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Parenteral Drug Association Connecting People, Science and Regulation ®

2018 PDA Combination Products Workshop

October 10, 2018, Orlando, FL

Speaker Biographies

  • Eric Chanie

    Eric Chanie

    Merck Group

    After an electronic engineering degree in France complemented by an MBA in Marketing, Eric 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 more recently got much more involved in business development and technology scouting in the space of digital health, AI & digital therapeutics.

  • Alastair Clarke

    Alastair Clarke

    Weaver Technical Solutions LTD

    Alastair Clarke has worked in the pharmaceutical industry for over 25 years with experience in respiratory, semi-solid and sterile liquid technology areas, becoming a strong protagonist for robustness in all aspects of technology and product development from strategy, through innovation to industrialization and scale-up.

    Latterly, Alastair setup his own consulting business to assist companies develop and implement product strategies, solve technology development problems, enhance development creativity and optimize processes. He has worked for a number of large pharmaceutical companies and during his time in industry he contributed significantly to his employers’ patent inventories, facilitated and implemented franchise strategy and delivered both sustainable organisations and a number of drug delivery platforms, which have made their mark in the industry.

    Alastair graduated in Mechanical Engineering, gaining a broad grounding in the oil and automation businesses and returned to full time education to study for a Masters in Engineering Design Management from Loughborough University.  A Chartered Engineer he is a Fellow of the Institute of Mechanical Engineers.

  • Sugato De

    Sugato De

    Parexel International

    Sugato De is a Principal Consultant at PAREXEL Consulting with wide-ranging experience in the development and regulation of medical devices and in the creation and implementation of scientific and regulatory policy.  Mr. De has greater than 11 years of experience in the Center for Devices and Radiological Health (CDRH) at the FDA and has specialized expertise in the development of performance assessment methodologies for drug-delivery systems and in the development of clinical trials to establish the safety and efficacy of medical devices.  He also served as CDRH’s lead representative on the review of over 50 combination product reviews submitted via INDs, NDAs and BLAs and has comprehensive knowledge of regulatory strategies for the approval of these products.  As a Senior Policy Advisor in the Office of the Center Director, Mr. De was heavily involved in the development of new policy development for combination products.  Mr. De uses his extensive scientific, technical, device development and regulatory experience to assist clients in the development of nonclinical and clinical development plans and regulatory strategies with FDA to achieve their company objectives.

  • Carolyn Dorgan

    Carolyn Dorgan, BBME, MS

    FDA

    Mrs. Dorgan serves as a Senior Lead Reviewer and Combination Products Team Lead in the General Hospital Device Branch in CDRH’s Office of Device Evaluation.  Within the Agency, Carolyn serves as the Agency’s standards liaison for over nine international standards, is part of the team developing three device specific guidance documents, participates on the Pediatric Steering Committee, and is a member of the Pediatric Extrapolation Review Committee. Prior to joining the FDA, Carolyn worked in the medical device industry for 5 years as an engineer. Carolyn earned her Bachelor’s Degree in Biomedical Engineering from the University of Minnesota and her Master’s Degree in Technology Commercialization from the University of Texas.

  • Dana Fashina

    Dana Fashina

    Sanofi

    Dana Fashina is medical device expert specializing in design, development and production of complex medical device systems. She has spent over a decade working across multiple fields within the Medical Device industry ranging from Robotic Assisted Surgery (RAS) systems at Medtronic to specialty MRI machines and Surgical Navigation systems at GE Healthcare.

    Dana currently works as the Manager of Software Quality at Sanofi Medical Devices where she leads the product quality team, focusing exclusively on Software as Medical Device (SaMD) and Digital Health Mobile Apps that integrate with drug delivery systems.

    She also serves as the subject matter expert for Software Quality in the Medical Technology (MedTech) group within Sanofi, providing teams with guidance and know-how recommendations for New Product Development and 3rd party software applications.

    Dana has an Electrical Engineering degree from Johnson & Wales University and an early master’s degree from MIT.

  • Paul Jansen

    Paul Jansen, PE

    Haelmeier

    Paul Jansen is currently Board Member & Snr Advisor with Haselmeier.  He also sits on the Board of Subcuject.  He was formerly Associate Vice President, Medical Device Development, Sanofi until his retirement in January 2017. Mr Jansen is a Professional Engineer with more than 30 years of experience in medical devices.  He completed his degree in mechanical engineering and has completed graduate work in biomedical engineering at the University of Toronto.

    Mr Jansen is a member of the International Standards Organisation and is currently Chair Elect of TC84.  He often convenes working groups within TC84 and is currently the Convenor for WG15 – ISO 20069: Assessment & Evaluation of Changes to Drug Delivery Systems.

    Mr Jansen has extensive experience in the design, development, manufacturing and lifecycle management of medical devices. Mr Jansen has several patents to his name and has deep experience in the creation and management of intellectual property portfolios.  He has successfully led teams that have developed and launched several award winning devices, including Lantus SoloStar the world’s most popular insulin pen injection device. In addition, he has expertise in the design and development of injection moulding systems and electronic components.

  • 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.

  • Paul Schultz

    Paul Schultz

    Flex

    Paul Schultz, Head of Partnerships, Flex Digital Health, has over 10 years of experience in the pharmaceutical, medical device and digital health industries. Paul started his career as a management consultant for the leading global life science consulting firm, Campbell Alliance (now Syneos Health) where he spent 4 years supporting global pharma and medtech clients, including leading numerous digital health initiatives. Paul then co-founded Nurep, a digital health startup with a vision of disrupting the $30B medical device sales rep market. Paul took Nurep from concept to clinical validation over 5 years in partnership with a large academic medical center and a leading medical device company while raising several million in funding from top early-stage investors. After Nurep, Paul was an entrepreneur-in-residence at Stanford StartX Med, the Stanford affiliated start-up accelerator, supporting their Med portfolio with strategic initiatives and partnerships. Paul is now the Head of Partnerships at Flex Digital Health, leading the partnership with Google in addition to other key strategic partnerships.

    Paul holds a Master in Business and Science from Keck Graduate Institute, a member of the Claremont Colleges, and a Bachelor of Science in Biotechnology from Washington State University.

  • Beat Steffen

    Beat U. Steffen

    Confinis AG

    Beat holds an MSc in electrical engineering, an Executive MBA and has 20+ years of experience in the development, registration and lifecycle management of medical devices and combination products. In 2005, Beat founded confinis, a global regulatory consulting firm based in Düdingen (Switzerland) and North Potomac, MD (USA). During this time, he has played a key role in obtaining marketing authorization for many combination products that were approved in the EU and the US, both for originator and generic/biosimilar drugs/biologics. Beat is also a lead auditor regarding ISO 13485, Directive 93/42/EEC and MDSAP (Medical Device Single Audit Program) for a Swiss Notified Body and a German Certification Body. In 2016, he co-founded Medical Human Factors (medHF), a company specialized in evaluating the use related safety, effectiveness and usability of medical products based in Lucerne (Switzerland), Hamburg (Germany) and London (UK).

    Prior to 2005, he worked for Disetronic and Ypsomed where he was responsible for a number of development projects for both small and large pharma/ biotech companies, which ranged from conception to successful registration and commercialization.

    Beat is also a co-author of the “Combination Products” chapter of Fundamentals of International Regulatory Affairs, Fourth Edition (RAPS) and is an expert representing Switzerland in ISO TC 84 regarding needle-based injection systems.