Creating a comprehensive drug development strategy is hard work that is likely to require significant research, thought, and discussion. The time and effort required to develop a rigorous development strategy may mean rescheduling a meeting with potential investors or delaying the start of a toxicity study. However, these setbacks should be more than offset by the long-term benefits of clear direction, up-front problem solving, and contingency planning.
Take a look at our detailed infographic, filled with eye-opening statistics, to learn more about the current overview of market and how to ensure your drug development strategy is truly complete.
Once you’ve answered the three foundational questions of a drug development strategy, it’s time to move into more detailed strategic planning in five key areas: regulatory, manufacturing/quality, preclinical/nonclinical development, clinical development, and other.
Regulatory: The regulatory strategy document, and the timeline in particular, often serve as a tracking tool for overall project status and can help identify risks to the program (e.g., cost overruns, delays, and competitor activities). However, it’s important to view the strategy as a living document that must be periodically reassessed and updated to retain its usefulness.
Manufacturing/Quality: The manufacturing and quality aspects of strategic drug development include all activities related to the production of the final dosage form, including sourcing the active pharmaceutical ingredient (API), creating a viable formulation, assessing and maintaining quality, packaging, and shipping. Robust answers from the three foundational questions are particularly important in this area, but the potential time and cost savings associated with advanced planning are also easy to see. A failure to integrate all of the disciplines in drug development from the beginning can very quickly leave the manufacturing/quality group making guesses and ill-informed decisions that can have costly implications.
Preclinical/Nonclinical Development: The goal of both preclinical and nonclinical research is the same: support the clinical trials that lead to product approval. While the strategic plan should include the “must have” studies in this area, it is often valuable to consider the “nice to have” studies. This approach, which costs more upfront, has the potential to save time and money later on in development, and may be most beneficial to companies whose end goal is bringing the product to market.
Clinical Development: A clinical development strategy should include detailed plans about study designs, identification of investigators, statistical analyses, and timelines. However, two important, but often overlooked topics are contingency planning and risk management.
It can be argued that successful drug development is all about contingency planning. The list of “what ifs” can easily grow to an unmanageable size, so concentrate on items that are most likely to happen.
Also, consider your risk management plan (RMP) or risk evaluation and mitigation strategy (REMS), which can be defined as “a set of pharmacovigilance activities designed to identify, characterize, prevent, or minimize risks related to the medicine; to assess the effectiveness of those interventions; and to communicate those risks to patients and health care providers.” Put more simply, this type of document is meant to ensure the benefits of a medicine outweigh the risks.
Other: The final area of strategic drug development is a catch-all for a range of other activities integral to the process. Issues to consider include:
- Intellectual property.
If you’re interested in more information on creating a comprehensive drug development strategy to get your drug successfully to market, please click here to watch a recorded webcast and here to download our related eBook.