PDA Medical Devices and Connected Health Conference 2024

Featured Presenters

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  Bettine Boltres, PhD

  West Pharmaceutical Services

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  Bettine Boltres, PhD

  West Pharmaceutical Services

  As Director Scientific Affairs & Technical Solutions, Glass Systems, Dr. Bettine Boltres is supporting the scientific exchange between West and the pharmaceutical industry. This is complementing her work as Product Manager for Schott Pharmaceutical Tubing, where she provided scientific consulting for glass primary packaging. Since 2015 Bettine is an active member of the USP Packaging and Distribution Expert Committee as well as the ISO TC76/WG 2 on rigid container systems and WG 4 on elastomers. Additionally, in 2018 joined the European Pharmacopoeia Commission Group of Experts 16 (elastomers and plastics) and the GLS Working Party (glass).

  Since January 2019 she is also a member of the PDA Board of Directors, actively supporting the role of PDA in the global pharma world. She was part of the PDA Glass Handling Task Force finalizing TR 87 and is actively involved in the Task Force working on an Annex to TR 73 addressing MDR GSPRs for PFS, is part of the Pharmacopeia Interest Group. In 2015 she published the book "When Glass Meets Pharma", which builds the bridge between glass for pharmaceutical primary packaging and drug substances.

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  Benjamin Cox

  Team Consulting

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  Benjamin Cox

  Team Consulting

  Ben is Head of Digital Design at Team Consulting, where he works with a highly cross-functional group of designers, researchers and engineers to craft engaging and intuitive interfaces and optimise the user experience of medical devices. Ben has previously worked in a number of design consultancy roles in London and as a clinical scientist and design engineer in the NHS. He has also conducted extensive research for DePuy Johnson & Johnson. Ben has a BEng degree from Cardiff University and an MSc and PhD in Biomedical Engineering from the University of Leeds.

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  Mehul Desai

  Vice-President of Medical Affairs, Enable Injections

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  Mehul Desai

  Enable Injections

  Mehul Desai, PharmD, MBA, serves as Vice-President of Medical Affairs at Enable Injections. His experience includes development and execution of tactical plans, driving strategic direction through key opinion leader insights, supporting clinical trial execution and contributing to business development activities across various therapeutic areas. His background includes being the Associate Medical Director for the haematology franchise at argenx. Prior to this, his experience included field medical assignments in rare disease for haematology at argenx, haematology/nephrology at Alexion, and nephrology/neurology at Mallinckrodt Pharmaceuticals. Mr. Desai holds a Bachelor’s degree in Biochemistry and Business Foundations from Indiana University (Bloomington, IN, US); a PharmD from Purdue University (West Lafayette, IN, US); and an MBA in Pharmaceutical and Healthcare Business from the University of the Sciences (Philadelphia, PA, US).

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  Kevin Dolgin

  Co-founder, Observia

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  Kevin Dolgin

  Observia

  Kevin Dolgin is the co-founder of Observia, a French company specializing in digital patient behavioral interventions. Prioviously, he was a co-founder of Areks, as well as a number of other companies, as well as having been a Senior Principal at IMS Health. He has worked in healthcare since 1992, in over sixty countries. Kevin is also an Affiliate Professor at the University of Paris (IAE – Paris I, Panthéon-Sorbonne), where he teaches behavioral science and entrepreneurship. He has been widely published in both trade and scientific publications around the world, and has spoken at, and chaired, numerous trade conferences in healthcare. Kevin has a BA in economics from Fordham University, an MBA from INSEAD and a Master of Research from the Sorbonne. He is currently finishing his PhD at Saclay University (Paris).

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  Paul Gardner

  Head of HW and SW Development, Ypsomed AG

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  Paul Gardner

  Ypsomed AG

  Paul Gardner studied in Cambridge, UK, where he completed a B. Eng. in Electronic Engineering. Paul has over ten years’ recent experience with medical devices development and more than forty years’ experience of safety critical systems design and implementation. He is Head of HW and SW Development at Ypsomed AG who provide a complete range of technologies and services for reliable and user-friendly injection systems for self-medication and was formerly Head of the CoE eHealth and a senior consultant at Congenius AG, where he led a team providing SaMD and Cybersecurity consultancy services to pharma and medical devices manufacturing companies.

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  Christoph Joosten, PhD

  F. Hoffmann-La-Roche

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  Christoph Joosten, PhD

  F. Hoffmann-La-Roche

  Christoph Joosten obtained a Ph.D. in Chemical Engineering from Cornell University (USA) in 2003, then worked as upstream process development engineer at Bristol-Myers Squibb (USA) and at Novartis (Switzerland). From 2009 to 2012, he held a CMC regulatory affairs role at Novartis. Since 2012, he has been employed at Roche (Switzerland) where he has led or supported several market authorization applications for biopharmaceuticals, with a focus on drug delivery devices and digital solutions.

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  Richard Mathera

  Irrational Labs

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  Richard Mathera

  Irrational Labs

  Richard Mathera solves real-world problems in health, tech, and finance using behavioral science. He leads Irrational Labs’ healthcare practice, overseeing behaviorally-informed collaborations with partners such as Optum, Talkspace, TytoCare, Belong Health, and One Medical. As a Senior Behavioral Scientist at Duke’s Common Cents Lab, Richard developed products and strategies that merged technology and behavioral insights. Richard holds an MPA in Advanced Policy and Economic Analysis from Columbia University’s School of International and Public Affairs and a BA in Economics from the University of Virginia. His expertise in combining behavioral economics, technology, and patient care place him at the forefront of health innovation.

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  Liam Mc Morrow

  Novo Nordisk

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  Liam Mc Morrow

  Novo Nordisk

  Liam Mc Morrow is the Novo Nordisk Global Launch Lead for Connected drug delivery devices for Growth Hormone. He is supporting teams across the world to deploy a connected drug delivery device device for caregivers and patients with growth hormone deficiency. Liam also has experience working with digital health companies in obesity and digital therapeutics in diabetes,. Prior to joining Novo Nordisk, Liam completed a PhD and postdoctoral research in health economics.

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  John Mulcahy

  S3 Connected Health

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  John Mulcahy

  S3 Connected Health

  John Mulcahy works with leading biopharma, healthcare providers, and medical device companies to enable the delivery care enabled by digital health from strategy through to deployment of services at scale. John is currently VP of Product at S3ConnectedHealth. Prior to this, John led HealthGenuity a Digital Health strategy consultancy, was chairman of a digital health startup, and global head of eHealth, patient care and software engineering in Merck KGaA. Altogether, John’s teams have developed and launched digital health solutions to 40 healthcare systems across 20 therapeutic areas.

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  Philippe Müller

  Ypsomed

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  Philippe Müller

  Ypsomed

  Philippe Müller is Innovation and Business Development Manager at Ypsomed Delivery Systems. His responsibilities include the definition and development of new platform devices and business models, with a particular emphasis on connected device systems. As such, he has been actively involved in the design and development of YpsoMate On – the prefilled connected autoinjector. Beside that he is part of Ypsomed’s Scientific Research & Communication Program with the goal of creating new insights around self-injection devices that are relevant to both industry and academia. In this context he contributed to several articles in peer-reviewed journals. Philippe holds an MSc in Applied Economic Analysis from the University of Bern, Switzerland.

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  Miriam Schulze

  CEO, BAYOOMED

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  Miriam Schulze

  BAYOOMED

  Miriam Schulze is the CEO of BAYOOMED GmbH, a leading company in the field of medical software development for MedTech, LifeScience, and pharmaceutical industries. She holds a background in computer science from Dresden and has accumulated over 14 years of experience in the medical technology sector. Her expertise spans across software engineering, quality management, risk management, and technical documentation, particularly in the development of safety-critical medical software and mobile medical apps compliant with IEC 62304. Throughout her career, Miriam Schulze has been instrumental in driving innovation within BAYOOMED, focusing on digital health technologies such as Clinical Decision Support Systems (CDSS) and reimbursable digital health applications (DiGA). She is recognized for her strategic leadership in integrating cutting-edge technologies with healthcare solutions, emphasizing patient outcomes and compliance with regulatory standards. Her work includes significant contributions to the fields of Diabetes Care, Women's Health and many other therapuetic areas where she has guided the product lifecycle from conception to CE marking and FDA approval of digital health applications. Miriam Schulze is also a noted speaker at conferences, where she shares insights on the challenges and innovations in medical software development, emphasizing the importance of documentation, and regulatory compliance in creating effective medical technologies.

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  Aaron Swick

  Senior Staff Engineer for Research and Development, Enable Injections

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  Aaron Swick

  Enable Injections

  As a Senior Staff Engineer for Research and Development at Enable Injections, Aaron Swick leads the connected healthcare program, driving collaborating with pharmaceutical partners to shape the evolution of enFuse technology. With over 15 years of experience in medical device and healthcare innovation, Mr. Swick leverages his extensive background in user and market research to steer product strategy and design. His diverse portfolio of work encompasses various healthcare technologies, including surgical instruments, diagnostics, capital equipment, consumer health and drug delivery products. He earned his MSE and BSE in Biomedical Engineering, and completed a post-graduate fellowship in medical innovation, all from the University of Michigan.

Presenters

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  Eric Chanie

  Merck Group

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  Eric Chanie

  Merck Group

  After an electronic engineering degree in France complemented by an MBA in Marketing, Eric Chanie joined a start-up company as Research & Development director involved in gas analysis for odor measurement. The company grew from 3 people to more than 100 with a successful IPO on the Paris stock exchange. In 2007, He then joined a medical device company developing miniaturized sensors for hemodialysis and neurosurgery (biosensing, intracranial pressure measurement) in which he leads the Research and Development team. He joined Merck Serono in 2010 as Medical Device innovation manager to strengthen product portfolio and contribute to the new generation of electronic devices. He was then appointed head of innovation in the newly created “Global Business Franchise Medical Devices” and got much more involved in business development and technology scouting in the space of digital health, AI & digital therapeutics. Eric joined a research organization in 2020 and co-founded a company called Epios, providing precision care for brain disorders enabled by implantable long-term brain sensing technology. In 2023, Eric joined back Merck as the head of device engineering and core team leader for connected pens.

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  Geraint Davies

  F. Hoffmann-La Roche

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  Geraint Davies

  F. Hoffmann-La Roche

  Geraint is a Principal Human Factors Engineer and Behaviour Design Specialist at Roche. He has 20 years experience of Medical Device and Digital Health development, and predominantly works on connected Medical Devices, SaMD, Digital Biomarkers and Digital Therapeutics. With a background in Product Design and more recent education in the behaviour sciences, Geraint focuses on bridging the gap between the opportunities offered by digital technology and the realities of human behaviour.

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  Stephanie Goebel, Dipl. Ing.

  Roche/Genentech

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  Stephanie Goebel, Dipl. Ing.

  Roche/Genentech

  Stephanie Goebel Senior Regulatory Program Director PTR Devices and Combination Products at Roche / Genentech Stephanie Goebel is a medical engineer with more than 15 years of experience in medical devices and combination products. She worked as auditor, technical documentation reviewer (MDD and ISO 13485) as well as product specialist on Article 117 (MDR) for a notified body and was a member of the Team NB (European Association of Notified Bodies) working group on Article 117 (MDR). As consultant, Stephanie supported clients in their transition to the MDR and/or quality system related activities though regulatory analysis, readiness audits/checks, document creation and personalized trainings. In her new role at Roche / Genentech, Stephanie will support end-to-end management of device regulatory strategies and implementation as well as building respective inernal regulatory capabilities.

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  Paul Greenhalgh

  Team Consulting

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  Paul Greenhalgh

  Team Consulting

  Paul has 20 years’ experience in the development of medical devices. Since joining Team Consulting in 2001 he has worked for some of the largest pharma companies and most innovative MedTech start-ups, developing ground-breaking solutions to improve the way healthcare is delivered. His experience spans a broad range of sectors, focusing on patient use products such as inhalers, injectors and consumer medical devices, as well as professional use systems including point of care diagnostics, surgical devices, and larger critical care systems for use in a clinical setting.

  As Design Director at Team, Paul has grown a group of specialists in industrial design, graphics and information, digital UX/UI and innovation – enabling them to create a coherent experience across all elements of a system and to tackle the complex human centred challenges that healthcare design brings.

  Paul is driven to develop solutions which provide the level of user experience we’ve come to expect from the very best consumer products, all while working within the tight constraints of a highly regulated industry.

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  Arnaud Guillet

  BIOCORP

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  Arnaud Guillet

  BIOCORP

  Currently VP Business Development at BIOCORP, in charge of seeking partnerships with pharma companies or disease management platforms to customize BIOCORP’s existing range of connected devices in the fields of injection and respiratory, and exploring opportunities for on demand programs. Before joining BIOCORP, he was a consultant for a firm specialized in Healthcare. He also worked in the pharma industry for Sanofi, and in the health insurance sector at AXA. In terms of academic background, he graduated from HEC, a European business school, with a major in strategy. He also has a degree in political sciences and public affairs.

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  Egmont Semmler, PhD

  TÜV Süd

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  Egmont Semmler, PhD

  TÜV Süd

  Dr. Egmont Semmler joined TUV SUD in 2019 as an expert in aseptic processing, sterilization and packaging with a strong focus on non-standardized applications in the medical device field and was appointed Team Lead Sterile Manufacturing in 2022.

  Before joining TUV SUD, Egmont was Director R&D Pharmaceutical Processes for Groninger & Co. GmbH driving developments in machine vision and connectivity, advanced sensor solutions and gas plasma decontamination barrier systems for isolator syringe tub transfer. His responsibilities included strategic R&D, technology scouting and quality assurance of single-use aseptic filling components. As a technical advisor he held internal and external trainings on regulatory requirements, pharmaceutical processes and best practices in the aseptic fill & finish area.

  Building on an experience of more than 10 years in the regulated pharma & life science sector he held different positions in technology transfer and science-to-business operations with a strong focus on medical and pharmaceutical applications, which also resulted in several patents.

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

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  Iain Simpson, PhD, MBA

  Phillips Medisize

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  Iain Simpson, PhD, MBA

  Phillips Medisize

  Iain Simpson is a Commercial Director at Phillips-Medisize, where he is part of a global team developing industry leading solutions and platforms for drug delivery, digital medicine and connected health. He has more than 30-years’ experience in multi-disciplinary technology and product development; the last 20 years have in healthcare and increasingly focused on the use of devices and digital technologies to create product differentiation, improve patient engagement and better measure clinical outcomes in real world settings.

  He has a degree and PhD in physics both from University College London and an MBE in Technology Management from the Open University. He has published and presented at conferences on drug delivery, digital biomarkers, healthcare technology and technology licensing. He is an associate lecturer at the University of Cambridge in Bioscience Enterprise.

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  Paul Upham

  Roche/Genentech

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  Paul Upham

  Roche/Genentech

  Paul is the Head of Smart Devices at Roche / Genentech. Paul has 20+ years of experience in medical device R&D, strategic marketing, product management, clinical research, and medical informatics.

  Prior to Roche / Genentech, Paul was with Becton Dickinson(BD), as Worldwide Director of Strategic Marketing in their Pharmaceutical Systems business.

  Paul was also the head of Product at WellDoc, Inc., where he led the product management activities for WellDoc’s portfolio of mobile health solutions. He was responsible for WellDoc’s landmark BlueStar™ product, a class II medical device and the world’s first reimbursed, prescription-only software for diabetes.

  Paul’s prior experience includes 10 years in BD’s Diabetes Care business. Paul was responsible for the award-winning BD InterActiv® Diabetes Software, and was a member of the BD / Medtronic team that launched ParadigmLink®, the world’s first wireless blood glucose meter.

  Paul holds four issued patents in medical software and drug delivery devices and has multiple patent applications. He is also an author of numerous peer-reviewed articles in medical informatics and diabetes. His education includes undergraduate studies in cognitive science and graduate work in health informatics and finance at the University of Minnesota and New York University.

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  Andrei Yosef, PhD

  LTS

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  Andrei Yosef, PhD

  LTS

  Dr. Yosef ist the General Manager of LTS. 
  Leading expert in drug delivery device market and high end technologies. Dr Yosef applies his industry knowledge in both technology and business to steer forward Eitan Medical to develop and commercialize novel drug delivery device. Dr Yosef founded several startup companies in the field prior to him joining Q Core Medical. He served in several executive positions at Q Core for a decade, before taking the helm at pharmaceutical solutions of Eitan Medical including Sorrel’s wearable injectors products. Dr Yosef holds a PhD in Biomedical Engineering and an MA in Mechanical Engineering, both from the Technion – Israel Institute of technology.