Michael Hufford, Ph.D.

Regulatory Affairs and Behavioral Science

Michael Hufford 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 our clients.  He currently is the Chief Executive Officer of LyGenesis, a biotechnology company, and co-founder and CEO of Harm Reduction Therapeutics.

Michael’s drug development experience includes serving as Cypress Bioscience’s Vice President of Corporate and Clinical Development, where he had responsibility for development of the drug and medical device portfolio for multiple CNS assets, including the FDA 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.

Michael 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.

An entrepreneur, Michael 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 Chief Executive Officer of MindApps, a company that provides mobile electronic Cognitive Behavioral Therapy applications focusing on major depressive disorder, anxiety disorders, and PTSD.

A graduate of Purdue University, Michael 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.