At BioIVT we are passionate about enabling the understanding and characterization of human disease targets and the identification of new, safe and effective therapeutic interventions that can modify disease. My PHASEZERO® Discovery Services team has been providing human tissue-based research solutions for over 22 years with the goal of helping our research partners to reduce clinical attrition. However, the attrition rates in clinical development of new medicines, while improving, remain high.
I believe that the key aspects to improving clinical development success rates are to identify the right, disease-relevant, drugable targets; to get the right balance of drug exposure, effect and safety and to identify the right patients who will respond to the drug and receive the maximum benefit-risk ratio. To help achieve this, the use of human tissues in drug discovery and development remains a critical approach to identifying and validating human disease targets and characterizing responses to novel therapeutics.
For our Discovery Services team, access to appropriately consented, high quality, well characterized human tissue and biofluid samples from a broad range of diseases and patient populations underpin our ability to partner with our clients to build knowledge around disease targets, interindividual variability and functional responses in native models. Specifically, we support validation of targets and biomarkers in human diseased / non-diseased samples, develop fit-for-purpose simple or complex primary cell-based assays for characterizing the effects and side effects of novel therapeutic molecules and, as required, generate comparative in vitro species translational data. Our GLP facility also supports the safety assessment of novel biologic molecules by performing tissue cross-reactivity studies for our pharma/ biotech partners.
For expression and localization of disease targets across cohorts of diseased patient samples, we generate data using immunohistochemical (IHC), in situ hybridization (ISH) or genomics techniques, with paramount attention to the development of optimized, robust assay performance. We have recently focused on development of multiplex IHC panels to support complex biology and diseases with an inflammatory component. These multiplexed assays enable the provision of high content data from limited samples, so lend themselves to maximizing the use of residual clinical trial biopsy samples for generating further data around specific disease biology. Such data provide support for focusing on the right targets and the right patients.
For achieving the right balance of drug exposure, drug effect, and drug safety, we work primarily with human primary cells to develop fit-for-purpose functional assays. Recently assay formats have evolved to provide more organotypic models for assessing the efficacy and safety of new therapeutic agents. At BioIVT, we provide data generated using both simple 2D and more complex organotypic 3D / co-culture primary cell models. For the assessment of drug disposition and safety, we provide a portfolio of human hepatocyte-based assays that focus on maintenance of transporter function and culture longevity, to enable mechanistic evaluation of challenging molecules.
It is our goal to continue to support our clients in their development of new approaches to treat disease. I take great pride in knowing that our expert scientific team delivers tailored research solutions and high quality human tissue-based data that are used to support regulatory submissions, initiate and progress clinical development of new medicines – ultimately helping our research partners to address the three key elements that aim to get the right drugs, with the right characteristics to the right patients.
I am is responsible for BioIVT’s PHASEZERO Research Services business, leading an expert team of scientists to deliver high quality, scientifically complex projects to our Pharma and Biotech research partners. As General Manager, I have a broad portfolio of operational, regulatory and commercial responsibilities, supported by a broad knowledge of the entire preclinical development process gained from over 25 years’ working in drug discovery within Pharma, Biotech and Life Sciences organizations. I have a passion for clinically relevant data preclinically to help drive successful drug development. I earned my PhD in in vitro drug-interactions from the University of Cambridge.