Key Takeaways | Pharma and MedTech Manufacturing and Contract Development - McDermott Will & Emery

Key Takeaways | Pharma and MedTech Manufacturing and Contract Development

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Overview


During the session, the panelists discussed investment strategies in the Contract Development and Manufacturing Organization (CDMO) space, emphasizing factors like supply and demand dynamics, quality control, and the impact of the BIOSECURE Act on manufacturing trends.

Session panelists:

  • Ritu Dhami, President, Network Partners Group
  • Elizabeth Hickman, Chief Business Officer, AustinPx
  • Kurt Orlofski, Chief Executive Officer, PAI Pharma
  • Michael Reslinski, Managing Director, Healthcare and Life Sciences, Sixth Street
  • Katherine Wood, Partner, TPG Capital
  • Moderator: Krist Werling, Partner, McDermott Will & Emery

In Depth


Top takeaways included:

  • Think Strategically About CDMO Investments. Investors in the CDMO space must adopt a strategic mindset. First, innovation plays a pivotal role. Understanding supply and demand dynamics within specific manufacturing subsectors allows investors to identify lucrative opportunities. Second, differentiation matters. Investing in both innovative products and enablers sets companies apart. Finally, gaining insights from both customer and service provider perspectives provides a holistic view, enabling better decision-making.
  • Double Down on Quality Control and Compliance. Quality control is non-negotiable. Investors should prioritize adherence to regulations and learn from warning letters issued by regulatory bodies. Rigorous due diligence ensures thorough inspections of all elements. Additionally, strong quality agreements between companies and CDMOs foster trust and mitigate risk. These agreements outline roles, responsibilities, and communication channels, creating a compliant and collaborative relationship.
  • Stay Up to Date on the BIOSECURE Act and Manufacturing Trends. The BIOSECURE Act, currently in committee in the US House of Representatives, significantly impacts the industry. It prohibits federal agencies from contracting with biotechnology companies doing business with specific Chinese-based firms. As a result, repatriation trends are emerging in manufacturing. However, the challenge lies in the intricacies of implementation details. Companies must balance onshoring costs without causing drastic price increases. Amid these shifts, maintaining quality and efficiency remain paramount.