Celera’s IVD product development, GMP manufacturing, clinical andregulatory expertise - combined with our unique experience in molecular technologies and our CLIA-certified laboratory at Berkeley HeartLab (BHL) - make Celera the ideal partner for many pharmacogenomic projects.
Today, drug companies recognize the potential value of including a patient stratification strategy into clinical trial design and marketing of drugs based on personalizing disease management. Our partnerships take advantage of our ability to validate biomarker signatures developed by either Celera or our partners. These signatures may be incorporated into clinical trial regimens conducted at our CLIA laboratory, BHL. Alternatively, partners may wish to have Celera provide expertise and/or reagents to support their internal research efforts and clinical studies conducted through another clinical partner.
Additionally, partners may rely on Celera’s discovery capability to explore the underlying biology of a disease or drug response. Some projects focus on the identification of disease subtypes or related diseases that may be suitable for a particular drug, leading to market expansion.
Celera’s proprietary expression, and findings may be used to distinguish responders from non-responders, resulting in shorter clinical trials and improved time to market for our pharmaceutical partners.
Celera has developed diagnostic markers potentially useful in the development of tests for diagnosis and prediction of therapeutic response in cardiovascular disease, autoimmunity, Alzheimer’s disease, liver disorders and cancer.
Celera’s capabilities to develop, manufacture and register resulting IVD products and provide CLIA-certified laboratory testing services allow for a wide array of available partnering structures.