Amanda Mathis, Ph.D.

Director, Clinical Pharmacology

Amanda Mathis, Ph.D.

Director, Clinical Pharmacology

Dr. Amanda Mathis has over 15 years of experience working in the pharmaceutical industry. As Director of Clinical Pharmacology, Dr. Mathis oversees all clinical pharmacology components of the Integrated Product Development programs and Regulatory Submissions, including strategic planning, gap analyses, and the design, execution, analysis and reporting of clinical pharmacology studies. Dr. Mathis has supported multiple IND and NDA submissions and has extensive experience authoring clinical protocols, study reports, regulatory submissions modules, briefing packages for regulatory meetings, and other regulatory documents. She is well versed in a variety of therapeutic areas including rare diseases, infectious diseases (antibacterial, antiparasitic, and antiviral), gastrointestinal disorders, hepatic encephalopathy and liver cirrhosis.

For a decade prior to joining Rho, Dr. Mathis served as a clinical pharmacologist at several small and mid-sized pharmaceutical companies, where she was responsible for the design, conduct, analysis and reporting of clinical pharmacology studies, as well as the overall clinical pharmacology strategy for multiple clinical development programs. Adding to her wide-ranging experience, she worked in drug discovery, supporting nonclinical drug metabolism and pharmacokinetics for drug candidates from start of chemistry to Phase 1 studies.

She received her Ph.D. in Pharmaceutical Sciences from the School of Pharmacy at the University of North Carolina at Chapel Hill.

Why Clinical Pharmacology?

“Clinical pharmacology studies give us the first information about how a potential drug behaves in humans, and whether it will have PK exposure and activity that could support development of an effective drug for patients. This inflection point between the nonclinical program and the start of the clinical program is exciting because it allows us to evaluate assumptions made about the PK and activity of a drug candidate from the nonclinical models and allows us to see whether the compound has the right properties for further development. I also enjoy clinical pharmacology because it can be very different from compound to compound, with each compound having its unique challenges. In the end, it all comes back to being able to generate the information that helps get the drug with the right dose to patients in need.”    

This is what drives Amanda:

“A big motivating factor for me has always been helping patients by contributing to the development of new drugs. I’ve spent the last few years working in the rare disease area and seeing the impact of new medications on patients’ lives has been incredibly rewarding. I also love a good challenge and figuring out a design for a clinical pharmacology study or interpreting the results and determining the impact on the overall clinical program can often be a challenging puzzle to solve.”

Content by Amanda Mathis, Ph.D.

Blog Post

505(b)(2) Bridging Studies

While a 505(b)(2) NDA can potentially get a drug to market faster than a 505(b)(1) NDA, the choice of a bridging strategy to the listed drug is important and involves consideration of multiple factors.