We have welcomed a new consultant to the team! Dr. Pallavi Limaye now serves as a Director in the Scientific Consulting Department where she is available to support clients with expert advice. Our consulting team provides gap analyses, mechanistic static modeling for drug-drug interactions, response to regulatory questions, and more.
Following her recent webinar, “In Vitro ADME and Drug-Drug Interaction Considerations for Toxicologists,” (access the full webinar here or start with the highlights) we asked her a few questions about her background and her approach to consulting for drug-drug interaction challenges.
Your most recent professional background is in toxicology, how do you think that influences your perspective of IND-enabling ADME and DDI studies?
In my opinion, ADME-DDI studies and preclinical toxicology studies complement each other and the knowledge from both, taken together, helps to build a strong drug development program.
Preclinical toxicology is a critical juncture in the overall drug development. Choosing the right species for these studies is essential for a successful preclinical toxicology program. Regulatory guidance urges the use of a species that characterizes the toxicity of a drug candidate adequately and reliably to predict toxicity in humans. ADME studies therefore offer a great tool for toxicologists to identify test species that are human-relevant or similar to humans in terms of metabolism and some other aspects of absorption, distribution, and excretion. These studies also provide an early warning of a human-specific metabolite formation (disproportionate drug metabolite) for which separate toxicology studies may be warranted. Thus, data obtained from the ADME studies help a toxicologist in planning and designing better preclinical toxicology studies.
Similarly, any available data from preliminary toxicology and pharmacokinetic studies can help in designing the ADME studies e.g. concentration selection, types of transporters to be studied, etc.
What kinds of problems are you best suited to help clients solve?
When it comes to drug development, every compound is unique in its own way. Although the studies required for drug approval are broadly standard, they still need to be tailor-fitted individually for each compound. My experience in both preclinical toxicology and in vitro ADME provides a much broader perspective and places me at an advantage in guiding sponsors in recognizing DDI potential early on to avoid early attrition or failure at a late stage of drug development. Gap analysis on ADME-DDI, recommendations on bridging studies, human equivalent dose (HED) determinations, determination on the need for combination drug toxicity studies, mining of drug lists for potential DDI are examples of some the problems that I am suited to help the sponsors with.
What do you look forward to as a consultant with SEKISUI XenoTech?
As a consultant at SEKISUI XenoTech, I look forward helping the sponsors to make decisions based on sound science and de-risking strategies.
Can you share any insights or lessons learned from challenges you’ve helped companies overcome before?
I have significant experience in working with various different but interlinked stages of drug development. I have also worked with a large number of diverse clients including all the way from one-man companies to large pharma. This unique experience also comes with a lot of lessons learned on the job. I have learned that it is important to provide realistic study designs and time lines, identify most critical issues early on and tackle them head-on rather than waiting for them to become major complications, and lets the data drive the decision making. Due diligence and detailed documentation are fundamental to any work submitted to regulator agency. Finally, developing long term client relationships is important component to success.
Dr. Pallavi Limaye completed her Ph.D. in Toxicology from The University of Louisiana in 2004 under the mentorship of Dr. Harihara Mehendale. She did her postdoctoral research in the Department of Pathology at University of Pittsburgh under the direction of Dr. George Michalopoulos and subsequently at the Department of Pharmacology, Toxicology, and Therapeutics at University of Kansas Medical Center under the mentorship of Dr. Curtis Klaassen. Pallavi joined SEKISUI XenoTech in 2011 as a Research Scientist and served as a study director for in vitro drug metabolism studies. In 2013, Pallavi joined Xenometrics LLC, now a part of Charles River Laboratories, as a Senior Scientist and served as a study director for regulated nonclinical IND- and NDA-enabling toxicology studies. From 2018 to 2020 Pallavi worked at MRIGlobal as a Principal Scientist and oversaw nonclinical toxicology and animal health studies, as well as contributed to containment research with select chemical agents. Recently Pallavi has joined SEKISUI XenoTech’s consulting team and provides input on drug-drug interaction study needs for the sponsors. Pallavi has published several original research articles in various journals (Hepatology, Toxicological Sciences among others) and has also contributed many book chapters in the field of toxicology and liver pathobiology. Pallavi is also actively involved in the scientific societies and currently serves on the Program Committee of American College of Toxicology and is the Vice President of Central States regional chapter of Society of Toxicology.
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