A complex and expensive process such as drug development requires a clear and coherent strategy from which a tactical action plan can be developed and implemented.
The regulatory strategy outlines major development milestones and success criteria, facilitates cost and timeline estimates, and provides a basis for sound decisions and project portfolio prioritization and management. This roadmap must be developed as early as possible and is a living document that is revisited regularly. A combination of multi-disciplinary experts is required to include alternative development options or scenarios that help avoid or mitigate risks.
The roadmap provides clear direction to a program’s ultimate destination. It’s a plan that identifies critical paths and issues, mitigates risk, and optimizes the overall time to a New Drug Application (NDA) or Marketing Authorization Application (MAA) filing.
Our team of experts facilitate and guide clients through the process of formulating the roadmap, provide critical review of one or more elements of the roadmap, or provide hands on operational support through authoring some or all the components.
Elements of strategic planning
The major parts of a comprehensive drug development strategy include the target product profile (TPP), and the regulatory, nonclinical, clinical, manufacturing and commercial plans. Integrating all of these elements together in a seamless strategy document is a critical first step on the road toward realizing a program’s ultimate goals.
TPP is a critical element of the strategic plan in product development. Including all elements of the expected prescribing information the TPP forms the basis for many elements of the product development but also for discussions with regulators and Health Authorities.
Assessment of the market and competition supports the preparation of the TPP. Normally the marketing function will provide this. This may also include elements of HTA where study end points can be mapped to clinical efficacy but also to payer reimbursement criteria.
Non-clinical plan considers the studies to be planned, timelines, and associated risks and issues. The required data for ongoing stages of clinical studies and ultimately MAA/NDA will be scheduled.
Clinical development approach is critical to the ultimate indication approved and has consequences in the largest budget allocation during development.
Regulatory strategy brings all the key disciplines together versus the expected regional requirements and approval pathway(s). Risk Management Plans (RMP) are normally considered early in development.
Life cycle management, whilst seemingly, a long way away at the point of product development, does influence decision making. For instance, should an additional study be conducted during development to save a burden of testing in post approval?
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Regulatory roadmap summary
Key elements of the planning process are:
- Development strategy
- Target Product Profile
- Non-clinical development strategy
- Clinical development strategy
- Quality and manufacturing strategy
- Overall regulatory strategy
- Market and competition analysis
- Life cycle management strategy and plan