Agenda ⇽ PDA CDMO Partnership Workshop 2024 | Parenteral Drug Association on Glue Up

Thursday, October 31, 2024 08:30 to 16:15

08:30 - 09:00

Registration

09:00 - 09:15

Welcome and Workshop Introduction

09:15 - 10:30

How to Get the Most Out of a CDMO Relationship
Jennifer Cheung•Michie (Mei Kuen) Ong

Effectively navigating a sponsor-CDMO partnership is a complex task with a mutually beneficial outcome. The chosen CDMO significantly impacts business success and maintaining a strong relationship hinges on recognizing each partner’s strengths and capabilities. This session will delve into potential partnership conflicts and the importance of working through short-term tensions to achieve long-term goals. Participants will apply the insights acquired from our presenters to navigate a sponsor-CDMO conflict, discovering effective ways to address the disagreement with respect, even in the face of unforeseen challenges.

Jennifer Cheung
VP Global QA Operations at Gilead Sciences
Michie (Mei Kuen) Ong
Executive Director, US Quality of WuXi Advanced Therapies

10:30 - 10:45

Q&A
Jennifer Cheung•Michie (Mei Kuen) Ong

Jennifer Cheung
VP Global QA Operations at Gilead Sciences
Michie (Mei Kuen) Ong
Executive Director, US Quality of WuXi Advanced Therapies

10:45 - 11:15

Coffee Break

11:15 - 12:00

Choosing the Right CDMO for Late-Phase Clinical Trials
Christy Eatmon

Christy Eatmon
Global SME, Sterile Drug Products at Thermo Fisher Scientific

12:00 - 12:15

Q&A
Christy Eatmon

Christy Eatmon
Global SME, Sterile Drug Products at Thermo Fisher Scientific

12:15 - 13:15

Lunch Break

13:15 - 14:00

Positioning for Global Success: Navigating CDMO Landscape for New Modalities
Grace Lee, Ph.D, MBA, CQA

As the biopharmaceutical industry evolves with diverse new modalities and technical innovations, partnerships with Contract Development and Manufacturing Organizations (CDMOs) are becoming increasingly important. CDMOs must navigate a complex global landscape to remain competitive. This presentation focuses on the strategic decisions CDMOs face, particularly the comparative advantages of small versus large CDMOs. We will examine key considerations in selecting the right CDMO partner, with an emphasis on emerging modalities that require innovative approaches. Through case studies, the presentation offers actionable insights to help CDMOs to position themselves and to secure a competitive edge in the evolving industry.

Grace Lee, Ph.D, MBA, CQA
Founder, Principal Consultant of Elevalue Consulting LLC at Elevalue Consulting LLC

14:00 - 14:15

Q&A
Grace Lee, Ph.D, MBA, CQA

Grace Lee, Ph.D, MBA, CQA
Founder, Principal Consultant of Elevalue Consulting LLC at Elevalue Consulting LLC

14:15 - 15:00

How to Manage Tech Transfer & Quality Management Systems: A Johnson & Johnson Case Study
Meekyung Lim

Meekyung Lim
Director, Partnership & External Supply Large Molecule of Johnson & Johnson

15:00 - 15:15

Q&A
Meekyung Lim

Meekyung Lim
Director, Partnership & External Supply Large Molecule of Johnson & Johnson

15:15 - 16:15

Workshop
Jennifer Cheung•Grace Lee, Ph.D, MBA, CQA•Meekyung Lim•Michie (Mei Kuen) Ong

Jennifer Cheung
VP Global QA Operations at Gilead Sciences
Grace Lee, Ph.D, MBA, CQA
Founder, Principal Consultant of Elevalue Consulting LLC at Elevalue Consulting LLC
Meekyung Lim
Director, Partnership & External Supply Large Molecule of Johnson & Johnson
Michie (Mei Kuen) Ong
Executive Director, US Quality of WuXi Advanced Therapies

The information presented at this conference is accurate as of its launch date. However, the organizers retain the right to modify, update, or amend any details as needed. As we aim to provide the most current information and updates, we encourage you to check regularly for any changes.