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September 24-26
San Diego, USA

Be part of the device engineering evolution: 
From PFS to smart injectors to delivering
quality patient care

AgendaSpeakers

Speakers

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Ellie Younger
Human Factors and Device Development Lead
Biogen

Ellie Younger is currently a combination product lead with a specialization in human factors and risk management.  She uses a human factors approach to recommending the right device for the right user and then navigates getting the final product approved and into the market.  She’s assisted both software and device teams through formative and summative studies to support product selection, design changes and regulatory approvals.  In her spare time, she is a lover of science fiction and is on the senior leadership team of a fan-run convention.

Day Two

Thursday 26th September 2019

11:50 am | Panel Discussion: Enhancing Your Combination Products Usability and Functionality

Ben Creelman
Technical Officer
PATH

Day Two

Thursday 26th September 2019

3:00 pm | Chair’s Closing Remarks & End of Conference

9:00 am | Chair’s Opening Remarks

Jerzy Wojcik
Senior Director, Regulatory Affairs and Quality Assurance
EdgeOne Medical

Day Two

Thursday 26th September 2019

11:50 am | Panel Discussion: Enhancing Your Combination Products Usability and Functionality

Daniel Latham
Head of Device Development & LCM
Novartis

Daniel Latham is the Head of Device Development & LCM,  where he leads an organisation of around 120 associates responsible for the development and life cycle management of delivery systems of drug/device combinations for both new biologic entities, biosimilars, and new chemical entities. Over the past 12 years at Novartis, he has overseen significant device and primary packaging developments and launches and has significantly supported the growth of device development and drug/device interaction within the organisation. Prior to Novartis, he worked in a variety of roles in consumer health­care, focusing on the development of OTC medicines, transdermal patches, and medical devices. He has a Ph.D. in controlled drug delivery from Queen Mary, Uni­versity of London and a bachelor’s degree and master’s degrees in engineering from the University of Sheffield.

Day One

Wednesday 25th September 2019

12:10 pm | Panel Discussion: Human Factors Considerations for Connected Injection Devices

Day Two

Thursday 26th September 2019

1:30 pm | It’s Time to Innovate – How Can Pharma Manage the Introduction of New Technologies Efficiently to Best Meet the Needs of Patients?

Delma Broussard
Director, Medical Devices & Combination Products PV Expert
CSL Behring

Delma L. Broussard, MD is an industry leader with 20 years of professional experience in risk management of drugs/biologics, medical devices and biologic/device combination products either in Pharmacovigilance (PV) directly, or as part of Regulatory Affairs and Medical Affairs/Clinical development positions.  She serves as Director, Medical Devices & Combination Products PV Expert at CSL Behring, and is responsible for leading the Medical Device & Combination Product Center of Excellence. Delma provides safety expertise to project teams and global regulatory groups for the implementation of medical device-biologic combination product regulations. She provides clinical knowledge for the creation and maintenance of design history files in collaboration with Quality and Engineering. Delma utilizes sound medical judgment for the assessment of safety signals and medical device trends, in addition to guiding the evaluations of expedited reporting and reportable malfunctions for ICSRs (across a broad range of therapeutic areas). In her prior roles, she served as subject matter expert for safety relevant discussions with global regulatory agencies to successfully gain marketing authorization approvals,  negotiate label revisions and clinical study designs (including postmarketing commitments). She is an adept cross-functional navigator with a good understanding of organizations to build successful relationships with internal and external stakeholders. Earlier in her career she held senior positions at major pharmaceutical companies, including Merck and J&J.  Delma holds a Doctor of Medicine degree and is board certified in pediatric gastroenterology. She is a former Associate Professor at University of Pennsylvania School of Medicine, with publications in peer reviewed journals. She is an active speaker/panelist on safety regulations for medical devices and combination products.

Day One

Wednesday 25th September 2019

9:10 am | Opening Address: Understanding the FDA’s Expectation for Postmarketing Safety Reporting (PMSR) for Combination Products

Dennis Lee
Senior Program Officer, CMC
Bill & Melinda Gates Foundation

Dennis Lee is a Senior Program Officer in CMC at the Bill & Melinda Gates Foundation, where he provides product development support for vaccines and drugs, with a focus on long-acting and other advanced drug delivery technologies. He began his career as a medicinal chemist with the SmithKline Beecham (a GSK legacy company). In 1999, Dennis relocated to the San Francisco Bay area as Director of Chemistry at Sunesis Pharmaceuticals, a start-up that developed molecular fragment-based approaches for drug discovery. He returned to GSK in 2001, and led a chemistry department in cardiovascular and urogenital diseases. Over the next several years, his group progressed several compounds into clinical development. In 2008, Dennis became Head of Chemistry and Preclinical Development in the new Ophthalmology unit at GSK. He contributed to the formation and evolution of the Ophthalmology business strategy, co-managed the discovery portfolio, and implemented and executed the drug delivery strategy for retinal diseases. He then joined GSK’s Discovery Partnerships with Academia, in which he and a group of senior drug discovery scientists identified and executed drug discovery collaborations with individual academic groups. In 2014, he became Director of Drug Delivery, Platform Technology and Sciences, a newly-formed drug delivery group, whose mission was to seek and develop novel drug delivery technologies that align with GSK’s portfolio. He relocated to Seattle to join the Gates Foundation in Jul 2018.  

Day Two

Thursday 26th September 2019

2:00 pm | The Bill & Melinda Gates Foundation’s Efforts in Supporting Innovations in Injectable Development

Mayumi Bowen
Senior Engineer
Genentech

Mayumi is a Senior Engineer in the Pharmaceutical Process Development Department at Genentech. She was born and raised in Japan, and earned B.S and M.S. in Material Engineering from Tokyo University of Science.  She has more than 20 years of biopharmaceutical and pharmaceutical industrial experience in the development and commercialization of drug, biologics, and biologics/device combination products, focusing on device sterilization, aseptic drug filling, and drug liquid/lyophilized formulations, has published 13 peer-reviewed papers and holds 4 international patents for her work.

Day Two

Thursday 26th September 2019

10:20 am | Lesson Learned in Developing an Ocular Injections

Erik Jin
Engineering Fellow, Combination Products & Device
Celgene

Day One

Wednesday 25th September 2019

12:10 pm | Panel Discussion: Human Factors Considerations for Connected Injection Devices

Darin Zehrung
Senior Program Director
PATH

Day Two

Thursday 26th September 2019

2:30 pm | Spotlight: PATH’s Initiatives in Developing Next Generation Injectables – The Journey from Needle Free to Microarray Patches

Jian Liu
Senior Scientist, Process Development
Amgen

Jian Liu is currently Senior Scientist, Process Development at Amgen working on extractables/leachables assessment and nonconformance investigations related to clinical and commercial products.

Day Two

Thursday 26th September 2019

11:20 am | A Strategic Approach to E&L Execution

Calvin Clark
Device Design & Development Engineer
Biogen

Day Two

Thursday 26th September 2019

9:10 am | Biogen’s Journey in Primary Container Development to Support Injectable Device and Therapeutic Progresses

John Majewski
Device Development Engineer
Gilead Sciences

John Majewski is a Device Development Engineer at Gilead Sciences in Foster City, CA. He joined Gilead in April 2018, where he develops drug-device combination products with a focus on patient-centered design. His experience ranges from early technical feasibility to commercial device support. John has expertise in injection, respiratory, and nasal devices across multiple therapeutic areas. Prior to joining Gilead, he worked at Teva Pharmaceuticals designing novel inhaler technologies and at Dexcom Inc. in manufacturing and process development for next generation continuous glucose monitors. John holds a Bachelor’s degree in Biomedical Engineering from the University of Virginia and a Master’s degree in Medical Device Engineering from UC San Diego.

Day Two

Thursday 26th September 2019

9:40 am | Exploring Device Design Space with In-Silico Subcutaneous Injection Modeling

Richard Featherstone
Research Director – Human Factors Research & Design
Emergo by UL

Richard Featherstone is Research Director, Human Factors Research and Design for Emergo by UL. Based in Cambridge UK, Richard has nearly 20 years of experience of usability research with a special interest in combination products such as autoinjectors and breath-actuated inhalers. Prior to his usability work, Richard worked for 20 years in a variety of roles in the pharmaceutical industry, and pioneered some of the early work on using observational data to compare outcomes for different types of pharmaceutical devices. He speaks internationally on the application of human factors to medical devices and leads Emergo’s human factors activities in Europe. Richard has more recently been instrumental in developing human factors testing methodologies for connected devices such as mobile apps and electromechanical autoinjectors for some of the world’s largest pharmaceutical and software companies.

Day One

Wednesday 25th September 2019

12:10 pm | Panel Discussion: Human Factors Considerations for Connected Injection Devices

Timothy Quigg
Program Development Lead
Crux Product Design Ltd

Day One

Wednesday 25th September 2019

2:20 pm | Expertise Talk: Digital Transformation: The New State-of-Art in Device Development

Joel Gresham
Simulation Expert
Crux Product Design Ltd

Day Two

Thursday 26th September 2019

9:40 am | Exploring Device Design Space with In-Silico Subcutaneous Injection Modeling

Paul Upham
Head, Smart Devices
Roche/Genentech

Day One

Wednesday 25th September 2019

1:50 pm | Selecting a Digital Health Partner to Deliver Business Value with Connected Devices

12:10 pm | Panel Discussion: Human Factors Considerations for Connected Injection Devices

Karthik Balasubramanian
Associate Director, Global Device R&D Operations
Teva Pharmaceuticals

Dr. Karthik Balasubramanian, Ph.D is an associate director in Global Device R&D Operations at Teva Pharmaceuticals. He has over 15 years of experience in all phases of medical device and combination product development, from R&D to Technical Operations. Prior to joining Teva, he has worked in numerous device areas in roles of increasing responsibility, from syringes to large scale diagnostic systems, as well as in sterile injectables and radioactive contrast imaging devices. He has a bachelors in Biomedical Engineering from Columbia University, and a Ph.D in Mechanical Engineering from Drexel University.  

Day One

Wednesday 25th September 2019

3:20 pm | Commercialization of Your Combination Products – From Proof-of-Concept to Operations

Stuart Chisholm
Senior Manager, Global Devices R&D Operations
Teva Pharmaceuticals

Stuart Chisholm, BEng(Hons)  is a Senior Manager in Global Device R&D Operations at Teva Pharmaceuticals. He has over 9 years of experience in all phases of medical device and combination product development, from R&D to life cycle management. Prior to joining Teva, he has worked with products from airway medical devices to complex sterile injectables. He has a bachelors in Design Product Development from University of West of Scotland.  

Day One

Wednesday 25th September 2019

3:20 pm | Commercialization of Your Combination Products – From Proof-of-Concept to Operations

Christina Stefan
Senior Design Researcher
Design Science Consulting

As a Senior Design Researcher at Design Science, Christina regularly bridges research and design teams to bring clarity to complex processes. She joined Design Science after receiving her BS in Industrial Design from University of the Arts. As part of her day-to-day work, Christina contributes to the development of information for use, research deliverables, and data analysis. Outside of work, Christina is passionate about environmental conservation and education, where she uses her expertise as a design researcher to engage with the community in impactful ways.  

Day Two

Thursday 26th September 2019

11:50 am | Panel Discussion: Enhancing Your Combination Products Usability and Functionality

Thomas Altobelli
Senior Manager, Device Quality & Risk Management
Janssen Pharmaceuticals

Day One

Wednesday 25th September 2019

9:40 am | Why Risk Management is Key to Support Your Next Generation Injectable Development

Leonel Vanegas
Former Director, Global Quality Devices & Combination Products, Principal
Merck, ResMedica Consulting

Day One

Wednesday 25th September 2019

11:40 am | How Quality Can Help Drug and Device Teams to be Agile

Henri de Parseval
COO Engineering & Industries
Crossject

Day One

Wednesday 25th September 2019

3:50 pm | Innovation Talk: Needle-Free Differentiation: A Glass Primary Packaging as the Make-or-Break?

Steven Badelt
Founder & Managing Partner
Suttons Creek, Inc.

Steve is a seasoned expert in combination products, engineering management, systems engineering, and business development. He has over 20 years of experience in the design and launch of combination products and medical devices, including autoinjectors, insulin pumps, implantable defibrillators, connectivity, and patient management software. Steve founded consulting firm Suttons Creek, Inc. six years ago, which serves as the device team for pharma on over 50 combination product programs. In his spare time, Steve advises several startups, speaks nationally about combination products and connectivity, and serves as a Graduate Professor at Loyola Marymount University.

Dirk Kreder
General Manager & President of the Board
anteris helvetia AG

Dirk is a seasoned team leader of pharmaceutical and medical device development teams gone entrepreneur. With more than 15 years of experience in small and mid-sized biotech, and global pharma in the US and Europe, Dirk has been focusing on medical device and biopharmaceutical drug development and registration. He has extensive experience in product development, including novel antibody drugs, biosimilars, complex generics, drug-device combination products and medical devices. Dirk is a recognized and successful leader of projects across diverse organizations in the North America, Europe and Asia. Prior to founding anteris medical GmbH, Dirk was the Alliance Manager at Sandoz and Global Decision Support Manager at Novartis.

Day One

Wednesday 25th September 2019

5:00 pm | Chair’s Closing Remarks & End of Day 1

9:00 am | Chair’s Opening Remarks

Thierry Jomini
General Manager
anteris helvetia AG

Thierry has more than 12 years of experience in product and project management in the LS industry. He's led product development, industrialization and marketing of injection devices and combination products for diabetes, Parkinson's and many other therapies. He has extensive experience in specification DHF structure, labelling, marketing and sales of combination products and injection devices, supported with deep understanding of regulatory affairs. Prior to joining anteris helvetia, Thierry was the Product Manager of Delivery Systems at Ypsomed AG and Project Manager at Frewitt SA.