Biotech Negotiates Successfully at FDA

Business Issue

The Regulatory Affairs Department at one of the largest and most successful biotechnology companies in the world faced a multitude of negotiation challenges. Regulatory Affairs staff were charged with coordinating the activities of cross-functional teams that research and develop therapeutics, test them, and usher them through the rigorous FDA approval process.

Product Development teams routinely unite individuals with a multitude of differing backgrounds including science, sales and marketing, biostatistics, clinical, legal and other perspectives to create a product and process that will meet FDA requirements. In addition, they must negotiate with the FDA itself to create a process that meets the FDA's interests in protecting public health while generating new medicines. Effective teams that resolve differences, manage conflict, and implement solutions usher products efficiently and successfully through the regulatory process.


The head of the U.S. Regulatory Affairs requested that product development teams improve their ability to conduct both internal and external negotiations. In diagnostic interviews with Accordence, Regulatory Affairs staff identified a need for strong facilitation skills and consensus building capabilities, and a desire for a common negotiation platform to be integrated into the product development cycle.

Accordence customized workshops to meet the company's challenges and delivered three 2-day workshops over six months. Participants applied Accordence's Negotiation Framework to specific negotiation challenges they faced and refined their abilities to identify interests among internal teams and between the company and FDA reviewers. Skill building sessions focused on Regulatory Group members' ability to negotiate differences more effectively and efficiently, and in a manner designed to create more value.

As an offshoot to these training programs, Accordence consulted with a product development team facing a crucial meeting with the FDA, and facilitated a "joint launch" meeting of the entire team and senior executives focused on goals, specific challenges and work to be done.


The product development team had a successful meeting with the FDA and reached mutually agreeable consensus on the pivotal trials in support of product approval. Accordence has provided ongoing coaching, training and facilitation to enhance that team's ability to bring the product to market.

To ensure full implementation of a standard negotiation framework, Accordence continues to work with the Regulatory Affairs Department senior leadership to align systems and policies to create a common language and systemic approach to key negotiations, providing ongoing training to new members of the Regulatory Group, and executive coaching to enhance senior leadership's ability to model effective negotiation behavior.

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