Welcome to the 4th edition of the Drug-Device Combination Products Summit, this time Online!
The annual Drug-Device Combination Products brings together generic or biologic drug and medical devices to deliver treatments effectively. Widen your horizons about these still relatively new delivery systems for the healthcare market.
New regulations and legal developments have improved the framework for combination product development and evolved the technology during the past few years. Therefore, that process increased technological requirements, as well as quality systems and lifecycle management.Read more
We will be streaming exclusively for our attendees, introducing the current state of combination products development, novel technologies, and regulatory challenges.
This webinar was designed for industry leaders and regulatory professionals.
During the webinar, you will have a unique opportunity to discuss the burning questions with our experts.
Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, Senior Managers, Principal Scientists, Chemists and Engineers specialising in:
Jakob Lange is an engineer and materials scientist by training with a master’s 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 more than 30 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. Currently he is a senior director of delivery systems, overseeing two teams of product managers, one managing Ypsomed’s autoinjector platforms and the other focussing on customer relationships for device development projects and marketed device products.
Ph.D. in Strategy and Organizations, Juan has specialized in regulatory compliance projects for devices and combination products, particularly focusing on the new Medical Device Regulation. Juan both leads and acts as subject matter expert in the MDR-remediation for pharmaceutical clients and the submissions for Notified Body Opinions for drug-device combinations.
Andrew is an experienced product developer; with world-class conceptual, engineering, and early development skills and a track record of delivering innovative drug delivery systems, including Smart Devices, Apps, and Connected Ecosystem Development.
An entrepreneurial and strategic thinker with expertise in ‘future-scaping’ both technical and business opportunities. Experience setting up and running technical design and development groups and leading global multi-disciplinary teams.
Andrew has worked for Novartis in Switzerland for the last 10 years, where he has been instrumental in building up their early digital device capabilities.
Susan Neadle joined Johnson & Johnson in 1995. Her distinguished career there includes integral leadership roles in R&D and Quality Engineering, spanning pharmaceuticals, medical devices, and consumer products sectors as well as J&J Enterprise. In her current role, Sr. Director, Global Value Chain Quality Design, she serves as Chair of J&J's Design Council, advancing world-class practices in product and process design and development to drive robust, customer-centric health care solutions across J&J. She also leads J&J's cross-sector Combination Products Community of Practice.
Among several achievements, Susan led the team that defined and implemented the globally integrated business model to meet the Combination Products' health authority regulations into J&J's Pharmaceutical sector (Janssen). She has applied her Design Excellence Blackbelt skills to drive and develop significant new products and business impacts. Her leadership, innovation, and best practices have been recognized with multiple awards, including the Johnson Medal, J&J's highest honor for innovation excellence. Susan holds numerous patents and publications and frequently speaks in public venues. She is actively engaged in several industry working groups on a range of Combination Products topics, including ASTM International, CPC, EFPIA, AdvaMed, Xavier/FDA Combination Products Summit Planning Committee, PDA and ISPE. She serves as Chair of the ISPE Combination Products Community of Practice and Vice-Chair of the Combination Products Coalition PMSR Working Group. Susan earned an M.S. in polymer science & engineering and a B.S. in biology/chemistry, as well as a Fellowship in the American Academy of Optometry. Prior to J&J, Susan held roles in materials analysis, product development, and commercialization at IBM, Unilever, and Organon Teknika.
Khaudeja is a Physician with a Masters in Clinical Research, Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional. She is an Abbott President’s award winner, avid Toastmaster and Coach. Khaudeja has more than 25 years’ professional experience, including clinical practice. She has held several global medical positions at Guidant, Abbott, and AbbVie Inc. Her career includes global medical / clinical and safety leadership roles in devices, diagnostics, pharmaceuticals and combination products. She currently serves as the chair for the Post Marketing Safety working group for the Combination Product Coalition (CPC).
Francesco Malavasi, is Life cycle Engineering specialist at Bayer Ag., is responsible for reconstitution kits and other parenteral products, life cycle management.
With 14 years of experience in medical devices and Combination products, he gained experience in all the LCM stages, from development till commercialization, passing through post-launch phases and scale-up activities.
Throughout his career, he has been involved in the development and commercialization of Autoinjectors, kits, Pen injectors, and other parenteral devices.
Francesco, besides an aeronautical background, holds a Bachelor in Engineering Management.
Kim is an Experienced Medical Devices and InVitro Diagnostics Executive Vice President with 26 years of working at the U.S. FDA Center for Devices and Radiological Health (CDRH) and working with Regulatory Agencies around the globe. Kim has industry experience as well as regulatory agency experience. Demonstrated history of working collaboratively with industry, regulators, and patient groups for the betterment of public health. Executes medical device regulatory services and recently developed a formal Education/Training business, as well as an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body in Ireland for EU IVDR/MDR Designation.
Kim is a recognized international expert in global medical device regulations, wrote and harmonized the US FDA Quality System Regulation 21 CFR § 820, and was on the international authoring group of ISO 13485 since inception. While at the US FDA conceived and developed the MDSAP international consortium of five Global Regulators, as well as its many foundational documents. She is a twenty-year veteran of the Global Harmonization Tasks Force (GHTF) and a foundational member of the International Medical Device Regulators Forum (IMDRF). Also a Medical Device expert on the Center for Drug Evaluation and Research (CDER) "GMPs for the 21st Century Initiative" Steering Committee and on the FDA authoring group for the Combination Product Good Manufacturing Practice (GMP) Part 4 regulation. Kim's last position at CDRH was Associate Director for International Affairs within the Office of the Director. Currently, at NSF International in the Health Sciences Division, Kim is leveraging her over thirty years of medical device sector experience to expand international regulatory affairs and compliance services for NSF International global clients.
Julia Frese is a biomedical engineer with a Master's degree in business administration. Julia gained experience in the development, regulatory approval of combination devices, and ATMP products. She was further involved in the development of standards for ATMP products. Currently, Julia Frese is heading the division of Medical and Health Services at TÜV SÜD Japan and is responsible for the development of article 117 service within the organization. She is further co-chair of the Team NB working group for article 117.
Didier Pertuy is vice president of drug-device integrated development & device strategy at Sanofi. He joined Sanofi in 2007 as vice president of global pharmaceutical sciences. Prior to joining Sanofi, he served in a number of senior management roles in new product development starting with 3 years at 3M Healthcare, then 10 years at E.MERCK, and finally 10 years at GSK. He has more than 30 years of experience in all aspects of pharmaceutical and biopharmaceutical drug product development activities including medical device development, ranging from research through development to final product commercialisation, and contributing to the development and launch of numerous new drugs including drug-device combination products. He is an engineer and holds a master’s degree in biochemistry from the Applied Sciences Institute (INSA) of Lyon, France and an advanced degree in pharmacology-toxicology from the University of Sciences of Lyon, France.
Mark A. Chipperfield spent 20 years working within large pharma (GSK, Sanofi Aventis, Novartis, Roche) in the field of drug delivery devices and special purpose packaging. Throughout his career, he has been heavily involved in the development of combination products in several forms: solution/suspension inhalers, multi-dose disposable and reusable dry powder inhalers, convenience kits, pen-injectors, auto-injectors, dispensers and special purpose applicators. Since 2015, he has been an independent consultant supporting pharma companies, suppliers and device innovators across the globe to develop, launch, and maintain their products.
Mark is responsible for the Health Solutions within Digital Health at TEVA Pharmaceuticals. Over ten years with TEVA 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. He 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 characterization, clinical evidence generation, registration within the US, EU, and International Markets, and ultimately, to successful global launch. Total Brand Leadership value >$2.5bn. 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.
Dr. Stefan Heck joined Intertek in 2014 and is currently responsible for business development, key account management, and the design and project management of technical analytical packages to help global clients meet their analytical and regulatory requirements. Mr. Heck has over 20 years of experience in project management and commercial roles across the pharmaceutical and chemical sectors and studied and earned his PhD. in organic chemistry at the Technical University in Darmstadt and Munich.
In several roles, Louis has worked for very small, medium-sized, and big organizations specialized in Medical Devices and Pharma. The last 22 years, he worked in the area of Quality Assurance and Regulatory Affairs. Before that time, he had roles in commercial environments as a specialist as well as in strategic marketing management functions in Life Sciences.
In his role as representative of the Quality Assurance and Regulatory Affairs functions within organizations, he focusses on the level of compliance to the relevant Legislations and conformity to Quality Standards in Medical Devices and related subjects. Beyond many other things, Louis is regularly involved in the assessment of Product Technical Documentation and Quality Management Systems and performs implementation audits.
It is his experience that the level of conformity to the requirements, and therefore the effectiveness and legal as well as economic efficiency, a critical dependent is on the way usability and user-friendliness are built in the system.
Louis is a certified trainer of one of Europe’s leading Notified Bodies involved in Medical Device as well as IVD Legislation, Risk Management, Process Validation, and (Lead) Auditing.
Frans Branten holds the position of Strategic Business Manager at IGS GeboJagema. With a mechanical engineering background and over 30 years of experience in the high-tech industry, his role is to further develop the relationships with our customers into partnerships, expand our business with existing customers and explore opportunities in the market. With a focus on the healthcare industry, IGS GeboJagema is one of the leading experts for the design, manufacturing, and validation of high-precision injection moulds.
With our skillset and our 120 Fte strong team, we are able to support our customers during the early days of product development onto the delivery of complete validated injection moulding cells that work out of the box.
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Thanks Dana Shapoval for a great event and the opportunity to join the great Susan Neadle, Mark A. Chipperfield, Mike Wallenstein, Roman Mathaes as speaker! An absolute pleasure to participate in this live event with you!
I absolutely enjoyed this meeting with such focused topic.
This webinar was very informative, speakers had valuabe information to share regarding this very relevant topic! Thank you all.
Thank you for your interest!
Apr 20, 2018
2nd Annual Drug/Device Combination Products Summit