Better Policies, Practices in Drug Manufacturing

Across the US, people who rely on prescription drugs are struggling to meet the soaring price tags these pharmaceuticals often carry—especially the novel treatments that face little competition.

More affordable drug treatments is one of many goals a nonprofit organization made up of 17 schools of pharmacy and chemical engineering, including the University of Minnesota’s College of Pharmacy, is working to reach. This organization, known as the National Institute for Pharmaceutical Technology and Education (NIPTE), received $35 million in funding last week from the US Food and Drug Administration to address a wide range of topics related to quality and manufacturing in the pharmaceutical industry.

NIPTE focuses on ensuring the quality, safety, and affordability of existing drugs and helping new medicines reach the market faster. The organization connects areas of research expertise from across disciplines and institutions to make scientific findings that inform FDA drug policies and improve the manufacturing processes and quality of medicinal drugs.

The new FDA grant will build off of a previous FDA grant in 2011, which led to more than three dozen research projects in pharmaceutical technology and manufacturing.

Vadim Gurvich, Ph.D., research associate professor in the College of Pharmacy and NIPTE’s executive director, said the organization is uniquely suited to address current industry practices and inform new policy because its efforts intertwine with those of regulators.

“Each project is being conducted in close collaboration with the FDA and its scientists are part of the team,” said Gurvich, who also serves as the principal investigator on the new grant. “That allows for a greater understanding of the needs and potential science-based solutions on both sides—the researchers and the regulators.”

NIPTE delves into a wide range of pharmaceutical subjects. One example is determining whether two drugs with the same active ingredient are “therapeutically equivalent”—that is, whether they share the same clinical effects and safety levels. Knowing which drugs are therapeutically equivalent provides patients with more options for taking the same medication, such as through the development of generic alternatives to brand-name drugs.   

Other examples of NIPTE research include designing painkiller medications meant to deter abuse, which could help curb the national epidemic of opioid addiction, and studying the characteristics of new and existing types of abuse-deterrent formulations.

A Key Role

The U of M’s College of Pharmacy plays an important role in NIPTE. With Gurvich as executive director, the college provides program staffing and administrative oversight for the organization.

In addition, several college faculty have been involved in NIPTE research projects, including professors Raj Suryanarayanan, Ph.D., and Changquan Calvin Sun, Ph.D., who have led projects focused on better ways to manufacture and store solid, single-dose drug delivery vehicles like tablets and gel capsules.

Right now, Professor Karunya Kandimalla, Ph.D., is contributing to studies to better understand the process of delivering drugs transdermally, or through the skin, the way nicotine and birth control patches work. Researchers aim to gain a better understanding about the rate at which transdermal patches deliver high-potency drugs to better prevent harmful or even fatal overdoses.

Kandimalla’s work may help improve industry drug labeling practices to ensure doctors and patients who handle these medications know about the potential overdose risk and can take steps to prevent it from happening.

With the U of M as just one of the 17 research institutions involved in NIPTE, Gurvich emphasized that the strength of the organization’s research capabilities lay in its broad spectrum of expertise.

“With 17 major universities and dozens of participating faculty, NIPTE can come up with a team of experts in nearly any relevant scientific area,” he said. “Collaboration is the key to success and most of the project teams are cross-institutional and cross-disciplinary.”