Personalised Medicine and Individualised Therapies have rapidly evolved in recent years, with a focus on bringing forth the “right medication for the right patient”. Although these treatment options offer a tailored medicine that can tremendously benefit the patient, the ability to bring them to market requires a multi-faceted approach which requires the consideration of many key elements to ensure their success. Companion Diagnostics (CDx) are one element that is a key factor contributing to the success of the development and commercialisation of the medicinal product. Organisations have to consider the development of not only the medicinal product, but also the co-development of a CDx in parallel. This co-development strategy for a medicinal product and the CDx has proven challenging for even the most experienced of organisations. There are also the challenges that organisations are facing, with the rapidly evolving global regulatory landscape, which must be considered when co-developing the medicinal product and the CDx. Giving the proper consideration to both the medicinal product as well as the CDx, will position many organisations for success in the precision medicine and individualised therpeutic space.
Companion Diagnostics & Why We Need Them
Robert Saiz has been in the Biotechnology Industry for over 30 years. He started as a bench scientist developing in vitro diagnostic (IVD) assays for disease gene hunting, microsatellite and single nucleotide polymorphism (SNP) genotyping. From a bench scientist, he transitioned into product development of IVDs in the regulated space. Robert eventually transitioned from product development into Global Regulatory Affairs where he has focused his efforts for the last 15 years. Robert has worked for various small, mid-size, and global organisations, and has also worked as a consultant. Throughout his career, Robert has worked on a variety of medical devices and specialised in IVDs and medical devices for infectious diseases, hospital acquired infections, women’s health, drug screening, and companion diagnostics in oncology and rare diseases. Robert has a Bachelors degree in Biology from San Diego State University as well as a Masters Degree in Clinical Research from the University of California at San Diego.