Discovery & Invention
For more than a century, we have been inventing medicines and vaccines for many of the world’s most challenging diseases.
- Achieved a number of regulatory approvals in oncology, as well as hospital acute care and vaccines
- The FDA approved ERVEBO (Ebola Zaire Vaccine, Live) for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older
- Advanced our late-stage pipeline, particularly in oncology, with several regulatory submissions in the United States and internationally
- We will evaluate and reflect global unmet medical needs in the research and development of our products
- We will invest in research and development to address infectious diseases that have a significant global public health burden, including in low-income and middle-income countries, and where emerging science suggests opportunities to substantively reduce this burden through medicines or vaccines
- We will collaborate with diverse partners to expand our research and development capacity to address unmet global health needs and pursue opportunities to provide access to compound libraries and molecules to spur discovery and development of new products
Pursuing the most promising science, our company discovers and invents medicines and vaccines that address vital global health needs where we can have the greatest impact, now and in the future.
We aim to discover and develop medicines to improve patients’ lives and transform breakthrough science into novel therapeutic options.
Our journey to invention and discovery is guided by science—and inspired by patients. And our research is guided by our commitment to preserving human and animal health and enhancing the quality of life.
Around the world, our objectives remain the same: to protect the safety of our employees and to produce and supply our essential medicines and vaccines for those who need them. Thanks to our colleagues, our manufacturing plants and clinical supply sites remain open around the world during the COVID-19 pandemic, and we are taking steps to make sure that continues to be the case.
As part of our company’s response to the COVID-19 pandemic, we are pursuing multiple efforts, including research across basic science, treatment, and prevention. As part of this approach, we are working in several partnerships to develop an effective response against SARS-CoV-2:
- Our company has entered into a collaboration with IAVI to develop, test, manufacture and distribute a potential vaccine against SARS-CoV-2. IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges.
- We have aquired Themis, a company focused on vaccines and immune-modulation therapies for infectious diseases and cancer. In March, Themis joined a consortium led by the Institut Pasteur and supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI), to develop a vaccine candidate targeting SARS-CoV-2 for the prevention of COVID-19.
- In addition, our company has entered into a research agreement with Ridgeback Bio to advance the development of novel antiviral candidate EIDD-2801.
Read more about our response to COVID-19.
We are committed to addressing unmet medical needs through innovative research and development (R&D). R&D expenses were $9.9 billion in 2019, $9.8 billion in 2018, $10.3 billion in 2017 and $10.3 billion in 2016 (which included restructuring costs and acquisition- and divestiture-related costs in all years).
R&D expenses in 2019 reflect higher clinical development spending and increased investment in discovery research and early drug development.
Our success is largely dependent on our continued ability to attract and retain highly qualified scientific, technical and management personnel, as well as personnel with expertise in clinical research and development, governmental regulation and commercialization.
We have strategically located discovery centers in regions with active biomedical research communities including Palo Alto and South San Francisco, California; Boston, Massachusetts; Elkhorn, Nebraska; as well as principal sites outside of the U.S., including the UK, Switzerland and China. These centers allow us to recruit talented local scientists and facilitate collaboration with local academic institutions and companies. These discovery sites complement and connect with our strong research and development capabilities and expertise based at our New Jersey and Pennsylvania sites.
Pediatric research and development
To address unmet medical needs in children, we include pediatric development programs in the company’s new drug and vaccine development strategies wherever appropriate. The evaluation of pediatric programs is an integral part of our product development team governance.
We prioritize our R&D efforts on advancing candidates that we believe represent the next areas of breakthrough science that will make a difference and deliver value for patients, physicians and payers.
Our research priorities are aligned with the current and projected global burden of disease (GBD) as defined by the World Health Organization (WHO), as well as with the increasing need for new therapies targeted at diseases such as cancer, cardiovascular diseases, diabetes and other metabolic diseases, infectious diseases, neurosciences, pain, respiratory diseases, and vaccines.
In 2019, we achieved a number of regulatory approvals in oncology, as well as hospital acute care and vaccines. In December 2019, the FDA approved ERVEBO for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older.
Throughout 2019, we also advanced our late-stage pipeline, particularly in oncology, with several regulatory submissions in the United States and internationally. We currently have several candidates under regulatory review in the United States and internationally.
Global burden of disease
As defined by the GBD 2010 Visualization tools developed by the Institute for Health Metrics and Evaluation (IHME), the diseases that we address rank high on the list of worldwide causes of death. Our research into vaccines and infectious diseases addresses major burdens of disease that are prevalent in all countries, and our preventive treatments could have the greatest impact in the developing world, where health care infrastructure is weak or nonexistent.
Considering our pipeline, the list of products we currently market and external collaborations, we estimate that our company is seeking to address 100 percent of the top 20 global burdens of disease as defined by the IHME, excluding road injury, self-harm, interpersonal violence and neonatal disorders.
Ensuring compliance with applicable laws and requirements in all business areas is critical. As such, the stated objective of the Compliance Committee Charter within our research laboratories is to ensure ongoing compliance through appropriate management structure, processes and training.
In order to manage compliance, the Compliance Committee is composed of members of the Research Leadership Team. As a result, compliance efforts encompass the entire division and go beyond simply addressing the conduct of clinical trials.
The Compliance Committee also promotes ethical science and provides guidance to our employees within the research organization on our company’s standards and corporate policies, as well as necessary education related to specific requirements applicable to the research community.
Early in 2020, we announced that we are spinning off products from our women’s health, legacy brands, and biosimilars franchises into a new independent, publicly traded company (Organon & Co.).
Programs and initiatives
We support academic and community-based physicians and researchers in expanding clinical and scientific knowledge and in improving understanding of the appropriate use of our products.
Our Investigator Studies Program exemplifies our efforts to advance science and improve patient care. Through this program, we provide medicines, vaccines and/or funding for research that is initiated, designed, implemented and sponsored by external investigators. This program fosters collaboration with researchers throughout the world who are active in emerging research areas of interest and has established a track record for scientific exchange through presentations and the publication of findings in peer-reviewed journals.
We are active participants within the scientific community providing support to many professional associations. In addition to promoting dialogue and the exchange of ideas in research, we also sponsor research conferences.
Public-private research partnerships and industry consortia
We recognize that individuals or companies cannot successfully develop medicines single-handedly. Most cases of true innovation come from robust and honest collaboration among individuals and organizations with diverse backgrounds and capabilities, brought together by the idea of improving human health.
As such, we have partnerships with a number of large companies within the industry, including AstraZeneca (oncology), Eisai (oncology), Pfizer (diabetes), and Bayer (cardiovascular).
We also collaborate with external researchers and other members of the biopharmaceutical industry through participation in selected scientific consortia. Consortia are an important mechanism by which researchers can work together in a precompetitive manner to address complex scientific challenges common to all parties.
For example, we are an active member of TransCelerate BioPharma Inc. (TransCelerate). TransCelerate is a nonprofit organization with the mission to collaborate across the global biopharmaceutical research and development community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high-quality delivery of new medicines.
TransCelerate works in three strategic priority areas:
- Improving the patient and site experience
- Harmonizing process and sharing information
- Enhancing sponsor efficiencies and drug safety
Our colleagues contribute across all strategic priority areas in a broad range of responsibilities. These include serving on the Board of Directors, Oversight Committee and Pharmacovigilance Steering Committee, as well as both leading and contributing roles within the portfolio of projects.
Drug discovery and development collaborations
As part of our R&D strategy, we pursue opportunities to establish external alliances with a broad range of partners that complement our internal research capabilities, including research collaborations and licensing agreements for preclinical and clinical therapeutic candidates and technologies that have the potential to drive both near- and long-term growth.
In 2019, we continued to prioritize business development aimed at enhancing our portfolio and strengthening our pipeline. We completed the acquisition of Peloton Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the development of novel small molecule therapeutic candidates for the treatment of cancer and other diseases, and Immune Design, a late-stage immunotherapy company employing next-generation in vivo approaches to enable the body’s immune system to fight disease.
We also announced an agreement to acquire ArQule, Inc., a biopharmaceutical company focused on kinase inhibitor discovery and development for the treatment of cancer and other diseases. The acquisition closed in January 2020.
We also continued our efforts to advance a number of external licenses and collaborations. Visit our Business Development & Licensing site to learn more.
|Research and development||2015||2016||2017||2018||2019|
|Research and development expenses (in billions)||$6.8||$10.3||$10.3||$9.8||$9.9|
|Employees involved in research activities||11,900||12,300||12,700||14,500||15,600|
|New products approved1||2||3||4||2||2|
|Products in the pipeline and under regulatory review||31||39||26||24||36|
|Top 20 global burdens of diseases addressed by our products and pipeline2, 3||88%||88%||88%||88%|| 100%|
|Established significant external licenses and collaborations||64||57||55||64||78|
|Filed U.S. patent applications||185||195||190||127||103|
|1 Candidates in our company’s research pipeline or under regulatory review as reported in the United States Securities and Exchange Commission Form 10-K, filed on February 26, 2020. Approval of new products only. This does not include approvals for supplemental indications. When candidates attain regulatory approval, they are removed from this pipeline view.|
2 As defined by the Institute for Health Metrics and Evaluation (IHME) using GBD 2017 data; excluding road injury, self-harm, interpersonal violence and neonatal disorders.
3This number is slightly higher in 2019 than in past years due to our expanded collaboration with MSD-Welcome Trust Hilleman Laboratories and our acquisitions of Immune Design and Peloton, Tilos Therapeutics and Calporta in 2019.