Access to advanced medical treatments remains a significant challenge in lower and middle-income countries (LMICs), often due to barriers in manufacturing, distribution, and regulatory complexities. This plenary session explores how Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) can play a pivotal role in bridging these gaps and enhancing patient access to essential therapies in LMICs.

CMOs and CDMOs are instrumental in the pharmaceutical supply chain, providing expertise in the development, production, and scaling of medicines. Their extensive networks and operational capabilities offer unique opportunities to address the access disparities faced by LMICs. The session will delve into strategies for leveraging these networks to overcome common obstacles, such as high production costs, limited local manufacturing infrastructure, and regulatory hurdles.

Key topics will include:

1. Optimizing Production and Distribution: Exploring how CMOs and CDMOs can help reduce costs and streamline production processes to make medicines more affordable and accessible. Case studies will highlight successful collaborations that have led to the establishment of local manufacturing facilities and improved distribution channels in LMICs.

2. Regulatory and Quality Assurance: Addressing the challenges related to meeting diverse regulatory standards and ensuring consistent quality across different markets. Discussion will focus on best practices for navigating regulatory environments and implementing robust quality assurance measures to ensure compliance and safety.

3. Innovative Partnerships and Collaborations: Examining partnerships between CMOs, CDMOs, governments, and non-governmental organizations (NGOs) that have facilitated patient access to life-saving treatments. The session will showcase examples of successful models and explore opportunities for scaling these approaches.

4. Capacity Building and Knowledge Transfer: Highlighting initiatives that focus on building local capabilities through knowledge transfer and training programs. This will cover how CMOs and CDMOs can support capacity building efforts to empower local stakeholders and enhance self-sufficiency in drug production.

By the end of the session, participants will gain insights into effective strategies and actionable frameworks for leveraging the strengths of CMOs and CDMOs to improve healthcare outcomes in LMICs. The discussion will emphasize the importance of collaborative efforts and innovative solutions to ensure that more patients in underserved regions receive timely access to essential medicines and treatments.

Session Speakers:

Accelerating Access to Essential Medicines by Maximizing the Benefits of Contract Manufacturing

Ken Kent, Gilead Sciences, Inc.

Virtual Presentation

Boitumelo (Tumi) Semete-Makokotlela, South African Health Products

MRNA Technology Transfer Programme: Towards a Better Prepared Global South

Antonio Grilo, Medicines Patent Pool (MPP)

Additional Panelists:

Dean Smith, Health Canada

John Kim

Appearances