Medicines discovered and developed by Merck scientists save and improve countless lives around the globe.
In the past 60 years, innovative medicines and vaccines have helped to dramatically improve public health and the economic well-being of societies and individuals in many countries.
As a result of such biomedical advances and increasing economic prosperity, diseases that were prevalent 100 years ago, such as smallpox and polio, have all but disappeared. The global burden of illness looks very different today, and the World Health Organization projects that it will be different again in 20 years.
Merck is committed to addressing medical needs through scientific excellence: Research and development expenses were $8.5 billion in 2011, $11.0 billion in 2010, and $5.8 billion in 2009. 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 R&D is focused on the following six disease areas:
- Cardiovascular Disease
- Diabetes and Endocrinology (including Women's Health)
- Neuroscience and Ophthalmology
- Infectious Diseases
- Respiratory and Immunology
We pursue therapies in a variety of modalities, from small molecule and vaccines to biologics (peptides, small proteins, antibodies) and RNAi (RNA Interferencea method of selectively silencing genes).
Merck Research Laboratories (MRL) commits resources to discover and develop innovative products that save and improve lives around the world, and to deliver the most value to our customers. 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 with the increasing need for new therapies targeted to treatment-resistant diseases, such as the Hepatitis C virus.
Merck is committed to research in specific therapeutic areas and to clinical development in support of new products. We maintain several long-term exploratory and fundamental research programs in biology and chemistry, as well as research programs directed toward product development. Learn more.
With the complex challenges of bringing important new drugs to our patients while simultaneously controlling the rising costs of innovation, Merck is also leveraging important new clinical and quantitative tools that help us rapidly differentiate between drugs that will clearly meet patient needs and those that will not.
A focus on translational medicine is critical to these efforts, enabling us to develop biomarkersthose characteristics that can be objectively measured and evaluated as an indicator (or marker) of normal biologic processes, disease or responses to therapy. Since biomarkers provide critical information in the drug discovery and development process, our intent is to apply them very early in the development of novel therapeutic candidates (Phase 1, if possible), to provide preliminary evidence for potential benefit before proceeding with further development.
In addition, Merck is using novel quantitative approaches to leverage what we learn from our preclinical experiments to inform our clinical trials, and to develop models based on published literature. By integrating our knowledge from these sources, we can develop mathematical models that allow us to explore possible clinical trial scenarios. Instead of running a single clinical trial, we first simulate the trial thousands of times, exploring the impact of different factors influencing the disease, the patient population, and efficacy and safety response.
With this integrated approach we can optimize the next phase of clinical trials, and, importantly make pivotal decisions earlier and more confidently, increasing productivity and improving the probability of success. By eliminating likely failures sooner and focusing on those mechanisms that appear more promising, we believe we will bring innovative products to patients faster, while still maintaining a rigorous focus on scientific excellence and safety.
We also recognize that one individual or company cannot successfully develop drugs single-handedly. Most cases of true innovation come from robust and honest collaboration among 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, therefore, we continue to pursue appropriate external licensing and partnering opportunities. In this regard, Merck Research Laboratories (MRL) establishes significant external alliances to accelerate drug discovery and development, improve R&D productivity, and successfully commercialize novel therapeutics and vaccines.
Merck's research pipeline1 illustrates the progress of our discovery efforts. The company currently has a number of candidates under regulatory review in the United States and internationally. An update on Research and Development can be found in the company's 10-K Report.
1 Reflects the Merck research pipeline as of February 21, 2012.
"Innovation is the centerpiece of our growth strategy at Merck. We continue to make significant progress on our strategy to drive growth from our existing portfolio and to bring forward breakthrough medicines and vaccines that address unmet medical needs and return significant value to our shareholders."
Kenneth C. Frazier
Merck Chairman & CEO
Governance of Our Research Agenda
The Research Leadership Team, headed by the executive vice president and president, Merck Research Laboratories (MRL), develops the divisional strategy, allocates resources and manages the portfolio of MRL products. The Research Leadership Team is made up of the heads of six functional areas within MRL. Each area provides expert, efficient support of our drug candidates-ushering them from drug discovery through product life-cycle management.
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.
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 Merck's policy on Reporting and Responding to Potential Company Violations.
To help ensure compliance, Merck has clearly articulated policies in place to provide guidance to employees on ethical and lawful conduct. However, every employee has a stake in the company, and it is each employee's responsibility to conduct him 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 to "ensure ongoing compliance with applicable laws and requirements in all MRL 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, 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, as well as on the necessary education on specific requirements applicable to the research community.
Safety is our highest priority. We rigorously study our products and work with regulators and healthcare professionals over many years to characterize their safety profiles. Initially, test compounds are evaluated in the laboratory. If they pass stringent laboratory tests, the compounds move into next-stage testing in animals. Only a few compounds ever make it this far. 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 actively monitor the safety of our medicines and vaccines in various ways, including through post-marketing studies. If we identify safety issues following a product’s approval, we work closely with the regulatory authorities to communicate promptly and appropriately with healthcare professionals and patients.
Pediatric Formulations and Indications
We are including pediatric clinical trials in the company's new drug and vaccine development strategies worldwide, in response to unmet clinical needs, where relevant. And, where appropriate, we will seek approval for pediatric indications and develop age-specific formulations. In 2010, Merck established an internal Pediatric Development Advisory Committee to review and provide input into all pediatric development strategies across various therapeutic areas. It serves as a center of excellence within Merck to consult on pediatric development issues and key pediatric policy questions. For a listing of all of our pediatric clinical trials, click here.
"I believe there is before us a wider field of the unknown than all that is behind us. Based on knowledge already developed, there are many ideas to be discovered. The still-greater progress to come will depend on fine intellects, inspiration and the efforts of both those who teach and those who benefit from such teaching. It also will depend upon the business and industrial world and upon teamwork on all fronts with, above all, a genuine and active interest in the welfare of humanity."
Merck supports academic and community-based physicians and researchers to expand clinical and scientific knowledge and improve 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 Merck Research Laboratories (MRL) and the Office of the Chief Medical Officer are aligned with the overall scientific and medical strategies of Merck and are evaluated for scientific merit.
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, an international forum where researchers discuss advances in biologic, chemical and physical sciences - that cover areas in which Merck is conducting research.
Merck also 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 common to all parties.
We believe in broader disclosure of financial relationships between physicians and the pharmaceutical industry. In 2008, Merck endorsed the Physicians Payment Sunshine Act, mandating disclosure of certain financial relationships. Even in the absence of a legislative requirement, in October 2009, we began voluntarily disclosing all payments to U.S.-based healthcare professionals who speak on behalf of Merck about our products and other healthcare issues. Click here for more information and a list of disclosures.
Public-Private Research Partnerships
Merck is a member of the Predictive Safety Testing Consortium (PSTC), a unique public-private partnership led by the nonprofit Critical Path Institute (C-Path). The PSTC brings together pharmaceutical companies to share and validate their safety testing methods under the advisement of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
The 18 corporate members of the consortium share internal experience with preclinical and clinical safety biomarkers in kidney, liver, skeletal muscle, testicular toxicity, vascular injury and cardiac hypertrophy. All biomarker research programs have a strong translational focus to select new safety tools that are applicable across the drug-development spectrum. Advancing the science and use of biomarkers in drug development is a critical area of focus for Merck. The following are notable PSTC achievements:
- The FDA and EMA qualified seven new urine tests that signal kidney injury
- The PSTC opened a biomarker qualification process with the FDA for new biomarkers of drug-induced liver and skeletal muscle injury
- The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) qualified new biomarker laboratory tests that signal kidney injury
The Biomarkers Consortium, in which Merck also participates, is a public-private biomedical research partnership managed by the Foundation for the National Institutes of Health. Its goal is to combine the forces of the public and private sectors to accelerate development of biomarker-based technologies, medicines and therapies for the prevention, early detection, diagnosis and treatment of disease. Working together, the members of the Biomarkers Consortium are building uniquely powerful collaborations that are accelerating the development of biomarker-based technologies, medicines and therapies.
To date, the consortium has launched eleven projects in areas such as Alzheimer's disease, metabolic disorders, immunity and inflammation, cardiovascular disease, cancer imaging and, most recently, drug-induced kidney injury. The consortium completed its first project, Adiponectin, in 2009, which established that cross-company collaboration is a feasible and powerful approach to biomarker qualification.
Merck has continued its participation in the National Institutes of Health Alzheimer's Disease Neuroimaging Initiative (ADNI), the largest public-private partnership in Alzheimer's disease research. This study, which is designed to gain new insights into the onset and progression of Alzheimer's disease, has now expanded to ADNI2, with the goal of improving clinical trial design and aiding drug development. ADNI2 will seek to identify and track early changes in the brain before the onset of Alzheimer's symptoms by using imaging techniques and biomarker measures in blood and cerebrospinal fluid.
Within Europe, Merck participates in the Innovative Medicines Initiative (IMI) project RAPP-ID (Development of Rapid Point-of-Care Platforms for Infectious Diseases). This consortium of 19 partners from across the pharmaceutical, diagnostics and academic world aims to address the need to diagnose and treat suspected infections rapidly, and will work to develop new diagnostics. The development of rapid, point-of-care diagnostic tests for specific infections would not only facilitate enrollment in clinical trials but also lead to more appropriate use of agents in clinical practice.
Merck along with Eli Lilly and Pfizer formed the Asian Cancer Research Group (ACRG), an independent, not-for-profit company established to accelerate research and ultimately improve treatment for patients affected with the most commonly diagnosed cancers in Asiagastric and lung cancers. ACRG aims to improve the knowledge of these cancers and to accelerate drug discovery efforts. Specifically, ACRG will create an extensive pharmacogenomic database composed of data from approximately 2,000 tissue samples from patients with lung and gastric cancer that will be made publicly available to researchers and, over time, further populated with clinical data from a longitudinal analysis of patients. Comparison of the contrasting genomic signatures of these cancers could inform new approaches to treatment.