Mireli Fino's path to leading MassBiologics

I don’t think there’s any question that MassBiologics can fulfill a very important role in the industry. The question for us to resolve is where in the ecosystem we can make the biggest impact and improve the most lives.

MIRELI FINO

Mireli Fino grew up in Calvillo, a small town in Aguascalientes in Central Mexico. Her family highly valued giving back to the community, which contributed to her father and his four siblings all becoming doctors. It’s also why Fino’s professional life has centered on the development of vaccines that improve the lives of millions of people. And ultimately, it’s what led her, after a 30-year career in pharmaceutical manufacturing, to the role of executive vice chancellor for MassBiologics of UMass Chan Medical School in July.

“My dad was one of just a few doctors in our small town,” said Fino. “Growing up, both he and my grandfather taught us it was a responsibility to do something with your life for the betterment of community, something that would contribute to the greater public good. That certainty, that you should always give back, has guided me throughout my career. MassBiologics’ mission to improve health on a global scale is what drew me here.”

In addition to being a town physician, Fino’s father was an organizer in their community, helping local farmers pool resources to pay for a well-water system that allowed them to begin growing cash crops. The extra money brought in from these new crops significantly improved the lives of many local families.

“My dad is really an entrepreneur,” said Fino. “I’d go with him to these massive drilling sites, with all these big machines, and I was fascinated. I was mesmerized by all the huge, complex engines.”

In some ways, Fino turned her father’s interest in farming into a career. “When I went off to college, I knew I wanted to do something on a large scale with my life that involved those big projects. I wanted to help more than one patient at a time. I wanted to do something big. But I also wanted to be in the public sector, giving back to and improving people’s lives.”

Armed with a degree in biochemical engineering, Fino has spent most of her career doing just that: working out the intricacies of manufacturing large volumes of vaccines so millions of people could receive lifesaving medicines.

The first product Fino worked on at Wyeth Pharmaceuticals and later Pfizer, Inc., was a pneumococcal vaccine for children that protects against 13 different serotypes of the bacterium Streptococcus pneumoniae. In 2005, the World Health Organization estimated that pneumococcal infections were responsible for the death of 1.6 million children worldwide.

“That vaccine has made a difference to so many lives,” said Fino. “Taking that work across the finish line, to a product that could help children, was a real milestone.”

Now, Fino sees her arrival at MassBiologics as the perfect alignment of her commitment to doing work that contributes to community and her love for accomplishing tasks on a large scale. “We’re striving to improve the lives of millions of people globally through science and health,” she said.

Fino believes MassBiologics is poised to have a growing role in the biosciences industry in the coming years by capitalizing on its unique commercial experience, its nonprofit and government relations, and its affiliation with the Medical School’s groundbreaking research enterprise. A division of UMass Chan Medical School, MassBiologics is the nation’s only nonprofit FDA-licensed manufacturer of vaccines and biologics in the country. MassBiologics’ leading manufactured biologic is TDVAX, which immunizes against tetanus and diphtheria. Roughly 5 million doses of the vaccine are made at MassBiologics every year, which makes TDVAX the largest part of MassBiologics’ manufacturing business.

Fino also sees a bright horizon for MassBiologics’ strategic partnerships and fee-for-service business, which she believes are positioned to capitalize on recent technological and scientific changes in the pharmaceutical industry that have been accelerating as a result of the COVID-19 pandemic. By serving as a partner and as a contract development and manufacturing organization to other pharmaceutical companies, MassBiologics can move promising therapies through Phase I and Phase II development toward commercial launch. Pharmaceutical companies can focus on drug discovery, distribution and marketing instead.

In fact, that’s how Fino first became acquainted with MassBiologics. Protein Sciences, a Sanofi company in Connecticut where Fino was senior vice president for manufacturing operations, approached MassBiologics about manufacturing an influenza vaccine the company was bringing to market. Protein Sciences was focused on launching its approved product and MassBiologics came on board and performed the mixing of the various ingredients of the vaccine so it could be filled in vials and distributed to health care providers.

Fino sees ample opportunities at MassBiologics for partnerships and fee-for-service offerings in the gene therapy and siRNA biologics space. She noted that because these segments often aren’t as advanced in their manufacturing protocols as some other segments, MassBiologics can fill an important niche providing commercial manufacturing expertise and scale.

As part of this effort, MassBiologics recently received a Good Manufacturing Practices (GMP) certification from the European Medicine Agency (EMA) to manufacture gene therapy products and aseptic preparation of small volumes of liquid at the MassBiologics facility in Fall River. MassBiologics was also certified to perform quality control testing of gene therapy products at its Mattapan site.

Having an EMA GMP certificate allows MassBiologics to contract with companies intending to sell pharmaceuticals in Europe. “This opens up a whole new market for us,” said Fino, who earned her MBA from MIT in 2018. “One of the biggest values we can add to the industry is our knowledge of and experience with Good Manufacturing Practices for biologics.”

Ultimately, revenue generated from manufacturing and contract-for-service business will support MassBiologics’ internal pipeline of biologics and vaccines, which includes a pre-exposure prophylaxis for Lyme disease, currently in Phase I clinical trials, and an oral, preventative treatment for enterotoxigenic Escherichia coli, a leading cause of death for children in developing nations.

“MassBiologics occupies a unique position among the public sector, academic science and industry that nobody else does,” said Fino. “I don’t think there’s any question that MassBiologics can fulfill a very important role in the industry. The question for us to resolve is where in the ecosystem we can make the biggest impact and improve the most lives. We have some ideas where that niche is and I’m excited to be able to play a part in the continuing success of this 125-year-old institution dedicated to protecting public health.” ■