Clinical Development and Validation Process for VeriPsych

Discovery Phase
Biomarkers linked to schizophrenia were discovered by measuring hundreds of biomarkers in serum samples collected from 445 individuals including 163 patients with recent-onset schizophrenia, 32 bipolar disorder patients, 50 major depressive disorder patients, and 200 healthy matched control subjects. These individuals were recruited from research partners at various universities in Germany. The results identified 36 individual biomarkers with serum concentrations that were significantly different between schizophrenia patients and healthy controls.

Clinical Evaluation Phase
Hundreds of biomarkers were measured from samples collected from three additional sites to confirm the performance of the 36-biomarker panel and to identify additional biomarkers. By inclusion of other major mental illness patient samples, an additional 15 biomarkers were identified that enhanced the accuracy of VeriPsych.

Clinical Validation Process
The 51-biomarker test, VeriPsych, was applied to 1,210 well-characterized samples. VeriPsych differentiated patients with recent-onset schizophrenia from normal controls with the following results:

* For further explanation please read this recent publication

Clinical Advisors
Our Clinical Advisory Board is composed of nationally recognized thought leaders in psychiatry who advise us on clinical trial, product development, and emerging trends and new opportunities. The members of our Clinical Advisory Board are:

Sabine Bahn, M.D., Ph.D., MRC Psych
Dr. Bahn is a co-founder of Psynova Neurotech Limited, and a leading research scientist. A psychiatrist by training, she established the Cambridge Centre for Neuropsychiatric Research, which has conducted comprehensive functional genomics studies on psychiatric disorders. Dr. Bahn’s main research interests have been to understand the molecular basis of neuropsychiatric disorders, with a focus on the major psychotic disorders, schizophrenia and bipolar disorder. Dr. Bahn has been awarded numerous grants, including funding from the Stanley Medical Research Institute, and she has had numerous peer-reviewed publications. In addition, Dr. Bahn serves on the editorial boards of Frontiers in Neuroenergetics and Clinical Schizophrenia and Related Psychoses.

Tyrone D. Cannon, Ph.D.
Dr. Cannon is the Staglin Family Professor of Psychology, Psychiatry & Biobehavioral Sciences, the Carol Moss Spivak Scholar in Neuroscience, and the Director of the Staglin Music Festival Center for Cognitive Neuroscience at UCLA. Dr. Cannon’s research aims to discover the causes of schizophrenia and bipolar disorder and to develop effective treatment and prevention strategies based on an understanding of the genetic and neural mechanisms that give rise to these disorders.

Andreas Meyer-Lindenberg, M.D., Ph.D.
Dr. Meyer-Lindenberg is the Director of the Central Institute of Mental Health, Mannheim Germany, and the Professor and Chairman of Psychiatry and Psychotherapy, University of Heidelberg. He received a Masters in mathematics from the University of Hagen, a Ph.D. from the University of Giessen, and an M.D. from the University of Bonn. He worked for over ten years at the U.S. National Institute of Mental Health (NIMH). Dr. Meyer-Lindenberg has investigated the interaction of the prefrontal cortex and striatum in people with schizophrenia, and he has developed methods to investigate complex interactions between genetic variants and their influence on the human brain. He now combines studies of genetic indicators of mental illness with neuroimaging in order to uncover the elusive biological mechanisms of mental disorders.

Wayne Drevets, M.D.
Dr. Drevets is the President of the Laureate Institute for Brain Research, within the William K. Warren Laureate Psychiatric Clinic and Hospital in Tulsa, Oklahoma. In 2008, the Laureate saw 3,633 inpatient admissions and over 84,000 outpatient visits. Dr. Drevets received his M.D. from the University of Kansas. He joined the Department of Psychiatry at Washington University Medical School where he rose to the rank of tenured Associate Professor. During these years he conducted positron emission tomography, or PET, imaging studies of mood and anxiety disorders under the mentorship of Dr. Marcus Raichle. He moved to the University of Pittsburgh, where he continued to study brain imaging and acquired additional training in the application of PET to receptor imaging. In 2001, Dr. Drevets joined the NIMH Mood and Anxiety Disorders Program as a Senior Investigator. He is currently involved in research employing PET and MRI technologies to better understand mood and anxiety disorders.

John M. Kane, M.D.
Dr. Kane is Professor of psychiatry, neurology, and neuroscience, and holds the Dr. E. Richard Feinberg Chair in Schizophrenia Research at the Albert Einstein College of Medicine. Dr. Kane directs the NIMH-funded Research Center for the Study of Schizophrenia for the North Shore Long Island Jewish Health System. He has published over 300 papers in scientific journals and is one of the most highly cited researchers in psychiatry. Dr. Kane has been a member of the Board of Scientific Counselors for NIMH. He has served on the council of the American College of Neuropsychopharmacology, and chaired the American Psychiatric Association Committee on Research on Psychiatric Treatments. He is president of the American Society of Clinical Psychopharmacology and the Schizophrenia International Research Society. Dr. Kane has chaired the NIMH Psychopathology and Psychobiology Review Committee as well as the Psychopharmacologic Drugs Advisory Committee of the FDA. He has served as a consultant to the Veterans Administration and the U.S. Department of Justice. Dr. Kane is a recipient of the Arthur P. Noyes Award in Schizophrenia, the NAPPH Presidential Award for Research, the American Psychiatric Association Foundations’ Fund Prize for Research, the Kempf Fund Award for Research Development in Psychobiological Psychiatry, the Lieber Prize for Outstanding Research in Schizophrenia, the Heinz E. Lehmann Research Award from New York State and the Dean Award from the American College of Psychiatrists. Dr. Kane received his MD from New York University School of Medicine.

Principal Investigators
Several of our academic collaborators have chosen to work with us as principal investigators, in which the collaborator receives no direct payment from the company, but does have a confidentiality obligation. These experts will assist in the design of additional clinical trials and the interpretation of the results. There is a potential for these relationships to change as the different assays progress through validation, evaluation and general usage in clinical practice.

S. Charles Schulz, M.D.
Dr. Schulz is a Professor and Head of the Department of Psychiatry at the University of Minnesota. He received his M.D. and psychiatric residency training at the UCLA Medical School. Dr. Schulz became a clinical associate at the National Institute of Mental Health where he worked in the Neuropsychopharmacology Section at the Clinical Center. In 1980, Dr. Schulz moved to the Medical College of Virginia where he started the Schizophrenia Program. His research interests focused on neuropsychiatric studies of teenagers suffering from schizophrenia, including CT research. In 1983, he became Medical Director of the Schizophrenia Module at University of Pittsburgh where his research focused on treatment of refractory schizophrenia. In 1986, he moved to the NIMH extramural program where he contributed to the National Plan on Schizophrenia Research. Along with Dr. Carol Tamminga, he started the biennial International Congress on Schizophrenia Research. Dr. Schulz was Professor and Chairman of the Department of Psychiatry at Case Western Reserve University School of Medicine and University Hospitals of Cleveland from 1989 to 1999. His research interests are MRI imaging in adolescents with schizophrenia and bipolar illness. He also has been active in clinical trials with antipsychotic medications.

Sheldon Preskorn, M.D.
Dr. Preskorn is President and Chief Executive Officer for the Clinical Research Institute and Professor in the Department of Psychiatry at the University of Kansas School of Medicine-Wichita. A fellow of the American Psychiatric Association and the American Psychopathological Association, Dr. Preskorn has served on advisory committees of the FDA, Veterans Administration, National Institutes of Health and National Science Foundation, and was a consultant to the Menninger Foundation on clinical psychopharmacology. He received his M.D. at the University of Kansas. An international lecturer and the author of over 400 scientific, professional articles and books, Dr. Preskorn has received continuous grant funding since 1978 for an estimated life-time total of $50 million. His clinical research has included pharmacokinetics, drug-drug interactions and drug development through all clinical phases from “first time in man” studies through phase III trials. He has been the principal investigator on over 250 clinical trials including drug development studies of many antidepressants marketed in the United States. In addition to this research work, his clinical and administrative experience includes six years as supervising physician for an acute psychosis ward, six years as chief of psychiatry for a university affiliated Veterans Administration Medical Center, five years as director of the KUSM-W Outpatient Psychiatric Clinic and eight years as Chair of the KUSM-W Department of Psychiatry.

Scientific Advisors
Our scientific advisory board consists of scientists with knowledge in mathematics, statistics, clinical trial design and applied biology. They act as strategic resources for our management and our board of directors.

Thomas Joos, Ph.D.
Dr. Joos is a leading expert and opinion leader within the field of protein microarray technologies and applications. Dr. Joos is head of the Biochemistry Department of the Natural and Medical Sciences Institute at the University of Tübingen. Dr. Joos is a scientific advisor of BioChipNet, and a member of the editorial board of Drug Discovery Today, Proteomics, Molecular Biotechnology and Expert Review of Proteomics. Dr. Joos is an invited speaker, advisor and chairman at major international biochip conferences. He has published numerous papers, including recent articles in Drug Discovery Today, Proteomics and Trends in Biotechnology.

Vladimir Vapnik, Ph.D.
Dr. Vapnik has studied learning theory-related problems for more than four decades. Together with Alexey Chervonenkis, Dr. Vapnik has studied the problem of uniform convergence of empirical means and developed the VC theory. He also developed the Support Vector Machines algorithm. Dr. Vapnik received his Ph.D. in statistics at the Institute of Control Sciences, Moscow in 1964. He worked at this institute from 1961 to 1990 and became Head of the Computer Science Research Department. At the end of 1990, he moved to the USA and joined the Adaptive Systems Research Department at Bell Labs. Vapnik left Bell Labs in 2002 and joined NEC Laboratories America, Inc., where he currently works in the Machine Learning group. He is a Professor of Computer Science and Statistics at Royal Holloway, University of London and an Adjunct Professor at Columbia University. He was inducted into the U.S. National Academy of Engineering in 2006. He received the Paris Kanellakis Award in 2008.

Michael Walker, Ph.D.
Dr. Walker has over 20 years experience in biostatistics and bioinformatics and is a Consulting Professor for the Department of Medicine at Stanford University. Dr. Walker teaches courses in biology and statistics and consults for biotechnology and pharmaceutical companies in the field of biostatistics and clinical trial design. His clients include Roche, Affymetrix, Inc., and Genomic Health, Inc. He has published in The New England Journal of Medicine, The Lancet, Genome Research and other leading journals, and has more than forty patents issued or pending for the discovery of disease-associated genes and statistical analysis methods. Dr. Walker received a Ph.D. from Stanford.

Matthew Albert, Ph.D.
Dr. Albert is an Institut National de la Santé et de la Recherché Medicalé INSERM director of research working at Institut Pasteur, where he heads a mixed INSERM / Pasteur Unit. His current positions also include Director of The Center for Human Immunology at Institut Pasteur; and Adjunct Faculty at Necker Hospital. He received his M.D. at Cornell University Medical College and his Ph.D. in immunology at The Rockefeller University. Dr Albert’s laboratory is centered around a ‘bedside-to-bench’ approach to translational research. His basic science and clinical research goals are to define the direct and indirect influence of apoptotic and autophagic cell death on immunity; identify mechanisms of tumor immunity in patients with superficial transitional cell carcinoma of the bladder; and characterize the complex role of type I interferons and interferon stimulated genes in hepatitis C virus disease pathogenesis and treatment. He has received the Burroughs Wellcome Fund Career Award (2000), The Doris Duke Clinical Scientist Development Award (2001), The European Young Investigator Awards (2006) and The European Research Council Young Investigator Starting Award (2008).