Public/Private Research Partnerships

Merck was a charter member of the Critical Path Institute's Predictive Safety Testing Consortium (PSTC), and a leader in subsequently setting and delivering the group's objectives. This consortium established five working groups to identify and evaluate safety biomarkers that can be used to help bridge animal toxicology studies and early human trials.The first example of the consortium's success has been the data recently provided by the PSTC to the European Medicines Evaluation Agency and U.S. Food and Drug Administration (FDA) to support the qualification of seven biomarkers for monitoring certain specific acute drug-induced kidney injuries with markedly improved performance characteristics over previous measures (blood urea nitrogen and serum creatinine).This submission also served to establish a standardized process with regulatory authorities that paves the way for subsequent safety biomarker qualifications.

Merck has participated in the Cardiac Safety Research Consortium (CSRC) since its inception. The CSRC is a public/private partnership formed through an agreement between the FDA and the Duke University Clinical Research Institute. The possibility of drug-induced cardiac rhythm and electrocardiogram (ECG) abnormalities and the need to identify them early in development has long been a significant focus of drug developers and regulators. To better understand this issue, the CSRC has developed a repository of digital electrocardiogram waveforms and organized the ECGs into an electronic library or warehouse. The warehouse was first populated by ECGs from studies contributed by Merck and two other pharmaceutical companies. The warehouse will be publicly available in the near future and will be a new resource for scientists to help them develop tools to identify more quickly potential safety problems while developing new drugs.

Merck also is a key participant in the Alzheimer's Disease Neuroimaging Initiative (ADNI) public/private consortium. Alzheimer's Disease is a significant and devastating disease that affects millions of people and their families. The overall goal of ADNI is to define the rate of progress of mild cognitive impairment and Alzheimer's Disease, to develop improved methods for clinical trials in this area, and to provide public access to a large database that will improve design and efficiency of treatment trials. It is expected that this project will provide information and methods to help lead to effective treatments for Alzheimer’s Disease.

The content on this page was last modified on September 15, 2009.

Merck & Co., Inc., Whitehouse Station, NJ, USA, and Schering-Plough Corporation, Kenilworth, NJ, USA, are now one company. We have combined our global operations under the name Merck & Co., Inc. We are working to update our corporate responsibility Web site to reflect our new, combined, global organization.