HHS Awards $304M Other Transaction for Drug Production to Advanced Technology International

Contract Overview

Contract Amount: $303,999,997 ($304.0M)

Contractor: Advanced Technology International

Awarding Agency: Department of Health and Human Services

Start Date: 2024-01-12

End Date: 2030-03-01

Contract Duration: 2,240 days

Daily Burn Rate: $135.7K/day

Competition Type: FULL AND OPEN COMPETITION

Pricing Type: COST PLUS FIXED FEE

Sector: Healthcare

Official Description: OTHER TRANSACTION: PRODUCTION OF DRUG SUBSTANCES AND DRUG PRODUCTS AT COMMERCIAL SCALE UNDER BIOMAP-CONSORTIUM

Place of Performance

Location: SUMMERVILLE, BERKELEY County, SOUTH CAROLINA, 29486

State: South Carolina Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $304.0 million to ADVANCED TECHNOLOGY INTERNATIONAL for work described as: OTHER TRANSACTION: PRODUCTION OF DRUG SUBSTANCES AND DRUG PRODUCTS AT COMMERCIAL SCALE UNDER BIOMAP-CONSORTIUM Key points: 1. Significant investment in domestic drug substance and product manufacturing capacity. 2. Competition method (Full and Open) suggests a potentially competitive bidding process. 3. Contract type (Cost Plus Fixed Fee) may lead to cost overruns if not managed closely. 4. Focus on Biologics Manufacturing Preparedness (BioMAP) indicates strategic national health security interest.

Value Assessment

Rating: good

The contract value of $304 million over approximately 6 years appears reasonable for establishing commercial-scale drug production capabilities. Benchmarking is difficult without specific contract details, but it aligns with investments in biopharmaceutical manufacturing infrastructure.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The 'Full and Open Competition' indicates that multiple vendors were likely solicited, promoting price discovery and potentially leading to a more competitive outcome. This method is generally preferred for achieving best value.

Taxpayer Impact: Taxpayer funds are being used to bolster domestic pharmaceutical manufacturing, which can enhance national health security and potentially reduce reliance on foreign supply chains, offering long-term value.

Public Impact

Enhances domestic capacity for producing critical drugs, reducing reliance on foreign manufacturing. Supports the BioMAP initiative, aiming to strengthen the U.S. biopharmaceutical ecosystem. Potential for job creation and economic development in the biopharmaceutical sector. Ensures greater preparedness for public health emergencies requiring large-scale drug production.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Cost Plus Fixed Fee contracts can incentivize higher spending if not rigorously monitored.
Long contract duration (over 6 years) requires sustained oversight to ensure performance.
Reliance on a consortium model may introduce complexities in management and accountability.

Positive Signals

Strategic investment in national biopharmaceutical manufacturing capabilities.
Full and open competition promotes a fair and potentially cost-effective process.
Focus on critical drug production addresses national security and public health needs.

Sector Analysis

This contract falls within the Healthcare sector, specifically focusing on pharmaceutical manufacturing. Spending benchmarks for similar large-scale production facilities and consortium agreements are typically in the hundreds of millions, aligning with this award.

Small Business Impact

While the awardee is Advanced Technology International, a large entity, the nature of consortiums and 'Other Transactions' can sometimes involve subcontracting opportunities for smaller businesses within the biopharmaceutical supply chain. Further analysis would be needed to determine specific SMB involvement.

Oversight & Accountability

The 'Other Transaction' authority allows for more flexible contracting, which can expedite development but may require enhanced oversight to ensure accountability and prevent cost overruns. The duration necessitates consistent monitoring by the Office of Assistant Secretary for Preparedness and Response.

Related Government Programs

Biological Product (except Diagnostic) Manufacturing
Department of Health and Human Services Contracting
Office of Assistant Secretary for Preparedness and Response Programs

Risk Flags

Cost Plus Fixed Fee contract type carries inherent risk of cost escalation.
Long contract duration requires sustained oversight and adaptability.
Complexity of managing a consortium and ensuring equitable performance.
Potential for scope creep if not clearly defined and managed.
Dependence on specific technological advancements within the biopharmaceutical field.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $304.0 million to ADVANCED TECHNOLOGY INTERNATIONAL. OTHER TRANSACTION: PRODUCTION OF DRUG SUBSTANCES AND DRUG PRODUCTS AT COMMERCIAL SCALE UNDER BIOMAP-CONSORTIUM

Who is the contractor on this award?

The obligated recipient is ADVANCED TECHNOLOGY INTERNATIONAL.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Office of Assistant Secretary for Preparedness and Response).

What is the total obligated amount?

The obligated amount is $304.0 million.

What is the period of performance?

Start: 2024-01-12. End: 2030-03-01.

What specific drug substances and products will be prioritized under this Other Transaction, and how does this align with current national health security needs?

The specific drug substances and products are not detailed in the provided data. However, the BioMAP initiative generally focuses on advancing manufacturing technologies for a range of biologics, including vaccines and therapeutics. Prioritization would likely be driven by HHS/ASPR's assessment of critical needs, emerging threats, and existing supply chain vulnerabilities, aiming to build robust domestic capacity for a diverse set of essential medicines.

What are the key performance indicators (KPIs) and milestones for Advanced Technology International under this Cost Plus Fixed Fee agreement to ensure efficient use of taxpayer funds?

Specific KPIs and milestones are not detailed here. However, for a Cost Plus Fixed Fee contract, they typically revolve around achieving production targets, meeting quality standards, adhering to timelines for facility readiness, and demonstrating technological advancements in manufacturing processes. Rigorous reporting and regular reviews by HHS/ASPR would be crucial to monitor progress and control costs effectively.

How will the effectiveness of this investment in commercial-scale drug production be measured in terms of national biopharmaceutical manufacturing resilience and emergency preparedness?

Effectiveness will likely be measured by the demonstrated increase in domestic manufacturing capacity for critical biologics, reduced lead times for production during emergencies, and the successful scale-up of new manufacturing technologies. Metrics could include the volume of drugs produced, the diversity of products manufactured, the speed of response to simulated or actual health crises, and the successful transition of innovations from research to commercial scale.

Industry Classification

NAICS: Manufacturing › Pharmaceutical and Medicine Manufacturing › Biological Product (except Diagnostic) Manufacturing

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

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 315 SIGMA DR, SUMMERVILLE, SC, 29486

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

Financial Breakdown

Contract Ceiling: $375,999,997

Exercised Options: $303,999,997

Current Obligation: $303,999,997

Actual Outlays: $19,551,939

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: 75A50123D00003

IDV Type: IDC

Timeline