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.
Proposed approaches under the DARPA BAA must be capable of meeting three primary objectives.
- First, proposed approaches must be capable of rapidly producing viruses in sufficient quantity for countermeasure development from discovery through testing, potentially by growing viruses in engineered cell types or through similar rapid processes. Although the BAA targets pathogens generally, successful offerors will be expected to work with viruses in performing contemplated activities.
- Second, proposed approaches must be capable of rapidly producing high-potency antibodies or other proposed biological products, with an expectation that offerors will likely identify an in vitro antibody maturation platform. Although DARPA is willing to consider a range of biological products that target particular viruses—including other proteins, peptides, and oligonucleotides—the BAA assumes that antibodies will be used to ensure rapid countermeasure development.
- Third, proposed approaches must identify delivery methods that are designed to induce in animal models complete protection against a targeted pathogen within three days, ideally following a single administration using a method that can be employed in austere conditions and with a protection period lasting more than thirty days.
Proposed approaches must also be capable of meeting additional objectives relating to the identification of viable antibodies or other biological products and manufacturing of clinical grade material, but DARPA expects that these additional objectives can be met with existing technologies.
The BAA envisions that successful offerors will implement their proposed approaches in multiple overlapping phases, with initial platform development activities extending through the first three years of performance and capability demonstrations beginning at the end of the first year of performance and extending through completion of a total four-year effort for all activities. During performance, successful offerors will be expected to complete a single Phase I clinical trial to confirm that their proposed platforms are capable of delivering safe products. Other capability demonstrations that will be required include:
- the completion of an animal study to demonstrate product delivery and protection within sixty to ninety days from initial growth of a virus;
- activities confirming the feasibility of scaled-up manufacturing, potentially covering up to 20,000 doses; and
- two final, complete demonstrations using pathogens selected and “blinded” by DARPA to simulate real-world events.
Successful offerors will have the option to select pathogens targeted during the first two capability demonstrations and must establish that selected pathogens have both pandemic potential and commercial interest. Successful offerors will also be expected to maintain developed platforms for use in response to future threats after completion of all DARPA-funded activities, although the mechanism by which DARPA may intend to enforce such an expectation is not specifically identified in the BAA.
The BAA anticipates that offerors will team with a number of subcontractors to address each objective. Importantly, the BAA allows platform components to be geographically segregated as long as appropriate third-party agreements are in place to ensure ultimate integration. The BAA specifically encourages offerors to identify credible, “even if risky,” approaches and cautions offerors against identifying “low-risk ideas with minimum uncertainty” or staffing efforts with junior personnel to lower costs.
DARPA anticipates making multiple awards in the form of procurement contracts, cooperative agreements, or other transaction authority agreements (“OTAs”), which typically may take the form of either (1) technology investment agreements that are subject to detailed regulatory requirements or (2) prototype project agreements that are relatively flexible and subject to recently updated agency guidance. As described in the prior version of this guidance, the Department of Defense has historically deemed a number of standard requirements to be inapplicable to OTAs, including requirements imposed under the Cost Accounting Standards, the Bayh-Dole Act, the Service Contract Act, and the Truth in Negotiations Act.
Offerors will not be required to propose cost sharing. However, DARPA will consider an offeror’s willingness to engage in cost sharing if required by the form of a particular award or if a proposed approach could have commercial applications. The BAA confirms that resulting awards will likely include provisions governing controlled unclassified information and restricting the free publication of data related to DARPA-funded activities, which can impact steps that must be taken to comply with export controls.
Potential offerors interested in participating in preliminary briefings about the BAA are required to register by 12:00 p.m. ET on February 16 or 24, respectively, for briefings to be held in Virginia and California. Attendance at these preliminary briefing is not required, and relevant information shared during the briefings will be made available to nonparticipating offerors.
The proposal process will proceed in two phases, with abstracts due by 12:00 p.m. ET on March 13 and full proposals due by 5:00 p.m. ET on May 1.