8:15 am Morning Coffee
9:00 am Chair’s Opening Remarks
- Ben Creelman Technical Officer, PATH
9:10 am Biogen’s Journey in Primary Container Development to Support Injectable Device and Therapeutic Progresses
- Calvin Clark Device Design & Development Engineer, Biogen
- Therapeutic advancements with examples of monoclonal antibodies: why it matters to the device team
- The aspiration for a higher volume/ high viscosity delivery – primary container challenges
- From materials to sheer pressures, what device engineers should consider
The Art of Engineering
9:40 am Exploring Device Design Space with In-Silico Subcutaneous Injection Modeling
- John Majewski Device Development Engineer, Gilead Sciences
- Joel Gresham Simulation Expert, Crux Product Design Ltd
- Developing a computational model to predict subcutaneous injection tissue behavior and device performance for challenging formulations
- The potential of such models in identifying key device parameters which impacts delivery prior to device component selection
- Learning from these simulations can inform both device and formulation development
10:20 am Lesson Learned in Developing an Ocular Injections
- Mayumi Bowen Senior Engineer, Genentech
- The unique challenges for ocular injection – from dosing requirements to user experience
- Device & packaging considerations: the critical aspects of primary container & closure selection and device & packaging design to demonstrate stringent sterility requirements
- The challenge for drug fill process
- What’s next? What will improve the current ocular injection format?
10:50 am Morning Coffee
11:20 am A Strategic Approach to E&L Execution
- Jian Liu Senior Scientist, Process Development, Amgen
- Performing a holistic E&L assessment to understand your primary container and single use systems
- How can your targeted leachable analysis influence your toxicity and immunogenicity study?
- Gaining an understanding of your final drug products
- E&L evaluation to ensure drug-device safety and quality
11:50 am Panel Discussion: Enhancing Your Combination Products Usability and Functionality
- Christina Stefan Senior Design Researcher, Design Science Consulting
- Ellie Younger Human Factors and Device Development Lead, Biogen
- Jerzy Wojcik Senior Director, Regulatory Affairs and Quality Assurance , EdgeOne Medical
With injectables, the real estate on the physical user interface is limited. Balancing between presenting important information and overwhelming the user is essential to an effective user interface. A seamless integration of the on device label, secondary packaging, and instructions for use (IFU) is the key to success. This panel will cover methods and best practices for optimizing these elements through iterative design and evaluation.
Panellists will share their expert insights on:
- Risk Mitigation: how do you decide where information goes?
- Hierarchy of Information: when is enough enough?
- Informational Design: how do you design the best IFU?
- Differentiation: consistency or uniqueness…which way do you go?
12:30 pm Networking Lunch
Translating Innovations into Real World Technologies – Novel Injector Development
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?
- Daniel Latham Head of Device Development & LCM, Novartis
- The rise of new technologies including cell & gene therapy and digital devices
- How pharma should manage such complexities and innovations, while ensuring quality and safety
- An end to end case study: Implementation of novel innovative drugs in autoinjectors maintaining safety and enhancing patient and user experience
2:00 pm The Bill & Melinda Gates Foundation’s Efforts in Supporting Innovations in Injectable Development
- Dennis Lee Senior Program Officer, CMC, Bill & Melinda Gates Foundation
- Initiatives for developing drugs for the developing world
- Injectable delivery format and considerations – from device design to cost to supply chain challenges
- Collaboration with industry and grants to support further development
- Blue sky thinking – what are the potential opportunities in the injectable space?
2:30 pm Spotlight: PATH’s Initiatives in Developing Next Generation Injectables – The Journey from Needle Free to Microarray Patches
- Darin Zehrung Senior Program Director, PATH
- PATH’s overview of work on injectable device and vaccine innovations, and new Center of Excellence for Microarray Patch (microneedle) technology
- Value proposition and cost modelling of alternatives to traditional PFS
- Clinical data to demonstrate efficacy of novel vaccine delivery devices
- Engineering challenges and opportunities ahead
3:00 pm Chair’s Closing Remarks & End of Conference
- Ben Creelman Technical Officer, PATH