Conference Day One

11:10 am - 11:15 am PharmaIQ Welcome

11:15 am - 11:20 am Chairman's Opening Address

11:20 am - 12:00 pm Case Study: Criteria to Select a CMO

David Caron - VP, CMC, Ayala Pharmaceuticals

• Discuss the desired goals and objectives of a new CMO, with an overview of the selection process

• Review the acceptance criteria for successful selection and tech transfer

• Specifically gain insight on the selection of a CMO for manufacturing HiPo DP, Low Volume Injectable

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David Caron

VP, CMC
Ayala Pharmaceuticals

12:00 pm - 12:40 pm MMTS Minitab - From Product Design to Commercial Scale

Giuseppe De Franza - Senior Manager, Technical Services & Operational Excellence, Adare
  • Discuss the significant unmet need to formulate medicines that are easy to administer to children to optimize acceptance, encourage adherence and improve health outcomes
  • Review how Minitablets can be one of the solutions - also for patients with dysphagia, and when flexible dose adjustments is needed
  • Identify the growing popularity of Minitablets thanks to recent guidelines and a growing understanding of children swallowing capability, but also because the manufacturing equipment used to produce Minitablet-based dosage forms are the same as those employed in manufacturing of standard tablet
  • Understand the adjustments and optimization of the manufacturing processes and testing approaches that are required to secure efficiency, robustness, and productivity
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Giuseppe De Franza

Senior Manager, Technical Services & Operational Excellence
Adare

12:40 pm - 1:20 pm Session Reserved for Sponsor


1:20 pm - 2:20 pm Networking Lunch

2:20 pm - 3:00 pm Session Reserved for Acino


3:00 pm - 3:40 pm Best Practices in Outsourcing CMC Development & Manufacturing for Biologics – A Big Pharma Perspective

Ulrich Rumenapp - Head of Launch Preparation - Product Supply, Bayer AG

·        Review the crucial make-or-buy question – what to outsource and what to do in-house?

·        Discuss the benefits and risks of outsourcing, including the special challenges in outsourcing biologics

·        Explore contract making to prevent pitfalls, and learn how to protect your IP

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Ulrich Rumenapp

Head of Launch Preparation - Product Supply
Bayer AG

3:40 pm - 4:20 pm Contract Manufacturing: The Lifeline for a Virtual Company

Alain Bernard - Chief Technology Officer, VectivBio

• Understand the difficulties for virtual companies at their early stage of growth, whilst they are devoid of any manufacturing capabilities, capacity and even internal expertise.

• Identify how CMO or CDMOs fill this gap and de-risk the virtual companies project and strategy

• Discuss guidelines to identify, select, contract and operationally work with CMOs

• Illustrate the positive synergies and identify high impact risks that should be avoided by reviewing brief case studies

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Alain Bernard

Chief Technology Officer
VectivBio

4:20 pm - 4:30 pm Chairman's Closing Remarks and Close of Webinar Day 1