New US player in contract assay services field
arrival of a brand new player with the launch of ReachBio, which is
opening its business operations this week.
Based in Seattle, the new contract research organisation (CRO) will focus on providing in vitro and in vivo stem cell and progenitor cell assays on a contract basis.
In particular, the company will offer services for evaluating the toxic inhibitory or stimulatory effects of compounds on haematopoietic and non-haematopoietic cells.
The company said its assays can check bone marrow toxicity (haematotoxicity, myelotoxicity, lymphotoxicity, neutropaenia, etc.), stem cell engraftment kinetics, maximum tolerated doses, and colony forming cell (CFC) content in clinical samples.
According to StemCell Technologies, another provider of contract assay services based in Canada, the major reasons for treatment failure in cancer chemotherapy are high levels of toxicity to normal haematopoietic progenitor cells and drug resistance to the malignant cells.
As a result, CFC assays are increasingly being recognised as an efficient in vitro method to check toxicity in drug development and determine dosage strategies, and some see such assays as having the potential to bridge the gap between high throughput screening technologies and in vivo studies.
In addition, biotech and pharma companies are realising that the use of these sensitive and highly relevant CFC assays within the drug screening process can help to reduce late drug failure and save much of the time and costs currently associated with drug development, ReachBio added.
"Bone marrow toxicity can be a major problem for a wide variety of potential drugs and other compounds," said Dr Eric Atkinson, president of BroadReach Biosystems, the business set up by ReachBio to offer management consultancy and strategic advisory services.
"The FDA [US Food and Drug Administration] and other regulatory authorities are increasingly requesting that drug candidates be tested within functional and predictive primary cell-based assays such as the sensitive haematopoietic Colony Forming Cell assays that ReachBio now provides."
The firm claims the data provided by CFC assays are often more predictive of the clinical situation than data derived using cell lines.
"Therefore, they can be particularly useful when the client's goal is to identify toxic compounds and exclude them before costly clinical trials commence," it said.
According to the latest data from the Tufts Centre, R&D costs to develop biopharmaceuticals reached $1.2bn (€0.9bn) on average and only three out of 10 biologic drug candidates that start clinical trials make it to market.
"However, despite the obvious value and utility of CFC assays in the drug development process, many people perceive them to be time-consuming and technically challenging - something I have seen time and again during my years of managing global CFC assay Proficiency Testing Programs and conducting numerous hands-on training courses", said Dr Emer Clarke, BioReach's chief scientific officer.
The newly-formed company claims it can tackle this by offering the technology without the technical obstacles by giving clients access to trained scientists with experience in performing these assays and interpreting their results.
Furthermore, " Our fee-for service model ensures our clients that there will not be any frustrations in negotiating who owns any IP resulting from our work: it's theirs clear and simple," said Rob Chaney, the company's chief operations officer.
"Also, we have no ties to internal or external R&D programmes, so there's no question about having any conflicts of interest, as there can be with other types of organisations that offer contract services as a sideline."
In addition to the standard offering, the company will also provide pharma clients with assay design and validation services, as well as an on-site contract assay service for those with particularly demanding assay requirements.
All members of ReachBio's management team come from StemCell Technologies, but neither of the companies was available to comment at the time of publishing.