BioServe: ‘On-demand biomaterials lower the risk of clinical trials’
Conducting in vitro clinical trials in the laboratory, rather than with patients in the field, could lower both the costs and the risk of advancing a drug candidate to a Phase I study.
The newly launched BioServe Network introduces an innovation in the supply and demand chain for biomaterials that allows researchers to simulate in preclinical experiments the exacting requirements a novel compound will be expected to face downstream in clinical phases.
Rama Modali, President, BioServe
“Early experiments using specimens that mimic the criteria of a clinical trial pose far fewer risks, and are dramatically less expensive, than trials with a broad patient population,” said Rama Modali, the President of BioServe.
“One of the exciting things about the BioServe Network is that we have immediate access to a broad range of human biomaterial banked at leading academic facilities, yet we now also have the ability to prospectively collect specimens,” he said.
“We are increasingly fielding requests from pharmaceutical partners seeking a particular sample collected in a specific way with a specific amount of data to support each sample,” he explained.
“Clearly, such precision means that these samples often do not exist in any biobank inventory,” he added.
According to Rob Fannon, who leads Clinical Operations at BioServe, pharmaceutical companies seeking to match such exacting specimen criteria face a significant challenge to prospectively collect samples.
“It sounds like a straight forward idea to collect and store samples, yet there are very demanding regulatory, ethical and logistical challenges, and it is a very costly exercise,” he said.
“The BioServe Network becomes the on-demand service that biotech and pharma companies can call upon to meet these emerging requirements,” said Fannon.
Rob Fannon, Clinical Operations Manager, BioServe
At BioPharm America™ 2010 in Boston, Fannon said he will be meeting with potential partners for the supply of specimens, as well as with researchers seeking greater precision in biomaterials.
“The combination of our molecular services, extensive in-house repository, and now the BioServe Network offers a unique value proposition for the right drug development partner,” he said.
“Biobanking is becoming more specific, and far more sophisticated,” said Fannon, driven by the pressures and urgency from pharma companies to reduce risk during the drug discovery process and identify the strongest candidates as quickly as possible.
“Our intention is to fulfill every request for samples,” he said, whether on a retrospective basis using previously banked samples in BioServe’s Global BioRepository and partners in the BioServe Network, or else on prospective basis where BioServe collects specific samples along with the supporting data.
On the supply side, BioServe’s Global BioRepository provides researchers with a library of 600,000 human DNA, RNA, tissue and serum samples linked to detailed clinical and demographic data from 120,000 consented and anonymized patients from four continents.
The BioServe Network, formally launched in August 2010, is a collaboration of academic, medical, and industry biospecimen repositories that includes:
* The Biosample Repository Facility at Fox Chase Cancer Center
* The Fairbanks Institute for Healthy Communities INbank™ Biorepository
* The University of Massachusetts Medical School Cancer Center Tissue Bank
* The Windber Research Institute
BioServe holds agreements with each facility to serve as the exclusive commercial partner representing the extensive inventories.
“We reached out and formally established these relationships in what has proven to be an elegant and sustainable business model with benefits for both partners,” he said.
These centers routinely collect biospecimens from patients coming through associated medical facilities to maintain a core biorepository used for internal research purposes, he explained.
A significant amount of these materials are underutilized, yet of interest to researchers elsewhere.
The BioServe Network becomes a win-win partnership creating access to needed biomaterials, while also creating an opportunity for the partner biobank to create utility from its underused material and fund core research activities.
For BioServe, the network creates a new channel to extend the scope and breadth of its retrospective inventory of materials, while also establishing a relationship for prospective collection of requested samples. The company is actively pursuing the expansion of its network not only in the USA but is also evaluating potential biobank partners and sample collection sites in Europe and India.
“Our direct customers are often basic researchers,” said Fannon, “yet their colleagues on the clinical side at a pharmaceutical company are acutely aware of the ultimate need to design a trial and prospectively identify patients to accrue in that trial.”
The trend toward personalized medicine is driving the demand to discover biomarkers, stratify patients as responders versus non-responders, and correctly identifying drugs that will bring the greatest benefit to specific subsets of patients, he explained.
“This pressure is increasingly shifting to the pre-clinical stages in an effort to align the design of the experiments with the expected criteria for the drug candidate,” he said.
“We have fielded a number of requests moving in this direction, and the BioServe Network is a proactive response,” adding, “We want to move ahead of this curve.”
“We don’t want to collect samples blindly,” he said. “We want to collect the samples needed by partners who turn to us to design better experiments that will give them the evidence and the data to support a decision for drug development.”
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