RARITAN, NJ, November 15, 2012 -- Janssen Research & Development, LLC (Janssen R&D) today announced the establishment of a global cross-pharmaceutical Investigator Databank designed to improve efficiencies of industry-sponsored clinical trials. Merck and Eli Lilly and Company are the first two companies to join Janssen in this effort.
The new Investigator Databank, established as part of this novel industry collaboration, will serve as a one-stop repository where key information about clinical trial sites, such as infrastructure and Good Clinical Practice (GCP) training records, is housed. This will allow participating pharmaceutical companies to reduce time-consuming and sometimes redundant administrative work involved in identifying appropriate clinical trial sites.
At the outset of every clinical trial, pharmaceutical companies initiate clinical trial site selection, prequalification and GCP training, which can be paperwork-heavy and time-consuming for trial sponsors and investigators alike. By housing critical information about investigators and trial sites in one place, the databank will reduce time, cost and duplicative efforts, making it easier for companies to identify appropriate trial sites and investigators for future clinical trials. Investigator sites that have opted-in to data sharing will have their relevant information accessible to pharmaceutical companies participating in the collaboration. This databank will not include any patient data.
“The current clinical trial environment is inefficient, costly and unsustainable. The Investigator Databank can help expedite the process to achieve our most important goal – to deliver high-quality, effective novel medicines to the patients who are waiting for them,” said Andreas Koester, MD, PhD, Head, Clinical Trial Innovation/External Alliances, Janssen Research & Development. “We are enthusiastic about working with other industry leaders to collectively apply our expertise, capabilities and shared passion for advancing science and improving lives.”
Earlier this year, Janssen joined nine other companies to launch TransCelerate BioPharma Inc. ("TransCelerate"), the largest initiative of its kind, which aims to identify and overcome common drug development challenges in order to improve the quality of clinical studies and to bring new medicines to patients faster. The initiative identified the centralization of site prequalification and training as one of five key projects, and the Janssen-led Investigator Databank project will serve as a foundation for the TransCelerate initiative.
“Industry collaboration, including pre-competitive data sharing, is critical to ensuring continued progress to improve industry-wide clinical trial practices,” said newly appointed CEO of TransCelerate BioPharma, Garry Neil, MD, Partner at Apple Tree Partners and formerly Corporate Vice President, Science & Technology, Johnson & Johnson. “This work is aligned with TransCelerate’s initial focus on clinical study execution and we encourage participation from our founding TransCelerate companies to solve industry-wide challenges in a collaborative environment.”
Member companies of TransCelerate who wish to join the Investigator Databank will automatically qualify for participation. It is anticipated that the Investigator Databank will be operational by the end of the year and incorporated into one of the priority projects within TransCelerate by mid-2013.
The Investigator Databank will be hosted by DrugDev.org, an independent, third party with expertise in clinical trial information technology and investigator community management.
Janssen Research & Development, LLC
Janssen Research & Development, LLC (Janssen), is one of the Janssen Pharmaceutical Companies. Janssen is headquartered in Raritan, N.J. and has facilities in Europe, the United States and Asia. Janssen is leveraging drug discovery and drug development in a variety of therapeutic areas, including Neuroscience, Oncology, Immunology, Infectious Diseases, and Cardiovascular and Metabolism to address unmet medical needs worldwide.
Janssen Healthcare Innovation and Clinical Trial Innovation
Janssen Healthcare Innovation (JHI) is an entrepreneurial team within Janssen Research & Development. Through collaborations, JHI is developing products and services to deliver high-quality, cost-effective healthcare. JHI’s Clinical Trial Innovation team is focused on identifying and testing novel approaches, processes, technologies, and best practices that have the potential to reduce trial set up and execution cycle times, and reduce cost. For more information, go to: www.janssenhealthcareinnovation.com.
Forward Looking Statement
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. 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 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, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Janssen Research & Development, LLC nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)