We aim to provide services at three levels. Firstly, as a CRO we will undertake to develop your Biological drug in the clinical environment which is mandated for its acceptance in the major markets of the world. At a higher level, we would aim to advise your in-house project team on the most strategic ways forward with the molecule which you have developed. This means an intense focus on the ultimate markets for which you are aiming and the customizing of the clinical trials program to meet those markets. In a perfect world, it would be possible to have one series of trials for all markets but regulatory differences between countries means, for instance, that the reference drugs may be different. In addition to the clinical trials program from Phase I to Phase III, we offer a full set of supporting capabilities both within our own services and with partners. These includes large-molecule bioanalytical services, immunogenicity analyses and pharmacovigilance both pre- and post- market authorization. Our teams comprising of fellow members of the Fusion partnership can set up studies globally to meet your regulatory needs and the geographical variation in disease incidence. The whole operation is supported by a global pharmacovigilance capability as well as a developed central laboratory function.
At the highest level we aim to interact with decision makers in companies beginning to explore the possibility of entering the biologicals field. Selection of the right drug for the right company is important and our experienced team can guide and support pharma in developing portfolios based on prior experience, capability and capacity.
We will identify sites, investigators and analysts to assist you in your decision making as well as provide guidance about the best manner to go about licensing your molecule. This is essential because of the balanced consideration of all the evidence in granting biosimilarity status as well as the implications of such status as the US FDA 505-b2 which has great implications in this area.
Alternative strategies for Biosimilar evaluation
The prolonged nature of evaluation of Biologicals and Biosimilars provides an initiative to seek alternative methods of analysis and the combination of the methodologies of clinical pharmacology and advanced statistical analysis techniques has enabled the evolution of the concept of Pharmacometric analysis. Ina a special initiative by Veeda CR and its partners, we now have a group of units working together to provide a Pharmacometric approach to Biosimilar evaluation; a new approach much favored by the Regulatory Authorities. The combined skills of the Statisticians of Datamagik Ltd, and of the Department of Pharmacology of the University of Singapore and our two clinical trials units means that we can offer this technique to our clients as a means of both reducing cost and speeding up trial completion. So we are setting up a dedicated multi-disciplinary Pharmacometrics Group. A fuller understanding of the principles may be gained by a study of the attached paper (Pharmacometrics.pdf). We are currently beta-testing the procedures in comparison with more established techniques in an on-going trial. Look out for the webinar on this subject which is planned for the near future. Contact Dr. Maurice Cross (firstname.lastname@example.org) for further information.