8:00 am Registration & Welcome Coffee
8:30 am Chair’s Opening Remarks
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
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)
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
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
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
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
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
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)
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