The Medicines for All Initiative has received approximately $5 million from the Bill & Melinda Gates Foundation to develop a more cost-effective way to manufacture Dolutegravir, a new HIV/AIDS therapy. The Initiative’s lead investigator is B. Frank Gupton, Ph.D., professor and chair in the Virginia Commonwealth University Department of Chemical & Life Science Engineering.
“[Dolutegravir] is a relatively new drug. Our expectation is that it will be a first line treatment. It’s a new member of an old class of AIDS drugs, and it seems to be much more effective,” said Gupton.
This grant represents the Gates Foundation’s third major investment in Medicines for All, having also funded the initiative’s work to bring down the cost of the first-line AIDS treatments Nevirapine and Tenofovir.
Medicines for All has developed a model that reduces costs by accelerating creation more efficient processes to synthesize the active ingredients in state-of-the-art AIDS therapies. Medicines for All also works closely with the Clinton Health Access Initiative (CHAI) to transfer the new production processes to manufacturers so the medications can reach communities in need.
“We develop the new process to decrease the cost. Then we transfer the know-how and the technology over to CHAI and they get it to the manufacturers,” said Gupton. Once CHAI receives the process from Gupton’s team, the manufacturing timetable is fast.
“For Nevirapine, six months after the transfer to CHAI, it was in commercial production,” says Gupton. “In academia, things rarely happen that quickly – and even in industry, it usually doesn’t happen that fast. Based on that past success the goal this time is for an even faster transfer to CHAI for the drug Tenofovir.”
Gupton, who has extensive experience in chemical and pharmaceutical companies including Boehringer Ingelheim, explains that one of the active-ingredient cost drivers is speed-to-market. This is because when a molecule is identified as a drug candidate, the company typically has only a year and a half to file its regulatory submission.
“They have 18 months to lock down the process, so they go with what they have. They don’t usually change the process after that,” said Gupton. Active ingredients represent only about 10 percent of the cost of a patented medication. But once the patent expires, the economics flip. Generic manufacturers are not tasked with research and development, so active ingredients make up a much larger share of their costs, usually 60-70 percent. By bringing down the cost of active ingredients, Medicines for All significantly increases access to lifesaving generics.
Gupton’s team includes Thomas Roper, Ph.D., who recently joined the VCU School of Engineering faculty after 22 years as a researcher for Dolutegravir manufacturer GlaxoSmithKline (GSK).
The team also includes Timothy Jamison, Ph.D., chair of the Department of Chemistry at MIT, who conducts screening studies prior to Gupton’s work on chemical development of the drug. Brian Marquardt, Ph.D., principal engineer at the Applied Physics Laboratory at the University of Washington, provides real-time analytical methods to measure the product quality. This is needed for a continuous production platform in which active ingredients are manufactured on an ongoing basis, in compact, closed units, with a higher degree of automation and fewer manual interventions.
Gupton’s goal for this work is a Medicines for All institute to develop new processes for manufacturing medications on a larger scale and establish research groups to work on multiple drugs in parallel. He thinks an institute would position VCU to magnify the effectiveness of the Medicines for All model and bring even more medications to communities that need them.
“I am pretty optimistic,” said Gupton. “The return on investment is pretty phenomenal.”