IRISYS provides contract pharmaceutical product development and manufacturing services, specializing in formulation R&D and GMP (Good Manufacturing Practices) manufacturing of clinical trial materials and specialty pharmaceutical products. Our headquarters, laboratories and state-of- the-art manufacturing facility are located in San Diego, California.
We also offer strategic consulting related to the drug development process. Our reach extends from working with local pharmaceutical companies in San Diego to providing customized services for international clients.
Under the direction of founder and CEO Gerald J. Yakatan, Ph.D., the IRISYS team has built a reputation for excellence and timeliness in pharmaceutical development services.
IRISYS’ scientific management includes prominent pharmaceutical product development leaders from industry and academia. Their years of hands-on experience with every facet of pharmaceutical research and development enables the IRISYS team to bring our pharma company clients’ new products to the market quickly and efficiently.
Highlights from 2020
2020 was certainly a challenging year for everyone. But, at IRISYS, we are adept at overcoming all challenges. The following are some highlights that we achieved during an unprecedented year. 104 contracts were signed in 2020. Our projects increased by 33% from the previous year.
IRISYS was awarded an NIH contract for the formulation of Drinabant.
IRISYS was awarded an $850,000 NIH contract to develop a new injectable formulation of Drinabant to treat acute cannabinoid overdose. Opiant had identified a potential new use for Drinabant, but needed a high quality CDMO to support their efforts. NIH then contracted IRISYS to develop the formulation and manufacture batches to pursue the new indication for the pharmaceutical, which includes phase I clinical trials as well as stability studies. “The need to quickly and effectively reverse ACO symptoms, including in vulnerable populations like children, is a strong motivating factor pushing us at IRISYS every day to put in the effort and detail needed to ensure that this drug is ready for clinical trials as soon as possible,” stated Robert Giannini, IRISYS president and CSO/CTO. Complete Drinabant Press Release
TFF Pharma Contract
A third contract with TFF Pharma was signed for the initial production and testing of TFF's dry powder formulation by an an inhalation delivery system. This could have the potential to be an effective vehicle for treatments for many pulmonary conditions as well as COVID-19.
“The most important part of this project is that we are not just helping develop a new formulation, but a new technology. With the versatility of this process, any lung therapeutic could potentially be applicable,” JJ Sigler, IRISYS Scientist Complete TFF Contract Press Release
Known for solutions that yield results, Seth Yakatan has completed or advised on acquisitions and corporate finance transactions totaling over $3 billion. He is CEO of Katan Associates International—a financial strategy and merchant banking firm specializing in commercialization and asset monetization—especially those within life-science and e-commerce sectors.