Conference Day One
11:15 am - 11:20 am
PharmaIQ Welcome
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
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
12:40 pm - 2:15 pm
Networking Lunch
2:20 pm - 3:00 pm
Going virtual: finding remote solutions for Acino’s clients during the pandemic
Yuliyana Manolova -
Head of Distribution and Clinical Trials Product Supply,
Zentiva/ Zent2U
· Challenges during the lock-down
· Prerequisites for success: proactive communication, openness, flexibility
· Case studies on virtual solutions in Business Development and Quality Assurance
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
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
