At General Dynamic IT's DynPort Vaccine Company (DVC), we help the government protect soldiers and civilians against emerging diseases and possible bioterror threats. We also manage product development programs for U.S. and international government agencies and provide consulting services to biotechnology and pharmaceutical companies. We're doing important work to help protect our nation's health and security.
We're a proven success:
- Government clients can rest assured; DVC has successfully managed large, complex medical countermeasure development government contracts since 1997.
- Biotech and pharma companies can rely on DVC for experienced program management and guidance through the complex government contracting process.
- Biodefense colleagues can look to DVC for regulatory and nonclinical strategy and support for FDA Animal Rule submissions.
- Service providers can register to be notified of upcoming opportunities to support DVC's research and clinical trials or contact us to discuss possibilities.
- Companies that have a biodefense or infectious disease therapeutic nearing Phase 1 clinical trials, can rely on DVC's Phase 1 Clinical Trial Unit.
How DVC Can Help
We know you can't afford to pay for a learning curve, and with DVC you don't have to. We’ve helped a client achieve FDA licensure of one of the first biodefense biologic products. We have advanced products into the clinic and managed and conducted all phases of clinical trials, including Phase 3 and overseas trials. Let us help you take your product to the next level. We can manage the whole program, or help with certain pieces. We have deep experience in the following areas:
- Program Management - DVC's program management team has managed complex biopharmaceutical product development programs specifically for government clients since 1997. We can integrate, facilitate and coordinate all activities required to execute successful product development programs, including government specific regulations and documentation.
- Risk Identification and Management - What is the cost of failure? Risk management can inform you… and help your program succeed. Our risk management team can help you identify what can go wrong, take steps to reduce or eliminate the probability that risks will occur, and lessen impact on your project’s quality, cost and schedule.
- Contracts - DVC's seasoned contracts professionals specialize in government contracting. We can provide guidance regarding contract types, support negotiations and provide assistance during the proposal development process, to ensure that your proposed solutions are compatible with current Federal contractual requirements.
- Subcontracts Management - Government contracting regulations pass from the prime contractor to subcontractors. We work with hundreds of subcontractors globally on vaccine development and other medical countermeasure development programs. We can assist our partners with subcontractor management as needed.
- Finance - Financial reporting requirements can vary widely from agency to agency. DVC can assist you with both Department of Defense (DoD) and civil agency financial management and reporting.
Workplace Awards and Affiliations
We strive for excellence, not only in protecting our nation from biothreats, but also in our work environment. In 2012, DVC was named to The Scientist Best Places to Work in Industry list. Ranked 9 of 20, this is DVC's fourth year on the list! DVC was also named to the Frederick County Best Places to Work list in 2011 and 2017 as the county's top large employer. In 2010, we were selected as one of three Business Health Award winners and received The Gazette of Business and Politics Exceptional 53 Business Award for a third consecutive year. DVC employees maintain active memberships in leading industry organizations. By participating with local affiliations, DVC employees share and further develop their expertise in biopharmaceutical product development and related topics. Our affiliations include: National Biodefense Analysis and Countermeasures Center (NBACC) Science and Technology Advisory Committee, Frederick Chamber of Commerce, and the Fort Detrick Alliance.
Meet DVC's Leaders
Dr. Nabors joined DynPort Vaccine Company as its President in February 2014. With over 20 years of experience in vaccine and biopharmaceutical product development, Dr. Nabors is responsible for the overall operational success of the company.
Dr. Nabors leads from his broad experience in biopharmaceutical development, managing programs to license products for pediatric, adult, travelers’ and biodefense markets. He has extensive experience in the regulatory environment for development of biologic products with an emphasis on vaccines and antibody products for prevention and treatment of infectious diseases. Dr. Nabors most recently served as the Deputy Director of the National Biological Threat Characterization Center, in support of the U.S. Department of Homeland Security.
Prior to that appointment, Dr. Nabors held positions of increasing responsibility at Emergent BioSolutions, including Director of Immunology, Director of Product Development, Vice President of Product Development, and Senior Vice President of Vaccines and Therapeutics. While at Emergent, he served as an author, major contributor, or principal investigator for 13 significant contract and grant awards from the US Government, totaling over $300 million.
Prior to his time at Emergent, Dr. Nabors served as Director of Immunology at Antex Biologics, and Manager of Immunology at Sanofi Pasteur. Dr. Nabors received his B.A. degree in Biology from Wake Forest University, his Ph.D. in Immunology from The University of Georgia, and he also completed a postdoctoral appointment at the University of Pennsylvania.
Dr. Hart serves as Chief Scientific Officer at DynPort, where she is responsible for setting and managing the overall scientific and technical direction for the development of products at DynPort. Dr. Hart joined DynPort in 2006 as Director of Nonclinical Research, developing, managing and leading the company’s Nonclinical department toward successful licensure of vaccines under the U.S. Food and Drug Administration (FDA) Animal Rule. Dr. Hart also served as Principal Investigator for DynPort’s seasonal and pandemic influenza vaccine program.
Prior to joining DynPort, Dr. Hart worked at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick in Frederick, MD, for 15 years in the Virology Division as a Principal Investigator, Branch Chief and ultimately Division Chief. She has more than 25 years of experience in vaccine research and development and has published more than 40 peer-reviewed manuscripts, chapters and reviews, and holds seven patents.
Dr. Hart earned a B.S. degree in Biology from St. Joseph’s University in Philadelphia, and her Ph.D. in Immunology from the University of Pennsylvania.
Dr. Morges joined DynPort in 2015 as Senior Director of Regulatory Affairs, and in 2016 took on the additional role of managing our Quality Systems department. Prior to joining DynPort, he served as Senior Vice President, Regulatory Affairs and Quality at PharmAthene. He held the position of Vice President, Global Regulatory Affairs-Vaccines for Baxter Healthcare Corporation, and various positions of increasing responsibility in Merck’s Vaccine Division, including heading Quality and Regulatory Affairs for licensed biologicals.
He has licensed multiple vaccines during his career at Merck, North American Vaccine and Baxter, including global licenses in the United States, Canada and Europe. He has successfully filed INDs and participated in all phases of product development; Phases 1 through 3 and post-licensure management. He has managed global teams including remote teams in Canada, Austria and the United Kingdom.
Dr. Morges earned a Ph.D. in Microbiology and Immunology from Hahnemann University (now Drexel) and a B.S. and M.S. from Pennsylvania State University.
Mr. Malagari has served as Director of Finance at DynPort since 2001, where he has both P&L and program financial responsibilities. In addition, he manages a staff of product financial analysts who provide the budgeting, estimating, and Earned Value Management System (EVMS) support to the integrated product teams charged with the development of FDA-licensed products for our clients. Prior to joining DynPort, he worked at Orbital Sciences Corporation in Germantown, MD, as Director of Program Planning and Control.
Mr. Malagari has over 35 years of program financial planning, budgeting, execution and EVMS experience in private industry, supporting a variety of Department of Defense and civil government contracts. The majority of his experience has been in a management role, providing leadership, training and mentoring.
Mr. Malagari earned a B.S. in Management and Finance from SUNY at Utica, in the College of Technology.
Mr. Daniels is responsible for the development and application of project management processes across all our projects and coordinates implementation with a team of experienced program and project managers. Prior to joining DVC in 2016, he managed the project management office (PMO) for the National Biodefense Analysis and Countermeasures Center from 2007-2016, overseeing early laboratory construction through full high-containment operations.
Mr. Daniels has managed two government acquisitions under Department of Energy (DOE) Order 413.3, the DOE’s most stringent project management and control requirement. He brings more than 15 years of project, program, and PMO management and control experience with a proven track record of implementing ANSI/EIA-748 compliant solutions.
Mr. Daniels holds a B.A. in Chemistry and a M.S. in Hazardous Waste Management from Idaho State University. He has been a certified Project Management Professional (PMP) since 2006.
Our products include vaccines and therapeutics to protect against emerging infectious diseases, biological and chemical warfare threat agents, and seasonal and pandemic influenza. We also manage a Phase 1 clinical trial unit and conduct preclinical studies for NIH/NIAID. We are also the recipient of a DoD Medical Product Research and Development contract, under which a variety of product development-related activities are conducted.
DVC manages product development programs for U.S. government agencies, and provides consulting, technical and project management services to companies in the biotechnology and pharmaceutical industries. We work with research institutions and other companies to help the government protect our nation against emerging diseases and possible bioterror threats.
DVC was one of the first biological defense companies in Maryland, formed specifically to work on a biodefense contract for the Department of Defense. For more than 18 years we have been developing a variety of biodefense vaccines and therapeutics. DVC’s Vaccinia Immune Globulin (VIGIV) was one of the first FDA-licensed biodefense products.
DVC was formed in 1997 as a joint venture between DynCorp (which was later acquired by CSC) and Porton International Inc., a member of the Ipsen Group. In 2004, CSC acquired Porton’s interest in DynPort and became the parent company. CSC split into companies in late 2015 and merged with SRA International to become CSRA Inc. General Dynamics acquired CSRA in April 2018. Currently, DynPort Vaccine Company LLC is a GDIT company.
The name came from our prior owners: DynCorp + Porton = DynPort.
DVC has furthered the development of vaccines against smallpox and anthrax, and we’re currently working on botulinum neurotoxin and plague vaccines as well as human butyrylcholinesterase for our DoD customers. DVC is experienced in serving a regulatory sponsor of biologic products, and achieved FDA licensure for vaccinia immune globulin (VIG). We’ve also branched out into public health, adding vaccines against seasonal and pandemic influenza to our portfolio beginning in 2006, and have conducted numerous clinical trials for the National Institutes of Health.
Our experience with vaccine technology includes:
- Alternative vaccine delivery systems
- Biological and chemical defense
- Biological therapeutics
- Emerging infectious diseases
- Live attenuated vaccines
- Recombinant vaccines
- Therapeutic polyclonal antibodies
We have comprehensive experience in all facets of program management for government contracts. Programs managed by DVC typically include all or most of these areas:
- Biological and clinical data management
- Clinical trial management
- Contract life cycle management
- Manufacturing, testing and analytical services
- Nonclinical study design and testing management
- Product and clinical quality assurance
- Product development strategy and management
- Regulatory oversight and strategy
We are always looking for qualified subcontractors, manufacturers, CROs and research facilities. We have worked with more than 300 subcontractors, research centers and universities worldwide. For more information, please contact us.
No, DVC does not maintain laboratory or manufacturing facilities; we work with qualified subcontractors to fill these needs.