The Exchange is a collection of casual podcast discussions featuring key opinion leaders in our community. If you would like to participate or would like to recommend a podcast guest please email us at bd@biomere.com.
In this webinar, Franklin introduces the basic concepts of bioanalysis, including the important role of bioanalysis in successful drug development. He also reviews currently used plate-based and non-plate-based assay methods to analyze large and small molecule therapies. He highlights some of the requirements and challenges associated with the bioanalysis of large molecule therapies, including antibody-drug conjugates (ADCs), bispecific monoclonal antibodies (mAbs) and protein replacement therapies.
In this webinar, Andrea focuses on the importance of ligand binding assays in the bioanalysis of small molecule and complex biologics, and highlights the role of orthogonal assays, such as LC-MS, in complementing ligand binding assay data. She covers preclinical, nonclinical (GLP), and clinical assay development and design, including the creation of immunogenicity assays, and the detection of anti-drug antibodies (ADAs). The webinar also features a case study demonstrating the value of bioanalysis data in developing a therapy for a rare pediatric disease.
In this presentation, Dr. Kamendi shares key considerations for an IND submission, noting the lack of established best practices. The goal of nonclinical drug development is to match the right patient population with the right drug, properties, dose, and timing. The process begins with building the target product profile (TPP) sheet. Other important factors include:
Non-GLP toxicology programs typically involve clinical observations of drug effects and macroscopic examination of organs in two species. Once pharmacology and toxicology studies are complete, the IND can be filed, but nonclinical studies, such as carcinogenicity and abuse liability, must continue. For systemic and local administration of gene therapy, it is necessary to assess the systemic effect of the transgene before moving forward with full toxicology studies.
This webinar explores the role of veterinary anatomic pathologists in the pharmaceutical and medical device industries. It highlights the skills they bring to development and safety teams, as well as the ancillary technologies they recommend and interpret. The session introduces technologies such as immunohistochemistry, immunofluorescence, molecular diagnostics, and digital spatial profiling, with examples of their potential applications in the field.
In this two-part webinar, Daniel Kraft examines the vital role of technological innovations in advancing healthcare and drug development. In the first segment, he explores how exponential thinking can reimagine healthcare and medical research, alongside the ongoing development of medical apps and devices that support end-to-end patient care, digital health, and faster drug discovery and development. In the second segment, Daniel discusses novel approaches in drug development including:
In this two-part webinar, Daniel Kraft examines the vital role of technological innovations in advancing healthcare and drug development. In the first segment, he explores how exponential thinking can reimagine healthcare and medical research, alongside the ongoing development of medical apps and devices that support end-to-end patient care, digital health, and faster drug discovery and development. In the second segment, Daniel discusses novel approaches in drug development including:
In this 5-part webinar, Patrick discusses several highly relevant topics in the drug discovery and development space.
In this 5-part webinar, Patrick discusses several highly relevant topics in the drug discovery and development space.
In this 5-part webinar, Patrick discusses several highly relevant topics in the drug discovery and development space.
In this 5-part webinar, Patrick discusses several highly relevant topics in the drug discovery and development space.
In this 5-part webinar, Patrick discusses several highly relevant topics in the drug discovery and development space.
Standard in vitro genotoxicity testing approaches have limitations for testing nanomaterials (NMs). Substantial developments in new approach methodologies (NAMs) have created opportunities to overcome these issues in recent years. In this webinar, Dr. Doak reviews the applications of co-culture models and 3D liver spheroids for in vitro genotoxicity testing to better support regulatory risk decision making.
