Regulatory strategy is at the heart of all drug development. It drives the allocation of development funds and dictates the strength of the resulting commercial opportunity. Whether your product is a traditional NCE, a recombinant biotechnology product, a biosimilar drug, a line extension or a generic, we can ensure that your regulatory strategy makes sense for your circumstances and objectives.
For many products, the overall regulatory strategy combines the principal marketing authorisation-directed strategy with additional objectives. Paediatric investigation plans, orphan drug designation, follow-on indications and out-licensing strategies all need to be incorporated. Whatever your objectives, Envestia will ensure that they are supported by a solid strategic platform.
Clinical drug development is the longest and most expensive part of the complex route that a molecule must travel from laboratory bench to pharmacy shelf. To define an optimal strategy for this crucial stage one must take into account a vast array of ethical, regulatory, scientific, medical and commercial issues.
We believe that the key to success is to first set clear objectives and to then work backwards identifying the steps that must be taken to reach those objectives. Once this is accomplished, it is possible to address the details of each step in the form of outline protocols. This in turn inevitably raises new issues that impact on other parts of the development and hence the process is intrinsically iterative, with the best solutions emerging from repeated consideration of each level of the strategy.
Our combined experience in the industry and in clinical medicine allows us to offer expert support in just about any area of clinical drug development. We are happy to take on projects ranging in size from the design of a single study to the writing of a complete clinical development plan and we will always seek out an approach which combines regulatory compliance, scientific rigour and cost-effectiveness.
We have prepared approximately 50 clinical development plans since Envestia was formed in 2007.
Many projects are discussed before kick-off and/or during execution at ad-hoc scientific advisory board meetings. Typically these advisory boards will comprise internal content experts and management plus external specialists in key disciplines. We are able to provide medical, clinical development and/or regulatory expertise for such meetings, either as an isolated event or throughout the lifetime of a project.
For many studies, especially large, long-term trials or studies involving children, companies, ethics committees and/or regulators stipulate an independent safety monitoring committee. As a well-established pharmaceutical physician with many years’ experience both as an investigator and as a medical director within the industry, Ian is happy to sit on such committees, as he already does for a number of studies.