About Pinney Associates

Pharmaceutical and consumer healthcare companies work within dynamic, sometimes unpredictable, regulatory and commercial environments. Our multidisciplinary teams anticipate your scientific and policy obstacles while guiding you toward regulatory and marketplace success.

Robyn Gougelet talking to Michelle Ertischek at a conference table.

History

Pinney Associates was founded in 1994, when we introduced an innovative, evidence-based approach to helping companies foster employee health.

Soon after our founding, SmithKlineBeecham (SKB; now GlaxoSmithKline) invited John Pinney to participate in a novel project: switching nicotine replacement therapy from prescription-only to OTC status in the United States.

John’s strengths were uniquely fitted to the task; his time in the military taught him the value of rigorous project management. And, from his work within the Department of Health, Education, and Welfare and the U.S. Public Health Service, he understood how science can provide practical solutions to complex public health problems.

Building a Team

John knew the Rx-to-OTC switch of nicotine replacement therapy (NRT) would be challenging, but that making this treatment more widely available would have an important impact on individual and public health. In response to SKB’s request for support, John assembled the core of the Pinney Associates team—scientists and academic experts united by a commitment to advancing individual and public health, and to finding innovative ways to assemble data that informs solutions to the challenges faced by pharmaceutical and consumer healthcare companies.

During the years that Pinney Associates supported the successful switches of other NRT products, our numbers grew to include a distinguished cadre of behavioral and clinical scientists, policy experts, statisticians, and data management specialists. Our growth in expertise and diversity continued long after the OTC switches of NRT products concluded, with work on the switches of numerous medicines for the treatment of a wide range of conditions, and expansion of our work in abuse liability, risk management, and CNS drug development.

Evolving Scope, Consistent Values

Through the years, our commitment to Rx-to-OTC switch and consumer health products continued. We’ve engaged with more than 50 products spanning 30 indications. Consequently, our clients have successfully switched numerous products that make a difference in people’s lives, and ensured important OTC products have remained available to consumers.

At the same time, we’ve smoothed the path to regulatory acceptance for clients in the prescription medicines sector; dietary ingredients and supplements category; and in tobacco harm reduction.

The evidence-based philosophy we applied to the challenges of our earliest clients has evolved into the issues management approach that today helps you meet increasingly complex scientific and regulatory challenges and achieve regulatory and commercial success. The commitment to advancing individual and public health that fueled the work we did for our very first client continues to drive the work we do for you today.

Team Approach

When you work with us, you get more than one person’s opinion. You get carefully considered strategic advice from the right group of our highly experienced experts.

Success depends on the right combination of expertise and experience. We begin by analyzing your project to understand your specific needs and goals. Then we assemble a cross-disciplinary project team handpicked to meet those needs and advance those goals.

From project planning through execution, our senior leaders and directors are hands-on. They work closely alongside other Pinney Associates specialists and staff, interacting directly with you and your team to ensure thorough analysis and response to your needs.

Evidence-Based Approach

Credible evidence based on sound science is the strongest foundation on which companies, regulators, and policy makers can build solid decisions. That principle guides us as we help you bring safe and effective medications—and other products—to the market and, in doing so, promote individual and public health.