To mark its 10th anniversary, Drug Discovery & Development magazine invited pharmaceutical and biotechnology companies to reflect on the history and made predictions about future of the industry. Featured here are verbatim comments from this company.
Merck & Co., Inc.
Headquarters
Whitehouse Station, N.J
Web site
About the company/organization
Merck & Co., Inc. is a global, research-driven pharmaceutical company dedicated to putting patients first. Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. Today, Merck has more new medicines and product candidates in its pipeline than at any other time in its history.
Research is the foundation of Merck's success and the heart of our company's overall strategy. Merck is dedicated to staying at the forefront of discovery, with a commitment to research and development. Merck scientists use the most advanced tools available, including bioinformatics, combinatorial chemistry, genomics, high-throughput screening, pharmacogenomics, recombinant DNA techniques, RNA interference technology and computerized molecular modeling.
Our research is conducted in a broad range of therapeutic categories, including Alzheimer’s disease, cardiovascular disease, diabetes and obesity, infectious disease and oncology.
A 10-year perspective: Advances and roadblocks
In the last decade, R&D costs have soared, and pharmaceutical companies have been searching for ways to make better and faster decisions earlier in drug development. Merck is using an advanced, integrated biomarker approach to R&D to help eliminate failures sooner and bring innovative products to patients faster, with a focus on scientific excellence and safety.
Merck has developed a leadership position in the study and application of gene expression. Using an integrative genomics approach to elucidate complex traits like disease and drug response, Merck scientists have identified and validated a number of novel drug targets and biomarkers.
With the acquisition of Sirna Therapeutics in 2006, Merck gained the capabilities to create one of the industry’s most comprehensive RNAi discovery and development programs. Merck is now integrating RNAi technology across all of its discovery platforms, with the goal of applying RNA therapeutics to most diseases.
R&D Challenges in the next 10 years
The pharmaceutical industry is under intense pressure from many stakeholders and is experiencing very challenging times. Merck concentrates its R&D in six therapeutic franchises – Atherosclerosis and Cardiovascular; Diabetes & Obesity; Infectious Disease; Respiratory, Bone, Arthritis & Analgesia; Neuroscience & Ophthalmology; and Oncology. Merck will continue to focus on science, innovation and technology to discover and develop novel medicines and vaccines to improve human health.
Business/regulatory challenges for the next 10 years
We anticipate that the Critical Path Initiative will begin to have a significant impact on drug development, registration and approval over the next decade. Along with other industry partners, Merck has worked closely with the FDA to establish a flexible, practicable process for identifying and validating new safety biomarkers, which are critical to the development of safe and effective drugs. Merck helped to focus the effort on biomarkers that would be most useful within a regulatory environment – i.e., those that could potentially be used in both the pre-clinical and clinical settings. This collaboration resulted in seven novel biomarkers for kidney safety that were recently endorsed by the FDA and the European Medicines Agency for use in the preclinical setting. Merck is using the new biomarker tests in animal studies used to assess experimental drugs that may be advanced into clinical trials in humans. With additional data, these markers may eventually be accepted for clinical safety assessment.
