Registration will open soon for the Biomedical Advanced Research and Development Authority’s (“BARDA”) 2018 Industry Day to be held on October 29 and 30 at the Grand Hyatt in Washington, D.C. This event has been an integral part of BARDA’s outreach efforts to the life sciences community since 2007, and the newest version of this event promises to continue to provide meaningful insight into BARDA’s role in the nation’s public health preparedness efforts.

BARDA is expected to revisit annual topics like revisions to its broad agency announcement and updates to its goals and Government-wide strategic plans. In addition, this year BARDA will have a particular focus on innovation with the rollout of its Division of Research, Innovation, and Ventures (“DRIVe”) and lightning talks on noteworthy development efforts. Applications to participate in lightning talks are due soon, and potential participants should consider whether to take advantage of this unique opportunity.

Background

BARDA was formed at the end of 2006 with the passage of the Pandemic and All-Hazards Preparedness Act. Less than one year later, BARDA held its first Industry Day and has increasingly become a focal point in public health preparedness with the passage of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 and the 21st Century Cures Act. BARDA’s role is expected to continue to expand once the Senate and House versions of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 are reconciled and passed in a final form later this year.

Current Authorities

Currently, BARDA has significant flexibility to enter into novel relationships to promote countermeasure development and procurement efforts. For example, BARDA has previously taken advantage of a countermeasure-based antitrust exemption to support collaborative studies among competing vaccine manufacturers. In addition, BARDA has to date entered into six high-value other transaction authority agreements (“OTA”), which are not subject to many of the rigid requirements that apply to standard procurement contracts, grants, and cooperative agreements. BARDA’s authority to enter into OTAs would be expanded under the House version of pending legislation.

BARDA has also been willing to use various authorities to enter into public-private partnerships to drive development efforts in non-traditional ways. For example, at the 2015 Industry Day, BARDA introduced the concept of working with an incubator through an OTA to make targeted investments in start-up development efforts relating to antimicrobial resistance. This idea was refined over time and reintroduced at the 2016 Industry Day when BARDA announced details about a new Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator—or “CARB-X”—which is now actively accomplishing similar goals through a cooperative agreement.

DRIVe and Innovative Development

At the 2018 Industry Day, BARDA is expected to continue to focus on promoting innovation with the rollout of DRIVe and programs that will likely be implemented by the new division in the relatively near future. After being in existence for only a few months, the division is already actively working with an Accelerator Network based on the CARB-X model and soliciting proposals for targeted small-scale investments relating to rapid diagnostics, responses to sepsis, and other innovative technologies. In addition, DRIVe is actively making efforts to set up a number of other programs, including:

  • DRIVe Launch, which will likely leverage BARDA’s relatively recent authority to work with a non-profit entity to engage in venture capital practices, including through the use of equity investments;
  • DRIVe Ventures, which is expected to provide similar support through corporate venture capital partners; and
  • DRIVe Fuel Laboratories, which are intended to make co-working laboratory space available to start-up companies with the potential for follow-on investment.

BARDA has indicated that it would like DRIVe’s portfolio to grow over time and ultimately rival that of the Defense Advanced Research Projects Agency.

With DRIVe already in the process of making targeted investments and BARDA’s contracting authority expected to expand by the end of the year, BARDA’s announcement that lightning talks will take place at the 2018 Industry Day presents an exciting and timely opportunity for participants to showcase their development efforts. Similar to the benefits of existing TechWatch meetings, BARDA expects lightning talks to both facilitate discussions with the life sciences community and help the agency with market research necessary to make funding decisions.

Companies that are interested in participating in lightning talks will need to submit applications by September 7 and will be notified during the week of September 24 if they are selected.

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Photo of Jennifer Plitsch Jennifer Plitsch

Jennifer Plitsch is co-chair of the firm’s Government Contracts practice group. Her practice includes a wide range of contracting issues for large and small businesses in both defense and civilian contracting. Her practice involves advising clients on contract proposal, performance, and compliance questions…

Jennifer Plitsch is co-chair of the firm’s Government Contracts practice group. Her practice includes a wide range of contracting issues for large and small businesses in both defense and civilian contracting. Her practice involves advising clients on contract proposal, performance, and compliance questions as well as transactional and legislative issues. Her practice also includes bid protest and contract claims and appeals litigation before GAO, agency boards and the federal courts. Ms. Plitsch has particular expertise in advising clients in the pharmaceutical and biologics industry. She advises a range of pharmaceutical and biologics manufacturers on Federal Supply Schedule contracts, including the complex pricing requirements imposed on products under the Veterans Health Care Act, as well as research and development contracts and grants with various federal agencies. She also has significant experience advising on the requirements of various programs under which vaccine products and biodefense medical countermeasures are procured by the Government.

Photo of Tyler Evans Tyler Evans

Tyler Evans is an associate in the firm’s Washington, DC office and a member of the Government Contracts and Litigation Practice Groups. He has experience advising clients in the life sciences and defense industries on schedule contracting, cost disputes, mergers and acquisitions, and…

Tyler Evans is an associate in the firm’s Washington, DC office and a member of the Government Contracts and Litigation Practice Groups. He has experience advising clients in the life sciences and defense industries on schedule contracting, cost disputes, mergers and acquisitions, and small business issues.