Stop by our exhibit to meet with our team of experts and discuss how BioIVT can support your pathway to CGT commercialization.  While there, you will have the chance to register and win one of three limited-run masterpieces.

Pharmaceutical Excipients: An Unexpected Source of Drug-Drug Interactions
Speaker: Mark Warren, PhD, BioIVT

Excipients are “inactive” ingredients that are added to therapeutic drug products that are not intended to exert therapeutic effects by themselves. However, these excipients may inhibit intestinal transporters that can be responsible for enhancing or reducing the absorption of not only the drug that is administered along with the excipient, but also the absorption of co-medications that have never been tested with that excipient. Generic products may contain different excipients than the original branded medication, which may also contribute to unexpected drug-drug interactions. Numerous excipients were tested and shown to inhibit OATP2B1, an intestinal drug uptake transporter, as well as BCRP and P-gp, intestinal drug efflux transporters.

The Use of GalNAc or Transfection-based siRNA to Assess Hepatic Gene Knockdown in HEPATOPAC Hepatocyte® Co-Cultures
Speaker: Karissa Cottier, PhD, Senior Scientist, BioIVT

Oligonucleotide therapeutics, including siRNA, are an increasingly popular therapeutic modality due to their high selectivity and relative safety compared to small molecules. For liver diseases, N-Acetylgalactosamine (GalNAc)- conjugation of siRNA is used to direct liver delivery by its strong affinity for the hepatocyte-specific asiaglycoprotein receptor (ASGPR). The continued successful development of siRNA therapeutics relies on the use of validated preclinical models for screening and optimization. Here we demonstrate the utility of the HEPATOPAC model, a micropatterned co-culture for long-term primary human hepatocyte culture, for assessing long-term knockdown efficiency and/or functional outcomes using traditional siRNA transfection or free-uptake of GalNAc siRNA. 

Integrating the New Draft ICH Drug Interaction Studies Guidelines into Your ADME Programs
Speaker: Brian Ogilvie, PhD, BioIVT

In June 2022, the ICH released the draft of its harmonized Drug Interaction Studies Guideline (M12).  The guideline resulted from several meetings of the Expert Working Group since 2018 with the goal of harmonizing member regulatory agencies’ guidelines into one that will be used across all member countries. After review, the guideline will be adopted in 2024. This presentation will provide an overview of the new guidance and recommendations on incorporating the guidance into ADME programs based on strategic objectives with NCEs.

Stop by our exhibit to meet with our team of experts and discuss how BioIVT can support your pathway to CGT commercialization.  While there, you will have the chance to register and win one of three limited-run masterpieces.