U.S. National Institutes of Health
The largest source of funding for medical research in the world, the U.S. National Institutes of Health (NIH) is made up of 27 institutes and centers. For more than a century, NIH scientists have paved the way for important discoveries that improve health and save lives. The medical research agency has created hundreds of thousands of high-quality jobs by funding thousands of scientists in universities and research institutions in every state across America and around the globe. Through February 2015, we have been awarded more than $8.8 million from NIH for preclinical and Phase 1 development of AV-101. In February 2015, we entered into a Cooperative Research and Development Agreement (CRADA) with the NIH. Under the CRADA, the U.S. National Institute of Mental Health (NIMH), part of the NIH, will conduct and fully-fund a Phase 2 efficacy and safety study of AV-101 in major depressive disorder.
U.S. National Institute of Mental Health
The U.S. National Institute of Mental Health (NIMH), part of the U.S. National Institutes of Health (NIH), is the largest scientific organization in the world dedicated to mental health research. NIMH is one of 27 Institutes and Centers of the NIH, the world's leading biomedical research organization. The mission of NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. For more information, visit www.nimh.nih.gov.
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory, and lifecycle management services. Its clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 16,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. VistaGen is working with PPD on the design and execution of our Phase 2b study of AV-101.
Cato Research is a global contract research organization (CRO) that offers a wide range of integrated services to pharmaceutical, biotechnology, and medical device companies. They specialize in complex development programs requiring innovative regulatory and clinical strategies and have experience implementing and conducting successful clinical trials and development programs. Cato Research provides us with regulatory and drug development expertise for our AV-101 development programs and also acts as a source of potential drug rescue candidates and strategic collaborations.
Massachusetts General Hospital - Clinical Trials Network and Institute
The Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI) is one of the leading academic research programs in the world with more than 25 years of experience in industry-sponsored multi-center clinical trials. Their innovative research methods are unmatched in helping sponsors meet their research goals. By exploring the brain science, genetics, and neurobiology of psychiatric disorders, the MGH CTNI has been instrumental in the development of novel treatments and surrogate markers of illness and therapeutic response. Its pioneering scientific and clinical research has been instrumental in defining the standards for the state-of-the-art practice of psychiatry. MGH CTNI works collaboratively with sponsors and researchers who are recognized as world leaders in many areas of psychiatric research, including anxiety, depression, bipolar disorder, women's mental health, schizophrenia, geriatrics/Alzheimer's disease, pharmacogenetics, neuroimaging, and pediatric psychopharmacology. MGH CTNI psychiatrists are currently serving as principal investigators or site investigators on over 50 industry sponsored clinical trials across the spectrum. MGH CTNI is assisting us with patient screening and recruitment of our Phase 2b clinical study of AV-101 for the adjunctive treatment of major depressive disorder.