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Nainika Majumdar

Chemistry and Clinical Studies with Eileen Castronova

Updated: Jun 20, 2023

Introduction:

In the realm of healthcare, the critical role of pharmacologists in ensuring safe and effective drug therapies cannot be overstated. These experts possess an intricate understanding of the interactions between drugs and the human body, enabling them to optimize treatment plans and minimize adverse effects.


Eileen Castronova is a clinical pharmacologist who works in a clinical study team in registering new drugs, ensuring that they receive authorization from regulatory agencies (ex: FDA) before they can be approved and administered. We’ve chosen to talk to Dr. Castronova to gain deeper insight into her remarkable achievements and journey, encompassing both her professional journey and the field of clinical pharmacology.


Becoming a Clinical Pharmacologist:

Dr. Castronova took a “circuitous” path in their education and career. She first started with a four-year college degree in biochemistry, followed by a master's degree in chemistry.


“I was not a fan of all that lab work” she later mentioned.


After that realization, she obtained a master's degree in molecular biology, during which she completed a thesis. After completing her master's degree, Dr. Castronova began working as a molecular biologist at Pfizer.


“I found myself craving contact with actual people and decided that the best way to achieve this was by joining this mentoring program offered at Pfizer where I was currently working. That’s where I learned about pharmacy school.”


Pharmacy school is very similar to medical school, with three years of academic coursework and the final year spent practicing pharmacy in labs and hospitals, similar to an internship or residency program. After completing pharmacy school, “I completed a two-year fellowship which is a collaboration between a pharmaceutical company and a university. That really helped me gain experience in the work setting and gave me an opportunity to learn and grow from mistakes.”


Dr. Castronova began to gain some insight into clinical pharmacology and pharmacokinetics and earned a Doctor of Pharmacy degree.


Throughout her career, Dr. Eileen Castronova has worked at various renowned organizations/companies, including Regeneron, Gilead, Canaphe, Cirtura, and GlaxoSmithKline.


However, the “barebones” or bare-minimum path to becoming a clinical pharmacologist involves obtaining a bachelor's degree and either a Ph.D. or attending pharmacy school to earn a Doctor of Pharmacy degree.



Day In The Life:

Dr. Castronova assists clinical study teams in determining the necessary dosage and monitoring the pharmacokinetics of drugs, providing insights into how the body interacts with certain drugs. This involves studying processes of absorption, distribution, metabolism, and elimination. When a pill is ingested, it travels through the esophagus, enters the acidic environment of the stomach, and undergoes breakdown. It then crosses membranes, potentially reaching the liver or entering the bloodstream.


By studying the kinetics of these drugs, their destinations, the time they spend in various locations, and their transformations, Dr. Casrtonova is able to establish the importance of blood tests as a crucial and accessible method. In clinical studies, individuals receive a specific amount of whatever drug is being tested. This drug becomes diluted within the body. However, there are evident variations in the absorption, distribution, and metabolism, due to a variety of diverse differences among individuals such as gender, race, etc. These differences can cause the body's response to the drug to differ.


“My job is to quantify these differences and assign numerical values to better understand the effects of a drug once it enters the real world” She examines how the body processes a drug, measures its concentration, and correlates it with clinical outcomes.


“Basically, I do a lot of math!”


“I dedicate approximately fifty percent of my time to attending meetings, most of which are study team meetings.” During these meetings, she assesses the amount of blood required for certain studies or discoveries, which involves conducting numerous studies on both healthy individuals and patients. Currently, her focus is on monitoring the presence of the hepatitis B drug in the bloodstream and tracking its elimination to determine how the drug is metabolized in patients' bodies. This information is crucial for the clinical team to evaluate the drug's effectiveness, potential toxicity, and overall characterization.


“The remaining portion of my time is divided between reading, which accounts for approximately ten percent, and performing data analysis in the bioanalytical laboratory.”


Hepatitis B:

Hepatitis B virus (HBV) is a highly contagious virus that affects primarily the liver, causing inflammation and potential long-term complications. The liver is an organ that acts as a gateway for many substances before they enter the bloodstream, housing numerous immune cells. The virus enters the body through contact with someone else who shares the virus. It can share contact through infected blood, semen, or other body fluids. Once inside the bloodstream, HBV replicates and begins to target liver cells. The virus releases its genetic material in the form of DNA, to the host cell.


The immune response to HBV varies among individuals, with some able to clear the infection on their own. In contrast, others may develop a chronic infection, which can lead to severe liver damage, cirrhosis, or even liver cancer.


Hepatitis B - which is what Dr. Castronova focuses on - is an infection affecting the liver, one of the main types of hepatitis alongside A, C, and the newly discovered D. Interestingly, the virus manages to propagate itself within the liver without causing immediate harm. If the virus successfully infiltrates a host, it aims to establish a favorable environment within the liver for its survival. Keep in mind that the virus relies on the liver to survive, so it does its best not to kill the liver entirely, as that would leave the virus without a habitat. Hepatitis B can cause varying degrees of liver damage, ranging from less severe outcomes such as impaired liver function and cellular carcinoma.


However, in some rarer, more severe cases, Hep B can lead to liver failure or human fatality.


It's worth noting that while hepatitis B is commonly found in individuals with liver cancer, it cannot be solely attributed as the cause. Vaccination is an effective preventive measure against HBV, as it stimulates the immune system to produce antibodies that can neutralize the virus and prevent infection.



In conclusion, Dr. Eileen Castronova's journey and achievements in the field of clinical pharmacology highlight the critical role of clinical pharmacologists in advancing healthcare and ensuring the safe and effective use of medications. A big thank you to Dr. Castronova for taking the time to sit with us.









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