On your mark, get set...

CAMBRIDGESHIRE, U.K.-Change is in the air at NextGen Sciences, a provider of gene-to-protein products and services, where the company recently appointed Dr. Mike Pisano as CEO and announced the expansion of its portfolio of services to include clinical protein biomarker monitoring. The new protein biomarker services from NextGen Sciences include assay development and validation, monitoring and verification of protein biomarkers from preclinical and clinical samples, and identification of putative protein biomarkers and proteins of interest.

"Outsourcing is becoming a bigger part of the industry," Pisano notes. "We have heard companies have been told to outsource what they can, do more with less, etc. We have increasingly seen that our customers, particularly big pharma, are looking for a single partner who can support their needs. They eventually would like to go to a sole source for all outsourcing-so the more areas of expertise that you can offer services in, the more likely you will be that sole source."

Currently, the company offers gene synthesis, recombinant protein expression (including screening and optimization, scale-up, purification and characterization), protein analytical services, proteomics and biomarker discovery and monitoring, Pisano says.

"A big challenge for us is that we need to continuously develop and expand our services so as to offer cutting-edge technology and additional services without sacrificing quality and timeliness," he adds. "This needs to happen both internally and through select strategic partners and alliances."

The mass spectrometry-based technique of multiple reaction monitoring has enabled NextGen to develop a platform for rapid and highly specific biomarker validation and monitoring, Pisano says, noting "Our investment in leading technologies, in combination with the expertise of our scientists, enables us to offer customers the best possible services for clinical biomarker discovery and development programs. We are already working with a number of major pharmaceutical companies to develop robust, accurate and precise assays to meet the needs of their clinical biomarker projects."

Pisano says he sees a substantial gap in the market for a company with the technical expertise and the ability to run the necessary numbers of samples for protein biomarker validation and for monitoring the protein biomarkers in clinical samples.

"So, NextGen Sciences now offers the ability to monitor and accurately quantitate proteins of interest, the routine assay of validated protein biomarkers which may involve multiple assay formats and routes and monitoring of protein biomarkers in clinical samples to a rigorous SOP-most likely to GCP standards in the near future," he says.