Research > Discovery & development

How we invent

Drug discovery and development is a complex and lengthy process. It requires creativity, tenacity and agility and the expertise of thousands of scientists working diligently toward our goal to save and improve lives around the world.

Drug discovery and development

We’re focused on transforming novel science into groundbreaking medicines and vaccines for patients. Our teams of scientists bring together diverse expertise and backgrounds, combined with cutting-edge technologies and tools, to help discover the next scientific breakthrough for patients.

Drug discovery: From hit to lead

Merck scientists explain how new technologies can accelerate the drug discovery process as we use the power of leading-edge science to save and improve lives. Learn more.

Analytical R&D: Partners in problem solving

Our talented scientists in our analytical research & development team are integrating state-of-the-art physical, analytical and bioanalytical solutions, and applying innovative technologies, to advance our company’s pipeline.

Formulation development: Putting the patient first

Our formulation development team explains how leading with a patient-centric approach helps advance our understanding of formulation design, material science and engineering to improve the patient experience.

Clinical supply and manufacturing: Serving patients worldwide

Our clinical supply and pharmaceutical operations teams explain the importance of staying current with trends and advancing technology for optimal clinical trials and patient outcomes.

From lab to patient: explore the journey of a molecule

Drug discovery and development involves dedication and commitment from a wide range of people — from scientists, data analysts and clinical trial volunteers to manufacturing, regulatory, development, marketing and commercial teams, among many others.

Discovery is the process of exploring new and unique molecules, compounds and biologics that may have the potential to treat or prevent disease. We consider variables such as disease prevalence, unmet medical needs and current treatment options when identifying a preclinical candidate (PCC).
It takes about 10 years for a new product to reach the marketplace after the initial discovery.
During this phase, the active pharmaceutical ingredient is produced to create the material that will be supplied for the clinical studies.
1 in every 5,000 compounds that enter discovery and progress to preclinical development actually become an approved drug.
Clinical studies determine the safety and efficacy of our products by gathering evidence through testing and analysis in trial volunteers — first in healthy volunteers, then in those with the disease. Once we have sufficient safety and efficacy data, we file an application with the information we know about the product — including study data, analyses and reports — with a regulatory agency (such as the U.S. Food and Drug Administration) for approval.
Less than 12% of investigational medicines that enter clinical testing make it to approval.
Manufacturing is the process of industrial-scale production, packaging and distribution of our medicines and vaccines. The process varies from product to product but is always in full compliance with all regulations and Good Manufacturing Practices (GMPs, also referred to as "cGMPs" or "current GMPs") to ensure a compliant, reliable supply for our patients.
GMP regulations outline the minimum quality standards for manufacturing and vary by country. Each country has its own agency to monitor meeting the regulations and requirements.
Once a product is approved and manufactured, we promote it — through education and awareness campaigns — to customers, including physicians, health care providers, pharmacies, patient populations, wholesalers and governments. With a customer- and data-focused approach, we develop a brand strategy to create a unique impression for each product.
Marketing teams are key to creating the campaigns to educate stakeholders (customers) about the efficacy and safety of our products to ensure appropriate use.
Post-marketing begins when the medicine or vaccine is released to the market. It includes activities to monitor and evaluate the product for safety and efficacy in a real-world setting.
Companies monitor approved medicines for as long as they are on the market. This meets regulatory reporting requirements, provides internal reporting for ongoing analyses and supplies data to support the safety of the product.

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Clinical trials

Clinical trials are a key part of the drug development process, testing the safety and effectiveness of medicines and vaccines in development and exploring how different people’s bodies respond to them. Ensuring our data represents varied backgrounds advances science and improves lives by reflecting the true diversity of the populations we aim to serve.

Learn more about clinical trials