A plan of action designed to achieve a major or overall aim.
A well-thought out plan is the first step towards achieving any goal, particularly the development of a novel therapeutic agent. While the general steps in development are the same for any product, the particulars of any given candidate or therapeutic indication create nuances that must be addressed individually. Early creation of a strategic plan not only identifies those nuances pro-actively, but also allows the astute organization the opportunity to effectively forecast resource needs, both human and financial.
A good strategic plan is like a roadmap for development, showing the starting point, the destination and the path to get from start to finish. A PharmaDirections plan will also identify where you need to “fuel up” along the way to keep the organization properly funded.
To suit our clients’ needs, we generate strategic plans with various levels of detail, from “30,000 foot” overviews for presentation to investors, to multi-tiered Gantt charts with hundreds of detailed tasks ready to be executed by project managers. Our plans can be tailored to a specific near-term goal or can incorporate all aspects of development: all disciplines and all phases.
In generating a strategic plan, we utilize the depth and breadth of experience among our >150 Associates.
Examples of recent strategic plans that we have created for our clients include:
- Novel micelle-based formulation for the treatment of cancer, through IND-filing
- Complete development plan, through NDA, for a new antiviral agent
- Full toxicology plan to support FDA registration of a novel peptide for cardiovascular disease
- Novel NCE with a complicated synthetic pathway, for parenteral administration to cancer patients
- Early development plan for a lipopeptide intended for use in the dermatology market