Thriving in Innovation

“We try to impact pharmaceutical quality, with research and a partnership with the FDA and funding from the FDA,” Gurvich continued. “So we are organizing faculty in a way that creates cutting-edge science with advanced manufacturing of small molecules and biologics.”

Key areas for academics associated with NIPTE involve their roles in advancing pharmaceutical development, analysis, manufacturing and instruction. “It is part of a critical path for young faculty,” said Dr. Fernando J. Muzzio, director of the National Science Foundation/Engineering Research Center on Structured Organic Particulate Systems based at Rutgers University, where he is a distinguished professor of chemical and biochemical engineering. NIPTE “promotes dialogue and cooperation among the different universities and creates the opportunity to work together and learn about each other,” Muzzio said, noting Rutgers’ NIPTE membership. “The most interesting thing is the interface between disciplines.”

For students, “these projects also allow them to become aware of what the FDA is and what it does and look into careers at the FDA,” he noted. “I have a number of students who went to work at the FDA and still work there.”

Preparing the Workforce

Education and skills development in pharmaceutical science are essential elements in preparing a new workforce, according to Gurvich. At NIPTE, courses are taught based on what the organization calls a “quality and integrated review concept” involving product development, delivery, manufacturing and outcome—with collaboration as a key with schools of pharmacy and engineering. Chemistry and materials science are also included in NIPTE’s strategic roadmap.

NIPTE said its scientists organize into centers of excellence and focus groups to “more efficiently collaborate and integrate their expertise across member organizations.” The focus groups target advanced manufacturing, biologics and biosimilars, nanotechnology and translational biomarkers. The idea is to link all areas within the scope of pharmaceutical production, from development to manufacturing.

“Large data has advanced more quickly than our ability to analyze the data and that’s a challenge,” said Barker. “That we cannot go alone. We can draw and tap into (NIPTE’s) tremendous expertise in engineering and even agriculture. That’s a factor for both basic knowledge and having a program to train data scientists to upskill the existing workforce—not expecting them necessarily to be experts but competent enough to work with the data.”

NIPTE’s examination of dosages (i.e., dosage forms) and complex molecules and specialty drug technology ties into Purdue’s strategic initiatives to expand its area of pharmaceutical and biotechnology instruction from basic science to clinical science for “cutting-edge educational programming,” Barker said. NIPTE has a collection of “a close-knit group of deans,” he said.

“Many of the NIPTE labs are doing dosage design research, and some of the information we are generating with prior knowledge may not be seen as cutting-edge research, but for pharmaceutical analysis and formulations and master’s and Ph.D. level students, this is an invaluable learning experience, both in mastering techniques and formulation design,” said Dr. Kenneth Morris, professor and director of Lachman Institute for Pharmaceutical Analysis at the Long Island University Pharmacy, which is a NIPTE member. NIPTE is also working to identify the next compounds and products likely to be important targets for the generic industry, Morris said.

As NIPTE collaborates with the FDA, the organization is also emphasizing the need to overcome workforce shortages in pharmaceutical sciences, according to Gurvich. “That was a big concern for the FDA several years ago and they couldn’t find enough qualified people with appropriate training in pharmaceutical sciences,” Gurvich recalled. “That led them to us, and they approached us to develop a training and certification program, which is very much a work in progress.”

There is irony in the work. As Gurvich and his team strive to improve pharmaceutical manufacturing in this country, “if it starts coming back to the U.S., the industry will face shortages in the workforce and that is another concern,” he said. “At NIPTE we discussed the situation, and (seek) to recalibrate education programs to solve that problem.”

More Accessible Generic Drugs

Even before the alarm over the spread of coronavirus throughout the world this past winter, NIPTE researchers began stepping up their research into improved mechanisms to manufacture and deliver generic drugs into the U.S. market. That market has been saddled by regulatory woes and much production overseas.

“The efficiency of the generic drug product system is quite low,” Gurvich said. “We noticed that about 60 percent of the drugs that are marketed by brand companies are not making it to generics. And that has caught our attention. That feeds into our priorities. It’s extremely important. It affects the drug supply, the quality of drugs, all sorts of things.”

Part of the organization’s strategy to improve access to generic drugs is wrapped around the words “new” and “prior knowledge.” Gurvich said NIPTE is pushing to highlight the distinction between the information that may involve proprietary and trade secrets and available knowledge in the public domain. Using that prior knowledge, he noted, can accelerate development and commercialization of generic drugs.

As an example of “new” and “old,” NIPTE published a paper last year titled “Pharmaceutical New Prior Knowledge: Twenty-First Century Assurance of Therapeutic Equivalence” that referred to manufacturer Apotex’s formulation of a nasal spray product, which used a different drug formulation so as not to infringe on a previous product’s unexpired patent. Years later, the situation changed: The FDA approved the generic version of the drug after the patent’s expiration. “Clearly during this review process, the FDA had access to previously disclosed” information, the paper states. Ultimately, it points to a “need for NPK (new prior knowledge) efforts to bridge the gaps between research to policy and policy to practice,” according to the authors.

Using the terms “new” and “prior knowledge,” Gurvich said, “sounds like an oxymoron. It may be a little bit provocative or paradoxical. But it needs to be taken up by public-private partnerships. NIPTE can be a partner and we had this discussion and talked to the FDA and the idea is we will have the scientific firepower to make a significant impact.”

Gurvich and other NIPTE leaders said their work comes at a crucial time: It occurs as the pharmaceutical industry is facing increased pricing pressures globally amid rising manufacturing costs. Drug quality also is under scrutiny, with so many drugs manufactured in China and India, where there also is concern about quality.

NIPTE was launched when funding for pharmaceutical science started to flatten, Gurvich said. Academic pharmaceutical science “was in decline domestically. NIPTE helped to slow that process, but it’s still in decline,” he said.

“The perception among academics was there was no funding source or government funding source that you could go to if you were working in pharmaceutical manufacturing,” according to the Journal of the American Association of Pharmaceutical Scientists, which reviewed the impact of NIPTE on academic research. The paper stated, “It seems that the landscape was right for a collaborative effort to expand public sector research efforts in this discipline.”

Gurvich said he’s hoping to add more universities to NIPTE and is excited about the possibilities of moving forward in pharmaceutical science, advanced manufacturing techniques and making inroads into generic production and gaining more funding.

Without rejuvenated pharmaceutical manufacturing, “the American public will face shortages of drugs and medications,” Gurvich said. Ultimately, “research itself is not the goal, it needs to have a purpose. There is a purpose—to help the patients, to help the public, and this is our chance to do it on a very big scale,” Gurvich said. “Everybody will benefit:  patients, students, the general public. It’s one of those win-win-win situations.”

Joseph A. Cantlupe is a freelance writer based in Washington, D.C.