KS- SEKISUI XenoTech now provides the opportunity for clients to work with top-tier consultants to analyze critical components of absorption, distribution, metabolism, and excretion of their drug candidate to optimize the data package for regulatory submission.
September 5, 2019
Kansas City, KS- SEKISUI XenoTech now provides the opportunity for clients to work with top-tier consultants to analyze critical components of absorption, distribution, metabolism, and excretion (ADME) of their drug candidate to optimize the data package for regulatory submission.
When a drug is being developed, it goes through a very rigorous battery of safety assessments to prove it poses minimal risks 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 only granted when exhaustive information is presented to detail parameters such as pharmacology, toxicology, and ADME.
With so many moving parts, 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.
With so much experience in the field of drug development and an emphasis on cultivating expertise in ADME, SEKISUI XenoTech has assembled a lineup of consultants who can equip our clients with highly specialized insight borne of years of experience in the industry and extensive scholarship. The consulting team is being led by Brian Ogilvie, Ph.D., who serves as SEKISUI XenoTech’s Vice President of Scientific Consulting and has over 20 years of experience at the company. Some of the consultants were also selected to be members of SEKISUI XenoTech’s own Scientific Advisory Board, created this past December to optimize innovation and forward momentum for future growth and development.
With this consultancy expansion initiative, clients can trust that their challenge will be addressed by a solution-oriented process to match with a consultant whose expertise uniquely qualifies them to evaluate options and provide invaluable guidance to an answer.
One of the consultants in the emerging team is Larry Wienkers, PhD, of Wienkers Consulting, LLC. Dr. Wienkers has more than 20 years of industry experience in drug metabolism and pharmacokinetic groups at Pfizer, Amgen, and Pharmacia & Upjohn, and is an American Association of Pharmaceutical Scientists (AAPS) Fellow. He has shepherded drugs from screening all the way through the development pipeline and places emphasis on scholarship and familiarity with minutia of attrition case studies to adequately and responsibly bring effective new therapeutics to market.
“The journey of a drug’s development is like a well-told story—you use elemental components of biology and chemistry to establish the pharmacological underpinnings of a molecule’s journey within a patient. Gathering the data for a submission is telling that story; it is very important not to miss any pieces,” said Dr. Wienkers.
For nearly 25 years SEKISUI XenoTech has been highly regarded for its extensive selection of drug metabolism-focused test systems and in vitro services investigating drug metabolism and drug-drug interactions in support of safety and risk mitigation for drug developers. Now with the formation of a pool of expert internal and external consultants, clients can expect even more from their partners in ADME.
To learn more about SEKISUI XenoTech’s consulting services or place an inquiry, visit www.xenotech.com/services/
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About SEKISUI XenoTech
SEKISUI XenoTech, LLC is a global Contract Research Organization with unparalleled ADME / DMPK / Drug-Drug Interactions experience utilized by 98% of top pharma companies and numerous other organizations. For the past 25 years, the company has offered proven drug development expertise in evaluating drug candidates in compliance with regulatory requirement and guidance prior to entrance to market. The company offers a variety of in vitro and in vivo safety assessment studies for drug candidate evaluation, as well as an extensive selection of products for drug metabolism and pharmacokinetic research. For additional information, please refer to the company’s website at www.xenotech.com or call (913) 438-7450.
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