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August 2020: Student Trainee Profile

Author: [AUTHOR] Published on 8/1/2020 12:00:00 AM

August 2020 K Lingineni
Karthik Lingineni, MS, University of Florida, Orlando, Florida

After completing his bachelor's degree in pharmacy, Karthik decided to go into applied sciences. He completed his master's in Pharmacoinformatics—the integration of bioinformatics, chemoinformatics, etc.—with his thesis focusing on machine learning approaches to predict blood‐brain barrier permeability. Then he started his career in Pharmacometrics at a CRO (Excelra Knowledge Solutions, India). While there he was trained by Dr. Ayyappa Chaturvedula, who is now an Associate Professor at the University of North Texas. Dr. Chaturvedula trained Karthik in various technical aspects of pharmacometrics. Karthik explains that Dr. Chaturvedula “gave me the opportunity to work in diverse projects in the field of Pharmacometrics.” This is where Karthik became fascinated with the field and set him on his path toward the PhD program at the University of Florida in Dr. Stephan Schmidt’s lab.

Karthik counts himself fortunate to have Dr. Stephan Schmidt as his mentor. He explains that Dr. Schmidt’s “unique style of mentorship helps students not only to be a successful researcher in the area of expertise but also to truly appreciate the importance of teamwork, short‐term goals, and also leadership skills.” Karthik is also grateful that Dr. Schmidt taught him the clinical interpretation of modeling and simulation in the realm of clinical pharmacology for enhanced decision making. He is very thankful for the opportunity to work in both “bottom‐up” and “top‐down” approaches in the area of pharmacometrics.

Quantitative Clinical Pharmacology and its potential in reaching unmet medical needs fascinates Karthik. He believes that it allows researchers to make dosing recommendations especially in special populations by ensuring the safety and efficacy of medications. Karthik explains that “we are going into an era of precision medicine dosing where the application of QCP, artificial intelligence, and machine learning play a key role.” He considers himself fortunate that he was able to work in these different areas with different applications from drug discovery to drug development. He is looking forward to integrating them to individualize dosing regimens.

In 2018, Dr. Schmidt encouraged Karthik to attend the ASCPT Annual Meeting. While he did not present a poster at that meeting, he was excited to listen to lectures, network, and attend poster sessions. The Meeting provided a good platform to learn from peers coming from different interdisciplinary fields and also to help build the network and advance his career. He was honored that he was selected as a Presidential Trainee for ASCPT 2020, and that he received the Jason Morrow, MD, Presidential Trainee Award.

Currently, Karthik is working on “quantitative evaluation of efficacy and safety of hormonal contraceptives in drug–drug interaction scenarios by integrating physiologically‐based pharmacokinetic (PBPK) modeling & model‐based meta‐analysis (MBMA).” Combined hormonal contraceptives formulations are currently the most common oral contraceptives. They consist of progestin and an estrogen component, typically ethinyl. Given their wide use, also in combination with other medications, drug‐drug interactions are of general concern. The US Food and Drug Administration draft guidance contains a drug class label for DDIs of CHCs with focus on cytochrome P450 (CYP) inducers. However, it is currently unclear if this drug class label is equally applicable across CHCs and to what extent other factors, such as demographics, should be considered. This work of integrated PBPK and MBMA analysis allows us to quantitatively assess the efficacy and safety on hormonal contraceptives in DDIs. Karthik is also working on the development of disease progression models for Duchenne muscular dystrophy using different clinical end points. These models will be submitted for regulatory (FDA and EMA) endorsement to optimize clinical trial design aspects.

Karthik has been a member of ASCPT since 2017.

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