8:00 am Registration & Welcome Coffee

8:30 am Chair’s Opening Remarks

  • Marieta Duvnjak Associate Director, Scientific Advisor in Global Analytical Research & Development, Novartis

Bottlenecks & Opportunities in the Development of Complex Injectable Products

8:45 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

9:30 am Injecting simplicity into the delivery of difficult-to-mix drugs

Synopsis

There is a growing need for better delivery systems capable of automating, speeding up, and reducing the number of user steps to prepare and inject lyophilized and powdered drugs. Windgap`s dual chamber reconstitution autoinjector platforms being developed to simplify, automate, and speed up the mixing and delivery of powdered or lyophilized medications.

  • Automatic mixing – no shaking required
  • Improving accuracy and reaction times
  • Decreasing user error
  • Reducing impact of heat and shelf-life

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

  • Marieta Duvnjak Associate Director, Scientific Advisor in Global Analytical Research & Development, Novartis

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 Breakfast & Speed Networking

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

11:30 am Driving Large-Volume Subcutaneous Infusion Development – Discover How KORU’s Proven Feasibility Process Can Optimize Your Drug Delivery from Clinical Trials to Commercialization

  • Keith Knapp Medical Device Professional, Entrepreneur, Advisor, & Board Member, KORU Medical Systems

Synopsis

  • What do we really mean by subcutaneous large volume drug delivery?
  • Delineating the growth of large volume subcutaneous/market trends towards home use
  • Examining & evaluating proven solutions to large-volume subcutaneous delivery in the market

Excellent Injectable Device Engineering

12:00 pm 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

12:30 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

1:00 pm Networking Lunch Break

2:00 pm 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

2:45 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

3:15 pm Afternoon Refreshments

3:45 pm Defining 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

4:15 pm Minimizing Failure Risks in Container Closure Integrity Testing (CCIT)

  • Rakesh Khilwani Principal Device Development Engineer, Teva Pharmaceuticals

Synopsis

  • Realizing the regulatory environment for container closure integrity
  • Deterministic or probalistic: Which test method to choose?
  • Delivering a case study that demonstrates method development and validation strategies to ensure the sterility and quality of the drug product, from product packaging to expiry

4:45 pm Chair’s Closing Remarks & End of Day 1