Ines Martinovic Berger, Epsilon Iota ‘05, RAC, PMP is the Associate Manager of Drug Product Project Management at Regeneron Pharmaceuticals, Inc. She graduated from Rensselaer Polytechnic Institute in 2008 and was the Vice President of Psi Upsilon’s Epsilon Iota chapter. Her work at Regeneron has involved the development of REGN-COV2, an experimental antibody cocktail that is being evaluated for the treatment and prevention of COVID-19.
REGN-COV2 is currently being evaluated as part of four late-stage clinical trials, including the RECOVERY trial in the United Kingdom, to determine its effectiveness in the treatment of hospitalized patients and prevention for those who have been exposed. The first preliminary human data from the ongoing, randomized, double-blind trial was released on September 29, 2020. Upon releasing the data, George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron, stated, “We are running simultaneous adaptive trials in order to move as quickly as possible to provide a potential solution to prevent and treat COVID-19 infections, even in the midst of an ongoing global pandemic.”
Ines’ role on the project is managing the process of getting bulk material filled into individual vials, labeled, packaged, and shipped out to distributors. Typically, her group works with the research and development teams over the course of a year to transfer the research process up to large-scale manufacturing. But, in order to rapidly respond to COVID-19, the teams had to work in parallel. “The research team began working on COVID-19 in early 2020, and by early Spring, we learned that a potential treatment would be coming our way quickly,” Ines said. “We needed to prepare for filing, labeling, and packaging it, without having all the details like number of molecules or their properties.” In addition to the physical process, a lot of documentation needs to be in place before any manufacturing work can proceed. Materials need to be ordered and often have a lead time of over six months – yet the team was aiming to have product manufactured and out the door within three.
Despite the challenge of preparing to manufacture a product so quickly, the team rose to the occasion. Ines stated, “The team worked long hours, weekends, holidays, and through the night. Getting this potential treatment to patients has been everyone’s top priority. One of Regeneron’s ways of working is to ‘make it happen,’ and we’ve banded together to find creative solutions and do just that. “I’m so grateful to have been a part of this exceptional team and to have had this opportunity.”