From Our Partners
Saturday, June 25, 2022
News on Pathogens and Preparedness
Global Biodefense
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe
No Result
View All Result
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe
No Result
View All Result
Global Biodefense
No Result
View All Result
Home Featured News

BARDA Looks to Expand Clinical Studies Network for Biodefense Countermeasures

by Global Biodefense Staff
January 14, 2019
Medical Countermeasure Development

Credit: Shutterstock, modified.

In an effort to improve preparedness, the U.S. federal government is seeking to bolster Clinical Studies Network service capabilities for advanced clinical development of medical countermeasures to treat the adverse health effects resulting from exposure to chemical, biological, radiological, and nuclear (CBRN) threat agents, pandemic influenza and emerging infectious diseases.

The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary of Preparedness and Response (ASPR), Department of Health and Human Services (HHS), oversees the national effort to develop such countermeasures.

BARDA’s Clinical Studies Network (CSN) conducts Phase I, II, III, and IV trials and provides other services for the development of vaccines and therapeutics. The results of these trials form part of the basis for advancing investigational products through development with the ultimate goal of submission to the FDA.

Lessons Learned

The Clinical Studies Network (CSN) was established as a Core Service in 2012 when BARDA awarded Indefinite Delivery/ Indefinite Quantity (IDIQ) contracts to five full service Contract Research Organizations (CROs) in 2013 to form the CSN infrastructure.

During the five years of the CSN’s existence, several important capability gaps were identified:

  • Lack of long-term storage capacity for records, investigational products, and biological specimens
  • Need for a data coordination center
  • Need to engage different CROs to provide services on a routine basis without urgent timelines
  • Need for services during a public health emergency (PHE) when rapid timelines are crucial

Anticipated Requirements

BARDA will seek to address these issues should any future CSN solicitation be released, by including the following enhancements:

  1. Diversification of the pool of contractors to include CROs in the CSN that can provide routine services or response services as primary contractors for the planning and execution of clinical studies. Services would include project management, study start up, site training and support, site feasibility and selection, site monitoring and management, specimen and IP management, laboratory services, regulatory services, Institutional Review Board services and quality assurance, as well as other services.
  2. Engaging a statistical service & data coordination center to standardize data collection, management, and analysis across CSN studies. Services would include study design, an interactive web response system, data management, safety monitoring (Safety Monitoring Committee or Data and Safety Monitoring Board), medical monitoring and other data analysis and reporting services. This CRO would also provide a centralized clinical study records (i.e., Trial Master File) archive for indefinite long-term storage that meets regulatory requirements. The capability of providing innovative trial design and rapid trial start-up would be of critical significance to meet the challenges of developing MCM for emerging public health threats. Additionally, access to data mining capabilities via health care utilization databases would be advantageous.
  3. Employing a single facility for long-term storage of clinical study specimens (possibly non-clinical specimens) and investigational products across BARDA-supported studies. Services may extend to managing transport of clinical study specimen and IP on studies, laboratory services, end-of-study archiving, and managing future use of specimens (retrieving, aliquoting, labelling, shipping, tracking, etc.).

Current Status

BARDA is currently compiling market research and industry input on pros and cons of the proposed structure and possibilities for contract configuration. One proposed contracting strategy is to award a Single Award IDIQ contract for storage of specimens and IP, and a Single Award IDIQ Contract for statistical services and data coordination. There would be several Multiple Award IDIQ Contracts for clinical trial planning and execution for regular services. Multiple Award Contracts would be awarded to a small number of sources demonstrating capabilities for rapid response to public health emergencies. The main contracting mechanism for each of the three CSN parts will likely be an IDIQ fee-for-service-model.

BARDA has not made a commitment to procure any items or services at this time. Any future announcements for this effort will be made on FedBizOpps.com.

From Our Partners
Tags: ASPRBARDADrug DevelopmentHHSPandemicRFISelect Agents

Related Posts

UK Health Security Agency Widens Monkeypox Vaccine Umbrella for Outbreak Control
Medical Countermeasures

UK Health Security Agency Widens Monkeypox Vaccine Umbrella for Outbreak Control

June 21, 2022
Biodefense Industry News
Industry News

Tonix Pharmaceuticals Opens Advanced Development Center for Vaccine Programs

June 20, 2022
Monkeypox Cases Prompt Additional Contracts for Bavarian Nordic Vaccine
Medical Countermeasures

Monkeypox Cases Prompt Additional Contracts for Bavarian Nordic Vaccine

May 30, 2022
Novavax Missed Its Global Moonshot but Is Angling to Win Over mRNA Defectors
Industry News

Novavax Missed Its Global Moonshot but Is Angling to Win Over mRNA Defectors

May 26, 2022
Load More

Latest News

Poliovirus Detected in London Sewage: Response Measures Emphasize Wastewater Surveillance and Vaccination Gaps

Poliovirus Detected in London Sewage: Response Measures Emphasize Wastewater Surveillance and Vaccination Gaps

June 22, 2022
Monkeypox Diagnostics: CDC Authorizes Five Commercial Lab Companies

Monkeypox Diagnostics: CDC Authorizes Five Commercial Lab Companies

June 22, 2022
UK Health Security Agency Widens Monkeypox Vaccine Umbrella for Outbreak Control

UK Health Security Agency Widens Monkeypox Vaccine Umbrella for Outbreak Control

June 21, 2022
Influenza Research

New Way to Identify Influenza A Virus Lights Up When Specific Virus Targets are Present

June 20, 2022

Subscribe

  • About
  • Contact
  • Privacy
  • Subscribe

© 2022 Stemar Media Group LLC

No Result
View All Result
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe

© 2022 Stemar Media Group LLC