Mathai Mammen leads Johnson & Johnson's global COVID-19 vaccine effort
Johnson & Johnson (J&J) announced today that it is resuming a global Phase 3 trial for its COVID-19 vaccine candidate.
On October 13, J&J temporarily halted the trial after a participant in Brazil had “an unexplained illness.” The company said it was resuming the trial since it found “no evidence” that the serious medical condition of the participant was caused by the vaccine candidate.
“We are one step closer to finding a solution for COVID-19,” Mathai Mammen, said in September, while launching the final Phase 3 trial for J&J’s single dose COVID-19 vaccine. Mammen,52, is the global head of research and development at Janssen Pharmaceutical Companies, the drug division of J&J, The main office of J&J is in New Brunswick, New Jersey. The American company has a market value of $390 billion.
Janssen is developing the vaccine with funding from the U.S. and U.K governments. It has gotten $1.5 billion in total grants from the U.S. Department of Health to rapidly pursue the development, manufacture and distribution of its potential vaccine. J&J says it will distribute the vaccine around the world at a not-for-profit price, which will cover its development, clinical trials, manufacturing and distribution costs. The pricing is based on a formula used by the Bill & Melinda Gates Foundation for selling cheap drugs in lower-income countries.
Typically, running large Phase 3 trials is costly, lengthy and risky. “Usually you know where your patients are, but here, the (COVID-19) pandemic is moving around. Usually it takes three, four or five months to start up a trial at a certain site, but by that time in the pandemic the virus has come and gone,” Mammen told Biocentury in August. Janssen and other potential developers of anti-COVID-19 vaccines are sharply accelerating the pace of the trials, unlike during previous trials for vaccines against other infectious diseases.
Janssen’s COVID-19 Phase 3 trial is studying the safety and efficacy of the vaccine candidate against that of a placebo. It plans to enroll 60,000 volunteers for the trial in the United States, Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.
J&J is simultaneously scaling up its manufacturing capacity, with the goal of providing one billion doses each year. If the study’s results are positive, it expects the vaccine will be available for emergency use in early 2021.
The vaccine leverages Janssen’s technology which was used to develop and manufacture its Ebola vaccine. The technology will enable the COVID-19 vaccine, if successful, to remain stable for an estimated two years at -20 °C and at least three months at 2 to 8° C. This makes it compatible with current standard vaccine distribution channels and hence would not require setting up a new distribution infrastructure. Also, the vaccination process would be easier and more effective since it would be given only once, in a single dose.
Janssen is the largest pharmaceutical supplier in the U.S. and fourth largest in the world. It has a total of 40,000 employees around the world, including in India. Mathai oversees an annual research and development budget of $4.5 billion. Janssen develops drugs to treat a variety of medical issues: cardiovascular and metabolism, immunology, infectious diseases and vaccines, neuroscience, oncology, and pulmonary hypertension.
Mathai joined Janssen in 2017. Earlier, he was a senior vice president at Merck, an American company with a market value of $202 billion. He was head of research in cardiovascular, metabolic and renal diseases, oncology/immuno-oncology and immunology. His team initiated and progressed eight drug candidates into early clinical development.
In 1997, Mathai co-founded and ran the R&D team at Theravance, a San Francisco Bay Area company, based on his work at Harvard University. Over the next 17 years, his team of 200 scientists identified 31 potential medications and created five approved products as well as a pipeline containing many additional drug candidates. In 2014, Theravance separated into two publicly traded companies: lnnoviva, focused on respiratory medicines, with a market value of $1 billion and Theravance Biopharma, focused in the areas of inflammation and immunology, with a market value of $1.2 billion.
Mathai has more than 150 peer-reviewed publications and patents. He received his M.D. from Harvard Medical School/Massachusetts Institute of Technology and his Ph.D. in Chemistry from Harvard University. He received his BSc in Chemistry and Biochemistry from Dalhousie University in Halifax, Canada.
He serves on the advisory board of the USA-India Chamber of Commerce, Washington DC. The chamber’s annual Biopharma and Healthcare summit is a major event in the industry, attracting senior executives and government officials, from the U.S. and India.
At Janssen, Mathai is working with J Labs, a start-up incubator within J&J, to test and develop ideas for new drugs. He is thereby using his entrepreneurial skills and likely has a financial incentive if the ideas lead to commercial success. The labs are in the San Francisco Bay Area, where Mathai lives, San Diego, New York, Boston, Toronto, Shanghai and other cities.
Scientists with ideas for new drugs can be at a university, a basic science center, a medical school or in a hospital, Mathai told a BioBuzz Center Conference in Boston in 2018. “Some sit within a university and don’t want to be in a company…(others) want to collaborate with a company…(our) goal is to partner with individuals and let them incubate ideas for awhile and talk to Janssen while doing so and come partner with us at the right time…Ideas can come from anywhere.”