Speakers

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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 Two

Thursday 26th September 2019

1:40 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, Clinical Safety Physician
CSL Behring

Delma L. Broussard, MD is a Director, Global Clinical Safety & Pharmacovigilance Physician at CSL Behring.  Dr. Broussard received her Bachelor’s and Medical Degrees from Harvard University, and completed Pediatric residency and Gastroenterology training at the Children’s Hospital of Philadelphia. Her Industry career has spanned 20 years in Risk management of drugs/biologics and medical devices either in PV directly, or as part of Regulatory Affairs or Medical Affairs/Clinical development positions. She currently has a strategic role at CSL Behring, under the Chief Safety Officer, focusing on Clinical safety of combination products and medical devices.  Earlier in her career, she held senior roles at major pharmaceutical companies, including Merck & JNJ. Delma is a board-certified pediatric gastroenterologist, formerly Associate Professor at University of Pennsylvania School of Medicine, with publications in peer-reviewed journals. Interested Topics Pharmacy and Medicine, Risk Management, Biotechnology, Biopharmaceuticals, Research and Development, Medical Device, Post-marketing safety reporting/surveillance, Connected Health/Digital Health

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

2:10 pm | The Bill & Melinda Gates Foundation’s Efforts in Supporting Innovations in Injectable Development

Erik Jin
Engineering Fellow, Combination Products & Device
Celgene

Day One

Wednesday 25th September 2019

12:20 pm | Quick Fire: How to Lay a Solid Foundation to Support a Robust Injectable Design

Darin Zehrung
Senior Program Director
PATH

Day Two

Thursday 26th September 2019

2:40 pm | Spotlight: PATH’s Initiatives in Developing Next Generation Injectables – The Journey from Needle Free to Microarray Patches

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

1:50 pm | Panel Discussion: Human Factors Considerations for Connected Injection Devices

Timothy Quigg
Senior Mechanical Engineer
Crux Product Design Ltd

Day One

Wednesday 25th September 2019

3:10 pm | Expertise Talk: Device Development Using In-Silico Techniques within an FDA Framework

Joel Gresham
Senior Mechanical Engineer
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

2:40 pm | Selecting a Digital Health Partner to Deliver Business Value with Connected 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 Two

Thursday 26th September 2019

11:10 am | 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 Two

Thursday 26th September 2019

11:10 am | Commercialization of Your Combination Products – From Proof-of-Concept to Operations

Katie Hansbro
CEO
Design Science Consulting

Katie Hansbro is the CEO at Design Science Consulting in Philadelphia, PA, where she manages all facets of human factors research including contextual inquiry and usability studies, labeling and instructional video development. Prior to joining Design Science, Katie spent 10 years at Baxter in research and development for the transfusion therapies, medication delivery, and renal therapies divisions. As a systems engineer, she worked closely with the human factors, clinical, and marketing teams to determine and validate user needs. Katie served as the Lead System Designer for a Baxter Top Project and received Baxter’s Innovation Award in 2012. Katie sits on the Human Factors Engineering and Home Care committees for AAMI and is the Vice President of Membership for the Philadelphia PDMA chapter.  She has a B.S. in Biomedical Engineering and Psychology and an M.S. in Product Design and Development from Northwestern University.  

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
Director, Global Quality Devices & Combination Products
Merck

Day One

Wednesday 25th September 2019

11:50 am | How Quality Can Help Drug and Device Teams to be Agile

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.

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.