Written by Bill Finger, Managing Director, Kineticos

I have been writing a lot about companion diagnostics lately, stressing the importance of getting key stakeholders involved early in the process, and being strategic about the therapeutic focus. Related to companion diagnostics is the growing use of biomarkers in clinical trials.

Outsourcing-pharma recently reported on a study conducted by Amplion, BIO and BioMedTracker that looked at 10,000 clinical trials across therapeutic areas. It was determined that the use of a biomarker increases the likelihood of approval of a new drug from 1 in 10 to 1 in 4.

The report’s findings were no surprise to me, given we are identifying biomarkers more effectively and efficiently than ever before. More and more companies are focused on biomarker discovery, from academic labs, to diagnostic companies, to pharma. Biomarkers help to identify patients who will respond to specific therapies, and those who will not. This is the theme of precision medicine that we’ve been watching unfold in the industry for years, but has gotten more press as of late.

An industry-wide focus on biomarkers was also exemplified when Astellas, Daiichi Sankyo and Takeda announced that they are collaborating to create a biomarker database.

I found it particularly interesting that the database is being developed for healthy adults. This collection of protein and metabolite biomarkers will be utilized for comparing biomarker data from healthy volunteers to patients in clinical trials. Given the challenges any one company would face in building this type of database on their own, Astellas, Daiichi Sankyo, and Takeda are going to publicize the data so all can utilize it, keeping the focus on meeting patient needs.

As discussions on biomarker use continues, it is important to realize the immense opportunity for all involved. As I think about the future of biomarkers and how they can be leveraged to improve the efficiency of clinical trials, and the ability to identify the best therapies for patients, I believe we need to follow the lead of companies like Astellas, Daiichi Sankyo, and Takeda. No company can do it alone; it’s imperative for companies to collaborate, share information, and remain patient-centric.


Bill Finger, Managing Director of Kineticos’ Diagnostics Practice, brings 20 years of diagnostics and laboratory experience to the team.  His team is focused on helping   diagnostic companies maximize their commercial potential at the corporate and product levels while ensuring companies operate in an efficient manner.

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