeanmart

    Laurent Jeanmart, PhD

    GSK Vaccines

    Laurent Jeanmart is head of Primary packaging and medical devices at GlaxoSmithKline Vaccine worldwide. He has more than 15 years of experience in the chemical and pharmaceutical sectors and worked for different companies. He has managed life cycle activities such as qualification, validation and implementation of elastomeric compounds (stoppers,…), new containers like vials, syringes, LDPE tube but also single use systems (bags,..).

    He has performed several studies about the compatibility between primary packaging and vaccines and also led life cycle development of secondary packaging items.

    Laurent is Chemical Engineer and graduated from Louvain-La-Neuve University (UCL Belgium) specialized in Polymer Science. He also has a PhD in Material Sciences based on glass surface treatments. He’s member of pharmaceutical associations and writer of scientific articles and patents.

  • 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.

  • Manfred Maeder

    Manfred Maeder, PhD

    Novartis Pharma AG

    Manfred Mäder is Head of BTDM (Biologics Technical Development and Manufacturing) for Devices & Combination Products, Development and Commercialization since October 2015. Prior to this, he held the position Head of Global Compliance & Audit for Devices & Combination Products overseeing all Alcon, Pharma, and Sandoz sites producing this type of products and Global QA Head of Technical Research and Development at Novartis Pharma starting in February 2011.

    Prior to this position, he was Senior VP of Quality Management & Regulatory Affairs, at Ypsomed, a company producing Medical Devices and Combination Products starting in 2007. Previously, he was responsible for Quality Assurance Management at Sanofi-Aventis for the Frankfurt Injectables site. Before then, based in Kansas City/ US, he had a global responsibility for Quality and Regulatory for one of the Aventis Blockbuster products. Prior to that, he held several positions in QA and QC.

    By training, he is pharmacist and holds a doctorate in pharmaceutical analytics and statistics by the University of Wuerzburg/ Germany.

  • Hanns-Christian Mahler

    Hanns-Christian Mahler, PhD

    Lonza AG
    Since September 2015, Dr. Mahler has been leading the product development organization at Lonza AG. Prior this position, he led the department Pharmaceutical Development & Supplies, Biologics EU at Roche, Basel, Switzerland from 2010 to 2015 and as Head of Formulation R&D Biologics, Roche, Basel, from 2005 to 2010. From 2000-2005, Dr. Mahler was working at Merck KGaA, Darmstadt, Germany as Principal Formulation Scientist, Lab Manager for Protein Formulation Development and Clinical Trial Manufacturing and CMC Team leader for Erbitux during its submission and launch phase. Dr. Mahler studied Pharmacy at the University of Mainz, Germany, holds in Ph.D. in Toxicology from the Institute of Pharmacy, University of Mainz and Pharmacist specialization degrees in Toxicology & Ecology and Pharmaceutical Technology. He was further trained in Economy and Marketing. Dr. Mahler obtained his venia legendi (German Habilitation) from the University of Frankfurt/Germany in 2010 and is adjunct faculty and lecturer at the universities of Frankfurt (Germany), Kansas (Lawrence, US) and Basel (Switzerland). He was elected an AAPS Fellow in November 2013. His work experience includes early- and late-stage/commercial and line extension formulation development, primary packaging and device development, drug delivery, Drug Product process development, process characterization and validation, transfer to clinical and commercial drug product production and production support and preclinical and clinical (phase 1-3) Drug Product GMP manufacturing of parenteral dosage forms of biologics, small molecules, peptides and oligonucleotides.
  • Brigitte Reutter-Haerle

    Brigitte Reutter-Haerle

    Vetter Pharma International GmbH

    Brigitte Reutter-Haerle is the Vice President of Marketing / Corporate Communications for Vetter, a leading contract development and manufacturing organization that serves the global pharma/biotech industry. She was called to this new position in September 2014 and is responsible for the company’s international marketing activities, product and service management as well as HR marketing and internal communication. Between 2004 and 2014, she obtained the position of Director Corporate Marketing. In 2009, she led the communications program for Vetter’s U.S. expansion. Ms. Reutter-Haerle joined Vetter in 1996, serving in the company’s sales and marketing function, and transferred to corporate marketing three years later. She began her career in 1983, holding various positions in the sales organizations of firms including Hilton International and TNT Express Worldwide. Ms. Reutter-Haerle earned a B.A. and a degree in Business Administration from Baden-Wuerttemberg Cooperative State University. She has been leading the Prefilled Syringe Interest Group/Europe of the Parenteral Drug Association since 2007.

  • Thomas Seiffer

    Thomas Seiffer, Dipl. Ing.

    Bausch & Ströbel

    In his function as industrial electronic engineer, Thomas Seiffer gained extensive experience in the field of machine and line qualification when he was working in the qualification department of Bausch+Ströbel from 1995 - 2001.

    From 2001 – 2004, he broadened his knowledge by completing academic studies in mechatronics. As “Diplom-Ingenieur” (German university engineering degree), he took over the research and technology department in 2004.

    In his role as Technology Manager, Thomas Seiffer has made significant contributions to the integration of new technologies into Bausch+Ströbel equipment.

    When it comes to Pharma Services, he as head of the Bausch+Ströbel lab has intensively dealt with dosing systems for pharmaceutical products during trials with and for customers over many years, achieving great success in this field.

  • Ian Thompson

    Ian Thompson

    Ypsomed AG
    Ian Thompson has been with Ypsomed AG since 1995 in a number of roles in key account management and business development working with pharma companies to develop and bring to market innovative self-injection systems. He studied biochemistry and biotechnology in the UK from 1979-1983, working initially in commercial roles for fermentation technology. He has worked in medical device companies since moving to Switzerland in 1990. Since 2003 his main focus has been business development and new product innovation leading to the development and launch of a range of new pen and autoinjector custom products for Ypsomed Delivery Systems.
  • Karthik Vaideeswaran

    Karthik Vaideeswaran, PhD

    Eli Lilly and Company

    Dr. Karthik Vaideeswaran leads the integrated Surface/Polymer Science, Packaging Systems, Materials Engineering and Performance Testing groups focused on primary containers innovation as well as materials engineering and test methods development for combination-product delivery system development and commercialization.

    Dr. Vaideeswaran earned his Ph.D. in Polymer Science and Engineering from the University of Connecticut in 1997 and completed his post-doctoral fellowship in Surface Science at the University of Cincinnati in 1998. Additionally, Karthik earned an MBA from the University of Kentucky in 2004.

    Karthik has gained significant industrial experience of 20+ years in the areas of polymer engineering and advanced materials technologies while working at Lexmark International, Saint-Gobain Corporation, Celanese Corporation and now, Eli Lilly and Company; in diverse roles encompassing increasing technical and people responsibilities.

  • Johan Ahstrom

    Johan Ahstrom

    Patient Speaker

    I have had Diabetes Mellitus since I was 25 years old (now 59).

    I have used an insulin pump for 9 years, utilising all functions, including carb-calculations, also carrying a Freestyle Libre for 5 years.

    Before, that I followed an five dose insulin pen regime. I have a solid history of excellent test results and no complications so far.

    My lifestyle is very active both work-wise and private. We raised three kids, travelled the world for work over time zones and I have been fly fishing in remote parts of the wilderness without roads or cell-phone cover, all without any difficulties.

  • John Alter

    John Alter, PhD

    Pfizer

    John is currently Vice President, Patient and Health Impact for Pfizer’s Hospital Business Unit, a $9 billion global business unit comprised of a well-balanced portfolio of differentiated and undifferentiated assets delivered across 10 therapeutic areas, with 50 molecules on the World Health Organization’s Essential Medicines List.

    John has been with Pfizer for over 20 years in multiple roles of increasing responsibilities, the last five years with the Patient and Health Impact team. He has presented at several international conferences on the topic of pricing and access and in 2016 was a guest lecturer on the subject of HEOR at Kings College London as part of the International Federation of Association of Pharmaceutical Physicians.

  • Michael Betz

    Michael Betz, PhD

    F. Hoffmann-La Roche AG

    Dr. Michael Betz studied Chemistry at the University of Konstanz in Germany and, in 1989, he went to the Swiss Federal Institute of Technology (ETH), Zürich for his PhD at the Institute of Molecular Biology and Biophysics.

    Between 1994 and 1997 he later worked as a Postdoc in Prof. Robert Huber`s Structural Sciences Department at the Max-Planck-Institute of Biochemistry. Working for Sandoz, Johnson & Johnson and since 2013 for F. Hoffmann-La Roche AG in Basel, Michael gained a wealth of experience within the industry covering most aspects of protein handling and transferring biotech products into commercial manufacturing.

    He also got certified as Six Sigma Black Belt. Newest camera and illumination technology in combination with proven Deep Learning algorithms in the field of automated inspection systems provide a huge potential. Michael is currently transforming this potential into tangible productive innovation for the inspection network at Roche.

  • Beate Bittner

    Beate Bittner, PhD

    F. Hoffmann - La Roche

    As Formulation & Device Franchise Leader at Roche, Dr. Beate Bittner is leading global cross-portfolio product optimization initiatives and multi-disciplinary formulation & device lifecycle management teams.

    Beate joined Roche in 1998 and has held numerous positions of increasing responsibility including Preclinical DMPK Project Leader, Laboratory Head Preformulation, Clinical Pharmacologist, Clinical Team Leader, Research & Early Development Project Leader, Global Development Team Leader, and Senior Portfolio Strategy Director.

    Since 2012, Beate is a Lecturer at the Baden-Wuerttemberg Cooperative State University in the field of Personalized Health Care, Developing New Drugs, and Pharmacology.

    Beate is trained as a Pharmacist with a PhD in Pharmaceutical Technology & Biopharmaceutics from the University of Marburg, Germany, and she holds a Diploma in European Market Access from the Aix-Marseille University, France.

  • Stefan Bohling

    Stefan Bohling

    Sanofi Aventis

    Stefan leads Sanofi´s pen injector technology platform, which comprises among others the successful disposable and reusable pen platforms. He has over twenty-six years’ experience in material research, device development and industrialization, as well as management roles at leading global companies such as Sony, Novartis, and Sanofi.

    For 13 years, he has worked primarily in the development and industrialization of delivery devices, encompassing both mechanical and electro-mechanical devices in the fields of injection, combination products and diagnostics.

    A particular area of expertise is Design- and Production-to-Cost in the field of medium to high volume devices in which Stefan has led Sanofi teams at the interface of development and industrialization to ensure continuous success in mature and emerging markets.

  • Nicolas Bralet

    Nicolas Bralet

    BD Medical Pharma Systems

    Nicolas Bralet is Worldwide Safety Platform Leader at BD Medical Pharmaceutical Systems.

    He is responsible for defining, implementing and managing the portfolio of safety advanced drug delivery solutions and the related product & process developments.

    Nicolas joined BD Medical – Pharmaceutical Systems in 1996 with various positions in Technical Services, Marketing and R&D Department.

    He obtained his Engineer diploma at l’Institut Polytechnique in Grenoble (INPG) with specialization in physico-chemistry and industrial engineering.

  • max_cambras

    Max Cambras

    LEK

    Max Cambras is a Managing Director and Partner in the Los Angeles office at L.E.K. Consulting, with more than 17 years’ experience working in pharmaceuticals and in health care institutions. He specializes in strategic growth strategy, commercialization in biopharma and off molecule innovation.

    Prior to joining L.E.K, Mr. Cambras managed the Forecasting & Marketing Analytics department at Purdue Pharma L.P.

    Mr. Cambras earned his Bachelor’s degree at the University of Chicago and his Masters degree at the University of Iowa.

  • Mark Chipperfield

    Mark Chipperfield

    Corvus Device Limited

    Mark Chipperfield, Independent Consultant after 20+ years in operational and senior roles (GSK, Sanofi, Novartis, Roche).

    Working with different combi products (PFS/pens/AI, patch, pMDI/DPI, kits), Mark has deep experience with execution (due diligence/technical evaluation, design control phases to market; industrialisation; in-market maintenance; change and issues management) whilst in parallel establishing right-sized operational frameworks including business processes; QMS; org structure; facilities, etc. 

  • Lucy Chung

    Lucy Chung

    SHL Group

    Lucy is currently the director at SHL’s Automation Department (AMSD) responsible for overseeing equipment design, development, manufacturing, as well as overall production quality.

    Prior to this, she held roles in project management, operations, and customer service in AMSD.

    Lucy was one of SHL’s first five employees in Taiwan and was instrumental in creating product testing and quality systems. In 2004, she participated in developing the semi-automatic testing machine (SATM) for SHL’s first auto-injector product.

    Lucy received her BS in Industrial Engineering from National Taiwan University of Science and Technology.

  • Simon Côté

    Simon Côté

    WEST

    Simon Côté has over 17 years of experiences in the pharmaceutical industry with a focus in drug product development and fill/finish processing.

    He is currently Director of West’s North America Technical Customer Services. In his role he supports both West’s Commercialization and R&D organizations as the subject matter expert on fill/finish processes, and as a technology lead on product platforms such as packaging, seals, and prefilled syringe/cartridge systems.

    Simon has been with West since March 2012. Prior to that, he worked approximately 10 years split between Centocor (J&J) and Merck. He has a Bachelor of Science in Bioprocessing Chemical Engineering from Penn State University.

  • Marty Coyne

    Marty Coyne, MBA

    Matchstick

    Marty Coyne is Principal and Co-Founder of Matchstick, a specialty consultancy focused on pre-concept and concept stage development for combination products. He has 20 years of experience with implantable and disposable medical devices, particularly drug delivery devices used in acute care, ambulatory and home settings.

    A thought leader on sharps injury protection, safe injection practices and healthcare worker and patient safety, he has innovated extensively in these areas individually and for clients, with 11 patents issued and over 40 patents pending.

    Mr Coyne has a BE in Mechanical Engineering from Stevens Institute of Technology and an MBA from Columbia University.

  • Alex Dahmani

    Alexander Dahmani, PhD

    QuiO Technologies

    Alexander Dahmani is Co-Founder and CEO of QuiO, a New York-based digital healthcare company. QuiO’s CRx platform offers patients the tools to better manage their treatment regimens, by combining connected therapeutics with analytics and behavioral interventions to improve adherence and outcomes.

    Alex started QuiO in 2014 while pursuing a PhD at Columbia University. His vision is to enhance the real-world efficacy of existing medications through technology and behavioral science.

    Prior to starting QuiO, Alex worked in biotech and technology commercialization. He holds degrees in immunology, genetics and business.

  • Kedar Datar

    Kedar Datar, MBA

    Boehringer-Ingelheim

    Kedar Datar is currently an Associate Director, CMC Project leader within the Bio Business Unit at the Boehringer Ingelheim Fremont facility. There he leads Drug Substance manufacturing operations from all aspects of CMC development.

    Previously, he worked as an Associate Director of Pharmaceutical Development at Santen Inc., an ophthalmology focused pharamaceutical company, where he lead a small molecule program from Phase III onwards, managing all aspects of manufacturing, stability, validation, LCM and launch readiness. During his stint with Santen, he was focused on developing solutions to deliver low volume doses using a Pre-filled syringe.

    Prior to Santen, Kedar held the positions of Project Manager at a CMO, and an Associate Scientist at a start up in Southern California.

    Kedar has a MS in Bioengineering from Clemson University, SC and an MBA from the Rady School of Management at UC, San Diego.

  • Geraint Davies

    Geraint Davies

    F. Hoffmann-La Roche

    Geraint is a Product Designer with over 16 years’ experience in the medical device industry. He joined Roche six years ago as a Senior Human Factors Engineer for Roche’s medical device portfolio, including prefilled syringes, auto injectors and small molecule delivery systems.

    Geraint now predominately works in the Smart Device Technology Center on connected medical devices and Software as a Medical Device (SaMD).

    He is currently leading a program which successfully launched Roche Pharma’s first SaMD earlier this year, and also leads a project applying behavioural design to the research and development of a medical device app to improve adherence / persistence to medication.

  • Robert S. Epstein

    Robert S. Epstein, MD

    Epstein Health

    Dr. Robert Epstein is a physician epidemiologist with an interest in accelerating the adoption of true innovations of novel healthcare solutions.

    For the past seven years, he has been the CEO and co-founder of Epstein Health LLC, a strategic consulting company servicing the private equity, healthcare and life science industries. Key topics in these engagements revolve around the application of digital solutions to research and/or healthcare, incorporation of genomics into the ecosystem, and the role of Real World Evidence in driving regulatory and/or commercial decisions.

    He most recently left a 17-year post as Chief Medical and Chief R&D Officer for Medco (a 65 million life publicly traded PBM), where he managed a global department of over 2000 researchers in 33 offices (UBC) servicing the Life Sciences Industry, and provided information and services to more than 2000 US payers. While there, he initiated a series of innovative Personalized Medicine initiatives that branded Medco the #3 Most Innovative Company by Fortune Magazine (behind Apple and Nike).

    Prior to Medco, Dr. Epstein was VP of Outcomes Research at Merck and had an earlier career in public health and academia focused on data mining to address epidemiologic questions. He has published more than 100 research papers in the peer-reviewed medical literature, and is currently tracking and engaging with developers of hundreds of new technologies.  He currently serves on the Boards of Directors of Illumina (ILMN), Fate (FATE) Therapeutics, Veracyte (VCYT), and Proteus Digital Health.

    He is Past President of ISPOR and has been a member of many federal working groups on leveraging data and genomics.

  • 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.

  • Gilbert Fluetsch

    Gilbert Fluetsch, MBA

    SHL Group

    Gilbert joined SHL’s Automation Department (AMSD) in early 2016. His responsibilities include leading the engineering teams, standardizing the existing equipment portfolio, and overseeing the development of high-speed assembly and testing machines.

    Prior to joining SHL, Gilbert served in various leading roles in engineering, operations, and sales management in the medical device and semiconductor industries for almost three decades.

    Between 2010 and 2016, he held key account management positions at several US-based automation companies, and from 2007 to 2010, he was vice president of Sales and Marketing at Ismeca Europe, stationed in Malaysia.

    Gilbert received his MBA in High Technology Management from the University of Phoenix and his BS in Business Administration from California State University San Marcos.

  • Jonas Fransson

    Jonas Fransson, PhD

    Swedish Orphan Biovitrum

    Dr Jonas Fransson is Director of Drug Product Development at Swedish Orphan Biovitrum AB, Stockholm, Sweden. He is trained at Uppsala University and received a Ph.D in pharmaceutics in 1996.

    Since then he has held various positions in the areas of formulation development and manufacturing focusing on product development of biologics. He has worked in a number of development projects covering conventional injectables, ophthalmic delivery, injection devices and lyophilization development. Dr Fransson is now at Sobi AB responsible for formulation, packaging and device development.

    Jonas is also engaged in various academic/industry collaborations and is chairman of the NextBioform consortium focusing on innovative methods for biological pharmaceuticals meeting end-user needs. Dr Fransson is also active in Sweden Drug Delivery.

  • Blake Green

    Blake Green

    Amgen

    Blake Green is a Regulatory Affairs Senior Manager with Amgen’s Global Medical Devices Regulatory team. Based in Cambridge UK. Blake is a Devices Regulatory lead for medicinal product/medical device combination products and co-packaged medical devices in the biopharmaceutical sector.

    Prior to joining Amgen, Blake had significant international experience securing multi-national market clearance for manufacturers of medical devices, medical device/medicinal product combinations, medical software, personal protective equipment, and biocides, located throughout the United States of America, European Union, North Africa, Middle East, Far East, Turkey, Israel, Australia, Canada, and Peoples Republic of China.

  • Paul Greenhalgh

    Paul Greenhalgh

    Team Consulting

    Paul leads Design and Innovation at Team, working closely with clients and colleagues to improve the user experience of medical devices, through carefully crafted industrial design, digital UI/UX, packaging and information design solutions.

    With over 20 years’ experience helping clients bring innovative, user centred products into reality, Paul focuses on helping clients at the front end of development, to set the right direction and ensure user, commercial and technical needs are thoroughly understood.

    His recent involvement in a number of early stage connected device programmes has reinforced Paul’s belief that the adoption of design thinking not only results in great products but helps to overcome many of the challenges that project teams face during the early stages of development.

    During his time at Team, Paul has led the development of many innovative award-winning products including drug delivery devices, surgical devices, consumer medical products and complex critical care systems.

  • Julia Häring

    Julia Häring, PhD

    Novo Nordisk

    Julia Häring is passionate about creating innovative offerings that make the lives of patients and caregivers easier.

    She has a leading role in the commercialisation and launch of Novo Nordisk’s digital health solutions. Her expertise is based on 12 years of experience from the pharmaceutical industry.

    Throughout her career she has worked with commercial strategy for early and late stage development projects with the ambition to embed commercial strategy in the development process.

    Her educational background is a MSc and a Ph.D. in Economics.

  • Gareth Hilton

    Gareth Hilton, MSc

    AstraZeneca

    Gareth graduated in 2007 with a Master’s degree in Chemistry from The University of Manchester. Following that, he spent seven years working in various medical device design and development roles for Molnlycke Healthcare and another three years for ConvaTec’s Continence and Critical Care franchise, winning an iF Design award in the process.

    Gareth worked on products ranging from single use surgical devices to patient home use devices. He joined AstraZeneca in 2017, supporting Combination Product and Digital Health Application projects with device development and design control expertise.

  • Philipp Hoerner

    Philipp Hoerner, B. Eng.

    Bausch & Stroebel

    Philipp Hörner holds a degree in industrial engineering.

    In 2014, he joined Bausch + Ströbel Maschinenfabrik Ilshofen GmbH + Co. KG. He has several years of experience as a product manager in the business fields of syringe and cartridge processing.

    His main responsibilities are market analysis and initiating new product developments to meet future market trends.

    At B-S he is also in charge of supervising new primary packaging solutions in the market and act as a member of the DIN/ISO group for primary packaging.

  • Stephanie Horn, PhD

    F. Hoffmann - La Roche

    Stephanie Horn is a medical device senior expert in the Technical Regulatory group of ROCHE Pharma in Basel, Switzerland. A biologist by education, she received her doctorate in Virology from the University of Erlangen-Nuernberg, Germany.

    For over 20 years, she has been engaged in the in-vitro diagnostics and medical device industry in Europe and the US.

    Stephanie has strong skills in regulatory compliance and regulatory affairs for medical devices and drug-device combination products. She is active member of several industry groups i.e. device group of EBE’s BioManufacturing WG and EFPIA-EREG.

  • Robin Hwang

    Robin Hwang, PhD

    ICP Consulting

    Robin is the founder of ICP Consulting Corp., specializing in injectable combination products.

    Prior to consulting, he was a Vice President in Drug Delivery Devices at Halozyme and led the drug delivery efforts, targeting subcutaneous high-volume devices in combination with hyaluronidase. Prior to Halozyme, he was a Director at Amgen and led the development and the commercialization of three combination products. Before coming to Amgen, Robin worked at Becton Dickinson Research Center and GE Plastics.

    Robin received his Bachelor degree from NCKU in Taiwan, Master degree in Chem Eng from IIT and a PhD degree in Chem Eng/Polymer Sci & Eng from UMASS-Amherst.

  • Peter Krulevitch

    Peter Krulevitch, PhD

    Janssen J&J

    Peter Krulevitch is Senior Engineering Director and Fellow at Janssen R&D, where he leads the Primary Container & Device group, responsible for large and small molecules across Janssen’s portfolio, from concept to commercialization.

    His team developed a variety of drug-device combination products.

    Peter joined Janssen from J&J’s MD&D sector, where he developed devices for treating diabetes. Prior to J&J, he worked at Lawrence Livermore National Laboratory’s Center for Microtechnology.

    Mr. Krulevitch received his Ph.D. in Mechanical Engineering from UC Berkeley with the Berkeley Sensor & Actuator Center, and is a co-inventor on 60+ issued US patents.

  • Juan Kuang

    Juan C. Kuang

    Amgen

    Juan Kuang is Vice President, Final Drug Product Technologies at Amgen. He is accountable for primary container science, secondary packaging technologies, device engineering, and human factors design.

    Juan joined Amgen in 2011 where he provided leadership in Operations Improvement for the AML Drug Product organization. In August 2012, he was appointed head of Drug Product Manufacturing at Amgen in Puerto Rico where he delivered significant results in the launch of new products, reduction of non-conformances, normal scrap as well as cost per unit and overall budget spent. 

    Juan has a Bachelor’s degree in Mechanical Engineering from the University of Puerto Rico. He has been involved with various industry/professional organizations where he has been appointed as President of the Puerto Rico Medical Devices Cluster, member of the Board of Directors of the Puerto Rico Manufacturers Association (PRMA), and member of the Board of Directors of Biopharma.

  • Jakob Lange

    Jakob Lange, PhD

    Ypsomed

    Jakob is an Engineer and Materials Scientist by training with an MSc degree in Chemical Engineering from the Royal Institute of Technology in Stockholm, Sweden and a PhD in Polymer Science from the Swiss Federal Institute of Technology in Lausanne, Switzerland. He has written and published more than 30 peer-reviewed papers on medical devices, packaging materials and polymers and is a regular contributor to technical and scientific conferences.

    Jakob started his professional career as a Research Scientist in packaging R&D with Nestlé at the Nestlé Research Centre in Lausanne, Switzerland. He then worked in R&D Management with GE Healthcare Biosciences in Uppsala, Sweden, before joining Ypsomed in Burgdorf in 2006.

    With Ypsomed he has held different positions within Marketing and Sales as well as in R&D Project Management. Currently he has the role of Senior Director Delivery Systems, overseeing two teams of Product Managers, one managing Ypsomeds autoinjector platforms and the other focusing on customer relationships for device development projects and marketed device products.

  • Daniel Latham

    Daniel Latham, PhD

    Novartis

    Dr. Daniel Latham is the Head of Device Development & LCM,  where he leads an organisation of around 120 associates responsible for the development and life cycle management of delivery systems of drug/device combinations for new biologic entities, biosimilars, and cell & gene therapy.

    Over the past 13 years at Novartis, he has overseen many device and primary packaging developments, approvals and launches and has significantly supported the growth and understanding of device development and drug/device interaction within the organisation.

    Prior to Novartis, he held a variety of roles in consumer health­care, focusing on the development and marketing of OTC medicines, transdermal patches, and medical devices.

    He has a Ph.D. in controlled drug delivery from Queen Mary, Uni­versity of London and a Bachelor’s degree and Master’s degrees in Engineering and Medical Physics from the University of Sheffield’

  • Dennis Lee

    Dennis Lee, PhD

    Bill & Melinda Gates Foundation

    Dennis Lee is a Senior Program Officer in CMC at the Bill & Melinda Gates Foundation, where he provides product development support for vaccines and drugs, with a focus on long-acting and other advanced drug delivery technologies.

    He began his career as a medicinal chemist with the SmithKline Beecham (a GSK legacy company). In 1999, Dennis relocated to the San Francisco Bay area as Director of Chemistry at Sunesis Pharmaceuticals, a start-up that developed molecular fragment-based approaches for drug discovery. He returned to GSK in 2001, and headed medicinal chemistry in cardiovascular and urogenital diseases.

    Over the next several years, his group progressed several compounds into clinical development. In 2008, Dennis became Head of Chemistry and Preclinical Development in the new Ophthalmology unit at GSK. He contributed to the formation and evolution of the Ophthalmology business strategy, co-managed the discovery portfolio, and implemented and executed the drug delivery strategy for retinal diseases. He then joined GSK’s Discovery Partnerships with Academia, in which he and a group of senior drug discovery scientists identified and executed drug discovery collaborations with individual academic groups.

    In 2014, he became Director of Drug Delivery, Platform Technology and Sciences, a newly-formed drug delivery group, whose mission was to seek and develop novel drug delivery technologies that align with GSK’s portfolio. He relocated to Seattle to join the Gates Foundation in Jul 2018.

  • 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.

  • Michael Pratz

    Michael Pratz

    Bausch & Stroebel

    Michael Pratz is responsible for the Bausch+Ströbel Academy with customer training and employee qualification.

    Over the past 30 years, his career went from technical IT (CAD, PLM, VR) to technical documentation, equipment validation, automation and research and development.

  • Andrew Ratz

    Andrew Ratz, PhD

    Eli Lilly & Co.

    Dr. Ratz leads the Delivery, Device and Connected Solutions organization at Eli Lilly and Company. He currently provides leadership and direction to the integrated design and development of devices (mechanical, electromechanical and software), drug device combination products, and packaging systems for both the biotech and small molecule portfolios.

    Andy's organization is responsible for the innovative design of new delivery platforms, comprehensive portfolio management, development of in-depth control strategies, and global product registration. He has worked for Eli Lilly and Company for over 20 years, with significant experience across all phases of drug and device development, manufacturing installation, and marketing applications.

    Andy graduated from Indiana University with a BS in Chemistry and earned his PhD in Chemistry from Harvard University.

  • Andrea Sardella

    Andrea Sardella, PhD

    Stevanato Group

    Andrea holds a degree in Physics from the Padua University and a master’s degree in Nuclear Engineering.

    As researcher at the National Research Council (C.N.R.) he developed several optoelectronic and nuclear scientific instruments for Magnetically Controlled Fusion Research setting up international collaboration with UWA Madison (Usa) and Garchin IPP (De).

    After 10 years of activity in research he moved to the industrial sector developing optical and vision controls for industrial application as CEO of a Tattile srl subsidiary now Antares Vision. This experience drove him into the pharmaceutical field where he started to develop several control applications with vision and spectroscopy tools. After several years he joined Brevetti C.E.A. spa as R&D Manager and he developed the latest inspection technology currently on BCEA machines.

    Since 2008 he has been with Stevanato Group as Product Manager to develop new automation and inspection products dedicated to the pharmaceutical customers of the group.

  • Jens S. Christensen

    Jens Schou Christensen

    Stevanato Group

    With a background as Automation Technician and Engineer, Jens Schou Christensen has acquired broad hands-on and strategic experience in developing automation solutions for assembly and packaging equipment.

    With passion for automation and the urge to push boundaries as key drivers, Jens has shaped innovative strategies and solutions in various complexities for SVM / Stevanato Group through two decades.

  • Gautam Shetty

    Gautam Shetty, PhD

    Congruence Medical Solutions

    Gautam Shetty is the founder of Congruence Medical Solutions, LLC based in Baltimore Maryland USA.

    Prior to Congruence Medical Solutions, Gautam was General Manager of Novel Drug Delivery Systems business unit at Unilife Corporation. He pioneered development of ophthalmic drug delivery devices and targeted organ delivery systems.

    Prior to that, Gautam was with Becton Dickinson & Co. (BD) where he held a number of positions involving R&D, Strategic Marketing, Commercialization Planning and M&A.

    Gautam holds a PhD in Biomedical Engineering from Case Western Reserve University. He has authored 12+ patents in the injectable drug delivery device space covering ocular drug delivery systems, novel delivery systems, pen injectors and patch pumps.

  • Rhea Sirkar

    Rhea Sirkar

    Eli Lilly

    Rhea Sirkar is a mechanical engineering graduate from the University of Michigan and has ten years of experience in the medical device and biotechnology industries. She has been with Eli Lilly & Company for four years and is currently an R&D Engineer at the Lilly Innovation Hub in Cambridge, Massachusetts.

    At Lilly, Rhea is focused on injection physiology research to support and improve upon all potential high dose delivery combination products.

    Prior to joining Lilly, Rhea spent time at Conformis designing total knee replacement systems and at Boston Scientific improving the quality system for endoscopy and urology products.

  • Nicholas Stones

    Nicholas Stones, MSc

    Novartis

    Nick holds Bachelors and Masters degrees in engineering from the University of Oxford in the UK. Since 1998, he has worked in research, development and commercialization of drug delivery systems for various medical device and specialty Pharma companies in the UK, US and Switzerland.

    Nick joined Novartis in 2009 and was responsible for establishing the Human Factors Engineering process within device development. He has supported the development of several marketed products including a pre-filled syringe for intra-vitreal injection as well as a pen for home use.

    Nick works within the human factors team with a focus on HFE strategy, health authority communication, HFE process and platforming as well as the translation of user needs into design inputs.

  • 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.
  • Yoshifumi Torii

    Yoshifumi Torii, PhD

    Fujifilm Kyowa Kirin Biologics Co., Ltd.

    Yoshifumi Torii received a PhD in Pharmacology from The University of Tokyo in 1994.

    He started his career in 1994 as a researcher at Pharmaceutical Research Laboratories of Kirin Brewery Co., Ltd., where he served in medical affairs, project management, strategic planning etc.

    He was seconded to Fujifilm Kyowa Kirin Biologics Co., Ltd. in 2013 as a General Manager of European Branch, and was appointed President in 2017.

  • Rob Veasey

    Rob Veasey

    DCA Design International

    Rob leads drug delivery device development projects within DCA’s medical sector. He has over twenty-five years’ experience in engineering, design and management roles for leading manufacturing and consultancy businesses and for nearly twenty years has worked exclusively in the field of drug delivery.

    Rob’s experience encompasses both mechanical and electro-mechanical devices, including injection devices, body-worn devices, metered dose inhalers, dry powder inhalers, intra-nasal sprays and topical applicators.

    Projects completed by Rob in these areas have been for global pharmaceuticals and leading medical device companies. A particular area of expertise is the field of pen-injectors in which Rob has led DCA’s team in the design and development Sanofi.  

  • Pascal Venneugues

    Pascal Venneugues, PhD

    European Medicines Agency

    Pascal Venneugues qualified as a pharmacist from the University of Paris, with a doctorate in the field of Molecular Genetics. He also holds masters’ degrees in Health Economics and in European Regulatory Affairs. From 2001 to 2003 he worked in pharmaceutical industry.

    He joined the European Medicines Agency in 2003 and works as Principal Scientist in Quality of Medicines, with a focus on Biologics.

  • Min Wei

    Min Wei, PhD

    AstraZeneca

    Min is a Director and Fellow at AstraZeneca.

    He has over 15 years of drug/device combination product development experience. During this time, he has worked at BD, Eli Lilly and Johnson&Johnson on projects from concept phase through commercialization.

    His experience spans device engineering, formulation development, process engineering and packaging. Currently, Min is focusing on delivery systems for new therapeutics, including high volume/high concentration protein formulation and cell&gene therapy.

    Min received his Ph.D. in Materials Science and his MBA from US. His MS degrees are in Biotechnology and Computer Science. Min is an inventor of more than 50 patents and patent applications. He is also a certified Six Sigma Black Belt from American Society for Quality (ASQ).

  • Wendy Woodley

    Wendy Woodley

    Becton Dickinson

    Wendy Woodley is a Staff Scientist for Parenteral Sciences’ Infusion group at BD Technologies in RTP, NC. She received multiple degrees, BS in Microbiology, BS in Zoology, BA in History, BA in English and a minor in Genetics, from North Carolina State University in Raleigh, NC.

    She has 19 years of R&D and Product Development experience in the medical device industry with a focus on innovation in drug delivery devices and diagnostics.

    Her current work at BD Technologies and Innovation focuses on drug delivery innovations with a concentration in preclinical development, clinical testing and translation of new ideas to product development.

  • Cathy Zhao

    Cathy Xia Zhao, PhD

    West Pharmaceutical Services

    Cathy Zhao (Formal Name Xia Zhao) has over 18 years of experience in the medical/pharmaceutical industry. She is currently the Director of Scientific Insights Lab in West Pharmaceutical Services, Inc, and leads SIL to differentiate West products and services. Prior to this role, she held various positions in West, such as Global PPS Research Director. Prior to West, Cathy worked for BD as a Principal Materials Scientist. She received her Ph.D in polymer chemistry from City University of New York and her BS in Polymer chemistry from the University of Science and technology of China. Cathy is the inventor of many US and European patents, and is an active presenter in conferences.