Society for Case Research MBAA 2023

Experience level: 
Intended Audience: 
George Whaley

Is Flexible Drug Development More Effective Than Conflict Negotiations with the FDA?

ABC, Inc was a small biopharmaceutical firm going through the usual phases of drug development, including phase three clinical trials with the U.S. Federal Drug Administration (FDA). The FDA advised ABC, Inc (ABC) to conduct additional clinical trials and did not approve the drug candidate, IDXBLA, for sale and distribution. This delay in anticipated FDA approval of IDXBLA led ABC management to substantially downsize the firm's workforce, reduce company expenses, and enter the FDA's formal conflict resolution process. Since firms did not usually prevail at this late stage of the FDA conflict resolution process, the understaffed VP of Regulatory Affairs reflected on ABC's past strategic decisions concerning IDXBLA and adversarial posture toward the FDA for viable internal and external options. Students are asked to reassess past ABC management decisions in strategy, leadership, and human resources that would improve the chances for internal and external effectiveness.