Precise Biospecimens are Integral to the Precision Medicine Initiative
Key factors Clinical Ops and Researchers should consider when seeking a source for biospecimens
President Obama’s Precision Medicine Initiative (PMI) is gaining traction, and here’s the proof: National Institutes of Health recently awarded $142 million dollars to Mayo Clinic to help establish the world’s largest research-cohort biobank for the Precision Medicine Initiative Cohort Program. Clinical Operations Managers and Researchers in biopharm firms should feel encouraged by the promise of increased access to precision biospecimens.
But what about today? Biopharm can’t wait 5 years to begin to see the fruits of the PMI Cohort Program. Clinical Researchers need a trusted bioservice partner and source of precise biospecimens to fuel their research now.
Here are 4 factors Clinical Operations Managers and Researchers should consider when sourcing precision biospecimens:
1) Exact Regulatory Compliance
A reliable source for biospecimens will uphold all regulatory and other mandates related to the procurement of human biospecimens, such as complying with HIPAA, IRB approval & consent standards.
2) Controlled Sourcing and Storage
Precision Science means being as precise as possible at every stage of discovery. That includes the use of precise samples of blood, tissue, and saliva. Human biospecimens should be treated like gold throughout the entire discovery cycle—from collection and prep to transport and storage. Any fluctuation or variation in a sample will affect the research, and can result in less than optimum results and/or a loss of credibility.
3) Verification of Source Documentation
Poor biospecimen collection practices can bring the reliability of research data into question, which is why it is critical for organizations to have a strong bioservice partner that follows high standards. A reliable source will provide biospecimens of known quality—meaning those that are well characterized, properly consented, sourced and appropriately prepared—and they will be able to provide evidence in advance to support your biospecimen annotation.
4) Proper Data and Specimen Management Systems
Human biospecimens and accompanying data are like money in the bank, and they must be guarded as such. Make sure your biospecimen source offers 21 CFR part 11 compliant Data and Specimen Management Systems with state-of-the-art security, 24/7/365 temperature monitoring, video surveillance and private 24-hour security patrol. Data should also be protected by layered network firewalls, anti-virus gateways and daily backup with redundancy at an off-site secure data center.
Aligning future clinical programs to trusted, reliable resources for precise human biospecimens and solutions enables a more efficient delivery of targeted therapies. That’s the idea behind the Mayo Clinic Precision Medicine Initiative Cohort Program, and one my company, ProMedDx, whole-heartedly supports.
In fact, ProMedDx was founded on this basic idea that quality biospecimens = quality research, and today we are putting pen to paper to see how we can evolve our services to support the PMI. We’ve been collecting biospecimens for nearly two decades, and we are in a unique position to offer a broad representation of blood and tissue from patients with genetic mutations or other alterations that can indicate the likelihood patients will respond to certain medicines and/or specific treatments.
Currently, biospecimens from our repository are being included in the development of several CDx tests that can aid in making better treatment choices for cancer patients. We are passionate about what we do, because we recognize the tremendous potential that Precision Medicine has for improving patient care and reducing healthcare cost.
If you would like more information about our biospecimen collections and support services please contact our Bioservices Team by email or at 800.785.7808.