Harry Kochat, PhD, remembers a time early in his career when a mother and her young son, a brain tumor survivor for more than four years, came to his office to thank him for developing the cancer drug that had saved the boy’s life. It was the early ’90s, and Dr. Kochat, working for a pharmaceutical company in Texas, had developed the oncology drug that was being used successfully at St. Jude Children’s Research Hospital to treat brain tumors.
Dr. Kochat has been named the new director of the Plough Center for Sterile Drug Delivery Systems at the University of Tennessee Health Science Center (UTHSC). He said that memory fuels his passion to develop life-saving drugs even today.
Recruited by Ken Brown, JD, MPA, PhD, FACHE, executive vice chancellor and chief operations officer at UTHSC, Dr. Kochat will direct the Plough Center’s two pharmaceutical manufacturing facilities on campus.
One facility has been in operation since 1963, producing small-batch preclinical and phase 1 drugs, and offering testing and training in aseptic manufacturing and production. It is located in the Van Vleet Cancer Center at 3 North Dunlap. Interestingly, the first batch of the oncology drug developed in the 1990s by Dr. Kochat in Texas and used at St. Jude to treat brain tumors was produced at the facility.
The other is a new $16 million state-of-the-art facility in the final phase of construction at 208 South Dudley Street on the eastern edge of campus that will expand the university’s pharmaceutical manufacturing capabilities to include development and production of drugs from the preclinical to the commercial for companies ranging from startups to pharmaceutical giants.
Dr. Kochat said he was impressed with the “passionate leadership” of Dr. Brown, who has been the prime force behind expanding and updating the existing Plough Center operation and building the new facility. The “intellectual power” of the university was also a draw, and sets the Plough Center apart from most other contract manufacturing operations, because it can offer research, development and manufacturing in one location.
“We recruited Dr. Kochat because of the kind of institution we are and the kind of mission we have,” Dr. Brown said. “We are not just about pharmaceutical production and the economic bottom line. We are about research, drug discovery, and saving lives.
“From a cadre of very talented people, we were very fortunate to recruit the one with the greatest sense of responsibility for the work he is doing,” Dr. Brown continued. “We were able to recruit the one who cared the most about what the benefits of his efforts will mean to the quality of human life. I believe we recruited the best person out there.”
The new Plough Center facility will house three 800-square-foot PODs, which will serve as sterile environments for manufacturing the pharmaceuticals. The PODs will allow the facility to attain and maintain aseptic conditions as specified by Good Manufacturing Practices (GMP) guidelines, the pharmaceutical industry’s standard for sterile facilities.
Contract manufacturing services in the new Plough Center will include vials, ampules and prefilled syringes; cytotoxic and controlled substances; orphan drugs to treat rare diseases; nanoparticulate drug delivery systems; suspensions and other forms for all phases of clinical trials and commercial use.
Construction on the new facility began in late 2015, and is nearing completion. Equipment is being installed and qualified. Dr. Kochat will be working to get the facility inspected and qualified by the Food and Drug Administration and other regulatory agencies. After validations and commissioning are achieved, manufacturing should commence. “Within eight to 10 months, we should be able to be completely ready to roll,” he said.
Dr. Kochat spent most of his career at BioNumerik Pharmaceuticals, Inc., in San Antonio, in drug development, quality and regulatory compliance. He received his PhD in organic chemistry at Purdue University on an International Exchange Scholarship. He also spent six years jointly with Purdue University, West Lafayette, and Rice University, Houston, as a National Institutes of Health postdoctoral fellow. He received Master of Science and Bachelor of Science degrees in chemistry from University of Kerala in India.
Dr. Kochat is an author and co-inventor with more than 350 issued patents domestically and internationally, and more than 60 scientific publications in peer-reviewed journals.