8:00am Registration & Morning Coffee
8:50 am Chair’s Opening Remarks
Accelerating Clinical-to-Commercial Development to Drive Yields
9:00 am Case-Study: Bridging Clinical Phase I to III Studies for Small Molecule Development to Demonstrate Quality Consistency & Safety
Synopsis
- Understanding how to use a bridging study to communicate process similarity to health authorities and regulators for streamlined approval
- Outlining the use of modelling to aid bridging studies for similarity demonstrations for maximal efficiency
- Pinpointing data and cost limitations for large biologics and using this as a decisionmaking tool to explain when is best to shift to continuous
9:30 am Leveraging Process Optimization for Cell Therapy to Enhance Speed-to Market & Efficiency
Synopsis
- Redefining continuous processing in the context of cell therapy for holistic clarity
- Navigating the complexity of cell therapies during continuous manufacturing to streamline development
- Futureproofing the cell therapy supply chain with facilities and location in mind to deliver drugs faster
10:00am Morning Coffee Break
Moving Towards Complete Integration Along the Production Line to Maximize Flexibility & Minimize Spend
10:30 am Panel Discussion: Recognizing Emerging Modalities for Continuous Manufacturing Applications to Advance Your Pipeline & Meet Demands
Synopsis
- How are emerging modalities adapting to continuous manufacturing?
- How must continuous manufacturing evolve as a standardized method for cell and gene therapy production?
- Where are the gaps in transitioning from small to commercial scale for continuous manufacturing of biologics and novel modalities?
11:30 am Session Reserved for Dec Group
12:00pm Networking Lunch
Assessing Value Added for Sustainability & Green Chemistry to Meet ESG Goals
1:00 pm Exploring Pfizer’s Modular-Based Approach to Flow for Indirect API Production to Refine Your Technical & Strategic Approach
Synopsis
- Outlining strategy optimization when considering flow to produce starting materials in a continuous fashion
- Addressing implementation of technologies fit for continuous flow for seamless integration
- Quantifying sustainability measures to overcome the data scarcity bottleneck and maintain green processes
1:30 pm Roundtable Discussion: Unlocking the Future of Small Molecule Commercialization: The Role of Continuous Manufacturing
Synopsis
- How can continuous manufacturing streamline the development-to-commercialization timeline for small molecules, and what key challenges need to be addressed to fully leverage its potential?
- What regulatory considerations and industry standards are critical for scaling continuous manufacturing in the small molecule sector?
- How can continuous manufacturing improve supply chain resilience and flexibility in the commercialization of small molecules?
2:00pm Afternoon Break
Getting Ahead of the Curve: Exploration of Novel Digital Tools & Advancements for Added Layers of Efficiency
2:30 pm Applying a Cross-Modality Perspective to Advance the Manufacturing of New Drug Modalities
Synopsis
- Understanding how to leverage synthetic molecule techniques for biologics to facilitate progression for newer modalities
- Applying rationale for continuous crystallization of small molecule to biologics continuous processing to tap into uncovered opportunities
- Addressing the mindset and skillset required to apply from small molecule to biologics to shorten time to market for all therapeutics
3:00 pm Exploring Membrane-Based Antisolvent Crystallization for Nanocrystals in Continuous API Manufacturing
Synopsis
Leveraging membrane-based antisolvent crystallization to continuously produce nanocrystals of various APIs
• How membrane technology can support a streamlined, scalable, and sustainable API production process for API nanocrystals
• Eliminates milling processes to obtain nanocrystals from microcrystals and minimizes operational challenges in pharmaceutical manufacturing
3:30 pm Working With Digital Twins to Improve Continuous Manufacturing & Explore Future Industry Potential
Synopsis
- Outlining how to begin implementation of digital twin-aided continuous manufacturing to direct real-time processes with minimal error
- Exploring challenges and opportunities in digital twin data management to increase accuracy and efficiency
- Exploring potential industry applications for digital twins paired with continuous manufacturing to shed light on innovation