Biomarkers
Protein Biomarker discovery, assay development and monitoring solutions from NextGen
Sciences.
The protein biomarker services from NextGen Sciences encompass any or all
of the following:
- Assay development
- Monitoring of protein biomarkers from pre-clinical and clinical samples
- Discovery of putative protein biomarkers and proteins of interest
- Sample collection
Ways to work with NextGen Sciences
NextGen Sciences have a flexible business model and are open to discussion as to how best to fit the customer's needs, for example:
Introduction
Biomarkers, including genomic, proteomic and metabanomic/metabolomic biomarkers,
are defined as measurable indicators of a biological state and hold a key
position in the new approach to drug development and diagnostics. Biomarkers
clearly have enormous potential in the diagnosis of disease and disease
progression and are under intense investigation due to their predictive
ability and safety indications throughout the drug development process.
This includes patient stratification, toxicity, efficacy and patient response
to therapy. It is therefore the desire (and most likely will become a requirement)
of pharmaceutical companies to develop biomarkers and biomarker assays to
aid in the drug development process.
NextGen Sciences are already carrying out projects as outlined here for
clients and have the technical expertise and equipment required to conduct
these advanced studies. This expertise in the challenging field of protein
analysis and proteomics has been developed through the building of a team
of highly qualified scientists with previous experience in pharmaceutical,
biotech and academic research who are trained to operate our state of the
art equipment to generate the desired results. The company has been supplying
the highest quality protein science services since it's inception in 2001
and the staff have worked in close cooperation with many major companies
and academic institutions around the world.
The FDA is keen that more companies work with them in the earlier stages
of biomarker development and provide voluntary data submissions. A pilot
process is in place to allow this to happen. It would appear that the FDA
would prefer that a single assay was used by a number of pharma/biotech
companies for a particular protein than have as many different assays as
interested companies.
The initial method of choice for NextGen Sciences will be the mass spectrometry
based technique of Multiple Reaction Monitoring (MRM). In addition to sample
collection and preparation we have the necessary experience and tools to
develop robust quantitative and precise MRM assays to meet the needs of
a clinical study. NextGen's close ties to a number of immunological reagent
suppliers will speed the development of an assay and allow us to attain
the analytical limits that are required. For an example of work carried
out using MRM measurements please see Anderson, L. & Hunter, C. L., (2006),
Mol Cell Proteomics, 5.4, 573 - 588. NextGen Sciences has presented some
of its own data during the 'Mining the Plasma Proteome' stream at the CHI
PepTalk Conference, January 7th - 11th 2008. Click
here to download a copy of the poster
Assay development
- Development of the required sample preparation and analytical parameters to assay the protein of interest in the required matrix, for example from plasma, serum, urine, CSF etc.
- Validation of the assay with regards to limit of detection, limit of quantitation, precision, accuracy and sensitivity.
Monitoring of protein biomarkers from pre-clinical and clinical samples
- Monitoring of protein biomarkers during all phases from pre-clinical through 'first in man' (Phase 0) to post-market monitoring (Phase IV).
- Monitoring of proteins present in formalin fixed paraffin embedded (FFPE) tissue samples.
Discovery of protein biomarkers and proteins of interest
- The identification of clinically relevant proteins (biomarkers) from research and/or clinical samples using a variety of proteomics technologies including, amongst others, label-free MS, iTRAQ, SILAC, spectral counting and 2-dimensional electrophoresis.
- Identification of proteins present in formalin fixed paraffin embedded (FFPE) tissue samples.
- In many areas the lack of samples which are fit for purpose is as great an issue as a lack of targeted assays. NextGen Sciences have developed a number of links to academic groups and companies with therapeutic area expertise and access to suitable patient sets
- If a suitable sample set is not already available then working with these groups it may be possible to develop a sample collection Standard Operating Procedure (SOP) alongside the assay development and begin sample collection including full patient histories and ethical consent.
Ways to work with NextGen Sciences
NextGen Sciences have a flexible business model and are open to discussion
as to how best to fit the customer's needs, for example:
- Through a straightforward fee for service offering it is possible to engage in a one to one relationship where a customer can fund the assay development for their particular protein biomarkers of interest and can then submit samples for routine analysis and monitoring using these assays. Under this model there are two further options where the customer can retain the exclusive rights to the assays or they can allow NextGen Sciences to offer the assays developed to other customers. These options vary in their pricing structure based upon individual customer requirements
- Several companies have expressed an interest in entering into a shared cost, shared risk consortium where a list of protein identities in a particular therapeutic area would be agreed by the consortium members. NextGen Sciences would then develop the assays on this list and make the assays available to each of the consortium members at a discounted price. In this scenario all the rights to the assays would be retained by NextGen Sciences and be made available to the wider market to encourage uptake of these particular assays. A consortium may develop around a particular therapeutic area or could be more general as long as there was interest in a majority of the proteins of interest from the consortium members
Key benefits to working with NextGen Sciences
- Vast knowledge and experience in the protein sciences arena which is a prerequisite for success in generating these assays and quality data
- State of the art equipment and facilities
- Checkpoints built into the project proposals to give regular discussion and decision stages giving the customer full control of the project scale, timescale and budget
- Scalable solution suited to the needs of our customers
- Regular open communication on the progress of the project
- Full data and analysis report at the end of the project
For further information on this area please contact:
Email: biomarkers@nextgensciences.com