UTHSC Hosting Pharmaceutical Safety Conference

By Andy Meek

The University of Tennessee Health Science Center is working toward playing a major role in the safety and quality of medical products and the global pharmaceutical supply chain.

Its latest step in that direction is the university’s designation as a Center of Excellence in global medical product quality and pharmaceutical supply chain security. That comes from the Asia Pacific Economic Cooperation, an international forum supporting economic growth in the Asia-Pacific region.

In tandem with winning that designation, the university plans to host a four-day conference that will welcome pharmaceutical industry representatives and regulators from 13 countries. The gathering, from June 26-29, will include a discussion of things like strategies to guarantee that global pharmaceutical manufacturing, shipping and delivery are all as safe and secure as possible.


“The reason the university is involved can be boiled down to that we train health care providers, pharmacists, physicians, (physician assistants) and nurses who bear the responsibility of taking care of the citizens of the state of Tennessee and people across the world,” said Dr. Ken Brown.

Brown is UTHSC’s executive vice chancellor and chief operations officer who’s also been active in APEC’s global pharmaceutical supply chain safety efforts.

It’s also a no-brainer for the university to focus on that work, he continues, for a variety of reasons. Its system, for example, includes teaching hospital affiliates where patients are treated – the implication being the university has a stake in the quality of how those patients are treated. The university also does drug discovery via its College of Pharmacy and through its College of Medicine, and it’s going to be in the pharmaceutical manufacturing business via the Plough Center for Sterile Drug Delivery Systems at UTHSC.

That’s the $16 million pharmaceutical manufacturing facility opening late this summer, which among other things will give the university new capabilities like drug development and production for everything from startups to big pharma players.

The facility will house pods that function as sterile environments for manufacturing drugs. Contract manufacturing services in the new Plough Center will include things like orphan drugs to treat rare diseases; nanoparticulate drug delivery systems; suspensions and other forms for all phases of clinical trials; and commercial use.

According to Plough Center director Dr. Harry Kochat, the push is on to get drugs out faster and more cost effectively today. That means there’s a dependence “on facilities like this for tomorrow’s delivery,” he said.

Meanwhile, Brown has already made presentations in China, the Philippines, Peru, and elsewhere to senior officials of APEC about the university’s desire to be involved in the global effort around patient safety and product security. He’s also hosted delegates from China and Africa at UTHSC to discuss pharmaceutical manufacturing, delivery and safety issues.

The upcoming conference will be held in the UTHSC College of Pharmacy. Its theme is “Protecting Patient Safety in the Global Marketplace through GDPs (Good Distribution Practices) and Product Security Measures.”

Participants representing organizations like the World Health Organization, the U.S. Food and Drug Administration and companies like Merck & Co. Inc., Pfizer and Johnson & Johnson are expected to be on hand. Topics that will be discussed include product security tools and tracking to mitigate vulnerabilities in the supply chain, risk factors and best practices to prevent product diversion, among other things.

Kochat will give a keynote on June 29 focused on ideas developed at UTHSC to support FDA security protocols.