Conference Day Two

8:30 AM - 9:00 AM Registration and Coffee

9:00 AM - 9:10 AM Chairman's Opening Remarks

Roger Cassidy, Managing Partner, Tamesis Pharma

Roger Cassidy

Managing Partner
Tamesis Pharma

9:10 AM - 9:50 AM Case Study: Investigation with CMOs

Nicolas Puljic, External Manufacturing Production Manager, Biogen
- What to do when problems arise?
- Determine what steps you can take to ensure better transparency/ communication with CMOs
- Learn what to look out for when investigation are performed at a CMO to know what to expect in your partnership

Nicolas Puljic

External Manufacturing Production Manager

9:50 AM - 10:30 AM Case Study: When to Move on from Your CMO

Luiz Barberini, Operations Mng - External Manufacturing Latin America Head, Bayer
-Understand when it is the right decision to walk away from your CDMO
-Learn how to rectify miscommunication between partners
-Establish the consideration in practicality and timelines of transferring of processes

Luiz Barberini

Operations Mng - External Manufacturing Latin America Head

10:30 AM - 11:00 AM Coffee Break

11:00 AM - 11:40 AM Open Floor Debate: What is The Best Case Scenario When Working With Your CMO?

-Share short case studies on successful relationships with CMOs
-Discuss the lessons learned when handling complex situations
-Understand what to look for when managing communication with a CMO

11:40 AM - 12:20 PM Case Study: Optimising Selection Processes for your CMO

Christophe Stevens, Associate Director External Manufacturing , UCB
• Discuss how certain models for CMO selection processes can be optimised to expedite timelines
• Establish what key considerations are needed to align expectations between pharma and external manufacturers
• Hear where criteria need to be met in order to avoid critical gaps in production cycles

Christophe Stevens

Associate Director External Manufacturing

12:20 PM - 1:20 PM Networking Lunch

1:20 PM - 2:00 PM Case Study: What to Look Out for When Visiting your CDMOs

• Identify the key points to focus on in the limited time available when conducting site visits to your CDMOs
• Determine key priorities to be established when on location
• Hear real life experiences from sponsors when visiting their CMOs, and what can ultimately go wrong!

2:00 PM - 2:40 PM Case Study: Risk Management Across the Life Cycle of a CDMO

Glenn Peace, Director Senior Director Operations – Global External Supply, Mallinckdrodt Pharmaceuticals
• Determine how to assess risk when working with CDMOs
• Understand how risk can be best managed across the life cycle and considerations that need to be made
• Discuss how to factor in risk assessments and monitor red flags in external relationships

Glenn Peace

Director Senior Director Operations – Global External Supply
Mallinckdrodt Pharmaceuticals

2:40 PM - 3:10 PM Coffee Break

Each round table will discuss a different “what if” scenario that mirrors a real CDMO
situation. Develop strategies to overcome these likely scenarios and share past
experiences and ideas. After 30 minutes, rotate round to be met with another scenario!
Luiz Barberini, Operations Manager - External Manufacturing Latin America, Bayer
Kyriakos Berberidis, Director External Manufacturing and Supply, Janssen
Patrik Kass, Director External Supply operations, Orion
Stefano Seminara, External Manufacturing Technical Manager, Bayer

Luiz Barberini

Operations Mng - External Manufacturing Latin America Head

Kyriakos Berberidis

Director Supply Chain and External Manufacturing

Patrik Kass

Director External Supply Operations

Stefano Seminara

External Manufacturing Technical Manager

4:15 PM - 4:45 PM Summative Panel – Developing Optimised Relationships with CMOs

- Analyse the different approaches that have been discussed throughout the forum
- Examine the shift to management of external relationships
- Generate value from CMOs and understand how to optimise communication and build on partnerships

4:45 PM - 4:50 PM Chairman's Closing Remarks