Bio-Correlations in Clinical Trials
Bio-Correlations in Clinical Trials: TopoGEN offers powerful and tractable services to assist:
New topo targeting compounds are constantly coming and going. Clinical trials in disease specific applications are active globally. TopoGEN can help with validation, target metrics and lead optimization by providing a framework for predictive response. Here are some of our services:
We can accept cell pellets or tumor samples to quantify total cellular amounts of topoI, topoII, topoII or topoIII. We can make the extracts or direct you, the client, on how to perform the extractions. This approach offers a way to predict response and determine which patient population may or may not show clinical improvement. Westerns are also useful as ‘band depletion’ analyses. What this means is that IFP type drugs, will result in loss of a signal (for example a Top2 IFP will reduce the p170 band on a Western gel) and this can be used as a metric of drug efficacy if properly controlled. We can help with this or perform the entire analysis for your lab.
To complement total polypeptide levels from Westerns, we can extract enzymatically active topo I or II to quantify the activity of tumor associated protein. Topoisomerases are subject to post-translational effectors, and it is possible to have high or low total topo polypeptide levels that do not match activity. As above, we can make the salt extracts with your pellets or we can instruct your staff on the processing.
Our Screening Services: Independent Validation, Expediency, Value
At TopoGEN, we developed, trademarked and patented many of the technologies associated with drug effects on DNA. We are leading experts at drug testing and assessment of drug action from a mechanistic standpoint. When you engage our services, we will describe and lay out a logical/rational approach that is rich in content and strongly mechanistic. We offer independent consultants who can validate our findings. Our services offer expediency and value as well. We can significantly accelerate the pace of your clinical research, produce publication quality data and you will own the intellectual property that comes with our studies. We routinely enter into confidentiality agreements on projects, so your results are protected. Our in-house testing program is flexible and efficient. The following are important points associated with our Western Blotting and testing services:
All Postitive & Negative Controls
We demonstrate internally that all testing platforms are perfectly functional. As a result, there is no guessing. Your data will be clear and unambiguous. We stand behind our findings and certify the data.
All Markers Will be Included
To document and validate the results. Again, we certify tractable results that will be internally controlled.
Testing & Costing Flexibility
We tailor each contract to offer maximum flexibility and coordinate with you over the course of the project to ensure intellectual flow of ideas and results. We will advise you on the best course of action with all hits. You can select the level of detail for the project that best suits your needs. In some projects, there will be a need to re-examine, re-test or alter the course. How do we correct for work-load adjustments in the mid-stream? Our solution: we include on all projects, a small indirect cost that will allow us to perform additional key experiments without asking for additional funds. This is an advantage for clients and ensures that our high standards of data quality will be maintained. For example, if additional testing regimens are required, we carry out the service automatically. Importantly, there is no guessing on the budget and you will not pay additional fees.
Consulting
We are a team of topo experts. All projects include email and direct SKYPE support over the course of the project. Our scientific staff will discuss and suggest future prospects or experiments.
Reporting
For complete flexibility and to ensure cost-effective contracts, we offer two levels of reporting. At a basic level, included in all contracts, we provide well-documented data (powerpoint, PDF or password protected cloud account). We draw conclusions, presented as bullets, on each slide and make a recommendation for further development and maturation of the project. For clients who wish to have a & ´manuscript´ style report, we offer fully referenced publication style reports. These reports are professionally prepared and are suitable for presentation to regulatory agencies. These publication style reports can be reviewed independently by third party opinion leaders in the field and the reviews appended to the final report.
Hands-on Experience
The company has been actively engaged in contract drug testing since the 1990s and we have the experience to get results that will enable ‘go/no go’ decision making on drug development.
Expedience
In most cases, the project will be completed over a period of several business days. We will clearly stipulate how long the project will take and we deliver on time.