Product Development: Which Way to Approval?
Stuart Madden, Ph.D., FRSC, CChem • Senior Vice President, Product Development Consulting and Non-Clinical Services • ICON Development Solutions
Which way to approval? At first, this appears to be a straightforward question. Why, the quickest of course! However, the appropriate (but not the better) answer is: “it depends…”
“It depends” is an appropriate answer because the question is so nebulous that further clarity is required. Routes to approval can include constraints from timing, resources (internal and external), funding and costs, indications sought, regulatory hurdles and technical issues from manufacturing, etc. Typically a number of these factors require consideration and ultimately it is a compromise between competing elements that sets the final development pathway. Thus, it is not always the quickest.
The plan is not static, either. Influencing factors may change over the product’s development lifetime, sometimes as a result of the program itself (e.g. unanticipated data, good and bad) and sometimes from external factors (e.g. unexpected competition in the market, unforeseen regulatory change due to market experience with a similar class compound, etc.).
To simplify discussion, it is assumed that product registration is the goal of the development program. This may not be the case in all instances. For some programs it may be the validation of a technology platform either by a successful proof of concept (POC) study or by the approval of a drug using the technology platform. In the former case, POC is the goal; in the latter, it is product approval. These examples also illustrate the point that overall product development objectives vary and depend on overall business objectives. Here the indication might be seen as of secondary importance over the technology platform. Irrespective of this caveat the drug product should provide some demonstrable benefit over the current standard of care from both an approval standpoint and from a commercial point of view, especially a marketing standpoint for a new technology platform.
The overall strategy employed in developing new products can also be applied to lifecycle management strategies. Effective strategies in product lifecycle management can substantially increase a branded drug’s revenues by additional exclusivity. These strategies could be the addition of a new indication, improvements in bioavailability leading to lower dosing and improved safety profiles, moving to a more convenient dosing regimen (e.g. three times to once daily) or changing the route of administration (e.g. switching from a nasal spray to an oral tablet or from an oral tablet to a transdermal patch) for improved patient compliance and convenience.