But Flow admits he failed to deliver on the two-year deadline, casting doubt on his four-year goals. The company’s slow progress underscores how many new and sometimes untested companies won contracts in the chaotic early days of Covid — and how, two years later, the federal government, now under the Biden administration — is still paying for products and services that have yet to come to fruition.. It also highlights how the allure of a safer and less expensive supply chain can be an almost irresistible prize for US health officials willing to partner with enterprising CEOs who say they can make it happen.
Flow fulfilled some parts of the agreement. BARDA has directed the company and its partners to immediately identify a list of essential medicines that are at risk of shortage, and to develop active ingredient potency and in-house fortification of these medicines. The company and its partners confirm they have delivered more than 2 million doses of essential drugs used to treat Covid-19 patients to the US strategic stockpile, although Flow declined to comment on which drugs those were, citing contract terms.
But the company has provided very limited details about its main goal, which is to develop sustainable pharmaceuticals. “I’m just scratching my head. What are you doing? Seriously, what are you doing?” said Tony Quinones, CEO of Bright Path Laboratories Inc., a biotech company that uses artificial intelligence to make pharmaceutical products through continuous manufacturing.
Both Flow and BARDA said they were pleased with the pace of progress on the contract. “We’re very pleased with the execution and the great progress we’ve made on multiple occasions today.” [active pharmaceutical ingredient] through program development to the production phase,” Flow Chief Business Officer Dan Heckman told POLITICO, though he declined to comment on when specific milestones will be reached.
He added that the company plans to open two U.S.-based drug ingredient manufacturing plants in the next 6 to 18 months — beyond the initial contract timelines. When asked about the delays, Hackman cited supply chain difficulties that have been exacerbated by the current pandemic.
From the start, industry experts were skeptical that Flow could meet the contract’s lofty goals. No commercial company in the US manufactures drugs using end-to-end advanced manufacturing.
“They weren’t even a company and they were given money,” said Carol Nessi, co-founder and CEO of Sequella, a Maryland-based company focused on developing antibiotics using continuous manufacturing.
Lawmakers’ attention has been drawn by questions about the circumstances of several companies that received BARDA contracts in the early days of the pandemic, including Phlow, and their lack of experience. That led to an ongoing congressional investigation.
With all eyes on Flow, a well-connected startup with no manufacturing experience, experts fear the U.S. government may miss an opportunity to fund more established companies that could bring pharmaceutical production back to U.S. soil sooner.
“This one [company] Absorbs a lot of oxygen in the room. You hope that they will be successful because what they have to do is important,” Quinones said. But, he added, with his lack of experience so far, he’s skeptical Flow will be able to deliver on his promises.
A broad search resulted in a specific company
Phlow acquired its federal contract in response to the agency’s broad announcement (BAA) about ways to optimize the US pharmaceutical supply chain. “Phlow was selected for a number of considerations, including the team of experts they assembled and the fact that they were the only entity that BARDA met out of over 300 companies that could provide this key service,” said a BARDA spokesperson.
As their name suggests, BAAs They are intentionally vague, allowing the federal government to accept and evaluate proposals that solve problems in different ways, said Stephen Schooner, a law professor at George Washington University School of Law. A BAA, unlike a request for proposals, can often lead to unsolicited proposals for the agency, which is not public and does not allow for competition between companies, he added.
Flow executives met with members of the Trump administration in the fall of 2019, facilitated by Rosemary Gibson, senior health advisor at the Hastings Center, a nonprofit bioethics think tank. Gibson now sits on Flow’s board of directors. Additionally, Peter Navarro, a White House trade adviser under former President Donald Trump, who wanted to replace Chinese generic manufacturers with American companies. It helped to strain via contract, POLITICO reported earlier. Neither Navarro nor Gibson responded to additional questions.
The company’s ties to the Trump administration are the subject of an ongoing investigation by the House Select Subcommittee on the Corona Virus Crisis. “We are concerned that … White House officials may have put undue pressure on federal agencies to award contracts to specific companies,” the subcommittee’s Democratic members said. wrote in a March 2021 letter to Health and Human Services Secretary Xavier Becerra.
“Evidence uncovered by the Select Subcommittee raises questions about whether White House officials, including Mr. Navarro, had undue influence over the signing of the contract.” [personal protective equipment] and medical equipment to be handled by career procurement personnel,” the letter continued.
Return of domestic production of drugs
The problem that federal officials hired Flow to address is a tangible health threat: Covid-19 has highlighted the fragility of the generic drug supply chain. Factories around the world that make ingredients or finished drugs have temporarily shut their doors as the virus rages, causing shortages, including in the US, that have drawn public health and White House officials scrambling to find ways to quickly produce drugs. To avoid future shortages.
Currently, most generic drugs or their ingredients are made overseas, where labor costs are lower and environmental regulations are more lenient. Manufacturers mix drug ingredients together in large containers called batches, like soup. It is difficult for manufacturers to control the quality of drugs made in this way; If internal testing finds that part of the finished product is off, the entire batch must be discarded. It is less reliable and can cause large amounts of waste.
Continuous manufacturing of pharmaceuticals is a form of advanced manufacturing—a buzz phrase that has caught the attention of the White House in recent years. Unlike batch production, continuous production involves making drugs on an assembly line on a smaller scale.
That means manufacturers can monitor product quality in real time, leading to increased efficiency, less waste and fewer errors, said Fernando Muzio, a chemical and biochemical engineer at Rutgers University who specializes in continuous manufacturing of pharmaceuticals. Taken together, these improvements in manufacturing techniques substantially reduce manufacturing costs—enough to potentially once again produce these drugs in-house.
The challenge with continuous manufacturing, however, is that it’s an essentially new way to make existing drugs—which means millions of dollars in research, development, facility construction, and regulatory adjustments required by the Food and Drug Administration. Although academic laboratories have advanced continuous drug manufacturing, no company manufactures drugs end-to-end using continuous manufacturing in the US.
What has Flow done so far?
Beyond its government contract, Flow has taken other steps to ease drug shortages in the U.S., Hackman noted. The company has established a contract manufacturing arm to advise other pharmaceutical companies on various best practices.
In 2021, under the Biden administration, BARDA approved Phlow to join a group of companies working with the US government as a contract development and manufacturing organization. HHS also recognized the company with the Office of Small and Disadvantaged Business Administration’s Best Small Business Contractor Award.
Flow founded the Children’s Hospital Coalition, a group of 20 institutions in the US. Coalition members and Flow representatives meet several times a month to discuss the hospitals’ drug needs. Marshall Sumar, a pediatrician who specializes in rare diseases at Children’s National Medical Center in Washington, D.C., a member of the coalition, sits on Flow’s board of directors.
This year, the company reached a private label deal with Fresenius Kabi, a drug company headquartered in Germany that specializes in injectable drugs. Fresenius Kabi has US-based facilities that stock four drugs often in short supply at children’s hospitals and add the Phlow label to those products. Flow then sells those drugs to members of a coalition of children’s hospitals “at a competitive price in the broader market,” according to Hackman, and fulfills the hospitals’ demand for the products.
Heckman would not comment on where Fresenius Kabi gets the active ingredients for these drugs. In previous conversations with POLITICO, Eric Edwards, Phlow’s co-founder and CEO, confirmed that those active ingredients were coming “mostly” from overseas. Fresenius Cabe declined to comment.
Meanwhile, Flow has shed some light on the subcontracts he awarded from his initial BARDA arrangement. Flow gave Civica Rx, a nonprofit generic drug maker, $100 million to help build a manufacturing plant in Petersburg, Va., where it makes the final form of the drugs. A Civica spokeswoman said the manufacturing plant would open in 2024.
Flow also announced agreements with Medicines for All, a nonprofit research group headquartered at Virginia Commonwealth University, and AMPAC Fine Chemicals, a contract development manufacturing organization that makes active drug ingredients for a number of companies. Heckman said these companies will be responsible for research and development, respectively, for continuous manufacturing and scale-up process.
Both Medicines for All and AMPAC were listed as subcontractors in Phlow’s original BARDA contract. An AMPAC spokesperson would not comment on the dollar amount Flow received for the contract, but Medicines for All received the contract for nearly $13 million.
Martin Van Trieste, an advisor to Civica Rx and a member of its board, and Frank Gupton, CEO of Medicines for All and co-founder of Phlow, both serve on Phlows board of directors.
Still, some experts are frustrated that they don’t know more about Flow’s plans to meet its contractual obligations. Schooner noted that there is no reason for the parties to keep this secret. “Why shouldn’t this information be public?” she said.
Those focused on continuous manufacturing are frustrated that the money awarded to BARDA has yet to pay off, meaning the country remains vulnerable to shocks to the pharmaceutical supply chain.
“Science is a group process,” Nessie said. “BARDA had a group [existing continuous manufacturing companies] Together as a unit… I think they would make significant progress.”
A Trump-era federal Covid contract recipient has yet to meet key deadlines
Source link A Trump-era federal Covid contract recipient has yet to meet key deadlines