The Beginning of a Beautiful Friendship: Clinical Diagnostics & Drug Development

Development of clinical diagnostics is a major target for pharmaceutical companies.

Drug development is facing new challenges as it becomes more difficult to identify broad ranging therapeutics. Personalized medicine where a diagnostic predicts the treatment regimen is becoming the standard. Due to this shift, clinical diagnostics have become a major development target for pharmaceutical companies.^{1, 2} Indeed, VisionGain (visiongain.com) predicts half of all drugs will be paired with a diagnostic in the future.

Clinical diagnostics add value to a therapeutic strategy by:

• Directing therapeutic decisions
• Improving outcomes
• Lowering costs

Adoption of clinical diagnostics has been building over the past decade, especially as genetic mechanisms underlying disease are identified. In particular, there have been clear successes with respect to clinical diagnostics for oncology therapeutics. The range of therapeutic areas where clinical diagnostics should be of use appears limitless with clinical diagnostics under development in many areas including gastrointestinal diseases, women’s health and autoimmune disorders. Genomic diagnostics are predicted to be one of the largest growth sectors in the healthcare industry over the next 10 years.^{1, 2}

An attractive feature of clinical diagnostics is the potential to expand a company portfolio and increase the return on investment of drug development. Developing a diagnostic alongside a therapeutic increases development costs minimally, while creating another product. Importantly, the life cycle for returns on diagnostics is not limited in the same way a patented drug is and new iterations of a diagnostic potentially create an extended revenue stream.

Creation of clinical diagnostics is not limited to drug development companies and is a ripe area for open science innovation. Because diagnostic developments are building on decades of scientific research, a thorough literature search can start the process to identify biomarkers. Scientist outlined the process in our blog post, How to outsource development of a clinical diagnostic assay. The expertise at contract research organizations is perfect for directing and implementing clinical diagnostic development program from a virtual platform. Clinical diagnostics will be part of the wave of innovation that creates more efficient drug development.