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Parenteral Drug Association Connecting People, Science and Regulation ®

2018 PDA Universe of Pre-Filled Syringes and Injection Devices

October 8-9, 2018, Orlando, FL

Speaker Biographies

  • Marcelo Abad Landa

    Marcelo Abad Landa

    Becton Dickinson

    Mr. Abad has been with BD since 2001 in diverse areas of leadership, including Supply Chain, Manufacturing-Operations, Continuous Improvement, Plant Director and more recently as a Senior Director for World Wide Manufacturing.  He leads the Manufacturing Sites for BD Pharmaceutical Systems Cluster driving the priorities of Manufacturing: Safety, Quality, Delivery, Cost and pursuing opportunities across the plant network that can enhance value and provide competitive advantage for BD.

  • Daniel Bantz

    Daniel L. Bantz

    West Pharmaceutical Services, Inc.

    Daniel Bantz brings experience in product performance testing to West’s pharmaceutical systems and components to his position as Packaging and Performance Technology Manager.  He’s competent in fluidics systems development, combination product testing and risk assessments.  Daniel implements testing technologies meeting ever-changing regulations in conjunction with customer needs.  He earned an associate’s in Electromechanical Technology from Allegany College of MD, a bachelor’s degree in Business Management from the University of Northwestern St. Paul and an MBA in Operations and Technology from Aurora University.

  • Tommaso Borghi

    Tommaso Borghi, PhD

    Flex

    In the last 10 years within Flex Tommaso led R&D teams through the development of connected devices for top medical devices and pharmaceutical companies working in close collaboration with marketing departments, top design firms and production sites around the world.

    He created partnerships with Italian universities and led programs with European research centres to bring cutting edge technologies into the market. He holds several patents and published research papers on international peer-reviewed journals.

    Tommaso holds a PhD in Electrical Engineering from Politecnico di Milano and worked as Visiting Scientist at the Massachusetts Institute of Technology on the development of Brain Machine Interfaces.

  • Anil Busimi

    Anil Busimi started his professional career in 2003 at SCHOTT AG in Germany. He worked in different positions including business development manager for microarrays, project manager for new business, and consultant in corporate strategy and development. In 2005, he moved to the business segment Pharmaceutical Packaging and played a key role in building long-term business strategy, market intelligence, product management and innovation for pharmaceutical systems business. From August 2009 until June 2016, he held various positions in global product management for pre-fillable syringe business (glass and polymer).  Currently, he is in the strategy & innovation team as senior global product manager for Cartridges and leads the iQ™ Platform market launch. He is a regular speaker at many conferences including PDA events.

    He holds M.Sc degree in Agriculture and Genetics and a MBA.

  • Kevin Deane

    Kevin Deane

    Phillips-Medisize

    Kevin Deane is the Executive Vice President of Front End Innovation at Phillips-Medisize, a Molex Company. Kevin is an expert in Connected Health, having led a wide range of technical connectivity and patient engagement projects for major pharmaceutical companies globally, including the first such system approved as a combination product (with a drug) by FDA.

    Kevin started his engineering career in the US, working in automotive and aerospace, before relocating to the UK in 1994. He worked for PA Consulting in Cambridge UK for over 20 years, becoming a Partner and leading their activities in medical devices, drug delivery and connected health. At Phillips-Medisize he works with leading pharmaceutical and biotech companies across the US and Europe, where his team develops electro-mechanical injection and infusion technologies, and associated Connected Health systems, improving the lives of patients across a range of diseases and conditions.

  • Ismael Del Pilar

    Ismael Del Pilar

    Amgen Inc.

    Mr. Del Pilar has been with Amgen Inc. since 2005 in diverse external supply management roles, including Supplier Quality Management, Global Strategic Sourcing and more recently as a Supplier Relationship Excellence leader.  He leads a cross-functional team of Amgen SMEs (Technical / Quality Assurance / Supply Chain / Strategic Sourcing / others) responsible for the engagement with suppliers of syringe system components and safety devices.

  • Claire Everitt

    Claire Everitt

    Pfizer Inc.

    Claire has a Masters degree in Mechanical Engineering and a BSc in Psychology. With over 20 years’ experience in engineering industries, from train crash investigation through to medical device use, she is particularly attracted to the interface between mechanical and human systems and the problem of human motivation.

    Claire joined Pfizer in 2012 and currently manages the Design Engineering team in Pfizer in Cambridge, UK. The team is responsible for the mechanical robustness and effectiveness of delivery devices, but also focusses on extending user understanding of specific patient populations to optimise device specifications.

  • 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.

  • Paul Geevarghese

    Paul Geevarghese

    mySugr, A Member of the Roche Group

    Paul Geevarghese has spent his career in the diabetes & obesity industry across pharmaceutical, medical device and digital health companies. He is currently Vice President of Market Access for mySugr across North America, with the aim to "make diabetes suck less". Since joining mySugr, Paul has been an integral part of developing and implementing mySugr's chronic disease management solutions within health plans, employers and health systems for diabetes population health.

    Paul holds a Doctor of Pharmacy from Rutgers, The State University of New Jersey and continued on to do a Post-Doctoral Fellowship in Medical Affairs, Diabetes & Obesity.  Paul is passionate about finding ways to bring efficiency and accessibility to healthcare without losing the personalized approach that is fundamental to medicine.
  • David Henderson

    David Henderson

    Beta Bionics, Inc.

    David Henderson joined Beta Bionics in the summer of 2017. David has over 15 years of industry experience, including the last 9 years of which have been in medical devices. Through his career, David has been entrusted with increasing levels of responsibility in operations leadership encompassing Production, Supply Chain, Manufacturing Engineering and Operational Excellence. David graduated from Purdue University with a Bachelor’s of Science degree in Mechanical Engineering and a passion for learning and continuous improvement. Since graduating, he has pursued industry training in operations including certifications in Lean Manufacturing and a Black Belt in Six Sigma. David is currently responsible for the design and implementation of the operations processes supporting the clinical testing and planned market launch of the iLet Bionic Pancreas system and the associated disposable infusion products.

  • Julian Jazayeri

    Julian Jazayeri

    Amgen Inc.

    Julian Jazayeri is a senior engineer at Amgen.  He is based out of the container science and engineering group and focuses on mechanical characteristics of primary containers and drug delivery device integration.  Julian earned a BS in mechanical engineering from the California Polytechnic State University of San Luis Obispo in 2012.  Before joining Amgen, Julian was involved in developing injection molds for medical device components and processes.  Since 2011, Julian has been heavily involved in the development of drug delivery systems of biotechnology products.

  • Patrick Jeukenne

    Patrick Jeukenne

    Aptar Pharma

    Patrick is an Industrial Pharmacist graduated from the Universities of Liège (Belgium) and Montpellier (France).

    Patrick started his career in 1993 at GSK Vaccines, holding successive Quality roles, culminating in leading the Quality activities for aseptic operations, packaging, warehousing and supplier management. He then joined Amgen (Breda, Netherlands) in 1999 where he was their QA Manager and Qualified Person until 2002. Patrick came back in Belgium in 2002 to become Sales and Marketing Director of Federa (CMO, now part of Catalent), with activities spanning over two sites (Brussels, Belgium and Limoges, France). In 2005, Patrick joined BDM – PS (Pharmaceutical Systems) where he held successive roles in in Sales Management, Commercial Development for new injection technologies, Innovation Project Management, Integration Leader for an acquired company (SSI) and culminating into managing the Safety Devices platform. Patrick was a member of the PS Leadership Team until his departure (January 2018).

    He then started his own consulting practice (Pharma Jump Consulting) and joined the Board of Directors of Lasea as an Independent Director.

    As of September 2018, Patrick stopped his consulting practice to join Aptar as VP Strategy for the Pharma Segment while retaining his position in Lasea’s Board of Directors.
  • Ashkay Kamdar

    Ashkay R. Kamdar, PhD

    Eli Lilly and Company
    Akshay Kamdar is the Director for Container Closure, Materials Engineering and Process Innovation group in the Delivery, Devices 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 within Lilly’s Delivery and Device organization focusing from novel container closure systems to combination product development from innovation through commercialization.
  • Daniel Kehl

    Daniel Kehl

    Swissfillon AG

    Daniel Kehl holds a master’s degree in process engineering. After the University of Applied Science he worked several years as a project manager at Lonza AG.

    After his time at the Lonza AG he founded the pixon Engineering AG, a company specialized in the planning, the realisation, the qualification and validation of pharma manufacturing facilities. Since 2014 he concentrates on the strategic issues of pixon as its president.

    5 years ago he has set up the Swissfillon AG, a company which is positioning itself as an agile fill & finish CDMO for high value, high potent injectables. As the CEO his main function is the guidance and coordination of the CDMO Fill & Finish business for fully automatic GMP sterile filling of biopharmaceuticals and high-potent products for clinical material and for the commercial launch of vials, syringes and cartridges.

  • Teddy Klein

    Teddy Klein

    Sanofi Pasteur

    Mr. Klein has been with Sanofi Pasteur since 2008 in Manufacturing Technology department first, then in Global Engineering department as Technology Program Manager, where he is now leading the Primary Containers Identification Program.

    He is Mechanical Engineer graduated from the Engineer School “Institut Catholique d’Arts et Métiers” in France. He also has a Master Degree in Mathematics.

    He has worked first in Automotive (Arvin Meritor) and Energy (General Electric) fields. Then he joined the pharmaceutical industry as a consultant for Big Pharma companies like AstraZeneca, Fareva or Cephalon mainly for Lean Manufacturing implementation.

    He has a strong and extensive expertise in pharmaceutical Filling & Packaging and is supporting different industrial projects related to Datamatrix coding, anti-counterfeiting measures and new packaging implementation.

  • Girish Kumar

    Girish Kumar, PhD

    TÜV SÜD America

    Dr. Kumar have been with TUV SUD America since Jan 2017. Most recently he was a scientific reviewer and biocompatibility expert at the Center for devices and radiological health at US FDA. Today Dr. Kumar is as a product specialist and medical device auditor in the areas of Cardiovascular, Neurovascular and drug-device combination products. Dr. Kumar is passionate about adding value to his clients mission by providing excellent and reliable service. Building on his past regulatory experience he is able to provide key insights that help medical device companies to reduce the size of their regulatory program and bring new medical products of public health importance into the market.

  • Mark K. Lee

    Mark K. Lee, PhD

    Flex

    Dr. Mark Lee is the Chief Technology Officer for the Health Solutions group at Flex Ltd. where he has responsibility for driving innovation, execution excellence the medical business focusing on Sketch-to-Scale™ solutions that extends from human-factors-based user needs definition through innovation and design, to ramp up, full scale production, and supply chain management.  The Health Solutions group is able to leverage technology, expertise and scale across Flex industries to offer unique and differentiated solutions to its customers.  Prior to Flex, he was the Global Head of R&D for J&J where he led research and development activities across the pharmaceutical, medical device and consumer health segments of the company and identified new growth areas.  Lee also held leadership roles in R&D with fortune 100 medical device companies including Baxter, GE medical and Amgen, where he developed the combination product design process for all of Amgen’s pipeline molecules.

    Lee holds a PhD in Engineering Science from the University of Western Ontario, Canada and a Master of Science, Bachelor degrees in Engineering Science from the University of Toronto, Canada.

  • Ling Lu

    Ling Lu

    Pfizer Inc.

    Ling is a Senior Principal Scientist in the Pfizer Biotherapeutic Pharmaceutical Sciences based in Andover, Massachusetts, leading design control group, supports the combination product development in the Formulation & Process Development department, from clinical trials through commercial licensure. Developed streamlined design control process for off-the-shelf components (syringes and drug delivery accessories), coached drug scientists to lead design control activities, and delivered a dozen biological products. Ling has 20 year experience in the Medical Devices and Pharmaceutical industries in positions at Pfizer, Hospira, Medtronic, and 3M, as a subject matter expert in design controls, device and combination product development, quality engineering and regulatory affairs.

    Ling received a MS degree in Organic and Polymer Science at Illinois Institute of Technology in Chicago, MS in Materials Science and BS in Chemistry from Fudan University in Shanghai, China, also an Assistant Professor at Fudan University; Ling has a Regulatory Affairs Certificate (RAC) from RAPS and Certificate of Quality Auditor (CQA) from ASQ

  • James Mellman

    James K. Mellman, PhD

    Novartis

    James has worked at Novartis in Basel Switzerland since 2014 as a device manager within the Packaging Technologies team in the Device Development & Commercialization department.

    His main responsibilities include developing primary packaging systems for combination products and supporting new technologies for development and operations. He has worked on several innovative projects in which the primary packaging system had to be developed for an injectable device. He has also helped to build and implement a renovated CCIT strategy for the Novartis Group.

    Before Novartis, James worked at Pfizer in their Devices Center of Excellence in Cambridge, UK (2008-2011) and Nutricia in their Advanced Medical Nutrition Division in Amsterdam, NL (2011-2014). He received his PhD from the University of Florida in Materials Science & Engineering in 2007 specializing in biomaterials.

  • Natasha Rivas

    Natasha L. Rivas

    Vetter Development Services USA, Inc.

    Natasha Rivas is the Director, Quality Assurance and Quality Control at Vetter Development Services USA, Inc. She has over seventeen years of experience in the pharmaceutical and medical device industry in various roles of increasing responsibility including quality control, quality assurance and regulatory affairs. Her current responsibilities include providing quality control and quality assurance oversight for clinical contract manufacturing services as part of Vetter’s Development Services in the United States. Natasha holds a Bachelor of Science in Molecular Biology and is an active member of PDA.

  • Marc Rohrschneider

    Marc Rohrschneider, PhD

    Novartis Pharmaceuticals AG

    Marc received his Master’s Degree in English and Biology from Ruhr-University Bochum, Germany and his Ph.D. in Pharmaceutical Technology from Heinrich-Heine-University Düsseldorf, Germany. He joined the medical device industry in 2001 as a Project Manager in Regulatory Affairs for Respimat® Soft Mist Inhaler with STEAG microParts GmbH, Germany. From 2004 -2011 he held positions of increasing responsibility in the development of inhalation devices and formulations within Boehringer Ingelheim. In 2012 he joined Boehringer Ingelheim’s Biopharma Division as Senior Manager, Technology & Innovation Delivery, before being appointed Head of Device/Combination Product Development for biopharmaceuticals in 2014. In July 2017 Marc moved to Basel and joined Novartis Pharma AG as Head of New Technologies for Device Development and Commercialisation, within the Technical Research and Development division.

  • Egmont Semmler

    Egmont Semmler, PhD

    TÜV Süd

    Before joining TÜV Süd in Germany, Egmont served in different managing positions in the technology transfer and science-to-business operations with a strong focus on medical and pharmaceutical applications, which resulted in several patents.

    Dr. Semmler held positions in Pharma as Senior Manager Pharmaceutical R&D, driving developments in machine vision, sensor solutions and gas plasma decontamination barrier systems for isolator syringe tub transfer.

    As Director R&D pharmaceutical machinery, his responsibilities included strategic R&D, technology scouting and quality assurance of single-use fill components.

    As a technical advisor he organized internal and external training on working principles and pharmaceutical processes in the fill & finish area.

    Egmont is involved in IoT platform development, looking into Augmented Reality and machine connectivity.

    He earned a PhD in Plasma Technology and holds a diploma in Electrical Engineering from Ruhr University Bochum.

  • Caitlyn Sofa

    Caitlyn Sofa

    Glaxo Smith Kline

    Caitlyn Sofa joined GlaxoSmithKline in 2013 as a member of the Biopharmaceutical Product Development Team working on early & late stage products. Prior to joining GSK, Cait studied Chemistry at Monmouth University before pursuing a Master’s Degree in Biochemistry from Villanova University, where her research focused on isolating protein drug targets for neglected tropical diseases. Following graduate school, she followed her passion for helping others to Merck where she worked in the Vaccine Manufacturing space before leaving to continue following her passion at GSK. Cait’s experience spans various scientific spaces with a focus on high throughput analyses, light scattering techniques, & biophysical characterization. In her spare time, Cait enjoys building furniture, repurposing antiques, planning her wedding, and gardening.

  • Chin-Wei Soo

    Chin-Wei Soo, DRSc

    Genentech, A Member of the Roche Group

    Chin-Wei Soo is the Global Regulatory Head, Combination Products and Devices at Roche. He is accountable to provide regulatory oversight to Roche’s entire device and combination product portfolio, covering all large and small molecules throughout the product lifecycle. He has over 17 years of medical device quality and regulatory experience, including expertise in combination products such as ocular implantable drug delivery devices, drug-eluting stents, drug-coated balloons, and implantable programmable drug infusion pumps. Chin graduated from Iowa State University with a Bachelor degree in Industrial and Manufacturing Systems Engineering, a Master of Science in Bioscience regulatory affairs from the Johns Hopkins University, and a Doctorate in Regulatory Policy from the University of Southern California School of Pharmacy.

  • Allison Strochlic

    Allison Y, Strochlic, MS, CHFP

    UL LLC / UL-Wiklund

    Allison Y. Strochlic is Research Director of the human factors engineering (HFE) team at UL–Wiklund. UL’s HFE team delivers HFE consulting services to the medical device, pharmaceutical, scientific instrument, and laboratory equipment industries. A board-certified human factors professional, Allison contributes to and manages research projects such as usability testing, contextual inquiry, and interviews. Furthermore, she helps clients develop key HFE documents for their design history files, including use-related risk analyses, and advises clients on how apply HFE during device development to meet regulators' expectations. Allison routinely contributes to clients’ pre-submissions to and interactions with regulators, including leading HFE-related discussions during several high-stakes FDA-sponsor meetings.

    Allison is co-author of Usability Testing of Medical Devices and several technical papers focused on applying HFE to medical device and combination products. She holds a B.S. in Human Factors from Tufts University and an M.S. in Human Factors in Information Design from Bentley University.

  • Jean-Christophe Veilleux

    California Institute of Technology

    Jean-Christophe Veilleux is a Ph.D. candidate at the Graduate Aerospace Laboratories of the California Institute of Technology in Pasadena, California. His research focuses on fluid-structure interaction in autoinjector devices. Jean-Christophe earned a BS in engineering physics from Laval University (Quebec, Canada) in 2012. He earned a MS in mechanical engineering from Laval University in 2014 (thesis title: Optimization of a Fully-Passive Flapping-Airfoil Turbine) after two years of research in the field of fluid-structure interaction using CFD. He also earned a MS in Aeronautics from Caltech in 2015.

  • Kai Worrell

    Kai Worrell

    Worrell Design Inc.

    Kai’s leadership and healthcare expertise comes from 18 years of interacting with health care professionals and patients through deep ethnographic research engagements across the world. He has a rare perspective on healthcare issues and solutions, brought about by his extensive travel and worldwide clinical immersion. Kai shares his experiences, insights, and passion for design in healthcare through many speaking engagements, including HLTH conference, PDA, Connected Health, Medtronic’s leadership summit, Body Computing Conference, and J&J’s Design and Human Factors Conference, and many private corporate innovation events.

    Kai and his design teams work closely with UHG, Google Verily, Medtronic, J&J, Amgen, and many other leading healthcare technology companies.

    Kai also co-founded Geneva Healthcare, a digital health cardiac remote monitoring company with two practicing electrophysiologists. Geneva created partnerships with 4 implantable cardiac manufacturers to unite critical cardiac data and provide more proactive care to patients. Kai lead Geneva through its original grant-funding, seed funding, incubation, and early product development. Kai currently serves on Geneva’s board of directors.

  • Justin Wright

    Justin M. Wright, PhD

    Novartis

    With 20 years of experience across med tech and pharma, Justin currently serves as Global Head of Innovation at Novartis where he is responsible leading the enterprise innovation system across the drug development process for both biologics and small molecules. This includes activation of the innovation strategy and leading cross-functional innovation governance internally and externally to Novartis.   

    Prior to joining Novartis, Justin helped launch and then lead Lilly’s Cambridge Innovation Center that was tasked with building Lilly’s next generation delivery and connected product systems. This also included developing new innovation and external partnership models in order to accelerate drug delivery innovation. Before this, Justin worked at BD where he served in various roles focused on developing and commercializing drug delivery systems for the biotech, vaccine, and pharmaceutical industries. Justin began his career at Merck & Company working in manufacturing, product commercialization, and franchise management.

    Justin holds a PhD in Bio-Organic chemistry from Clemson University and completed a research fellowship at Harvard Medical School. He is the author of more than 35 patents and publications.

  • Enrico Zanetti

    Enrico Zanetti

    Swissfillon AG

    Enrico Zanetti holds a master’s degree in Agrochemical sciences.

    He’s been working in the pharmaceutical field for many years mostly on Sales and Business Development of Drug Delivery and Medical Devices companies taking care of European and Far Eastern countries.

    After several years in the sales field he decided to improve his technical background by joining the R&D of a Medical Device company, working first as Project Manager, and then managing the R&D team located in the Swiss branch for about 7 years.

    He also worked as consultant, in 2017, for many companies, supporting them in finding new businesses/products/drug licenses, etc. and providing support to those companies interested in entering the medical device respiratory business.

    He recently joined Swissfillon to support the take-off of the business projects with all companies interested to partner with Swissfillon, a CDMO Fill & Finish company, with fully automatic systems, working in GMP sterile conditions, specialized in filling of biopharmaceuticals and high-potent products for clinical trials and for the commercial launch of vials, syringes and cartridges.