This tiny federal agency was built to respond to a crisis like coronavirus. Now that it’s here, is BARDA ready?

WASHINGTON — It seems like an agency tailor-made for a crisis like the coronavirus pandemic.

The Biomedical Advanced Research and Development Authority, or BARDA, was created to invest in drug development projects that private industry wouldn’t touch, such as anthrax vaccines and therapies for Ebola, Zika, or swine flu.

Lawmakers were so confident that BARDA could help scientists develop a coronavirus vaccine, therapy, or even a diagnostic test that Congress has showered the agency with a $3.5 billion boost in funding, more than tripling its total budget.

But consultants and experts in biotech and in academia told STAT they had serious concerns about BARDA’s preparedness to absorb the massive new workload it will take to identify targets for a coronavirus vaccine or therapy.

Already, stakeholders are raising concerns about the responsiveness of a long-troubled contracting shop within BARDA, which will play an outsized role in doling out the new funding. In addition, the office has informed the companies it is partnering with on other matters — Ebola or influenza, for example — that its staff needs to put aside other obligations to focus solely on Covid-19.

“Zika and Ebola were very much a dress rehearsal for coronavirus,” said Chris Stanley, a consultant that focuses on helping companies get BARDA contracts. “This is on another scale.”

While BARDA has had early successes in responding to Covid-19, drug industry officials are pressing the agency to move even faster, and to use every tool at its disposal — including controversial contracting authorities that bypass a number of government safeguards — to get money flowing to industry as soon as possible.

“Everyone knows that the government wheels can turn slowly and bureaucracy can raise its ugly head, and this is a race against time,” BIO President Jim Greenwood said. “This is a matter of life and death.”

An agency spokesperson insisted that the organization is using “every mechanism available under [existing regulations] to speed the contract award process,” and noted that BARDA has been able to award up to $750,000 grants within 12 days.

The mission of BARDA’s scientists is to set out to identify promising targets, offer federal funding, and then provide free consultations with engineers, chemists, and regulatory experts.

To its credit, BARDA already has a hand in some of industry’s splashiest Covid-19 projects. It is pouring millions into Johnson & Johnson’s Covid-19 vaccine research, helping Moderna Therapeutics prepare for late stage clinical trials of its potential Covid-19 vaccine, and offering advice to help device companies get their Covid-19 tests through the Food and Drug Administration’s emergency clearance process.

BARDA is, as some staffers put it, the closest thing the government has to a venture capital firm.

Indeed, like a venture capital firm, BARDA doles out funding and advice to biotech companies trying to push a product through the FDA approval process. BARDA’s longtime director, Rick Bright, talks like a venture capitalist, too. He speaks frequently of BARDA’s role in bridging the “valley of death,” the dearth of funding that often keeps promising developments from proceeding into late stage trials.

BARDA even holds its own annual version of the pitch fests that have become wildly popular among venture capitalists. Companies swarm the event to vie for the opportunity to give a “lightning talk,” as BARDA calls the pitches for funding.

The agency was created in 2006 in response to the 2001 anthrax attack, when envelopes of the bacteria were mailed to major news organizations and lawmakers, killing five and infecting 17. It’s the brainchild of Sen. Richard Burr (R-N.C.) and his staffer at the time, Dr. Robert Kadlec, who currently serves as the assistant secretary for preparedness and response, the Health and Human Services official with oversight over BARDA.

Its creation was not without controversy: Science groups publicly warned that BARDA would duplicate existing efforts run out of the Department of Defense, and they feared the office’s contracts would be shrouded in secrecy.

Since then, BARDA has invested in everything from a test to detect the intestinal infection known as Clostridium difficile to a vaccine for smallpox.

BARDA measures its success by the number of products it has helped earn FDA approval. The office takes that metric so seriously that it commemorated its 50th approved product with a gold “challenge coin” emblazoned with fireworks and BARDA’s slogan: “Savings Lives and Protecting Americans.”

BARDA’s advocates insist that the organization has helped develop products that would be virtually ignored by the private market.

“If you think about some of the stuff like smallpox antivirals or certain drugs for anthrax, those probably wouldn’t exist if BARDA hadn’t really pulled them through,” said Dr. Amesh Adalja, a spokesperson for the Infectious Disease Society of America and a senior scholar at Johns Hopkins University’s Center for Health Security.

Industry officials can be more critical, sometimes arguing that comparing BARDA to a venture capital firm isn’t a perfect analogy, because of the at-times infuriating level of oversight BARDA demands from grantees, as well as its aversion to risk.

“You could describe them, charitably, as a very activist VC organization,” said Stanley.

Yet those concerns haven’t kept the pharmaceutical and biotech industries from partnering with the office. BARDA has penned over one hundred partnerships in the last decade alone, from a $60 million multiyear partnership with Genentech to a $10 million dollar contract with an unknown vaccine company, Public Health Vaccines LLC.

Grantees aren’t just drug makers, either. BARDA gave the University of California, San Francisco, for example, $6 million in 2019 to create a “Center of Excellence” focused on pediatric disaster care.

In addition to doling out millions each year in grants, BARDA provides a team of experts that help coach companies through the drug development process.

“They’ve been able to recruit people to serve as advisers within their own organization that typically have 20 to 30 years of pharmaceutical development experience,” said Joe Larsen, a former BARDA executive who now is the vice president of strategic portfolio development at VenatoRx Pharmaceuticals, which receives BARDA funding. “They bring their team of consultants in to help companies like ours [and] provide advice on how to navigate certain technical issues.”

“We would simply not be where we are and have the depth of pipeline that we have … if it wasn’t for them,” Larsen added. “Getting seven free consultants is definitely helpful.”

In response to Covid-19, BARDA is actively seeking proposals for everything from respirators and ventilators to vaccines and therapeutics. Already, BARDA has held roughly 100 meetings with industry over potential partnerships, Bright told drug makers late last month.

BARDA has its hands in many of the most closely watched Covid-19 products being developed. They put together a $1 billion partnership with Janssen to develop a Covid-19 vaccine; a partnership with Regeneron to develop monoclonal antibodies that could be used to treat the disease, and they’re already working with Moderna Therapeutics to prepare now for Phase 2 and 3 clinical trials for its potential Covid-19 vaccine — despite the fact that the company is just starting its Phase 1 trial.

Other smaller initiatives have already had some success. A $561,330 partnership helped push a 30-minute Covid-19 test from a little-known California biotech through the FDA authorization process. They’ve helped push six other Covid-19 tests through FDA’s processes, too.

But already, there are concerns that BARDA won’t be able to keep up with demand. Its website warns companies it will not be able to meet previously promised timelines for non Covid-19 related products and that any non-Covid-19-related proposals “will be put into a queue.”

“Someone came to me with an Ebola thing and I was like ‘You’re too late,’” said Stanley, the consultant.

BARDA’s director, Bright, has also publicly pleaded for industry to come work at BARDA, even on a temporary basis.

“If you have people who would like to join the fight on behalf of the government, we are hiring rapidly. We could use support,” Bright told industry representatives at a recent BIO forum.

As Tara O’Toole, a former Homeland Security under secretary focused on science and technology, put it, “This is a very different situation than BARDA is used to.”

Several biotech veterans who’ve worked with BARDA raised particular concerns about the agency’s contracting office, which controls the money that flows from BARDA to its partners, serving as the primary point of contact for the agency and the oversight arm for anything from travel requests to clinical trial funding.

The biotech veterans complained that the office often holds up the release of the money companies are relying on to begin their research, sometimes forcing them to operate “at risk” until BARDA funding comes through. They also complained that the office has been plagued with turnover that has forced companies to be jostled around from contract officer to contract officer.

“There have unfortunately been some issues with how quickly contracts can roll out,” said Phyllis Arthur, BIO’s vice president of infectious diseases and diagnostics policy.

Another representative from a company that worked with BARDA on a product unrelated to the coronavirus, said they struggled to get answers from contract officers at BARDA and its parent department within the Department of Health and Human Services — though they also insisted BARDA is the most well-equipped part of the government for this work and deserves the influx of funding.

“It’s very hard to even get people to call you back,” the representative said. “Sometimes I email people three, four times … I may never hear back from them.”

Robin Robinson, the first director of BARDA, who led the organization from 2008 to 2016, acknowledged those complaints, but insisted they’re waged at all parts of the government, and that they’re improving .

“Are there instances when I was there, that it took too long? Yes. But as we matured as an organization certainly we were able to improve,” said Robinson, who added that he believes BARDA is “demonstrating a very high capability to respond to this event.”

That office’s issues have been the subject of debate in Washington virtually since BARDA’s conception 14 years ago. The office was even one of the main points of focus for a blue ribbon panel in 2015 charged with reforming the U.S. biodefense system.

Part of the problem: control over the contracting office in particular has shifted multiple times. When Congress created BARDA in 2006, contracting was under the sole discretion of the BARDA director. That changed in 2009 when the office was instructed to report directly to the head of the assistant secretary for preparedness and response, a higher-level position within HHS. Congress moved the office back under the BARDA director’s control in 2016 in hopes of eliminating “confusion, unnecessary delays, and uncertainty regarding time sensitive national security countermeasure contracts.”

Robinson acknowledged the impact that changing the lines of authority have had on BARDA morale, though he insisted that BARDA’s current leadership is working to fix the issue.

“Anytime there’s a transition from one office to another there [are] going to be consequences in morale and performance until they actually can make that transition complete and become reassimilated into the culture,” Robinson said. BARDA declined requests for an interview with Bright, the organization’s current director.

The agency spokesperson declined to answer STAT’s questions about staffing, except to say that it is “working aggressively to fill vacancies to meet national health security needs.”

Some industry executives say the concerns are overblown. “We’ve had some responsiveness challenges, but you know what, [BARDA] probably had the same challenges with [our company], too,” said Sean Kirk, executive vice president of manufacturing and technical operations at Emergent BioSolutions, which has signed multiple contracts with BARDA. “I find it intriguing that people want to … vilify an organization over the outlier events that occur, rather than focus on all the positive things.”

And early signs show that BARDA has moved quickly in penning contracts with Covid-19 test developers. Matt Lesho, a senior director at Luminex, which received $642,000 in funding from BARDA, called working with the office “as easy a process as I’ve ever experienced in getting governmental funding,” and “quicker than anything I’ve ever experienced.”

Scott O’Brien, senior vice president of global marketing and international sales at GenMark Diagnostics, which received $749,000 in funding from BARDA, said similar. Their approval process for GenMark took roughly two weeks.

“It’s hard to know if this is really a function of the level of urgency in the U.S. or if this is how they normally operate … but we’ve been pleasantly surprised so far,” said O’Brien.

Congress has also relaxed certain restrictions on BARDA’s funding agreements in hopes of speeding the development of Covid-19 treatments or vaccines, and at the urging of the drug industry. The changes waive oversight provisions that are otherwise common in traditional federal contracts, as well as some drug pricing restrictions.

The rapid change has drug pricing and government accountability activists concerned, but preparedness experts say that the coronavirus emergency demands it.

“If ever there was a time to use OTA authority, this is it,” said Gigi Kwik Gronvall, a senior scholar at Johns Hopkins University Center for Health Security.

BARDA’s supporters say that change — and especially the massive boost in funding — are going to give BARDA the chance to show off what it can do.

“BARDA personnel,” said Johns Hopkins’ Adalja, “have been waiting for a long time to be able to really show all that BARDA can do.”

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