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At MassBiologics, Heidi Smith works to move innovative therapies from bench to bedside

The Women in Science video series on UMassMedNow highlights the many areas of research conducted by women at UMass Medical School.

As an infectious disease expert at MassBiologics of UMass Medical School, Heidi Smith, MD, PhD, is focused on developing products that address unmet medical needs and diseases of public health concern.

“We have an appreciation for those infections that are still out there that impact populations with less access to care than we have, as well as those populations here in the U.S. with access to care in which our old medicines are no longer working effectively,” said Dr. Smith, associate professor of medicine and senior director of clinical affairs at MassBiologics, the only nonprofit, FDA-licensed manufacturer of vaccines and biologics in the United States.

A physician–scientist, Smith’s primary role is to help move projects from the discovery phase of drug development through to the clinic. To do this, she and fellow researchers work to identify a target within an infectious disease that they’d like to prevent or treat with an antibody and then develop a means and mechanisms by which to administer a preventative or treatment. One such initiative, accomplished in partnership with the Serum Institute of India, was recently launched with the licensing of Rabishield, a rabies monoclonal antibody that offers an alternative treatment to prevent rabies after an exposure. The life-saving therapy is more potent and easier to manufacture than existing treatment, which is costly and in short supply.

The project Smith is most passionate about is the development of a modern treatment for diphtheria, an infection that destroys tissues in the respiratory system, making it difficult to breathe and potentially causing injury to heart and nerve tissue. The existing treatment for diphtheria, first administered in the 1800s, is made from a horse serum. It can be difficult for some people to tolerate and poses a risk of allergic reaction because human bodies recognize equine serum as foreign.

Despite the success of global diphtheria immunization programs that caused a dramatic reduction in the infection worldwide, there are still thousands of cases of the disease reported annually in developing countries.

“There have been several large outbreaks in the past six to 12 months that have been highlighted in the media and indicate just how much has been going on under the radar and how much we really do need to bring it to the forefront,” Smith said. “It’s getting incredibly hard to find this crucial medicine and we’re developing a product to address that.”

Scientists at MassBiologics have identified a human monoclonal antibody that neutralizes the toxin produced by diphtheria, an important advance that could replace the current horse-serum derived antitoxin. MassBiologics is trying to obtain funding to produce the antibody necessary for clinical trials in humans. It is a challenge, as it is difficult to raise money for medicine in which return on investment may be minimal. MassBiologics’ mission is to develop products that address unmet medical needs and diseases of public health concern, which sets it apart from commercial producers of medicines and biologics.

“MassBiologics has a unique role in that we can really look critically at these medical needs, which perhaps might affect a smaller population or a population in the developing world that larger pharma, perhaps, couldn’t. That places us in a role where we can really do some good in areas that have been, perhaps, underserved by medicine and pharmaceutical development, in general,” Smith said.

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