Pre-Conference Workshop Day
Tuesday March 26, 2024

8:30 am Conference Registration & Morning Coffee

Workshop A

9:00 am Building a Business Case for Continuous Manufacturing for Your Pipeline Profile ROI & Flexibility

  • Richard Steiner Senior Manager - Business Strategy, Pharmatech Associates Inc.

Synopsis

In today’s rapidly evolving landscape of pharmaceutical and biotech industries, the implementation of continuous manufacturing is pivotal. It offers the promise of increased

efficiency, shorter time to market, and improved product quality. However, successful adoption hinges on building a compelling business case that emphasizes flexibility and return on investment.

The essential components of building a convincing business case for introducing continuous manufacturing processes will be addressed in this workshop. Explore valuable insights into

building a robust business case, integrating it with organizational objectives, and cultivating an innovative and collaborative culture that can lead to long-term success.

Join this interactive workshop to delve into:

• How to harness the myriad benefits of continuous manufacturing, ranging from operational efficiency enhancements to accelerated product launches

• Investigating how the scalability and adaptability built into continuous manufacturing may support an organization’s long term growth strategy and make it more alluring to stakeholders and investors

• Discussing the steps in instigating a paradigm shift within the industry

• Understanding how to align continuous manufacturing with broader business objectives to demonstrate its capacity to fuel growth and profitability

• Emphasizing cross-departmental collaboration as a key component in supporting continuous manufacturing initiatives, ensuring comprehensive and successful implementation

11:00 am Networking Break

Workshop B

11:30 am Scaling Continuous Manufacturing : A Multi Modalities & Multi Stakeholders Perspective

  • Atul Dubey Senior Principal Scientist, U.S. Pharmacopeia
  • Ciby Abraham Senior Director - Group Manager, Project & Product Leadership CMC Regulatory Affairs, AstraZeneca

Synopsis

The transition of small molecules, biologics, and ATMPs from laboratory development to commercial manufacturing demands a strategic approach, involving regulatory and quality control stakeholders. This workshop will highlight the paramount importance of collaboration among stakeholders to ensure the seamless implementation of continuous processing strategies and the rising application towards newer modalities.

Featured Presentation: Overcoming Challenges in Control Strategy for Continuous Manufacturing for Seamless Manufacturing

• Understanding control objectives and performance metrics for continuous manufacturing processes

• Identifying potential sources of process variation and disturbances

• Addressing challenges related to scalability, such as ensuring consistent control performance across different production scales

1:30 pm Lunch

Site Visit

2:30 pm See It in Action: Site Visit to CONTINUUS Pharmaceuticals

Synopsis

CONTINUUS Pharmaceuticals is leveraging a novel continuous manufacturing platform called Integrated Continuous Manufacturing (ICM), initially developed through an $65m joint research project between Novartis and MIT. With ICM, they aim to improve affordability and accessibility of pharmaceuticals on a global scale. From facility design to equipment selection, tech transfer to validation, this unique site visit will give you the opportunity to see an ICM facility in person, ask the CONTINUUS Pharmaceutcals team your burning questions in real time.

There will be 3 separate tours running across the day, and has always been a sold-out section for our CCP pre-workshop day and places are strictly limited.

What you can expect?

  • Transportation to and from CONTINUUS Pharmaceutical from conference venue
  • Tour of end-to-end ICM pilot plant and high potent manufacturing plant
  • An in-depth presentation on how to design, implement integrated continuous manufacturing’s do’s and dont's
  • Q&A on technical solutions and pre-competitive collaboration 

5:30 pm End Of Pre-Conference Workshop Day

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Register for the Pre-Conference Continuous Pharmaceuticals Site Visit now