8:40 am Chair’s Opening Remarks

  • C. Oliver Kappe Professor, Scientific Director, Research Center Pharmaceutical Engineering GmbH (RCPE)

Safer & Greener? Enabling Novel Chemistries

9:00 am Development of a Flow Screening Platform in Discovery Chemistry – Scope and Limitations

Synopsis

• The presentation will focus on our work on High Throughput Experimentation as
a technology to advance the Oncology Chemistry discovery portfolio in terms of
exploring new chemical space as well as expediting scale-up
• Challenges of batch screening will be presented leading to our work to develop a
flow-based platform
• Initial validation and use will be presented with the talk focusing on expanded
capabilities since our first disclosure most notably around exploiting photoredox
transformations on this system, and the unique challenges that this reactivity
paradigm presents to flow screening
• New technologies are often cited as having benefits from a sustainability
perspective, and we will strive to demonstrate the synergistic advantages that
can be gained through exploiting both flow chemistry and High Throughput
Experimentation in a single system

9:30 am Enabling Atroposelective Syntheses via Simultaneous Processing of Antagonistic Chemical Events (SPACE)

  • David Snead Associate Director, Chemical Development, Mirati Therapeutics

Synopsis

• Optical resolution is a reliable method for separation of atropisomers but it is
plagued by a maximum-yield of 50%
• Axes of chirality can be thermally epimerized but this conflicts with conditions
required for crystallization (cooling)
• Continuous flow can be applied to resolve these competing needs, resulting in
high-yielding synthesis of atropisomers which in turn reduces consumption of
solvent and valuable chemical intermediates

10:00 am

Structured Networking

Synopsis

Kick off your time spent at the meeting making valuable connections with industryleading
chemistry, engineering & analytical expertise.
Meet peers and establish common ground through focussed conversation, forming
meaningful connections lasting beyond this 3-day summit.

10:30 am

Morning Break

11:00 am Developing a Continuous Photochemical Sequence

Synopsis

– Presentation details to be confirmed shortly

12:00 pm Panel Discussion: Forward Thinking in Flow – Addressing the Skills Gap

Synopsis

• A look at the current status of talent flow in continuous processing
• What does current knowledge transfer for commercialization in flow-chemistry look like?
• How can industry & academia collaborate for promoting flow chemistry capabilities and
decreasing burden for in-house training
• What is the potential for continuous chemistry if talent shortages are met?

12:45 pm

Networking Lunch

Transitioning from Batch towards Continuous

2:00 pm Flow Chemistry as a Route Enabling Technology for API Manufacturing (Case Study)

  • C. Oliver Kappe Professor, Scientific Director, Research Center Pharmaceutical Engineering GmbH (RCPE)

Synopsis

• How to access shorter and more cost-effective routes using flow
• Harnessing hazardous high energy intermediates in a flow environment
• Mixing plug flow, CSTR and batch reactors for efficient multistep processing

Regulatory & CMC Updates for Flow Chemistry

2:30 pm Building Trust While Reducing Barriers to Adoption of Continuous Manufacturing: A Three-Prong Approach

Synopsis

• To facilitate adoption of new technologies and help accelerate the safe and efficient production of quality
medicines when and where they are needed, a broad approach, from early decision making to commercial
manufacturing is needed
• Working on the next generation of quality standards and technical guides to help bring quality assured products
to market
• Supporting innovation through a CM center of excellence that provides R&D solutions, supports lowering the
knowledge gap, and translates science
• Consulting and training to help companies understand if and how CM benefits their business, make the correct
strategic choices, and work out the initial business case

3:00 pm Panel Discussion: Planning for Regulatory Submissions: Expectations to be Aware of & Data Requirements

Synopsis

• What are the current regulatory pathway considerations in continuous API manufacturing?
• How is industry implementing flow technologies for agency filing preparedness?
• What regulatory guidance is there for bringing technologies into later phases of development?

3:45 pm Chair’s Closing Remarks

  • C. Oliver Kappe Professor, Scientific Director, Research Center Pharmaceutical Engineering GmbH (RCPE)