When patients take a dose of prescription medication, its quality is what gives them confidence in their next dose of medicine.
Credit Stelios Tsinontides, PhD, and his colleagues in the Office of Pharmaceutical Quality (OPQ) for providing that assurance.
Tsinontides, who worked more than 25 years in pharmaceutical research, development and technical operations, is currently the Director of the FDA’s Office of Pharmaceutical Manufacturing Assessment in the OPQ of the Center for Drug Evaluation and Research (CDER). He and his team of interdisciplinary chemists, microbiologists and engineers evaluate and assure that quality pharmaceuticals are consistently manufactured at commercial scale and meet expected quality standards over the product lifecycle.
“Having spent many years in the pharmaceutical industry, I fully understand the challenges and efforts that go with developing, scaling up and manufacturing high quality medicines,” he said. “Working for the FDA was an opportunity to make a positive impact on the way industry and regulators work together to assure high quality medicines to our patients.”
A native of Cyprus, Tsinontides received a B.E. in Chemical Engineering in 1986 from City College of New York with Summa Cum Laude Honors. He continued his studies at Princeton University, earning an M.A. in Chemical Engineering in 1988 and a Ph.D. four years later. He also graduated from the Wharton Management Program at the University of Pennsylvania in 2004.
His interest in science, and with help and encouragement from Dr. George Millili, his mentor and good friend from Cherry Hill, NJ, he started his career in pharmaceuticals as a senior development engineer with Schering-Plough Research Institute, where he specialized in the scale-up of sterile pharmaceutical formulations.
“I gravitated to science – it seemed a natural path,” he said. “Applying science and engineering to improve quality of life is a never-ending quest. I feel very fortunate to having a chance to work in the pharmaceutical area and develop medicines for patients.”
Moving to Merck & Co. in 1996 as a Research Fellow, Tsinontides directed the formulation and development of InvanzR, a beta-lactam antibiotic indicated to treat severe skin, lung, stomach, pelvis and urinary tract infections. The last years of his eight-year tenure were devoted to managing three pilot plant facilities (biologics, pharmaceutical and antibiotics) to manufacture products to support clinical, safety assessment and stability programs and scale-up of the manufacturing processes to commercial scale.
Tsinontides spent the next eight years with Cephalon/Teva, working in both US technical operations and worldwide process development. He established technology transfer and continuous improvement programs and harmonized scale-up and technical support for products to US sites, including the development and commercialization of TreandaTM, an oncology product for the treatment of chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma (NHL).
Before joining FDA in 2019, Dr. Tsinontides was Senior Director, Global Drug Product Manufacturing Science and Technologies, with Shire/Takeda. He oversaw technology transfer and supported commercial manufacturing and implemented best practices to enhance the supply chain for the company’s small molecule solid and sterile drug products worldwide.
Like two sides of the same coin, Tsinontides’ experience with big pharma made him an ideal candidate for his FDA post.
“To the pharmaceutical industry, how the FDA works is often a black box – the multi-disciplinary collaborations of our medical, scientific and engineering experts to assess an application and make final recommendations are not transparent to industry,” he said. “Industry knows they need the FDA stamp of approval to market their drugs, but often the right level of chemistry, manufacturing and controls (CMC) information that is submitted to show that they can manufacture the medicinal product to assure its safety, effectiveness and quality is incomplete.
In his role, Tsinontides aims to bring more transparency on the Regulator’s expectations so that medicines can be manufactured at the expected quality standards and assure continuous supply to patients.
“Our guiding motto regarding pharmaceutical quality is that every pill in the bottle should be as effective as every other one – it is what gives confidence in the next dose,” he said. “We want to assure safe, effective and high-quality medicines are available to the American public.”
When his office assesses applications to approve a drug in the US, it applies the same standard for review of its quality irrespective of where the drug is made or whether it is branded or generic. The pharmaceutical industry is a global enterprise and more than 50 percent of drugs marketed in the US are produced globally, including in Canada, the EU, India and China. Approximately, 90% of the drugs in the US are generic medications.
During the COVID-19 pandemic, industry and government worked very closely to develop vaccines and complimentary therapies, including several mAbs, Paxlovid and Molnupiravir. As pharmaceutical companies met the challenge of creating safe and effective medications, the FDA provided critical support to guide industry on what data they needed, so that such medications could be authorized to use to combat the pandemic.
“My office prioritized evaluation of multiple facilities to assure quality manufacturing and enable prompt authorization of these urgently needed medications,” he said. “Given the limitations of travel, the agency used alternatives methods of inspection, such as remote regulatory assessments, while maintaining the same quality standards for product manufacturing. The pandemic also prompted collaboration with international regulators to ensure that critical medicines and vaccines are made available globally.”
Apart for his busy professional engagements, Tsinontides has maintained a strong connection with his homeland as an officer of the Cyprus Society of Greater Philadelphia. He has served as President and Chairman for many years since 2004 and is currently Vice President. During his leadership, the Cyprus Society has become among the most active members of the Federation of Cypriot American organizations and is a vibrant organization in the greater Philadelphia area, promoting Hellenic culture.
He and his wife, Laurie, have two adult children whose pursuits reflect the family’s scientific and artistic values. Their daughter Tatiana, a graduate of Temple University, is a biologist with Bristol Myers Squibb; son Christopher, has a marketing degree from Lehigh University, and graduated this May with a second bachelor’s degree in art design from the Fashion Institute of Technology in New York City.
