Merck is committed to addressing medical needs through scientific excellence: we invested almost $5 billion annually on R&D in 2006, 2007 and 2008. The talent of our scientists, combined with the dramatic scientific and technological advances of the past decade, has led to an exciting period of Merck research as we seek new and more effective ways to treat diseases.
Merck's research philosophy is based on satisfying unmet medical needs globally. In assessing our research priorities, we also explore the scientific and commercial feasibility of conducting research with the potential to develop a product that is useful, considering available knowledge, theories, technologies and skills. Our research and development is focused on the following six franchise areas:
- Atherosclerosis and cardiovascular disease
- Bone, respiratory, immunology and endocrine disorders
- Diabetes and obesity
- Infectious diseases and novel vaccines
- Neuroscience including Alzheimer's disease and pain
- Oncology
Within these therapeutic areas, we commit resources to achieve research breadth and depth and to develop best-in-class targeted and differentiated products that are valued highly by patients, payers and physicians.
Merck’s research pipeline4 continues to grow as we accelerate our discovery efforts.
Medicines discovered and developed by Merck scientists save and improve countless lives around the globe. Thanks to the more than 10,000 people behind the life-enhancing discoveries of Merck Research Laboratories, we are among the world's most innovative institutions in the medical sciences for producing first-in-class medicines.
Our products and research priorities are aligned with the current and projected global burden of disease (as defined by the World Health Organization [WHO]), as well as the emerging need for new treatments for increasingly treatment-resistant diseases such as HIV.
Governance of our Research Agenda
The Research Management Committee, chaired by the Executive Vice President and President, Merck Research Laboratories (MRL), reviews and approves the Company's research objectives and strategy annually. In addition, our Research Strategy Review Committee (RSRC) includes external scientific experts and provides critically important input that helps inform Merck's strategic decisions. The research strategy and goals of our franchises and functions are reviewed by the RSRC on a regular basis to ensure that our efforts stay properly focused and internally aligned, and that we remain responsive to advances and changes in the field.
Merck is committed to research in specific therapeutic areas and clinical development in support of new products. We also maintain several long-term exploratory and fundamental (“basic”) research programs in biology and chemistry as well as research programs directed toward product development.
Critical to these efforts is a focus on biomarkers — those characteristics that can be objectively measured and evaluated as an indicator or marker — of normal biologic processes, disease or responses to drugs. Biomarkers provide critical information along the drug discovery and development pathway. Merck is using a unique, highly integrated biomarker approach in which three departments — Imaging, Molecular Profiling and Experimental Medicine — work together to develop biomarker based clinical methodologies. The intent is to apply these research platforms very early in the clinical development of novel mechanisms (Phase 1 if possible), to gain some preliminary evidence of potential benefit before substantial exposure to patients. By eliminating likely failures sooner and focusing on those mechanisms that appear more promising, we believe we will bring innovative products to patients faster. Throughout this process, a rigorous focus on scientific excellence and safety is maintained.
Merck’s R&D model is designed to increase productivity and improve the probability of success by prioritizing MRL's resources. We believe that drug development is not an effort that can successfully be driven by an individual or just one company. Most cases of true innovation come from robust and honest collaboration amongst individuals with diverse backgrounds and capabilities joined together by the idea of changing the course of human health. As part of our R&D strategy, we continue to pursue appropriate external licensing opportunities. MRL recognizes advancements in scientific knowledge external to Merck and we are vigilant in leveraging, licensing and acquiring new technologies and compounds that are consistent with our R&D strategy.
Code of Conduct
All Merck employees must abide by our Code of Conduct, which also applies to the way we work with external researchers, doctors and academics. According to Merck's Guiding Principles for Business Practices Involving the Medical and Scientific Community, all activities involving the medical and scientific community that are sponsored or supported by Merck, including our subsidiaries, should have a well-articulated business purpose. In addition, all activities should be implemented in accordance with the highest standards of ethics and integrity, having the utmost regard for patient health and safety.
Research Misconduct
In accordance with MRL policy, Merck does not tolerate fraud or misconduct in our research activities – whether by an employee or an external business partner. Merck deals promptly, directly and appropriately with all reported cases. MRL Policy is aligned with the Corporate Escalation, Investigation, Remediation, Recognition Guidelines.
MRL Compliance Committee
To help ensure compliance, Merck has clearly articulated policies in place to provide guidance to employees for ethical and lawful conduct. However, every employee has a stake in the Company and it is each employee's responsibility to conduct himself or herself ethically and lawfully.
Merck's Compliance Program is based on Chapter Eight of the U.S. Federal Sentencing Guidelines, Sentencing of Organizations, as amended, which set forth the elements of an effective compliance program, as well as more specific guidance for the pharmaceutical industry issued by the Office of the Inspector General in 2001. For more information on Merck's compliance programs, click here.
In January 2002, the Company's Compliance Charter allocated responsibility and accountability for compliance to the divisional level. Therefore, each division established its own compliance committee to tackle specific divisional issues and requirements.
The MRL Compliance Committee Charter has as its stated objective "ensure ongoing compliance with applicable laws and requirements in all Merck Research Laboratories business areas through appropriate management structure, processes and training." To manage compliance in MRL, the Committee has a core cross-functional team representing the key functional areas within MRL. In this way, MRL Compliance efforts encompass the entire division and go beyond compliance with clinical trial conduct.
The MRL Compliance Committee also promotes ethical science and provides guidance to MRL employees on Merck Standards and Corporate Policies and on the necessary education on specific requirements applicable to the research community.
Product Safety
Safety is our highest priority. We rigorously study our products and work with regulators and health care professionals over many years to characterize the safety profiles of these products. Initially, test compounds are evaluated in the laboratory. If they pass stringent laboratory tests, the compounds move into the next stage in which they are tested in animals. Only a few compounds ever make it to this stage. If the compound makes it through this stage of testing we then begin clinical development in which multiple studies are conducted over several years.
Clinical testing begins in Phase I in a small number of people and progresses through Phase III in which the safety and efficacy of a medicine is confirmed. If the clinical studies are successful, we submit extensive documentation and data to regulators in a product licensing application. Before approving a medicine or vaccine for use, regulators scrutinize these extensive data and analyses. Even after a product is approved, we continue to monitor the safety of our medicines and vaccines in various ways, including through post-marketing studies. If we identify safety issues following approval, we work closely with the U.S. Food and Drug Administration and other regulatory authorities to communicate appropriately with health care professionals and patients.
Medicines and vaccines approved for sale must be produced, handled and distributed according to precise manufacturing specifications and regulations.
Pediatric Formulations and Indications
We are including pediatric clinical trials in the Company's new drug and vaccine development strategies worldwide, where they are relevant. And, where appropriate, we will seek approval for pediatric indications and develop age-specific formulations. For a listing of all of our pediatric clinical trials go to www.clinicaltrials.gov.
Working with the External Scientific Community
Merck is a member of and supports numerous professional associations, including, but not limited to, the American Association for the Advancement of Science (AAAS), the U.S. National Institutes of Health (NIH), the U.S. National Science Foundation (NSF), the World Medical Association (WMA), and the Institute of Medicine (IOM). In addition to promoting dialogue and exchange of ideas in research, Merck sponsors research conferences such as selected Gordon Research Conferences that are related to areas in which Merck is conducting research. A Gordon Conference is an international forum where researchers discuss advances in biologic, chemical and physical sciences.
Over and above this, Merck collaborates with external researchers and other members of the pharmaceutical industry by participating in selected scientific consortia. Consortia are an important mechanism by which researchers can work together on nonproprietary scientific challenges that are common to all parties.
Contributions
Merck supports academic and community-based physicians and researchers in expanding clinical and scientific knowledge and in improving the understanding of the appropriate use of Merck products. To this end, Merck supports requests from the external scientific community by providing drug, funding and/or human resources, in accordance with laws and regulations and Merck's own Code of Conduct. Grants awarded by MRL are aligned with the overall scientific and medical strategies of Merck and MRL, and are evaluated for scientific merit.
Merck is committed to broad disclosure of payments to health care professionals, including payments made to US-based medical, scientific and health care business experts who provide commercial consulting or clinical research services. We believe uniform reporting standards are needed to ensure that clear, understandable data is disclosed to the public about industry relationships with the medical community. Until such standards are established, either legislatively or through an independent organization, Merck will move to disclose those payments independently.
Support for Science Education
Our long-standing support for science education is consistent with our overall commitment to scientific innovation. Merck programs help to promote the development and training of future leaders in science and biomedical research from K-12th grade through to the post-doctoral level; to stimulate interest among undergraduate students to pursue graduate study in the health sciences and possible research careers; and to create opportunities for graduate and post-doctoral training in a variety of basic and clinical research areas.
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.
4 Candidates shown in Phase III include specific products. Candidates shown in Phase I, II and II include the most advanced compound with a specific mechanism in a given therapeutic area. Back up candidates are not shown. This chart reflects the Company's current research pipeline as of July 15, 2009. This chart has been exerpted from the Company's quarterly report on Form 10-Q filed with the SEC on August 3, 2009 and should be viewed along with disclosures in that filing.
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