On the heels of a production-tinged executive order earlier this month, the Trump administration is doubling down on efforts to boost medicine manufacturing in the U.S.
In a new public-private partnership spearheaded by the administration, the Department of Health and Human Services' (HHS') Administration for Strategic Preparedness and Response (ASPR) and the Defense Advanced Research Projects Agency (DARPA) are linking up with several universities and companies in a bid to improve manufacturing for essential medicines using technologies such as artificial intelligence, machine learning and informatics.
The project, dubbed Equip-A-Pharma, will allow the federal agencies to work directly with Battelle Memorial Institute and Aprecia, Bright Path Laboratories, Rutgers University and Mark Cuban’s Cost Plus Drugs as the partners strive to boost domestic manufacturing of eight drugs and their active pharmaceutical ingredients, the ASPR said in a Thursday press release.
Incorporating emerging technologies like AI in the drug production process has the potential to boost manufacturing efficiency, lower costs, curb drug shortages and speed approval timelines, the ASPR said.
The overall goal, to hear the ASPR tell it, is for each company and its partners to demonstrate over the next year how their respective “agile technologies” can potentially help produce APIs and finished drugs at points of care such as hospitals.
“Traditional pharmaceutical manufacturing is often too rigid and slow to adapt to changing demands, especially during national emergencies,” John Knox, HHS principal deputy assistant secretary for preparedness and response, said in a statement. “We’re launching projects aimed at completely changing the approach not just to bring pharmaceutical manufacturing back to the U.S. but to do it better.”
Taking a closer look at the individual projects, partners Battelle Memorial Institute and Aprecia will wed their advanced process analytics and machine learning know-how to produce 3D printed tablets of levetiracetam for epilepsy and seizures and linezolid for treatment of gram-positive infections like bacterial pneumonia.
Bright Path will leverage continuous flow manufacturing to crank out the local anesthetic lidocaine HCL and the chemotherapy carboplatin, according to the release. The idea is to show that Bright Path’s continuous flow approach is more efficient, scalable and adaptable than conventional production methods.
Rutgers University will utilize an AI-powered manufacturing platform—which the school has already been working on with the ASPR and DARPA—to demonstrate production of registration batches of the anesthetic bupivacaine HCL and the lung and asthma med albuterol sulfate.
Lastly, Mark Cuban’s compounding firm Cost Plus will deploy an “automated and flexible” manufacturing platform that uses AI and machine learning to assess quality and optimize production in real time, the government said in the release. Cost Plus will test its manufacturing approach on lidocaine and diltiazem, a calcium channel blocker that’s used to treat heart conditions.
Ultimately, all partners enrolled in the initiative are “expected to submit Abbreviated New Drug Applications to the U.S. Food and Drug Administration within a year as a result of leveraging the government-supported development work,” the ASPR explained in its release.
Manufacturing has played an outsized role in how the Trump administration has approached the biopharma industry. With the threat of pharmaceutical-specific tariffs looming, many major drugmakers have made billion-dollar pledges to boost U.S. production and other local operations in recent weeks.
Meanwhile, President Donald Trump earlier this month signed an executive order asking the FDA to “reduce the amount of time it takes to approve domestic pharmaceutical manufacturing plants.” The president also called on the U.S. drug regulator to “increase fees for and inspections of foreign manufacturing plants.”
The idea, in essence, is to reduce “duplicative and unnecessary” barriers to registering U.S. plants as well as to streamline FDA reviews and provide early support before facilities come online. The order itself is slim on details and specific goals.
The Equip-A-Pharma initiative, for its part, somewhat resembles the public-private efforts to onshore drug production during the COVID-19 pandemic, when the biopharma industry’s global supply chain was exposed as a notable weak point in times of crisis.
Those efforts saw many formerly unknown companies, such as Continuus and Phlow, rise to prominence on pledges to overhaul domestic drug manufacturing in the U.S., often with government contracts to back them up. Not all of those initiatives have panned out well.