Tuesday, Dec. 13, 2016

The Virginia Commonwealth University School of Engineering’s Medicines for All project 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 grant is the third major investment in Medicines for All in three years from the Gates Foundation, which also funded the initiative’s work to bring down the cost of the first-line AIDS treatments nevirapine and tenofovir.

“[Dolutegravir] is a relatively new drug,” said lead investigator B. Frank Gupton, Ph.D., professor and chair in the VCU Department of Chemical and Life Science Engineering. “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.”

Medicines for All has developed a model that reduces costs by accelerating creation of 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 to transfer the new production processes to manufacturers so the medications can reach communities in need.

“For nevirapine, six months after the transfer to CHAI, it was in commercial production,” Gupton said. “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, explained that one of the active-ingredient cost drivers is speed-to-market. When a molecule is identified as a drug candidate, the company typically has only a year and a half to file its regulatory submission.

Gupton’s team includes Thomas Roper, Ph.D., who recently joined the VCU School of Engineering faculty after 22 years as a researcher for GlaxoSmithKline, and was the previous head of Global Exploratory Development Sciences; Timothy Jamison, Ph.D., chair of the Department of Chemistry at MIT, who is conducting screening studies prior to Gupton’s work on chemical development of the drug; and Brian Marquardt, Ph.D., principal engineer at the Applied Physics Laboratory at the University of Washington, who provides real-time analytical methods to measure the product quality, ensuring 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 longer-term 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.