8:00 am Registration & Coffee
8:50 am Chair’s Opening Remarks
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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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
Synopsis
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