Michael Hufford

Michael Hufford is vice president for regulatory affairs, behavioral science and innovation at Pinney Associates.

He brings more than 20 years of experience in clinical research, drug and medical device development, and behavioral science across a wide range of therapeutic areas to the company’s clients.

Hufford’s drug-development experience includes serving as Cypress Bioscience’s vice president of corporate and clinical development, where he was responsible for development of the drug and medical device portfolio for multiple CNS assets, including the U.S. Food and Drug Administration approval of Savella (milnacipran) for fibromyalgia. Before joining Cypress, he worked at Amylin Pharmaceuticals, leading drug development teams focused on orphan drug development for rare metabolic diseases, and combination peptide and protein therapies for obesity.

Hufford has also consulted extensively with the pharmaceutical industry, including serving as vice president of scientific affairs at Invivodata, where he was responsible for scientific consulting on patient-reported outcome claim construction for more than 50 drug-development programs. He also served as chief operating officer for NeuroCog Trials, which specializes in providing clinical and neurocognitive assessment, experimental design and data analysis services for clinical trials.

Hufford has co-founded multiple pharmaceutical, device and mobile health companies. He is the co-founder of NQ Oncology, a clinical stage oncology drug company. He also co-founded and served as chief medical officer of e-Nicotine Technology, a device company committed to reducing the harms associated with combustible tobacco products. He was also the co-founder and CEO of MindApps, a company that provides mobile electronic cognitive behavioral therapy applications focusing on major depressive disorder, anxiety disorders and post-traumatic stress disorders.

A graduate of Purdue University, Hufford earned his master’s and doctoral degrees in clinical psychology from the University of Pittsburgh, where his research focused on smoking and other addictive behaviors.