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Life Sciences

NIH Guidance on International Subcontracting

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Maximizing the Value of Foreign Collaborations While Safeguarding U.S. Investments The National Institutes of Health (NIH), the nation’s primary medical research agency, recently issued guidance on the use of international subcontractors in NIH-funded research. This announcement reflects NIH’s dual mission: advancing health outcomes for Americans while ensuring responsible stewardship of U.S. taxpayer dollars. While global

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The NIH’s Strategic Plan for Autoimmune Disease Research

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Enhancing Innovation, Collaboration, and Impact Autoimmune diseases are one of the most significant and complex public health challenges of our time. Affecting an estimated 23.5 to 50 million Americans, these conditions range from rheumatoid arthritis and type 1 diabetes to multiple sclerosis and lupus, impacting nearly every organ system and disproportionately affecting women (over 80%

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NIH’s New Policy on AI and Proposal Limits: What You Need to Know

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NIH just released NOT-OD-25-132: “Supporting Fairness and Originality in NIH Research Applications.” There are two major changes that will shape how you plan and submit proposals beginning September 25, 2025: Originality & AI: NIH reiterates that applications must be the investigators’ original work and flags risks from AI-generated text (e.g., plagiarism, fabricated citations). Institutions should

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BARDA’s mAb “Smart Manufacturing” Opportunity

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Background The Biomedical Advanced Research and Development Authority (BARDA) within the Administration for Strategic Preparedness and Response (ASPR) has released a Draft Statement of Objectives (SOO) for feedback to help refine requirements for the upcoming “Smart Manufacturing” solicitation aiming to support the development of advanced monoclonal antibody (mAb) manufacturing and development techniques. The solicitation’s overarching

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Inside the New Executive Order on Strategic API Reserves

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Introduction On August 13, 2025, President Trump signed a sweeping Executive Order titled “Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve.” The order addresses a long-standing vulnerability in the U.S. healthcare system, the nation’s heavy reliance on foreign suppliers for the active pharmaceutical ingredients (APIs) that make up the

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DTRA’s “Plume” RFI for Marine Toxin Aerosol Exposure Models

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Advancing Countermeasures for Marine Toxin Threats The Defense Threat Reduction Agency (DTRA), through its Research and Development Chemical and Biological Technologies Directorate in support of the Joint Science and Technology Office (JSTO), has issued a Request for Information (RFI) titled “Plume”. This initiative seeks information on the capabilities and availability of suitable animal models for

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Navigating the SF-1408: A Guide to Pre-Award Accounting System Approval

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For companies eager to break into the federal market, the compliance landscape can feel like a maze of unfamiliar acronyms and requirements. One of the earliest and most critical checkpoints in this journey is the SF-1408: Pre-Award Survey of Prospective Contractor’s Accounting System. If you are bidding on a cost-reimbursement or time-and-materials contract, you will

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BARDA’s Onshoring of Viral Hemorrhagic Fevers Vaccine Candidates

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As the global health landscape evolves, so too must the United States’ ability to respond rapidly to biological threats. To strengthen its readiness posture, the Biomedical Advanced Research and Development Authority (BARDA), in coordination with the Administration for Strategic Preparedness and Response (ASPR), has released a new opportunity under the BioMaP Consortium OT Vehicle. This

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DTRA RAVEN Program

DTRA’s Reimagining the Next Generation of Biodefense Vaccines

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Reimagining the Next Generation of Biodefense Vaccines: DTRA’s RAVEN Opportunity The Defense Threat Reduction Agency (DTRA), through its Joint Science and Technology Office (JSTO) and the Research and Development-Chem/Bio Medical Vaccines (RD-CBMV) division, has launched the Reimagining Available Vaccines and Envisioning Novelty (RAVEN) initiative. This forward-looking program is designed to modernize the nation’s medical countermeasure

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BARDA Solicits Enzymatic Debridement Solutions

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BARDA RFP – Enzymatic Debridement Products for Treatments of Deep and Full- Thickness Severe Burn Injuries – 75A50125R00007 – Amendment 0001 The Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services (HHS), has released a significant new opportunity to strengthen national preparedness for burn mass casualty

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Biothreat Pathogens

BARDA Launches RFP for vaccines targeting Marburg virus (MARV) and Sudan ebolavirus (SUDV)

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BARDA RFP – Marburg Virus and Sudan Ebolavirus Vaccine Licensure and Procurement On July 12, 2025, the Biomedical Advanced Research and Development Authority (BARDA) issued Request for Proposals (RFP) #75A50125R00006. This RFP seeks proposals for the advanced development, FDA licensure, and procurement of vaccines targeting Marburg virus (MARV) and Sudan ebolavirus (SUDV). With recent outbreaks

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BARDA Launches New RFP to Bolster Antibiotic Stockpiles Against Drug-Resistant and Biothreat Pathogens

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Request for Proposals (RFP) for Antibiotic for Treatment of Bacterial Pneumonia or Bloodstream Infections Bolstering Biodefense with Advanced Antibiotics: BARDA’s Strategic Move As the threat of antibiotic-resistant infections intensifies, the U.S. Department of Health and Human Services (HHS), through the Biomedical Advanced Research and Development Authority (BARDA), has issued a pivotal solicitation under Project BioShield

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