Therapeutic drug monitoring (TDM) is a branch of clinical pharmacology and clinical chemistry focused on the measurement of drug concentrations, typically in serum or plasma. Quantifying a drug concentration in the body enables a clinician to tailor/optimize prescribed drug dosages to the individual patient, based on establishing and understanding the associated pharmacokinetic and pharmacodynamic relationships of drug metabolism, which can vary drastically between patients. Thus, TDM is critical toward personalizing patient treatment plans and enabling precision medicine for improved patient care and outcomes. However, there is currently no simple, rapid (<15 min), easy-to-use, and inexpensive device that can accurately measure drug levels from a given sample. In response to this technology gap, during this program, Electronic BioSciences (EBS), in collaboration with a highly interdisciplinary team of field experts, will develop a truly unique, enabling, and state-of-the-art TDM technology that overcomes the known target characterization problems that have plagued the biosensor/immunoassay field for years. During this project, EBS will be focusing specifically on antiepileptic drug monitoring, a subset of TDM that has an urgent and pressing need for improved characterization methods, along with a significant commercial potential for the proposed technology once it is developed. However, it should be noted that the technology and associated methodology developed during this program will be transferable to other TDM applications, including but not limited to antibiotics, immunosuppressants, antipsychotics, etc.

Public Health Relevance

The development of the of our proposed nanotechnology-enabling concept for antiepileptic drug monitoring has the potential to make a significant positive impact on the field of therapeutic drug monitoring (TDM) by greatly improving testing accessibility, turnaround times, cost, and ease-of-use over presently available technology. Ultimately, such a technology will enable rapid R&D-based, point-of-care (POC), and at home testing. Furthermore, once realized, the proposed concept will greatly enhance medical response efficiency, patient care, and patient outcomes.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43NS119024-01
Application #
10080343
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Caporello, Emily Laura
Project Start
2020-09-01
Project End
2021-08-31
Budget Start
2020-09-01
Budget End
2021-08-31
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Electronic Biosciences, Inc.
Department
Type
DUNS #
129852864
City
San Diego
State
CA
Country
United States
Zip Code
92121