8:15 am Morning Coffee

9:00 am Chair’s Opening Remarks

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

Synopsis

  • 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 Senior Mechanical Engineer, Crux Product Design Ltd

Synopsis

  • 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

 

10:10 am Primary Container Development and CCIT Development

Synopsis

  • Primary container material development to support next generation injectable drug products
  • The transition into a 2ml container – what it means in practice
  • Container closure integrity testing to ensure sterility at all times
  • Validation testing and visual inspection

Session Reserved for Program Partner

10:40 am Morning Coffee

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

Synopsis

  • Getting it right first time: excellent device design
  • Tighten your control to avoid deviation: design control and risk management
  • How to translate engineering success into commercialization
  • Post-launch device operations and lifecycle management

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

Synopsis

The success of your injectable device starts from initial design decisions through preparing submissions for regulatory bodies. While the last few years we have focused on the importance of human factors testing, we continue to see shortfalls and failing regulatory agencies’ approvals, which subsequently results in delay in gaining approvals.

Panellists will share their expert insights on:

  • Discovering what users want and how your product can meet their needs to shape your design direction early on
  • From the FDA to EMA – your product isn’t limited to one country, nor should your study be
  • From device design to packaging to user manual: visual development and UX testing

12:40 pm Networking Lunch

Translating Innovations into Real World Technologies – Novel Injector Development

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?

Synopsis

  • 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

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

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

Synopsis

  • 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?

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

Synopsis

  • 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

3:10 pm Chair’s Closing Remarks & End of Conference