Army Medical Research: $24.2M for Tafenoquine Ophthalmic Safety Study by Dynport Vaccine Company

Contract Overview

Contract Amount: $24,238,921 ($24.2M)

Contractor: Dynport Vaccine Company LLC

Awarding Agency: Department of Defense

Start Date: 2017-03-22

End Date: 2022-07-31

Contract Duration: 1,957 days

Daily Burn Rate: $12.4K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 2

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: IGF::OT::IGF - RESEARCH&DEVELOPMENT IN SUPPORT OF THE US ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY (USAMMDA) FOR THE PERFORMANCE OF A PHASE I, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE LONG-TERM OPHTHALMIC SAFETY OF TAFENOQUINE VERSUS PLACEBO.

Plain-Language Summary

Department of Defense obligated $24.2 million to DYNPORT VACCINE COMPANY LLC for work described as: IGF::OT::IGF - RESEARCH&DEVELOPMENT IN SUPPORT OF THE US ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY (USAMMDA) FOR THE PERFORMANCE OF A PHASE I, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE LONG-TERM OPHTHALMIC SAFETY OF TAFENOQUINE VERSUS PLACEBO… Key points: 1. The contract focuses on critical medical research for the US Army Medical Materiel Development Activity. 2. Dynport Vaccine Company LLC secured this significant award, indicating specialized capabilities in vaccine and pharmaceutical research. 3. The study's long-term safety assessment of Tafenoquine highlights a focus on patient well-being and drug efficacy. 4. This research falls under the broader 'Research and Development in the Physical, Engineering, and Life Sciences' sector.

Value Assessment

Rating: fair

The contract value of $24.2M for a multi-center, double-blind study appears reasonable given the scope and duration. Benchmarking against similar large-scale clinical trials would provide a more definitive assessment of value.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, suggesting a robust price discovery process. This method typically leads to more competitive pricing as multiple vendors have the opportunity to bid.

Taxpayer Impact: The investment supports critical medical research, potentially leading to improved soldier health and reduced long-term healthcare costs for the military.

Public Impact

Enhances understanding of drug safety for military personnel and potentially the general public. Contributes to the development of effective treatments for malaria, a significant concern for deployed forces. Supports advanced medical research infrastructure and expertise within the United States. The findings could influence future drug development protocols and regulatory standards.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for cost overruns in long-term clinical trials.
Uncertainty in research outcomes and efficacy.
Dependence on a single contractor for a critical research phase.

Positive Signals

Addresses a critical health need for military personnel.
Utilizes a rigorous scientific methodology (double-blind, placebo-controlled).
Awarded through full and open competition.

Sector Analysis

This contract falls within the Research and Development sector, specifically focusing on life sciences. Spending in this area is crucial for advancing medical countermeasures and ensuring the health of service members, with benchmarks varying widely based on research complexity and scale.

Small Business Impact

The data does not indicate any specific involvement or set-asides for small businesses in this particular contract. Large-scale R&D contracts are often awarded to established companies with specialized capabilities.

Oversight & Accountability

The contract is managed by the Department of Defense's Defense Health Agency, which is responsible for overseeing medical research and development. Standard oversight mechanisms for research grants and contracts would apply.

Related Government Programs

Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
Department of Defense Contracting
Defense Health Agency Programs

Risk Flags

Potential for long-term adverse effects not fully captured.
Reliance on a single contractor for a critical research phase.
Complexity of multi-center clinical trial management.
Uncertainty of research outcomes and efficacy.
Cost overruns in extended research projects.

Frequently Asked Questions

What is this federal contract paying for?

Department of Defense awarded $24.2 million to DYNPORT VACCINE COMPANY LLC. IGF::OT::IGF - RESEARCH&DEVELOPMENT IN SUPPORT OF THE US ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY (USAMMDA) FOR THE PERFORMANCE OF A PHASE I, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE LONG-TERM OPHTHALMIC SAFETY OF TAFENOQUINE VERSUS PLACEBO.

Who is the contractor on this award?

The obligated recipient is DYNPORT VACCINE COMPANY LLC.

Which agency awarded this contract?

Awarding agency: Department of Defense (Defense Health Agency).

What is the total obligated amount?

The obligated amount is $24.2 million.

What is the period of performance?

Start: 2017-03-22. End: 2022-07-31.

What is the projected long-term cost savings or benefit to the DoD from the successful development and deployment of Tafenoquine based on this safety study?

The long-term cost savings are difficult to quantify precisely at this stage. However, a safe and effective antimalarial drug could significantly reduce healthcare expenditures related to treating malaria in deployed soldiers, decrease lost duty days, and improve overall force readiness. The initial investment of $24.2M aims to mitigate future, potentially larger, costs associated with adverse drug reactions or ineffective treatments.

What are the primary risks associated with the long-term ophthalmic safety of Tafenoquine, and how does this study aim to mitigate them?

The primary risks involve potential ocular side effects that may manifest over extended periods of use or exposure, such as vision impairment or other eye-related conditions. This study mitigates these risks through a rigorous, multi-center, randomized, double-blind, placebo-controlled design. This methodology ensures objective data collection, minimizes bias, and allows for direct comparison of the drug's effects against a placebo over a significant duration.

How effective is the chosen contracting method (full and open competition) in ensuring the best value for taxpayer dollars in complex R&D projects like this?

Full and open competition is generally considered effective for complex R&D projects as it allows a broad range of qualified vendors to submit proposals, fostering competition that can drive down costs and encourage innovation. However, the success in achieving best value also depends on the clarity of the solicitation, the evaluation criteria, and the government's ability to assess highly technical proposals accurately. For specialized R&D, ensuring a sufficient number of capable bidders is crucial.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)

Product/Service Code: RESEARCH AND DEVELOPMENT › General Science and Technology R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: SUBJECT TO MULTIPLE AWARD FAIR OPPORTUNITY

Solicitation ID: W81XWH13R0038

Offers Received: 2

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 64 THOMAS JOHNSON DR, FREDERICK, MD, 21702

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Limited Liability Corporation, Not Designated a Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $24,238,921

Exercised Options: $24,238,921

Current Obligation: $24,238,921

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: W81XWH15D0037

IDV Type: IDC

Timeline