Johnson & Johnson Announces Open Translational Science Project in Schizophrenia

Collaborators seek insights about schizophrenia and advancement of treatment safety and efficacy

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Jun 09, 2015, 09:00 ET

TITUSVILLE, N.J., June 9, 2015 /PRNewswire/ -- Johnson & Johnson announced today that Janssen Research & Development, LLC (Janssen), a Janssen Pharmaceutical Company of Johnson & Johnson, and a group of leading research organizations are launching the OPTICS Project -- Open Translational Science in Schizophrenia.

The project will create a new forum for collaborative analysis of Janssen's clinical trial data with data available from the National Institutes of Health (NIH) about schizophrenia. Its goal is to advance scientific knowledge about the disease and create new models for conducting research. The current collaborators and members of the project's advisory board are Yale University School of Medicine, Rutgers University, Harvard T.H. Chan School of Public Health, and the National Institute of Mental Health (NIMH).

"Sharing clinical trial data advances the science that is the foundation of medical care," said Joanne Waldstreicher, MD, Chief Medical Officer, Johnson & Johnson. "Over the past year, Johnson & Johnson has worked with the Yale School of Medicine Open Data Access (YODA) Project to provide participant-level data from our pharmaceutical and medical device clinical trials to more than a dozen qualified researchers."

The OPTICS project will foster collaboration among qualified researchers in the analyses of Janssen's clinical trial data about schizophrenia therapies made available by Johnson & Johnson through the YODA project (http://yoda.yale.edu/optics-trial-bundle) with data about schizophrenia available through the National Institutes of Health's Center for Biotechnology Information (http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/collection.cgi?study_id=phs000887.v1.p1). This collection includes studies about the molecular etiologies of schizophrenia in a variety of populations. This is the first time data about the causes of the disorder and data from clinical trials of therapies will be available to researchers in one place.

"As a society, we have a responsibility to further advance care for people with mental illnesses," said Husseini K. Manji, MD, Global Head, Neuroscience Therapeutic Area, Janssen Research & Development, LLC. "Schizophrenia can be a devastating illness and has a significant impact on individuals living with the disease, as well as their families. OPTICS will foster open-science collaborations and lead to new, fundamental insights about schizophrenia so that we can improve therapies and treatments, and ultimately find a cure."

Marsha A. Wilcox, EdD, ScD, Scientific Director and Fellow, Janssen Research & Development, LLC, is leading the project. All data analyses proposed for OPTICS must support at least one of three defined project goals:

Advance efficacy and safety of medicines for schizophrenia;
Increase understanding of schizophrenia, including disease natural history, subtypes, and causes; and
Contribute to the development of analytic and design methods for disparate data types, including novel statistical methods and research designs.

Qualified investigators may apply to participate in the collaboration. They need to agree to meet the data access and use requirements of all data owners. They also must agree that any knowledge generated from this project (e.g., publications, models predicting outcome) will be dedicated to the public and will be free for everyone to use. Manuscripts describing results from this project will first be published in the OPTICS volume in an open-access online journal. One of the goals of the project is to encourage collaborations among industry and academia, including those that will exist outside traditional disciplines, such as econometrics and computer science. The OPTICS project will provide a web-based workspace in which such collaboration can occur, and groups with similar methods and research topics will be encouraged to work together.

The OPTICS project is one part of a larger effort at Janssen and other Johnson & Johnson research companies to share clinical trial data to enhance public health, advance science and bring innovative medicines to patients faster. In 2014, Janssen announced a novel agreement in which YODA serves as an independent body to review requests from investigators and physicians seeking access to anonymized clinical trial data owned by the company. This collaboration was expanded in 2015 to include data from clinical studies on medical devices conducted by other Johnson & Johnson subsidiaries.

The OPTICS project is governed by an Advisory Board comprised of scientists from academia, the biopharmaceutical industry, and the NIMH.

For more information please visit https://sites.google.com/site/opticsschizophrenia/.

About Schizophrenia
Schizophrenia is a complex and chronic brain disorder that can be severe and disabling. It often begins in early adulthood and affects approximately one percent of the population globally. Schizophrenia can greatly interfere with future education, employment, and relationships if left untreated. The course of schizophrenia is varied for some, often involving a series of relapses or the return of disease after partial recovery.

About Johnson & Johnson
Caring for the world one person at a time inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Our approximately 126,000 employees at more than 270 Johnson & Johnson operating companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

About Janssen Research & Development, LLC
Janssen Research & Development, LLC is headquartered in Raritan, N.J. and has affiliated facilities in Europe, the United States and Asia. Janssen Research & Development is leveraging a combination of internal and external innovation to discover and develop novel medicines and solutions in five distinct therapeutic areas: Neuroscience, Oncology, Immunology, Infectious Diseases and Vaccines, and Cardiovascular and Metabolism. For more information about Janssen Research & Development, LLC visit www.janssenrnd.com. Janssen Research & Development is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Driven by our commitment to patients, we work together to bring innovative ideas, products, services and solutions to address serious unmet medical needs around the world.

Forward-Looking Statement
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to a new collaboration. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the potential that the expected benefits and opportunities related to the collaboration may not be realized or may take longer to realize than expected; challenges and uncertainties inherent in new product development, including the uncertainty of clinical success and obtaining regulatory approvals; and global health care reforms and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 28, 2014, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The Janssen Pharmaceutical Companies and Johnson & Johnson do not undertake to update any forward-looking statement as a result of new information or future events or developments.

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