Biodefense

Last week, the Defense Advanced Research Projects Agency (“DARPA”) issued a new broad agency announcement (“BAA”) seeking proposals to support the creation of an integrated “capability platform” for the delivery of medical countermeasures to prevent a pandemic threat within sixty days of targeting a known or newly emerging pathogen.  The BAA confirms DARPA’s commitment to addressing national security concerns raised by both naturally occurring public health emergencies and bioterrorism, as well other biological threats to members of the U.S. military.  Learning from recent experiences with Ebola, Zika, and Middle East respiratory syndrome, DARPA is targeting prophylactic solutions that are designed to prevent or halt the spread of an infectious outbreak, rather than solutions intended solely or primarily to treat infected individuals.

DARPA’s approach is consistent with recent guidance from the President’s Council of Advisors on Science and Technology in that it focuses on platform technologies and processes, which represent general approaches to medical countermeasure development that can be rapidly and reliably applied to varying threats.  The Biomedical Advanced Research and Development Authority has adopted a similar focus in its own platform-based BAA, and additional opportunities for platform development will likely arise in the near future under the most recent strategy and implementation plan of the Public Health Emergency Medical Countermeasures Enterprise.Continue Reading DARPA Seeks to Establish New Platforms for Rapid Development of Medical Countermeasures

Concerns about the spread of Zika virus and potential complications associated with infection may soon lead to new research and development opportunities for government contractors and grant recipients.  Similar to developments after the recent Ebola outbreak in West Africa, a need to better understand Zika’s characteristics and develop an effective countermeasure or vaccine has led both domestic and international public bodies and private industry to begin mobilizing resources in response to the virus.  As a result, both new and existing contractual vehicles will likely be used to fund a wide array of activities, extending from epidemiological studies to the development of new diagnostics and countermeasures.

Similar to yellow fever, dengue, West Nile, and Japanese encephalitis viruses, Zika is a flavivirus that is generally transmitted through mosquitoes.  Although Zika was first discovered in 1947, it has only recently been identified as a significant threat to public health based on a potential connection between Zika and microcephaly in newborns—a condition associated with incomplete brain development.  Recent events have also provided additional evidence of a potential link between Zika and Guillain-Barré syndrome, which is a nervous system disorder that could affect Zika’s carriers.

Previously, the virus was understood to have relatively limited consequences, only causing mild, flu-like symptoms in one of five of its hosts.  However, an outbreak of the virus in French Polynesia in 2013 and 2014 has now been associated with an increase in cases of Guillain-Barré syndrome.  In addition, an ongoing outbreak of the virus that began in Brazil last year has affected over one million individuals and been linked to both an increased incidence of Guillain-Barré syndrome and a dramatic rise in cases of microcephaly.  Zika RNA has been discovered in the amniotic fluid of women with affected fetuses in Brazil, and a recent report indicates that an affected newborn in Hawaii acquired Zika in the womb.Continue Reading Zika Virus Complications Lead to Expected Government Partnership with Private Industry

Yesterday, President Barack Obama signed into law a $1.1 trillion appropriations act that allocates approximately $5.4 billion in emergency funding to support the U.S. Government’s response to the Ebola outbreak in West Africa.  Although this funding falls short of the Administration’s initial $6.18 billion request—approximately $1.54 billion of which was to be allocated to a contingency fund similar to appropriations made in response to pandemic influenza—all emergency funding for Ebola provided by the act is available for immediate use.  The funding is split between the Department of Health and Human Services (“HHS”), the Department of Defense (“DoD”), the Department of State, and the Agency for International Development (“AID”).  Government contractors and grant recipients can expect these agencies to use their respective shares of the funding to create a number of opportunities in the coming months.
Continue Reading President Signs Act Authorizing $5.4 Billion in Emergency Funding to Combat Ebola

The U.S. Department of Health and Human Services (“HHS”) published a declaration today under the Public Readiness and Emergency Preparedness (“PREP”) Act covering activities relating to three Ebola vaccine candidates that are currently in development.  The declaration went into effect on December 3, 2014 and extends liability protection to manufacturers, distributors, program planners, and qualified persons who prescribe, administer, or dispense the vaccine candidates identified in the declaration when distributed in connection with a federal contract, grant, or other agreement, or as directed in a public health emergency.  The declaration represents another significant step in the federal government’s response to the Ebola outbreak in West Africa, following recent actions taken by HHS and the Defense Threat Reduction Agency to fund the development of Ebola countermeasures and related products and services.
Continue Reading HHS Issues PREP Act Declaration Covering Ebola Vaccines

The Defense Threat Reduction Agency (“DTRA”) issued a broad agency announcement (“BAA”) at the end of last week seeking “near-term” solutions that can be developed in time to assist with the current (Zaire) Ebola virus outbreak in West Africa.  Expanding on the BAA under which the U.S. Department of Health and Human Services (“HHS”) is seeking solutions to Ebola, which we covered in a recent post, the BAA issued by the DTRA covers a significantly wider array of potential technologies, products, and services, including protective equipment and rapid disinfection processes.  In addition, unlike the BAA issued by HHS, the BAA issued by the DTRA is primarily seeking solutions with almost immediate results—with a number of suggested timeframes calling for a solution’s development in less than six months.

Contracts can be awarded on a fixed price, cost reimbursement, or cost plus fixed fee basis.  The BAA contemplates the potential award of a number of contract types, including indefinite delivery, indefinite quantity (“IDIQ”) contracts, task orders issued under existing IDIQ contracts, and Other Transaction Agreements (“OTAs”).  Other than OTAs, contracts awarded under the BAA will be subject to FAR and DFARS requirements.Continue Reading Defense Threat Reduction Agency Seeks “Near-Term” Solutions to Ebola Outbreak

As the U.S. government works to address the threat posed by the Ebola virus, one tool available to the Department of Health and Human Services (HHS) in this effort is a broad agency announcement (BAA) originally issued in 2009 as a means of accelerating the development of vaccines, therapeutics, and diagnostics to prevent and treat the disease. On October 16, for instance, the agency highlighted that BAA in announcing the award of an $8.6 million contract for the development of an experimental Ebola vaccine. That announcement came on the heels of another HHS award in September 2014 — this one worth $42.3 million — for the development of a separate drug to treat Ebola infections, ZMapp. Additionally, HHS recently issued a task order under its Centers for Innovation in Advanced Development and Manufacturing (CIADM) program inviting three qualified laboratories to submit proposals for the acceleration of production of experimental ZMapp doses. HHS officials have signaled a readiness to look to the BAA in order to identify other qualified technologies for additional awards to combat Ebola.

In a recent press release announcing that HHS is “seeking additional proposals” for the advanced development of Ebola treatments, Robin Robinson, the Director of HHS’s Biomedical Advanced Research and Development Authority (BARDA), vowed that the agency would “push[] hard to advance the development of multiple products as quickly as possible for clinical evaluation and future use in preventing or treating this deadly disease.” For companies with an interest in assisting the government in its Ebola prevention and treatment efforts, a strong working understanding of the above-referenced BAA and its requirements is vital.Continue Reading Government Looking to Existing Procurement Vehicles to Stem Ebola Threat