The Pharmaceutical Research and Manufacturers of America estimate that for every 5,000 to 10,000 compounds entering the pipeline, only one will make it to market. As such, it is necessary for pharmaceutical and biotechnology companies to develop a comprehensive drug development strategy that can help cut costs, shorten timelines, and increase the probability that their compound will be one of the few to succeed.
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.
Before diving straight into regulatory strategy or clinical trial design, it is essential to consider these three foundational questions that form a base for building the specific sections of the comprehensive drug development strategy:
- What is the end goal? While the obvious answer to this question is “get the drug on the market”, many small companies may choose instead to focus on attracting a larger biopharmaceutical firm to buy, in-license, or partner on the compound in development. To borrow a popular phrase, if you don’t know where you’re going, how will you know when you get there?
- What are the desired product attributes? A good way to approach this question is to draft the ideal prescribing information for your product. At this stage the information is largely educated guesses and conjecture, but the process helps companies focus their objectives before building a detailed plan. In particular, consider indication/usage, dosage/administration, clinical pharmacology, adverse reactions/toxicology, and clinical data. In whom will the drug be used? How much of an effect is needed for the drug to be considered worthwhile by patients, providers, or payers? What level of toxicity will be acceptable?
- Where will the drug be marketed? It may be tempting to start by seeking approval in the United States and planning to file paperwork for other regions later, but the process isn’t that simple. No single country or region has the most conservative regulations in all areas, and having to repeat key studies because the air handling procedures on the tablet compression line didn’t meet European standards, or because the Phase III trial included only one investigative site in Europe is time consuming, expensive, and frustrating. In most cases, it is worthwhile to plan the development program to meet the most stringent criteria among the intended markets. That may mean using the US standard for safety monitoring, the European Union (EU) standard for manufacturing quality controls, and including at least 100 patients in from several sites in Europe in the Phase III trials.
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.