Breast cancer is the leading cause of cancer death among women worldwide.
And Klarissa Hardy is determined to do something about it.
This fall, Hardy, a researcher and assistant professor of pharmaceutical sciences in Lipscomb University’s College of Pharmacy, got a big assist in her quest to find another option in the arsenal to fight the disease that kills about 400,000 around the world each year. She received a $660,000 National Institutes of Health grant, the largest research grant in university history, to help fund her investigation, which she hopes will provide an effective treatment option for breast cancer patients.
A chemist at heart, Hardy has devoted much of her career to learning the impact the chemical make-up of drugs has on the human body. After graduating from Vanderbilt University with a doctorate degree in pharmacology, Hardy’s professional journey took her to the far northwest corner of the country to the University of Washington, where she received a fellowship grant for a post-doctorate opportunity to work with professor Sidney Nelson to study the affects of the anti-cancer drug lapatinib on the liver.
“We examined how the liver metabolizes lapatinib and how the products that are formed from this process might be linked to the toxic effects of the drug on the liver,” said Hardy. “I learned a lot from Dr. Nelson, from his previous work and experience in this area. What he discovered and the process that he started opened the door for us to study how genetic differences in individuals might affect the safety and toxicity of this drug in different people.”
When Nelson died in 2011, Hardy devoted her research to continuing the study that he started in his memory. In 2013, Hardy joined the College of Pharmacy and brought her research with her to the university’s Pharmaceutical Sciences Research Center, a 15,000-square foot, state-of-the-art laboratory and collaboration facility that opened in November 2013. Hardy’s research is one of the many investigations being conducted in the facility currently.
Her study is aimed at discovering genetic factors such as metabolism that may contribute to a patient’s risk of developing a toxic reaction to the drug, thereby limiting the use in certain patient populations. Identification of these genetic traits and what causes the toxicity to occur could lead to the ability of the drug to be used as a more aggressive, effective treatment for a broader population.
“This research answers the question of how the differences in the way each person’s body processes this specific anti-cancer drug impacts their liver,” she said. “The goal is to improve the safety of using this drug and to discover ways to minimize reactions to the drug. If we can determine what causes the toxicity that the drug creates in the liver in some patients then we will be able to offer more patients a viable treatment option that will hopefully improve the quality of their lives.”
The NIH grant provides Hardy dedicated time to devote to this research as well as funding for conducting experiments, research assistants, conference travel and other resources that are crucial to the success of this project.
“We are so thankful to God and excited for the opportunity to carry out this research at Lipscomb,” she said. “I have been blessed to work with an outstanding team of mentors and scientists, and I am grateful for the leadership and support from the Lipscomb College of Pharmacy and the university as a whole, whose commitment has helped to make this vision a reality. This funding opportunity will allow us to build upon critical research efforts to help patients receive the best possible treatments for breast cancer.”
Hardy’s grant is a K01 grant, which is a “National Cancer Institute Mentored Research Scientist Development Award to Promote Diversity.” The five-year grant provides funding for research, salary support and administrative assistance among other expenses related to the project. A major component of the grant is career development, which includes being mentored by others in her field. Among Hardy’s mentors are F. Peter Guengerich, professor of biochemistry, primary mentor; Daniel Liebler, professor of biochemistry and director of the Center in Molecular Toxicology; and Scott Daniels, director of drug metabolism and pharamacokinetics, all from Vanderbilt University’s School of Medicine; and Scott Akers, professor of pharmaceutical sciences and chair of the department in Lipscomb’s College of Pharmacy. She will also get to tap into NIH resources such as previous studies, networking with and meeting other researchers and the potential collaborations that result.
Roger Davis, dean of Lipscomb’s College of Pharmacy & Health Sciences, said the NIH grant is significant as the college continues to increase its research efforts.
“This grant validates Lipscomb’s commitment to do core research that has wide-ranging patient application. The impact of this specific research could be immense. We have hired several innovative and passionate researchers in the College of Pharmacy. Grants like this one helps us support them in a significant way. It also puts the university and this college in a different category in the research realm. We are on a level with larger research institutions and indicates that we can do NIH-level work,” said Davis.
“What I’m most proud of Dr. Hardy for is the creative thought process to solve real-world patient problems. When you have that encapsulated in a Christian persona that you want in this profession—someone of high moral and ethical vales, with compassion and a great deal of knowledge—in one person, that’s pretty powerful. This grant is just as much about Dr. Hardy’s professional development as it is about the science she will produce.”
This is the latest achievement for the College of Pharmacy, which was announced in 2006 and enrolled its first student in fall 2008. After the graduation of its first class of 71 pharmacists in May 2012, the College of Pharmacy was granted full accreditation by the Accreditation Council for Pharmacy Education. More than 300 student pharmacists are enrolled at the college that also includes more than 40 faculty and staff members. In November 2013, the university opened its 15,000-square-foot Pharmaceutical Sciences Research Center, which provides collaborative classroom space, core analytical labs and other learning environments that support research. Hardy has been conducting her research in this facility since it opened.
Davis said the NIH grant is significant in demonstrating the university’s commitment to its faculty.
“It shows that when we recruit faculty who are passionate about research we are able to deliver on that promise,” said Davis. “It helps raise the College of Pharmacy’s academic credibility. It also validates the building process we’ve been in for the last eight years.”
Gentry, Daniels investigators on other NIH grants
In addition to Hardy's grant, Chad Gentry, assistant professor of pharmacy practice at Lipscomb, received a subcontract to a NIH/NIDDK R01 grant. The research entitled “Improving Medication Adherence Among Underserved Patients with Type 2 Diabetes” was awarded to Chandra Osborn at Vanderbilt University School of Medicine in September 2014. The goal of the project is to design and test an SMS text messaging and IVR application to promote diabetes medication adherence among low income, racially diverse adults. Gentry will provide pharmacotherapeutic expertise in diabetes related medications.
Nate Daniels, assistant professor of pharmaceutical sciences at Lipscomb, is a co-investigator on a NIH/NIDDK R01 grant that was awarded April 1. The principal investigator on the grant, titled “Allosteric Modulators of MC4R Signaling,” is Roger Cone at Vanderbilt University. The goal of the project is to develop allosteric modulators that could be used in the treatment of syndromic obesity or cancer cachexia. The Daniels lab will receive $85,000 over the next four years for the synthesis of novel allosteric modulators of MC4R signaling.
For more information about Lipscomb’s College of Pharmacy and its research, visit pharmacy.lipscomb.edu.