NIH awards $16.3M for alcohol use disorder clinical trial data center to Fast-Track Drugs & Biologics

Contract Overview

Contract Amount: $16,342,406 ($16.3M)

Contractor: Fast-Track Drugs & Biologics, L.L.C.

Awarding Agency: Department of Health and Human Services

Start Date: 2009-01-15

End Date: 2014-09-15

Contract Duration: 2,069 days

Daily Burn Rate: $7.9K/day

Competition Type: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES

Number of Offers Received: 1

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: ESTABLISH A DATA COORDINATING CENTER CAPABLE OF CONDUCTING MULTI-CENTER CLINICAL TRIAL FOR THE TREATMENT OF ALCOHOL USE DISORDERS USING NOVE DRUG CANDIDATES

Place of Performance

Location: NORTH POTOMAC, MONTGOMERY County, MARYLAND, 20878

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $16.3 million to FAST-TRACK DRUGS & BIOLOGICS, L.L.C. for work described as: ESTABLISH A DATA COORDINATING CENTER CAPABLE OF CONDUCTING MULTI-CENTER CLINICAL TRIAL FOR THE TREATMENT OF ALCOHOL USE DISORDERS USING NOVE DRUG CANDIDATES Key points: 1. The contract focuses on a critical public health issue: alcohol use disorders. 2. The award is for research and development in biotechnology, a key sector. 3. The use of a definitive contract with cost-plus-fixed-fee pricing warrants scrutiny. 4. Competition was full and open after exclusion of sources, suggesting a specific justification.

Value Assessment

Rating: fair

The $16.3M award for a 5-year project appears reasonable for establishing a multi-center clinical trial data coordinating center. Benchmarking is difficult without specific details on the scope of 'multi-center' and the complexity of the data coordination required.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under 'full and open competition after exclusion of sources,' indicating that while competition was sought, specific sources were initially excluded. This method can impact price discovery if the exclusion was not fully justified or if it limited the pool of qualified bidders.

Taxpayer Impact: Taxpayer funds are being used to advance research into alcohol use disorders, potentially leading to new treatments and improved public health outcomes.

Public Impact

Potential for new treatments for alcohol use disorders, impacting millions of individuals. Advancement of scientific understanding in a significant public health area. Investment in research infrastructure that can support future clinical trials. Job creation within the biotechnology and research sectors.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Cost Plus Fixed Fee pricing can incentivize cost overruns.
Exclusion of sources in competition needs clear justification.
Long contract duration (5 years) may not adapt well to evolving research needs.

Positive Signals

Addresses a critical public health need.
Supports R&D in a vital scientific sector.
Utilizes a full and open competition framework.

Sector Analysis

This contract falls within the Research and Development in Biotechnology sector, specifically focusing on clinical trials for a significant health issue. Spending benchmarks for establishing data coordinating centers for multi-center trials can vary widely based on the number of centers and data complexity.

Small Business Impact

The awardee, Fast-Track Drugs & Biologics, L.L.C., is not identified as a small business. The contract details do not indicate any specific set-asides or subcontracting goals for small businesses.

Oversight & Accountability

The Department of Health and Human Services, through the National Institutes of Health, is responsible for oversight. The definitive contract structure and cost-plus-fixed-fee payment type require diligent monitoring to ensure cost control and adherence to research objectives.

Related Government Programs

Research and Development in Biotechnology
Department of Health and Human Services Contracting
National Institutes of Health Programs

Risk Flags

Cost-plus-fixed-fee contract type.
Exclusion of sources in competition.
Long contract duration.
Lack of small business participation noted.
Potential for cost overruns.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $16.3 million to FAST-TRACK DRUGS & BIOLOGICS, L.L.C.. ESTABLISH A DATA COORDINATING CENTER CAPABLE OF CONDUCTING MULTI-CENTER CLINICAL TRIAL FOR THE TREATMENT OF ALCOHOL USE DISORDERS USING NOVE DRUG CANDIDATES

Who is the contractor on this award?

The obligated recipient is FAST-TRACK DRUGS & BIOLOGICS, L.L.C..

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (National Institutes of Health).

What is the total obligated amount?

The obligated amount is $16.3 million.

What is the period of performance?

Start: 2009-01-15. End: 2014-09-15.

What was the specific justification for excluding certain sources prior to the full and open competition?

The justification for excluding sources prior to the full and open competition is crucial for understanding the competitive landscape. If specific expertise or unique capabilities were required, excluding sources might be warranted. However, if the exclusion was arbitrary, it could have limited competition and potentially led to a less favorable price for the government. Further review of the contract's Justification for Other Than Full and Open Competition (JOFOC) would be necessary.

How does the cost-plus-fixed-fee structure mitigate risks associated with research and development uncertainty?

The cost-plus-fixed-fee (CPFF) structure aims to balance risk between the government and the contractor. The contractor is reimbursed for allowable costs plus a fixed fee, which is negotiated upfront and does not change. This incentivizes the contractor to control costs, as any savings below the estimated cost benefit them. However, it can also lead to cost overruns if the initial cost estimates are inaccurate, requiring careful government oversight to manage expenditures effectively.

What are the key performance indicators (KPIs) for this data coordinating center to ensure research effectiveness?

Key performance indicators for this data coordinating center would likely include metrics related to data accuracy, completeness, timeliness of data collection and reporting, system uptime and reliability, adherence to data security protocols, and successful integration of data from multiple clinical trial sites. Effective tracking of these KPIs will be essential for ensuring the integrity and success of the multi-center clinical trials and the overall research objectives.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology

Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Offers Received: 1

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 5 PARAMUS CT, GAITHERSBURG, MD, 20878

Business Categories: Category Business, Limited Liability Corporation, Service Disabled Veteran Owned Business, Small Business, Special Designations, U.S.-Owned Business, Veteran Owned Business

Financial Breakdown

Contract Ceiling: $18,379,855

Exercised Options: $16,342,406

Current Obligation: $16,342,406

Contract Characteristics

Multi-Year Contract: Yes

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Timeline