DoD Awards $39.4M for ETEC Clinical Study Product Manufacturing to Scandinavian Biopharma

Contract Overview

Contract Amount: $39,431,108 ($39.4M)

Contractor: Scandinavian Biopharma Holding AB

Awarding Agency: Department of Defense

Start Date: 2020-09-25

End Date: 2028-09-30

Contract Duration: 2,927 days

Daily Burn Rate: $13.5K/day

Competition Type: NOT COMPETED

Number of Offers Received: 1

Pricing Type: FIXED PRICE LEVEL OF EFFORT

Sector: R&D

Official Description: THIS AWARD IS FOR THE DELIVERY OF A CGMP MANUFACTURED PRODUCT OF QUANTITY AND QUALITY THAT IT IS SUITABLE AND APPROPRIATE FOR USE IN PIVOTAL CLINICAL STUDIES TO DEMONSTRATE EFFICACY AGAINST ETEC IN ADULTS WITH THE GOAL OF FDA LICENSURE.

Plain-Language Summary

Department of Defense obligated $39.4 million to SCANDINAVIAN BIOPHARMA HOLDING AB for work described as: THIS AWARD IS FOR THE DELIVERY OF A CGMP MANUFACTURED PRODUCT OF QUANTITY AND QUALITY THAT IT IS SUITABLE AND APPROPRIATE FOR USE IN PIVOTAL CLINICAL STUDIES TO DEMONSTRATE EFFICACY AGAINST ETEC IN ADULTS WITH THE GOAL OF FDA LICENSURE. Key points: 1. The award focuses on manufacturing a CGMP product for pivotal clinical studies against ETEC. 2. The contract aims to demonstrate efficacy for FDA licensure, indicating a high-stakes R&D effort. 3. Competition was not pursued, raising questions about price discovery and potential value. 4. The sector is Research and Development in Biotechnology, a critical area for public health.

Value Assessment

Rating: questionable

The contract value of $39.4 million for a definitive contract with a fixed price level of effort is difficult to benchmark without specific details on the product and study scale. The lack of competition makes a direct pricing comparison challenging.

Cost Per Unit: N/A

Competition Analysis

Competition Level: sole-source

This contract was not competed, indicating a sole-source award. This limits price discovery and may not ensure the best value for taxpayer dollars.

Taxpayer Impact: The lack of competition could lead to higher costs for taxpayers if alternative, more cost-effective solutions were available.

Public Impact

Potential for a new treatment to combat ETEC infections in adults. Investment in critical research and development for public health preparedness. FDA licensure goal signifies a significant step towards a new medical countermeasure.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Lack of competition
Potential for cost overruns due to sole-source nature

Positive Signals

Supports critical R&D for public health
Aims for FDA licensure, indicating high potential impact

Sector Analysis

This contract falls within the Biotechnology R&D sector, specifically focusing on developing a product for clinical trials. Spending in this area is crucial for advancing medical countermeasures but requires careful oversight due to inherent research risks and high development costs.

Small Business Impact

There is no indication that small businesses were involved in this specific award. The nature of advanced biopharmaceutical manufacturing often involves specialized capabilities that may be concentrated among larger entities.

Oversight & Accountability

The lack of competition warrants close oversight to ensure the contractor is meeting quality standards and cost objectives. Transparency in reporting on study progress and expenditures will be crucial for accountability.

Related Government Programs

Research and Development in Biotechnology (except Nanobiotechnology)
Department of Defense Contracting
Defense Health Agency Programs

Risk Flags

Sole-source award limits competition and price discovery.
Potential for cost overruns due to lack of competitive pressure.
Reliance on a single entity for critical R&D product.
Complexity of biopharmaceutical manufacturing and clinical trials introduces inherent risks.

Frequently Asked Questions

What is this federal contract paying for?

Department of Defense awarded $39.4 million to SCANDINAVIAN BIOPHARMA HOLDING AB. THIS AWARD IS FOR THE DELIVERY OF A CGMP MANUFACTURED PRODUCT OF QUANTITY AND QUALITY THAT IT IS SUITABLE AND APPROPRIATE FOR USE IN PIVOTAL CLINICAL STUDIES TO DEMONSTRATE EFFICACY AGAINST ETEC IN ADULTS WITH THE GOAL OF FDA LICENSURE.

Who is the contractor on this award?

The obligated recipient is SCANDINAVIAN BIOPHARMA HOLDING AB.

Which agency awarded this contract?

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

What is the total obligated amount?

The obligated amount is $39.4 million.

What is the period of performance?

Start: 2020-09-25. End: 2028-09-30.

What is the justification for the sole-source award, and were any market research efforts conducted to confirm the absence of viable alternatives?

The justification for a sole-source award typically stems from unique capabilities, proprietary technology, or urgent needs where only one source can fulfill the requirement. Without specific details, it's presumed the agency identified Scandinavian Biopharma as the only capable entity. However, thorough market research should have been performed to validate this assumption and ensure no other qualified sources exist, especially for a contract of this magnitude and duration.

How will the agency ensure cost-effectiveness and prevent potential overruns given the fixed price level of effort contract awarded on a sole-source basis?

Ensuring cost-effectiveness in a sole-source, fixed-price level of effort contract requires robust performance monitoring and clear deliverables. The agency should establish detailed milestones and key performance indicators. Regular reviews of progress, expenditures, and any potential scope changes are essential. Transparency from the contractor regarding challenges and resource allocation will be critical for proactive management and to mitigate risks of cost overruns.

What are the key performance indicators (KPIs) for this contract, and how will the success of the clinical studies and the ultimate goal of FDA licensure be measured?

Key performance indicators will likely focus on the successful manufacturing of the CGMP product according to specified quality standards and timelines. For the clinical studies, KPIs would include patient recruitment rates, data integrity, and achievement of primary efficacy endpoints as defined in the study protocol. The ultimate measure of success is the demonstration of efficacy and safety data sufficient for submission and approval by the FDA, leading to licensure.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology (except Nanobiotechnology)

Product/Service Code: MEDICAL SERVICES › MEDICAL, DENTAL, AND SURGICAL SVCS

Competition & Pricing

Extent Competed: NOT COMPETED

Solicitation Procedures: ONLY ONE SOURCE

Solicitation ID: W81XWH20R0005

Offers Received: 1

Pricing Type: FIXED PRICE LEVEL OF EFFORT (B)

Evaluated Preference: NONE

Contractor Details

Address: INDUSTRIVAGEN 1, 4TR, SOLNA

Business Categories: Category Business, Foreign Owned, International Organization, Not Designated a Small Business, Special Designations

Financial Breakdown

Contract Ceiling: $51,663,682

Exercised Options: $51,663,682

Current Obligation: $39,431,108

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline