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Committee & Speaker Biographies

Committee & Presenter Biographies

2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference

18-19 October 2022

  • Mathias Romacker

    Mathias Romacker

    Consultant

    Mathias Romacker was most recently Senior Director, Device Strategy at Pfizer HQ in New York City. He joined Pfizer in March 2015. In this commercial role, he focused on the front end of device technology. He worked 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.

    Mathias is on the PDA Board of Directors.

  • Jeffrey Givand

    Jeffrey Givand, PhD

    Merck & Co., Inc.

    Jeff Givand is currently leading the Device Development R&D team within Merck as Executive Director. Jeff’s team leads the concepting, design, development and commercialization efforts for device and combination products in support of small molecule, biologics and vaccine products in development at Merck. Device technologies within his team’s scope include inhalers, injectors, implantation and associated drug delivery devices. He has over 23 years of experience at Merck in areas ranging from solid oral dosage formulation and process development, Quality by Design and process analytical technology implementation within pharmaceutical drug product processes, sterile primary container characterization, and device/combination product development.

  • Josh Gonzalez

    Josh Gonzalez

    SHL Medical

    Josh Gonzalez is the Chief Commercial Officer (CCO) at SHL Medical. He is responsible for overseeing all business development activities and laying the blueprint for SHL’s long-term commercial strategy.

    Josh has over 20 years’ experience in the biopharmaceutical industry. Prior to joining SHL in 2012, he worked at Amgen in various functional areas, including Process Development, Supply Chain, and Finance. While at Amgen, Josh first connected with SHL while supporting the launch of two of the world’s first modern autoinjector devices based on the DAI technology.

    Josh graduated with a BS from Michigan State University and holds an MBA from the University of Miami.

  • Laurent Jeanmart

    Laurent Jeanmart, PhD

    GSK

    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.

  • Ashkay Kamdar

    Akshay R. Kamdar, PhD

    Eli Lilly and Company

    Akshay Kamdar is the Sr. Director for Container Closure, Materials and Process Innovation in the Delivery, Device and Connected Solutions (DDCS) organization at Lilly.  Akshay joined Lilly in 2009 after receiving his Doctorate in Polymer Science and Engineering from Case Western Reserve University and his Masters in Materials Engineering from Rochester Institute of Technology. He has held various technical leadership roles focusing on novel container closure systems and combination product development from innovation through commercialization and is responsible for driving Lilly’s device and packaging sustainability strategy. He is a long time PDA member and has co-authored the Prefilled Syringe User Requirements for Biotechnology Applications (fondly called PDA Technical Report No. 73).

  • Christian Kollecker

    Christian Kollecker

    Harro Hoefliger

    Christian Kollecker is working in the aseptic and liquid filling business for over 14 years and has experience in project and product management, as well as a strong focus to sales and business development.

    Christian Kollecker is working at Harro Höfliger as Director Aseptic Technologies. In this position, he is worldwide responsible for all projects regarding liquid filling applications and aseptic requirements for customized equipment solutions.

    In this position, he is supporting and consulting his customers during product development until final production scale up. Following the credo “from lab to production”, all kind of aseptic projects are handled by Christian and his team at HH to find solutions for customer specific equipment and needs.

    During his engagements in different companies, he gained experiences in various pharmaceutical manufacturing areas like parenterals device handling and manufacturing, product development and integrated machine solutions as well as different countries and cultures all over the world. He holds a graduate degree in industrial engineering from a German university as well as an Open University degree.

  • Jakob Lange

    Jakob Lange, PhD

    Ypsomed AG

    Jakob Lange 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 close to 40 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. He is currently Senior Director Delivery Systems and the head of Ypsomed's autoinjector business. In this role he oversees two teams, one managing product platforms and the other focusing on customer relationships for device development projects and marketed device products.

  • Alessandro Morandotti

    Alessandro Morandotti

    Stevanato Group

    Alessandro has a background in Electronic Engineering with a Master's in Biomedical applications and Devices at the University of Padua. He has been working in the primary packaging field for more than 20 years, focusing on pharmaceutical glass products, combination products, and drug delivery devices.

    Member of the PDA, he attended several conferences providing presentations and lectures about primary packaging solutions in the last years.

    In addition, as a teacher, he was part of different training sessions with a focus on glass primary packaging properties.

    Thanks to his expertise, his role has always been linked to highly technological projects, focusing on developing and promoting innovative solutions considering the different competencies part of Stevanato Group.

    He was successfully contributing to developing and commercializing Pre-fillable syringes for Biologic Drug Products.

  • Brigitte Reutter-Haerle

    Brigitte Reutter-Haerle

    Vetter

    Brigitte Reutter-Haerle is Vice President Product Management & Marketing for Vetter. In this role, she is responsible for both existing and new product and service offerings that support Pharma & biotech companies as well as marketing and public relations activities. She joined Vetter in 1996, serving in the company’s sales and marketing function and later transferring to corporate marketing. She began her career in 1983, holding various positions in the sales organizations of companies including Hilton International and TNT Express Worldwide.

    Brigitte joined PDA in 2005 and has been Vice Chair of the Marketing Advisory Board since March 2019. She has also been a leader of PDA’s Pre-Filled Syringe Interest Group/Europe since 2007, and served on various committees, including as Chair of the PDA UPS Program Planning Committee. In 2014, Brigitte received the PDA Distinguished Service Award and, in 2017, the PDA Europe Service Appreciation Award for her long-standing commitment. The awards were in recognition of special acts, contributions, or services that have helped build on the success and strength of PDA

    Ms. Reutter-Haerle earned a BA and a degree in business administration from Baden-Wuerttemberg Cooperative State University.

  • Maurice Verschuren

    Maurice Verschuren, MSc

    Amgen Inc.

    Maurice Verschuren is an Engineering Director at Amgen with 15+ years of experience in the pharma and fast-moving consumer goods industry. Maurice joined Amgen in 2015 and after building extensive experience within manufacturing, he is currently a device platform lead within the process development organization at Amgen’s corporate office. Maurice is accountable for decision making and adherence to Amgen’s largest combination product platform, ensuring product development and improvement are applied consistently and optimally to further enhance the overall patient experience. Maurice obtained a MSc degree in Mechanical Engineering from the Delft University in the Netherlands.

  • Reza Abedian

    Reza Abedian, PhD

    Gerresheimer

    Reza is currently working as Senior Medical Affairs Manager with Gerresheimer companies. He specializes in medical affairs and clinical research, supporting value-based product development with strong focus on patient centricity. Reza holds a PhD in musculoskeletal biomechanics and tissue engineering from Hannover Medical School, Laboratory for biomechanics and biomaterials. He has supported several product development/launches and market authorization of medical devices under FDA, MDD/MDR and other global market requirements, during the past 10 years while having worked in multiple sectors of the medical device and pharma industry.

  • Reut Atarot

    Reut Atarot, BSc

    West Pharmaceutical Services, Inc.

    Reut Atarot has over 15 years of experience in medical devices and combination products, the majority of which in the drug delivery industries. She joined West Pharmaceutical Services in 2014 and is a Systems Engineering Manager. Her primary responsibilities are to lead technical aspects of the development programs of the SmartDose® 10 platform on-body delivery systems, and to support West’s pharmaceutical partners with development and marketing of a system that fits the intended use and drug treatment.

    Prior to joining West, Reut worked in Perfaction Technologies, a developer and market leader of a needle-free injection system for intradermal compound delivery. She has extensive background in development of products for professional and home-use, product life-cycle management, system engineering, and project management. She has led multi-disciplinary teams and conducted feasibility studies, and design verification and validation. Reut holds a B.Sc in biomedical engineering from Tel-Aviv University in Israel.

  • Ugljesa Babic

    Ugljesa Babic

    SCHOTT Schweiz AG

    Ugljesa Babic leads the process development team at SCHOTT R&D Pharma, focused on developing processes for new primary packaging. He coordinates the study program with the goal on transferring R&D efforts into new products and functionalities. Ugljesa started at SCHOTT as a product engineer in the glass syringe segment in January 2020. Before, he worked as a post-doc at the EPFL from 2019, and a PhD research fellow at the PSI/ETHZ from 2015. In this time period he authored or co-authored 10 peer-reviewed articles and 2 patents. He holds a PhD degree in physical chemistry, MSc degree in power engineering and BSc degree in mechanical engineering.

  • Sherri Biondi, PhD

    AstraZeneca
    Sherri joined AstraZeneca in March 2018 and as Head of Device Development. She is responsible for parenteral drug delivery devices including early stage technology selection, development and late stage scale-up for commercial manufacturing. Currently, her group is developing products such as prefilled syringes, autoinjectors, on-body delivery systems, and pen injectors as well as a range of other new technologies to meet the AstraZeneca pipeline needs. Prior to working at Astra Zeneca, Sherri was Director of Device Development at Genentech and Director of Product Development at Alexza Pharmaceuticals developing both injection and inhalation products.  
  • David Booth

    David Booth, PE

    LMI

    Mr. David Booth is an expert in medical device product development with over 30 years of experience. He graduated with a Bachelor of Mechanical Engineering, a Master of Management – Business Administration, and a Master of Engineering while working for Alcon Laboratories, developing and launching over 30 ophthalmic surgical products. In 2013, Mr. Booth joined Becton, Dickinson and Company, leading a multi-national, cross-functional team in developing their first wearable injector for biologic drugs and a SMART wearable auto injector. He has over 25 medical device patents, patent applications and trade secrets. As a senior consultant, he is currently advising the U.S. Department of Defense in the development and manufacturing of parenteral drug delivery systems. Mr. Booth is a registered professional engineer, a doctoral candidate, and a combat veteran, retiring after 23 ½ years of service with the U.S. Army as a Major.

  • Naresh Budhavaram

    Naresh K. Budhavaram, PhD

    Eli Lilly and Company

    Naresh Budhavaram is a Senior advisor in the Delivery, Devices and Connected Solutions (DDCS) organization at Eli Lilly. He leads material selection and evaluation efforts for new products within R&D division. He is currently leading the Sustainability initiatives in the Devices Group. He has held various technical roles within DDCS. Before joining Lilly, Naresh worked as a polymer product development engineer at Celanese. In this role his focus was developing engineering thermoplastic and bio-based grades for automotive, consumer and electronic applications.  Naresh obtained his Bachelor’s in Chemical Engineering from Osmania University, Master’s in Chemical engineering from University of Mississippi and has a Doctorate in Biological Systems Engineering from Virginia Tech.

  • Marty Coyne

    Marty Coyne, BEME, MBA

    Matchstick, LLC

    Marty Coyne is Principal and Co-Founder at Matchstick. He has experience with technical, commercial, and strategy aspects of medication delivery spanning infusion, injection, inhalation, and orals. He is recognized by clients for exposing new points of differentiation, developing market-shaping strategies, and inventing new product and service solutions. His work includes physical combination products, digital components/SaMD, and hybrid physical-digital systems. He also leads the innovation practice at Matchstick, collaborating with pharmaceutical clients on novel innovation approaches within highly constrained and regulated environments. He has 11 issued patents, numerous pending patents, and hundreds of invention disclosures for pharmaceutical clients. He actively contributes to the scientific literature on combination products, patient initiation, and medication preparation. Marty has a BE in Mechanical Engineering from Stevens Institute of Technology and an MBA from Columbia University. He is an Adjunct Assistant Professor at the University of Rhode Island College of Pharmacy.

  • Lisa Dick

    Lisa Dick, PhD

    Kindeva Drug Delivery

    Lisa Dick, PhD is a Senior Scientist at Kindeva Drug Delivery in Woodbury, MN where she works with the Microstructured Transdermal System team from the technical perspective.  In this role, she works with a team to develop solid coated, hollow, and dissolvable microneedle-based drug products, and design associated applicators for these transdermal microneedle systems. In her 20 years within the pharmaceutical field at Kindeva and 3M Drug Delivery Systems, she has contributed to the development of inhalation and transdermal drug products from early-phase feasibility through launch and marketed product support.  She has extensive experience with drug product development, preclinical studies, materials science, extractables and leachables, quality, and she contributes to regulatory filings.  She received her PhD in chemistry from Northwestern University and did postdoctoral training at Princeton University.

  • Paul Draper

    Paul Draper, MEng

    DCA Design International

    Paul Draper is one of the senior management team at DCA, servicing the medical sector. His 19 years of product development experience has been almost entirely on drug delivery device development projects. His mechanical engineering degree and years of experience working on and leading medical device projects culminates in the hands-on leadership of complex multi-disciplinary projects encompassing strategy, research, design, mechanical engineering, electronic engineering, software engineering and industrialisation. Paul has experience of low part count mechanical devices through to advanced electro-mechanical devices including IEC 62304 software development for embedded software and supporting mobile applications. As selected examples, Paul led DCA’s work on the development of Toujeo Max SoloStar for concentrated insulin and the AllStar Connect reusable connected pen injector.

  • Andrea Dwyer

    Andrea Dwyer, MS, CHFP

    Emergo by UL

    Andrea Dwyer is an Associate Research Director with Emergo by UL’s HFR&D team and has been with the team since 2010. A board-certified human factors professional, Andrea leads and oversees research activities required to meet regulators’ expectations for applying human factors engineering (HFE) during medical and drug delivery device development. She composes HFE project plans and helps medical device and pharmaceutical manufacturers develop key HFE documents for their design history files, including authoritative HFE reports and comprehensive use-related risk analyses. She frequently conducts workshops, speaks at industry events, and advises clients on how to implement HFE in the medical device development process. Andrea is co-author of Medical Device Use Error – Root Cause Analysis. She holds a B.S. in Human Factors and an M.S. in Engineering Management, both from Tufts University.

  • PaulErik Fabricius

    Paul Erik Fabricius

    Phillips-Medisize

    Paul Erik Fabricius is a Director of Front-End Innovation at Phillips-Medisize, and is responsible for Concept Development and Industrial Design. He has more than 30-years of experience in innovations related to healthcare and medical technology. He has a BSc degree in Mechatronics Design from Technical University of Denmark.

  • Esther Foo

    Esther Foo, PhD

    Merck & Co., Inc.

    Esther Foo is currently a senior scientist in the Device Development group at Merck Research Laboratories. She is responsible for leading human factors activities for combination products across a variety of delivery modalities such as prefilled syringes, autoinjectors, and inhalers. She received her Ph.D. in Human Factors and Ergonomics from the University of Minnesota, and completed her B.S. and M.Eng. in Biomedical Engineering from Purdue University and Cornell University respectively.

  • Emil Fraenkel

    Emil Fraenkel, MEng

    Phillips-Medisize

    Emil Fraenkel is a Sustainability Engineer at Phillips-Medisize, based in the company’s Development Centre in Denmark. Mr. Fraenkel holds an MSc in sustainable product development and is passionate about resolving environmental issues in the pharmaceutical industry.

    At Phillips-Medisize, Mr. Fraenkel works with quantitative sustainability assessment, practices lifecycle assessment and drives product sustainability initiatives.

  • Pari Gaikwad

    Pari Gaikwad, MS, MBA

    Cambridge Design Partnership

    Pari heads up the digital organization, leading digital projects across healthcare, consumer and industrial sectors. These projects include digital tools such as connected devices, apps, web portals and data analytics platforms.

     

  • Jeffrey Givand

    Jeffrey Givand, PhD

    Merck & Co., Inc.

    Jeff Givand is currently leading the Device Development R&D team within Merck as Executive Director. Jeff’s team leads the concepting, design, development and commercialization efforts for device and combination products in support of small molecule, biologics and vaccine products in development at Merck. Device technologies within his team’s scope include inhalers, injectors, implantation and associated drug delivery devices. He has over 23 years of experience at Merck in areas ranging from solid oral dosage formulation and process development, Quality by Design and process analytical technology implementation within pharmaceutical drug product processes, sterile primary container characterization, and device/combination product development.

  • Paolo Golfetto

    Stevanato Group

    Paolo Golfetto is the Director of Business Development for Drug Delivery Systems and CDMO, leading the development and execution of the business strategy and plan in the fields of pen and auto injectors, large dose wearables and respiratory drug delivery systems. In his position, while managing the external technical communication, dissemination and promotion of the global Drug Delivery Product platforms, services and solutions, he supports the projects acquisition and the transfer to the internal development structures of the Group.

    Before taking this position, Paolo Golfetto was in charge of the Product Design and Development, including the technical support to the Group’s biopharmaceutical clients, coordinating experts in glass technology, process engineers and designers. Member of PDA, Mr. Golfetto provides presentations and lectures widely in the healthcare industry Organizations and Associations; furthermore, he is the author of some papers for important magazines in the field.

    Formerly Mr. Golfetto was the R&D Manager of the Appliances Engineering Team within a well known worldwide manufacturer of Household Appliances. During his latest 5 years in this position, he was responsible of moving the Company’s R&D to Guangdong, China. Mr. Golfetto contributed in the development of European Norms and Regulations focused on users safety consumer products.

  • Josh Gonzalez

    Josh Gonzalez

    SHL Medical

    Josh Gonzalez is the Chief Commercial Officer (CCO) at SHL Medical. He is responsible for overseeing all business development activities and laying the blueprint for SHL’s long-term commercial strategy.

    Josh has over 20 years’ experience in the biopharmaceutical industry. Prior to joining SHL in 2012, he worked at Amgen in various functional areas, including Process Development, Supply Chain, and Finance. While at Amgen, Josh first connected with SHL while supporting the launch of two of the world’s first modern autoinjector devices based on the DAI technology.

    Josh graduated with a BS from Michigan State University and holds an MBA from the University of Miami.

  • Lauren Guimond

    Lauren Guimond, MS

    SHL Medical

    Lauren Guimond has been working at SHL since 2018. As Manager of Analytical Sciences, Lauren oversees the implementation of new laboratory and testing equipment, as well as Test Method Development, Validation, and Transfer to Operations.  The Analytical Sciences team works with our customers to develop and complete studies to support regulatory filings, including stability programs, Transportation Validation studies and Container Closure Integrity testing.

    Prior to joining the medical device industry, Lauren worked as a forensic engineer, performing accident reconstruction and biomechanical analyses in Ann Arbor, Michigan. At that time, she also obtained her Master’s degree in Biomedical Engineering from the University of Michigan.

  • Amy Hartl

    Amy Hartl, PhD

    SHL Medical

    Dr. Amy Hartl has been working at SHL since 2016. As Director of Process Development, Dr. Hartl oversees the operations, testing, and statistical analyses that are crucial for the successful design transfer of autoinjector devices from development to commercialization. The process development team develops, validates, and transfers device testing, final assembly, device labeling, final packaging, and serialization processes. In parallel, her team also develops strategies for increasing and optimizing the site’s capacity by implementing high-speed equipment, expanding technological capabilities, and leaning out existing processes.

    Prior to joining the medical device industry, Dr. Hartl taught Statistics and Experimental Design courses at Florida Atlantic University where she also obtained her Ph.D. in Experimental Psychology.

  • Jeremy Hemingway

    Jeremy Hemingway, MS, PE

    Stress Engineering Services, Inc.

    Jeremy Hemingway has 17+ years of experience developing product, equipment, and processes from feasibility through launch in the pharmaceutical, medical device, and animal health industries.  Jeremy has served various roles including design and risk leads, program management, and technical consulting for a range of products including drug delivery, surgical devices, catheters, capital equipment, and connected devices.  Jeremy has led the technical development of 10+ product lines and provides a focus on integrating robust and efficient engineering into prototype/test development cycle.  Jeremy graduated with a BS and MS from the University of Cincinnati, Ohio and is a registered Professional Engineer in the state of Ohio, USA.