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I Have My Data… Now What?

As a drug moves through the development pipeline, it undergoes a rigorous battery of safety assessments to prove it will pose minimal risk to participants in clinical trials. However, there are myriad options for preclinical tests in terms of which studies to perform or contract and when, so long as the data paints a complete picture. While there is no ‘roadmap’ per se of required data, approval is granted only when exhaustive information is presented to detail parameters such as pharmacology, toxicology, metabolism, and the potential for drug-drug interactions (DDI).

With so many moving parts, drug developers often need external guidance to help go through all the data with a fine-tooth comb and minimize risk of seeing costly or dangerous unexpected circumstances in clinical trials, especially a catastrophic late-stage failure resulting in huge financial setbacks and even sometimes putting the survival of the company in jeopardy.

Because components of ADME and DDI represent only a fraction of the information needed for a successful data package, sometimes in-house DMPK groups may not be equipped with the background and familiarity needed to be thorough in planning and evaluation of these studies, especially if they yield unexpected data. This is where the wealth of experience from a trusted CRO becomes your advantage, particularly with a specialty CRO that brings a focused level of expertise not available in-house or with a general contractor. With this detail comes attention to every study done in the lab, and guidance from expert ADME/DDI study directors. When you make a choice to trust a CRO with your data and your investment, make it one you know will get you reliable data and one you can count on to help you understand what each data point means and how it helps you build a complete picture of your compound.

At SEKISUI XenoTech, we also keep a finger on the pulse of regulatory guidance updates, latest science in the field, and avoidable mistakes made when a pharmaceutical company overlooks preclinical data that warrants further investigation. To minimize failure, we have recently expanded our offerings to include high-end consultancy available to our clients to help make sure there is no stone left unturned.

Our tailored, consultative approach can be seen not only on the large scale of IND-package guidance and advice, but also throughout each and every contracted study performed in our labs. The value we place on meaningful and reliable results is prevalent in our Executive Management all the way down through study directors who oversee each study. Each member of our team prioritizes communication and ensures that at the conclusion of a study you receive not only data you can trust but also meaningful context, and even potentially next-step planning, in response to unforeseen results.

Equipped with decades of working in and with drug development companies, our pool of top-tier external and internal consultants has a rich balance of diverse professional portfolios and focused expertise. Invaluable, well-rounded experience culminated from years in academia, DMPK groups, positions of leadership in large and small pharma, advising IND submissions for developers of small molecule therapeutics as well as biologics, uniquely qualifies the team we have assembled to provide guidance when expertise is needed to help put together the pieces.

Along every step, from the initial planning stages of a single study to the comprehensive ‘what are we missing’ examination of the IND data package, drug developers want to make sure their compound is shepherded through development with expertise, thoughtful planning, and thorough analysis. We provide that for you; we are the experts when it comes to the ADME and DDI steps along your compound’s journey.

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About the Authors

Madison (Knapp) Esely-Kohlman received her BS from the University of Missouri – Columbia and is currently SEKISUI XenoTech’s Marketing Communication Specialist, developing scientific content that communicates the value and expertise of internal contract service and test system production teams. Madison joined SEKISUI XenoTech as the Scientific Communications Coordinator in 2019 after serving in similar positions at CropLife America, Bond Life Sciences Center and the University of Missouri CAFNR Office of Communications.

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