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Leidos Life Sciences

Frederick, Maryland, United States
Leidos is a Fortune 500® information technology, engineering, and science solutions and services leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets.

The Leidos Life Sciences team executes a diverse portfolio of medical science, biopharmaceutical, and grant/program review contracts that encompasses a spectrum of infectious diseases, cancers, and neurological disorders. Our virtual pharma approach involves production and testing of vaccines and biotherapeutics for use in human clinical trials, and utilizes a proven operating model that leverages the technical expertise of multiple Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs), biotech firms and academia. This strategy supports the broad requirements of our customers and helps to ensure our success in three prime markets:

(1) Global Health: Emerging, neglected, and tropical infectious diseases;
(2) Defense Medical: Products designed to protect and treat our warfighters; and
(3) Threat Reduction: Biodefense vaccines, biotherapeutics, and diagnostics.

Our specific expertise is in biopharmaceutical concept prototyping, regulatory strategy, and product development. Leidos scientists currently manage a large malaria biologics pipeline and have developed four experimental malaria vaccines for inclusion in government clinical studies. Other ongoing or previous vaccine and therapeutic projects are related to Anthrax, West Nile Virus, HIV, Polio, Candida, and influenza. We also maintain a collection of internally funded feasibility studies for novel candidates to feed future drug development opportunities.

Successfully managing diverse science and technology platforms, the Leidos Life Sciences team has established itself as a corporate leader by filling a market niche that unites sponsor mission and operational necessities with regulatory requirements and technical expertise. Our solid experience has led to tremendous proficiency in the identification, qualification, and oversight/coordination of current Good Manufacturing Practices (GMP)/Good Laboratory Practices (GLP)/Good Clinical Practice operations for the development, manufacture, and testing of pharmaceutical products, including multiple novel biopharmaceuticals (primarily monoclonal antibodies).

In addition to developing large-scale technology programs for U.S. federal agencies with a focus on health, Leidos provides a broad range of clinical services and solutions to researchers, product sponsors, U.S. government agencies, and other biomedical enterprises, hospitals, and health systems.

Our broad research experience enables us to support programs throughout the development life cycle: from concept through the exploratory, development, pre-clinical, and clinical phases, as well as with product manufacturing and launching. Leidos designs and develops customized solutions that support groundbreaking medical research, optimize business operations, and expedite the discovery of safe and effective medical products. We apply our technical knowledge and experience in selecting institutions, clinical research organizations, and independent research facilities to meet the specific needs of each clinical study. We also manage team integration, communication, and contracts throughout the project.

Finally, Leidos has a proven track record of ensuring that research involving human subjects is conducted in compliance with U.S. and international regulations and guidelines, and we bring this important skillset to the table when developing and implementing clinical approaches for our clients.

Long-term customers include the U.S. Army Medical Research and Materiel Command, the National Institute of Allergy and Infectious Diseases, and the Department of Homeland Security. Additional clients comprise domestic and international pharmaceutical and biotechnology companies seeking drug development, regulatory affairs, and current GMP/GLP compliance support.
Our newest clients are public and private funders of biomedical research, where we provide support through our Health Research Management Practice (HRMP) for mission and vision support, patients/stakeholder engagement, and business operations.

From improving program processes to optimizing business operations, we design and deliver customized solutions that help our customers perform more efficiently and overcome their most difficult challenges. Leidos Life Sciences' approach is innovative, efficient, and collaborative with proven results.
Presentations
Leidos, Inc., a Fortune 500® company, was formed in 1969 by a small group of scientists led by a preeminent physicist and company founder, Dr. Robert Beyster. Since our inception, we have continuously expanded our expertise in rapidly evolving technologies and markets of national concern. Leidos…