Michael Cole, PhD, MBA, Chief Executive Officer, NeuroHealth Technologies, joining us from the San Francisco Bay Area

The COVID-19 pandemic has greatly amplified the incidence, and personal, social, and economic costs of mental illness; and this impact will continue long after a COVID-19 vaccine is distributed. Unfortunately, mental health generally has been neglected by investors and impact funds. Unlike other areas of medicine, mental health treatments have seen little significant innovation in decades. Another critical concern is the extreme shortage of mental health care providers that existed before the pandemic and has risen exponentially. The pandemic forced a rapid shift to telehealth to meet this unprecedented demand, but remote mental health care is still in its infancy. It is ripe for applications of data science, artificial intelligence, and neuroscience. NeuroHealth Technologies is developing Neuro-ARTTM, a remote, data-centric, precision mental health care platform. Our solution will provide digital biomarkers for real-time patient insights, asynchronous assessment for scalability, and predictive analytics for precision therapy. Clinical studies are planned for long-term addiction recovery, cognitive rehabilitation with aging, and treatment of depression and anxiety disorders. NeuroHealth Technologies is building cutting- edge solutions to revolutionize mental health care. The future of mental health care is here.

Dr. Cole serves as CEO at NeuroHealth Technologies, an early-stage company developing a data-centric precision mental health platform called Neuro-ARTTM to improve treatment outcomes, improve provider experience, and derive additional revenue streams for healthcare systems through enhanced care. He is also a part-time Assistant Clinical Professor at UC Berkeley. Dr. Cole’s previous work at early-stage companies includes developing a computerized remote care platform for assessment and treatment monitoring of individuals with cognitive disorders, developing an AI in silica research platform for neurological disorders, and developing machine learning-based neuroimaging diagnostic algorithms for mental illnesses and neurologic diseases. Previous positions include a joint appointment as Associate Clinical Professor at UC Davis School of Medicine and Director of the VA Northern California Neuropsychology Residency Program, and Director of Medical Affairs at Pacira Pharmaceuticals. Dr. Cole received his PhD in clinical neuropsychology from the University of Florida, completed his clinical neuropsychology internship and NIH Fellowship at the UCLA School of Medicine, and obtained an Executive MBA from UC Berkeley.

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Anil Gulati, MD, PhD, Founder, Chairman and Chief Executive Officer, Pharmazz, joining from Chicago, IL

Pharmazz is a revenue-generating research-and-development critical care company whose first compound, Lyfaquin, is selling in India, since November 2020, to treat hypovolemic shock in life-or-death circumstances. US FDA advanced Lyfaquin without a Phase I or a Phase II. Pharmazz has a US FDA Phase III application on file, since November 1, 2020, under the agency's Special Protocol Assessment program. Pharmazz has more indications for Lyfaquin as well as two additional endothelins in its pipeline, one of which is in Phase III in India for ischemic stroke. These are the first endothelins brought to market. Each is first-in-kind and w/o competition. Pharmazz is preparing to fund the start of the US FDA Phase III, to grow sales in India, to expand sales to other Asian nations and to prepare for an IPO.

Dr. Gulati is leading clinical development and commercialization of first-in-class drug products in critical care medicine. He led the discovery, development and launch of Lyfaquin for hypovolemic shock. He has 54 issued patents and is Professor Emeritus at Midwestern University, and is recipient of Paul R. Dawson Biotechnology Award 2014, and Littlejohn Award 2014. Dr. Gulati is a United States Fulbright Scholar 2008-2009 and winner of International Ranbaxy Research Award 2007. Dr. Gulati was the Scientific Reviewer, United States Defense Medical Research and Development Program, Combat Casualty Care Research Program 2016 and 2017.

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Dean Maglaris, Chairman and Chief Executive Officer, Cytogel Pharma, and A. Thomas McLellan, MS, PhD, Scientific Advisor to Cytogel Pharma, Professor Emeritus at the University of Pennsylvania, and former US Deputy Director of the Office of National Drug Control Policy (2009-2012)

Cytogel is a clinical stage bio-pharmaceutical company developing first-in-class drug candidates, from the novel endomorphin family of molecules, that target key pain pathways and alleviate pain. This groundbreaking approach is backed by scientific evidence that elucidates its novel mechanism of action, differentiating it from that of the existing opioids and presenting an attractive alternative treatment for people in pain.

Mr. Dean Maglaris is a seasoned leader with more than 30 years in the pharmaceutical industry, joining Cytogel as its CEO in 2005. He has successfully guided the company through the identification of attractive compounds and the development of its lead compound, CYT-1010, which is entering Phase 2 clinical development, following a successful Phase 1 study in humans. Mr. Maglaris has long understood the need for a breakthrough solution to effectively and safely treat moderate to severe pain and has recognized the potential benefits CYT-1010 could provide to patients. As such, Cytogel has a clear priority on developing this new class of drugs and continually pursuing new intellectual property, which has resulted in several issued patents.

Dr. Thomas McLellan is founder of the Treatment Research Institute (TRI), an independent, nonprofit research and development organization dedicated to science-driven reform of treatment and policy in substance use, and Professor of Psychiatry at the University of Pennsylvania. He has more than 35 years of experience in addiction treatment research.

In 2016, he served as Senior Editor for the US Surgeon General report on Facing Addiction. From 2009 to 2010, he was Science Adviser and Deputy Director of the White House Office of National Drug Control Policy (ONDCP), a Congressional-confirmed Presidential appointment to help shape the nation’s public policy approach to illicit drug use. At ONDCP, McLellan worked on a broad range of drug issues, including formulation and implementation of the President’s National Drug Control Strategy and promotion of drug treatment through the broader revamping of the national health care system. In 1992, he founded and led TRI to transform the way research is employed in the treatment of and policy making around substance use and abuse.

In his career, he has published over 450 articles and chapters on addiction research and successfully completed over 150 NIH research grants. From 2000-2009 he was Editor-in-Chief of the Journal of Substance Abuse Treatment, and he has also served on several other editorial boards of scientific journals. Dr. McLellan is the recipient of several distinguished awards including the Life Achievement Awards of the American and British Societies of Addiction Medicine (2001 & 2003); the Robert Wood Johnson Foundation Innovator Award (2005); and awards for Distinguished Contribution to Addiction Medicine from the Swedish (2002) and Italian (2002) Medical Associations. In the 1980s, with his colleagues from the Center for the Studies of Addiction at the University of Pennsylvania, Dr. McLellan introduced the Addiction Severity Index and, later, the Treatment Services Review. Both are among the most widely used assessment instruments in the world.

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