8:00 am Welcome Coffee

8:45 am Chair’s Opening Remarks

Bottlenecks & Opportunities in the Development of Complex Injectable Products

9:00 am Roundtable: Combining Formulation & Device Innovation to Enable Delivery of Drugs with High Viscosity & Volume

  • E Guan Head of Injection Systems, Takeda

Synopsis

  • Revealing trends of an increasingly complex, long-acting injectable formulation
  • Identifying considerations of injectable device selection – from material to primary container to needle size
  • Building your device with the best performance and patient-centricity upfront
  • Breaking the silo between the drug and device teams for co-development to ensure speed-to-clinic

9:45 am Collating Considerations in the Development & Manufacturing of Long-Acting Injectables (LAIs)

Synopsis

  • Resolving formulation feasibility and delivery device selection issues toward product development
  • Establishing in vitro-in vivo relationship (IVIVR) for quality control of LAI dosage forms
  • Demonstrating bioequivalence of LAIs
  • Reflecting on market development challenges for long-acting injectable drug products

10:15 am Speed Networking & Morning Coffee

11:00 am Addressing Scale-Up and Technology Transfer Challenges for Injectables

  • Ram Halthore Director of Engineering, Devices & Combination Product Technology, Merck

Synopsis

  • Identifying challenges from Proof of Concept (POC) to the manufacturing line
  • Examining analytical validation and testing techniques for injectables
  • Ensuring drug-device compatibility for storage and stability conditions

Excellent Injectable Device Engineering

11:30 am Roundtable:Unlocking Manufacturing Challenges in Assembly, Sterilization, Shelf life, & Stability of Combination Products

  • Ram Halthore Director of Engineering, Devices & Combination Product Technology, Merck

Synopsis

  • Advancing sterility assurance and shelf-life with complex injectable devices with novel formulations
  • Performing robust validation and testing for quality control

12:00 pm Understanding the Evolving Extractables & Leachables (E&L) Regulatory Expectations to Circumvent Drug Product Approval Delays

  • Keith Faucher Sr. Director Device Development & Innovation, Aura Biosciences

Synopsis

  • Highlighting potential drug-device interactions early on in development to reduce risk and achieve the best possible outcome
  • Exploring E&L testing and analysis to quantify and assess risks associated with leachable impurities
  • Reviewing regulatory requirements within Extractable & Leachable testing for combination products

12:30 pm Networking Lunch Break

1:30 pm Roundtable:Integrating Human Factors (HF)/Usability Engineering into the Design of Connected Injectable Devices

Synopsis

  • Addressing human factors challenges relating to the scope of the user interface and the speed of product development
  • How do you align the clinical outcomes of your connected injectable device with the usability outcomes you validate?
  • Discussing available regulatory guidance for validating connected injectable devices

2:15 pm Fast-forwarding Agile Design & Development for Combination Products

Synopsis

  • Reviewing the FDA’s waterfall diagram
  • Exploring the advantages of agile product development
  • Generating sprint plans and system integration checks

2:45 pm Afternoon Refreshments

3:15 pm Approaches to Combination Product Characterization During Early Development

  • Guangli Hu Principal Scientist, Device Characterization Lead, Merck

Synopsis

  • Examining examples of combination product failures
  • Revealing considerations when conducting combination product characterization in early development
  • Proactively identifying risks in combination product development
  • Leveraging both simulation and experimental tools towards the robust image

Patient-Centric Combination Product

3:45 pm Container Options for Injectable Devices to Meet User Needs

  • Sriman Banerjee Head of Packaging Development & Commercial Device Engineering, Takeda

Synopsis

  • What are the requirements for the development of combination products?
  • How can you best determine the component design and material selection of a device for self-administration?
  • How do you address complex interactions between components, containers, and processes?

4:15 pm Chair’s Closing Remarks & End of Day 1