BioIVT, a global research partner and biospecimen solutions provider for drug and diagnostic development, today announced that it will be showcasing its newly expanded ADME-Tox research capabilities at the 25th North American International Society for the Study of Xenobiotics (ISSX) Meeting, which will be held from September 10-13 in Boston, MA.
“We’re excited to be back in Boston to meet with the research community attending ISSX,” said Dr. Christopher Black, BioIVT Senior Vice President ADME-Tox. “At last year’s meeting, we announced that XenoTech had joined BioIVT, significantly expanding our portfolio of hepatic products and ADME services. Since that time, we’ve successfully combined our scientific teams, product lines, and built out new, streamlined tiered service offerings based on complexity. We’ve implemented these new tiered ‘fit-for-purpose’ study designs for metabolism, drug-drug interaction, and transporter programs. They take advantage of our electronic notebook system and automated reports, enabling us to better meet clients’ needs by reducing turnaround time, all the while maintaining the highest level of scientific expertise and quality that clients expect from us,” he added.
In addition to expanding its ADME research services capabilities, BioIVT also strengthened their consulting team that works with clients to develop effective ADME-Tox and DMPK strategies, designed to achieve their drug development objectives.
“A thorough understanding of the regulatory guidance is critically important for a successful ADME program, even if you don’t immediately intend to submit an investigational new drug application. At some point during the development of a drug candidate, stakeholders will expect to review the in vitro data within the context of the regulatory guidelines,” said Dr. Brian Ogilvie, VP of Scientific Consulting at BioIVT.
To provide more guidance, Dr. Ogilvie is speaking at an industry-sponsored symposium at ISSX on how the draft ICH Drug Interaction Studies Guideline (M12), which will go into effect in 2024, differs from the current in vitro drug-drug interaction guidance from the U.S. Food and Drug Administration, European Medicines Agency, and Japan’s Pharmaceutical & Medical Devices Agency. He will also propose drug development strategies to meet those new requirements.
His presentation entitled “Highlights of the In Vitro Sections of the Draft ICH Drug Interaction Studies Guideline (M12) and Comparison with Current Guidance” will take place at 7:15 am on September 13.
The BioIVT team will also present two posters in the Galleria Hall from 12:30-1:30 pm on September 12. Dr. Chris Bohl, Scientific Advisor, Products will discuss the “Impact of Donor Diversity on Phase I and Phase II Activities in Cryopreserved Hepatocytes and Human Liver Microsomes (P27)” and Dr. Michael Voice, GM, Operations will outline the “Development of a Simple, Fast Inhibition Assay for Rat CYP3A Enzymes (P23).”
Dr. Mark Warren, Senior Director of Transporter Assay Services, will present a third poster in the same venue from 12:30-1:30 pm on September 13 entitled “Monocarboxylate Transporter 10: Substrate-Dependent Mode of Transport (P179).”
In addition, BioIVT experts will be available in booth #401 to answer questions and discuss how they can help to design and implement ADME research programs that are tailored to meet client needs.
Detailed descriptions of the company’s ADME products, which include hepatocytes, subcellular fractions, and recombinant enzymes, are provided at www.bioivt.com/cell-products.
Further information about the ISSX meeting can be found at https://issx2023.org/na/invitation-to-attend.
BioIVT enables smarter science and accelerates medical breakthroughs by delivering high-quality personalized biospecimen solutions and research services to the life science and diagnostic industries. We specialize in control and disease state samples including human and animal tissues or preparations, ADME-Tox products and research services, cell and gene therapy products, blood, and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples. By combining our technical expertise, exceptional customer service, and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in elevating science. For more information, please visit www.bioivt.com or follow the company on Twitter @BioIVT.