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SEKISUI XenoTech Expands Access to Drug-drug Interaction Consultancy

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SEKISUI XenoTech has expanded opportunities for clients to work with top-tier consultants to evaluate drug-drug interaction potential of their drug candidate and bolster their preclinical data package for regulatory submission.

As of March, Dr. Pallavi Limaye has joined the team, bringing 15 years of experience in IND- and NDA-enabling toxicology and in vitro drug metabolism studies. Her skillset equips her with the tools needed to assist sponsors with challenges related to nonclinical absorption, distribution, metabolism, and excretion (ADME) and drug-drug interaction (DDI) data.

“When it comes to drug development, every compound is unique in its own way,” says Dr. Limaye. “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.”

Prior experience in toxicology studies and current position as Program Committee member and regional chapter vice president for the Society of Toxicology (SOT) give Dr. Limaye a unique perspective and add an extra dimension to her expertise in in vitro drug metabolism. She recently presented a live webinar titled “In Vitro ADME and Drug-Drug Interaction Considerations for Toxicologists,” explaining elements of study design, context, and how to avoid missteps in data interpretation.

Dr. Brian Ogilvie, VP of Scientific Consulting commented, “The addition of Dr. Limaye strengthens this important sector of our company, providing valuable advice for drug development. We now have an all-star group comprised of a designated Scientific Consultancy department, external experts, and internal support. The mix of specialized areas of expertise creates a mesh of talent that together can provide clients an invaluable source for solutions to DDI challenges.”

Along with expert opinions on in vitro DDI data, services provided by the growing consulting group include:

  • Gap analyses for in vitro victim and perpetrator studies
  • Recommendations for planning risk-based approach (including strategic study timing advice)
  • Response to regulatory questions
  • Introductory in vitro DDI study package design
  • Mechanistic static modeling for DDIs (i.e., AUCR calculations)
  • Propose metabolic scheme, elucidating relevant drug metabolism pathways and determining which metabolites to be evaluated in vitro
  • Basic IVIVE scaling for CLint