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Committee & Speaker Biographies

Committee & Speaker Biographies

2020 PDA Europe Medical Devices & Connected Health

Online Conference, 8-9 September 2020

  • Markus Bauss

    Markus Bauss

    SHL Connect, 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.

    Markus graduated from Clausthal University of Technology with a degree in Process Engineering and Chemical Engineering.

  • Iain Simpson

    Iain Simpson, PhD

    Phillips Medisize

    Iain is a motivated and commercially focused professional with 20 years’ experience in delivering innovation to the pharmaceutical and MedTech sectors, particularly around the development and use of devices and digital technologies to improve patient engagement and better measure clinical outcomes.

    He has been a long-term supporter of PDA as speaker, program planning committee member, and Iain is the conference chair of the inaugural conference of Medical Devices and Connected Health.

  • Lauren Bataille

    Lauren Bataille, MS

    Novartis

    Lauren is Director, Digital Strategy Lead - Clinical Trial Innovation at Novartis. She designs and leads multi-stakeholder digital health initiatives focused on data generation, curation and analysis.

    Lauren has extensive experience in strategy and roadmap development, partnership cultivation, and the design, implementation, and evaluation of innovative research programs.

  • 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.

  • Paul Upham

    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.

  • Fiona Adshead

    Fiona Adshead

    Sustainable Healthcare Coalition

    Fiona chairs the Sustainable Healthcare Coalition that inspires partnerships and action on sustainable healthcare. She also works as an independent expert advisor and board member for national and global organisations. This includes advising on person centred care, promoting health through business, economic and sustainability strategies, wellbeing at work, and technological transformation of health services.

    Her previous roles include: Deputy Chief Executive of the global NCD Alliance leading strategic and commercial partnerships, strategy and governance; Bupa’s Chief Wellbeing and Public Health Officer leading global commercial strategy on workplace health and wellbeing, behaviour change, partnerships, and sustainability; Director at PricewaterhouseCoopers consulting on health and sustainability.

    She is a high profile wellbeing and public health leader with a track record of reframing thinking and developing innovative strategy and programmes at the heart of business and government. A strategic systems thinker she is able to bridge private, public and third sector environments, delivering social change and business benefit.

    Fiona is a visiting Professor at UCL and teaches at Cambridge Institute for Sustainability Leadership. Her recent board roles include British Land’s Sustainability Advisory Panel, Marks and Spencer’s Sustainable Retail Advisory Board, and Business in the Community’s Wellbeing Leadership Team.

  • Mark Birse

    Mark Birse

    Parexel

    As part of the Regulatory Consulting Services group, Mark helps implement knowledge-centered activities, innovate methodologies and service offerings to expand Parexel’s global regulatory and compliance consulting services.

    He is developing and implementing business solutions addressing specific client needs using expertise, best practices and knowledge of the client’s business and key industry drivers. Mark is eligible to be named as a Qualified Person under Directive 2001/83/EC.

  • Daniel Cooper

    Daniel P. Cooper

    Covington & Burling LLP

    Daniel Cooper advises clients on information technology regulatory issues, particularly data protection, e-commerce and data security matters. He has personally managed five BCR applications in the past few years, engaging with the Belgian, Irish and UK authorities.

    Mr. Cooper has deep experience with the regulation of mobile and e-health technologies. He regularly assists leading technology companies, including social networking sites, online content and entertainment providers, and e-shopping sites, on their European and global compliance strategies.

    He is also known for his ability to guide clients through the issues arising from data breach incidents, and has advised a number of high-profile clients in this area.

    Mr. Cooper is qualified to practice law in the United States, the United Kingdom, and Ireland, and has been working in the data protection field since 1998.

  • 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.

  • David Dixon

    David Dixon, MSc

    Merck KGaA

    David Dixon holds an Master’s Degree in Information Systems and Management Studies from Kingston University. He has over 10 years of experience in the healthcare and pharmaceutical industry working for diverse organisations including digital health start-ups, large MedTech and pharma, as well as the public health sector (NHS).

    He is a strong advocate of lean and agile methodologies and is a big believer in keeping things simple, starting small and scaling fast.

    David is now a Senior Product Manager for digital health solutions in the Connected Health and Devices unit at Merck. He manages the product roadmap and strategy for the company's digital health initiatives, to build best in class patient-centric digital solutions designed to improve the treatment experiences and outcomes for people living with chronic diseases.

  • Stephanie Göbel

    Stephanie Goebel, Dipl. Ing.

    BeyondConsulting

    Stephanie was auditor within the department of active medical devices TÜV SÜD Product Service GmbH for several years before founding her own consultancy.

    Apart from her role as auditor, Stephanie has gained experience in various positions within the medical device and pharmaceutical industry for more than 10 years: as development engineer in the field of bioresorbable implants and as quality manager in the field of in-vitro diagnostic devices and drug-device combination products.

    Stephanie studied medical engineering at the Technical University Munich (Germany), at the University of Applied Sciences Ulm (Germany) and at the University of Bradford (UK); She holds an engineering degree in medical engineering.

  • 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.

  • Christoph Herdlitschka

    Christoph Herdlitschka

    Wilco

    Christoph Herdlitschka has more than 10 years of experience with pharmaceutical fill and finish solutions, including CCIT and inspection, gained as technical sales and project manager at Bausch+Ströbel and Wilco.

    He studied industrial engineering at the University of Cooperative education Baden-Württemberg, Germany and the Technologico de Monterrey, Mexico. He holds a Master's degree in Business Administration from the Zurich University of Applied Sciences, Switzerland.

    Since 2016, Christoph has been in charge of product management at Wilco AG, Switzerland. In this function, he is responsible for product strategy, roadmapping and innovation management.

    In January 2019, he became the head of marketing and product management at Wilco.

  • Oliver Hilgers

    Oliver Hilgers

    CEplus

    Oliver Hilgers is the Head of the Active Medical Devices Team at CE plus, a regulatory service provider located in Germany.

    Oliver is Regulatory Expert for Medical Device Software / Digital Health and looks back on 10+ years of experience in CE-marking digital products.Being a member of several European regulatory committees helps him to discuss the latest trends and software practices and to transfer his experience to the clients. This includes classical Medical Device Software as well as Digital Therapeutics, Digital Biomarkers or AI-driven software.

    Oliver´s passion is to support Digital Health companies to make sure that innovative software reaches the patient´s computer or smartphone quickly and safely.

  • Christian Kollecker

    Christian Kollecker

    Harro Hoefliger

    Christian Kollecker is working in the aseptic and liquid filling business for over 11 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.

  • Quentin Le Masne

    Quentin Le Masne, PhD

    Merck KGaA

    Quentin Le Masne holds a Master’s Degree in Engineering from Ecole Centrale de Paris and a PhD in Physics from Paris University. He worked in various positions in the field of medical devices, leading engineering teams with diverse expertise like electronic, mechanics, human factors, physics and manufacturing to bring new products in the doctor’s and patient’s hands.

    Quentin is now in charge of the Product Development team in the Connected Health and Devices unit at Merck. This team leads the development of novel electronic injectors, connected devices and software as a medical device in various therapeutic areas with a special focus to extend the portfolio of connected & digital health solutions at Merck.

  • Mark Milton Edwards

    Mark Milton Edwards, MBA

    TEVA Pharmaceuticals

    Mark is responsible for the Health Solutions within Digital Health at TEVA Pharmaceuticals.

    He has been with TEVA over ten years and prior to that sixteen with AstraZeneca.

    Mark has held various positions including R&D Project Leader, VP Sales & Marketing, Strategic Planning & Business Development, and Global Brand Lead.

    Mark graduated in Aeronautical Sciences and completed his MBA at Durham University, UK. During his career, he has led technology & especially inhaler development teams through engineering, CMC characterisation, clinical evidence generation, registration within US, EU and International Markets, and ultimately to successful global launch.

    Mark has numerous patents granted and pending in electronic communications, sports technologies, inhaled pharmaceutical development, and respiratory physiological function & predictive AI. Mark is the inventor of Digihaler®, the first FDA approved digital inhaler with built-in sensors.

  • John Mulcahy

    John Mulcahy

    HeatlhGenuity

    John Mulcahy is founder of HealthGenuity, who enable Medical Device Vendors, Pharmaceutical companies, and healthcare providers to develop and deliver care services enabled by software and connected medical devices.

    He is also Chairman of MIOTify, a digital health startup that enables companies to rapidly create high-quality compliant software medical devices.

    Prior to this, John was the global head of eHealth and patient care in Merck; providing patient-centered care services into 40 countries enabled by digital health and connected medical devices. John joined Merck from S3 Connected Health, where he led the Telehealth organization that developed and deployed remote patient monitoring solutions at scale.

    Altogether, John’s teams have launched digital health solutions to 40 healthcare systems in innovative care and business models.

  • Scott Mullen

    Scott Mullen, MBA

    Ascendis Pharma

    Scott is currently the commercial lead for connected healthcare projects at Ascendis Pharma. Prior to joining Ascendis, he was employed at Bayer as the brand lead for Betaseron (interferon beta-1b), where he led the U.S. launch of the BETACONNECT connected healthcare system. His prior work includes positions with prominent pharmaceutical companies such as Novo Nordisk, Merck, and Wyeth.

    Now in his 29th year of working in the pharma industry, Scott brings a broad, cross-functional background to the connected healthcare field. His past roles include experience in pharma manufacturing (both solid dosage forms and sterile products), as well as roles in market research, medical education, field sales and brand marketing leadership.

    Scott is an expert on managing the logistics and roll-out of connected healthcare systems, his current focus is on the utilization of patient-generated data in areas beyond the adherence monitoring role it has traditionally fulfilled. He holds a BSc in Biology and an MBA in Marketing, both from Syracuse University.

  • Andreas Schneider

    Andreas E. Schneider, PhD

    Ypsomed AG

    As Innovation & Business Development Manager, Andreas is responsible for the design and development of new business models and platform devices with a particular emphasis on connected and smart device systems. Furthermore, he co-leads Ypsomed’s research & science program with the objective to advance new insights around self-injection devices that prove relevant to both industry and academia. Andreas has published various articles in refereed journals and held conference speeches in the area of innovation management and drug delivery, including a presentation at last year’s PDA Universe of Pre-Filled Syringes and Injection Devices in Vienna 2017. He received his PhD in Innovation Management and Organization Sciences from ETH Zurich.

  • Yves Streffen

    Yves Steffen

    Novartis

    Yves Steffen has over 16 years of experience in the pharmaceutical industry holding various positions. His career started at Cilag AG (a Johnson& Johnson company) as a project engineer where he was responsible for installation, qualification and validation of aseptic filling, visual inspection and packaging lines.

    In 2006, he joined Novartis being first responsible for technical services at the production site in Switzerland and then moving into a role responsible for product transfers and launches for biopharmaceuticals.

    In 2014, he established a devices and packaging commercialization group first for biosimilars and later for biologics at Novartis. As per today, Yves is responsible for the commercialization of medical devices and combination products at Novartis.