8:00 am Registration & Coffee

8:50 am Chair’s Opening Remarks

  • Mark DeStefano Director of Combination Products and Devices R&D, Teva Pharmaceuticals

Where Are We with the Fast-Moving Injectable Device Evolution to Accelerate Speed-to-Clinic

9:00 am Progressing Next Generation On-body/Wearable Device Development


  • Regulatory considerations and market overview of on body delivery devices
  • Development of long injections for wearable devices to allow for at home-delivery
  • Connected wearables to allow for granular control of flow rate to improve patient comfort

9:30 am Accelerating the Mixing & Delivery of High Viscosity Injectables


  • Presenting an innovative approach to reconstitution and mixing which enables the development of self-administration devices for broader patient populations
  • Explore how to increase the working viscosity and volume range of complex injectable formulations through a combination of gas power and a side-by-side cartridge configuration
  • Discuss complementary patient-centric design features such as automation, reciprocated mixing, and sequential delivery of multiple liquids.

9:45 am Biocompatibility for Injectable Combination Products

  • Soumen Das Medical Device Qualification Lead & Associate Scientific Medical Devices Fellow, Takeda Pharmaceutical Co. Ltd.


  • Update on the recent global regulatory standards landscape
  • Overview of biocompatibility strategy for combination device development so that you can develop your own strategy for biocompatibility in device development
  • Recent experiences with the global regulatory agencies to assist you in understanding the requirements in this field of constant development

10:15 am Morning Refreshments & Speed Networking

11:15 am What’s Beyond 10mL? Unique Learnings in Large Volume Subcutaneous (SC) Infusion

  • Joshua Bennett General Manager - International Novel Therapies, KORU Medical


  • Better understand the growth trends in the >10 mL volume subcutaneous (SC) home infusion space
  • Learn about the benefits of >10 mL volume subcutaneous (SC) home infusion
  • Unique clinical and commercial risk mitigation in the delivery of >10mL drugs

11:30 am Panel Discussion: Sustainability Strategies for Injectable Device Development

  • Soumen Das Medical Device Qualification Lead & Associate Scientific Medical Devices Fellow, Takeda Pharmaceutical Co. Ltd.
  • Peter Petrochenko Associate Director of Regulatory Strategy, Regeneron
  • Laurent Wagniere Senior Director Medical Device Program Lead, Fresenius Kabi
  • Mark DeStefano Director of Combination Products and Devices R&D, Teva Pharmaceuticals


  • Novel material development selection with cost, biocompatibility and sustainability all in mind to promote the sustainability profile of your device
  • Waste reduction strategies during manufacturing, such as injection moulding and thermos softening plastics to promote the sustainability profile of your device

12:15 pm Lunch & Networking

1:30 pm What Does It Take to Win for Biopharma Companies Within the Injectable Drug-Device Combination Space

  • Didier Pertuy Vice President & Global Head of Drug Device Integrated Development, Sanofi


  • Continued development in the injectable drug-device combination market offers significant growth opportunities for biopharma companies in the healthcare industries
  • Successful navigating this challenging space via strategic improvements and positioning can create a competitive advantage for biopharma companies
  • Embracing a paradigm shift in drug and device development approaches is crucial for biopharma companies to effectively tap into the potential of the injectable drug-device combination market

2:00 pm Correlation between Bulging in Cartridge Seals & Container Closure Integrity


  • Introduction to combiseals and applications
  • Background and limitations of CCI test methods
  • Materials and test methods used – Recommendation based on this study

2:15 pm Afternoon Networking Break

Designing & Developing a Human Centric Injectable Device

3:00 pm Patient Centric Device Development: Human Factors Validation Studies for Disposable Autoinjector


  • Demonstrate how the risk analysis shapes the human factors validation study activities
  • Identify considerations for robust human factors validation study design and conduct
  • Explain how to interpret study results to continue to promote patient centricity in product development

3:30 pm Mastermind: Identifying the Implications of Connectivity on Human Factors Study Design & Additional Studies that You Should Run

  • Tracy VonBriesen Director, Clinical Development, Fresenius Kabi
  • Andrew Mkwashi Senior Research Associate in Health Innovations, NIHR, Newcastle University


In this mastermind session, Tracy will first lead a 30mins roundtable discussion on identifying implications of connectivity on HF study and design, followed by Andrew's session focusing on mitigating injectable device connectivity risks. You will get the opportunity to understand the different stakeholders involved in developing and commercializing a patient-centric, connected device to enhance patient experience while remaining compliant.

  • Evaluating the complication of connectivity in device design and usability during your study design
  • Specific age-related HF and usability considerations in patient groups
  • How to effectively engage with the FDA and the specific human factors for biosimilar combination products

Injectable Device Connectivity & Mitigating Risks

In this interactive and hands-on session, Andrew Mkwashi will share practical examples and expand your knowledge of developing a safe, patient-centric connected device. He will also bring his insights from the European medical device market to give you the best tips navigating regulatory pathways in the EU market:

  • Understanding software requirements of connected injectable devices to ensure reliable data, usability for the patient and ensure a long life cycle of the product
  • What are the cyber security issues with connected devices?
  • Enhancing compliance including GDPR, and other regional data regulations for patient privacy
  • Effectively assessing risks of your connected device
  • Increasing interoperability and stakeholder engagement throughout device lifecycle

5:30 pm Chair’s Closing Remarks & End of Day 1

  • Mark DeStefano Director of Combination Products and Devices R&D, Teva Pharmaceuticals