Data-Driven Regulatory Science and Policy

While data is increasingly being used to support decision making in all fields, regulatory science and policy decisions could be further augmented by leveraging existing and hidden data sources. At Sanofi, I applied data science principles to analyze U.S. Food and Drug Administration policies and their results. In one project I identified a correlation between increased FDA regulations on type-2 diabetes clinical trials and decreased number of clinical trials, a proxy measure for capital investment, of drugs for the treatment of diabetes. Separately, I performed qualitative and quantitative analyses of FDA’s inconsistent use of patient experience data by the FDA in new drug approvals in their efforts to comply with Section 3001 of the 21st Century Cures Act. Additionally, I worked on methods to extract standardized data from regulatory PDF documents to support additional analyses.

​NEUROTRANSMITTER SYSTEMS IN MOUSE AIRWAYS 

Asthma is a chronic disease of the airways characterized by excessive airway constriction leading to reduced airway diameter and limited airflow. Inflammation, smooth muscle structural remodeling, increased mucus secretion and enhanced bronchoconstriction can all contribute to shortness of breath, wheezing, and coughing. The US CDC estimates that 50% of cases of asthma in adults are uncontrolled, indicating a need for more effective therapies.
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​Autonomic and sensory nerves containing a variety of neurotransmitters innervate the lungs and control airway diameter. However, the populations of nerves present and the types of neurotransmitters released in human lungs and in animal models of human lung disease are poorly understood. 

Airway stimulated by EFS from one of my experiments

For instance, the limited usefulness of antimuscarinic drugs in asthma may point to a need to shift away from the traditional parasympathetic/acetylcholine dominated model of lung innervation. Understanding the neurotransmitter systems causing nerve mediated constriction and/or dilatation of mouse airways may support the use of mouse models to study the functional role of nerves in lung disease.  Furthermore, elucidating these mechanisms may identify novel therapeutic targets on autonomic or sensory nerves for treatment of asthma and other lung diseases. 

The purpose this this study was to examine the functional effects of electric field stimulation (EFS) on airways. EFS can be used to study the functional neuronal input to airways by causing release of total neurotransmitters which can be pharmacologically blocked to decipher their role in airway modulation.

USING ARDUINO TO STUDY ACUTE E-CIG VAPOR EXPOSURE IN MICE 

The first e-cigarette became available in the United States around 2006. This novel, battery-operated nicotine delivery system continues to be marketed as a less toxic way to smoke and as a smoking cessation aid. However studies have identified formaldehyde, a known carcinogen, as well as other trace toxins in e-cigarette vapor and flavorings. More research is needed to understand both the acute and chronic effects of e-cigarettes.

Custom Arduino controlled open-field test

The Arduino Uno is an open-source microcontroller designed to be a simple to use electronic prototyping platform . It is a robust system that is easily customizable and, at under $25, it is ideal for use in labs with limited budgets.  The microcontroller board is physically wired to peripherals that can be controlled using the Arduino software. In this project I wired and programmed two Arduino Unos to 1) operate an automated vaping chamber for animal exposure to e-cigarette vapor and 2) measure mouse locomotor activity in an open field test. ​

"It wasn't cheating, but it was Science, which was almost as good."
-Harry Potter and the Methods of Rationality