Dynamic Collaborations for the Development of Immune Checkpoint Blockade Agents.

Area of Science:

• Oncology
• Pharmaceutical Sciences
• Biotechnology

Background:

• Drug discovery and development involves complex interorganizational collaborations.
• Anticancer drug approvals by the US Food and Drug Administration (FDA) between 1999 and 2018 provide a dataset for trend analysis.
• Immune checkpoint blockade has emerged as a significant therapeutic modality in cancer treatment.

Purpose of the Study:

• To analyze trends in drug discovery and development.
• To identify success factors in interorganizational collaboration for anticancer drugs.
• To evaluate the role of immune checkpoint inhibitors in drug development.

Main Methods:

• Review of 1204 transactions related to 107 anticancer drugs approved by the FDA from 1999 to 2018.
• Comparative analysis of interorganizational transactions across different mechanisms of action (small molecules, biologics, immune checkpoint blockade).
• In-depth examination of acquisitions and alliances for specific drugs like pembrolizumab and nivolumab.

Main Results:

• Immune checkpoint blockade demonstrated significantly higher interorganizational transaction activity, particularly alliances, compared to other anticancer agents.
• Pembrolizumab and nivolumab exhibited rapid expansion in approved indications post-2014.
• Biologics from US-based biotechnology and start-up companies were frequently involved as combination partners for these immune checkpoint inhibitors.

Conclusions:

• Immune checkpoint blockade represents a paradigm shift in cancer therapy, characterized by substantial sales and continuous indication expansion.
• Interorganizational collaboration, especially trial collaborations, is a critical strategic element for developing immune checkpoint blockade agents.
• Empirical practices in immune checkpoint inhibitor development are expected to guide future innovative drug research and development.