Product design in the pharmaceutical industry is unlike product design in most other industries – in that it seems to be almost non-existent.
It appears that Pharma frequently comes out of the Phase I gate with products forgetting that typically, what they have are in fact, molecules. Although some may rightly argue that in drug development, product design is not paramount given that we are looking for tailored solutions, the scarcity of this type of solutions, the limited knowledge around how most of our drugs work and the immense unknown underlying most biological processes make the theory of tailor-made solutions questionable – at least for the moment.
New technologies, such as microarrays, improved cell tissue culture processes, proteomics and so on, have made testing numerous molecules more efficient and have produced better compounds and healthcare solutions. This evolution in technology has certainly fomented improved tailor-made (or targeted) drugs. Still, despite the drugs being more targeted and our understanding of the fundamental pathways improved, most molecules fail to make it into human trials due to safety concerns. Likewise, even when molecules are tested in humans, safety is generally the larger hurdle to surmount. Thankfully, several molecules are found to be polyvalent and “safe” which allows for their use in multiple diseases. Nonetheless and of important note, the proposed pathways underpinning many drugs’ polyvalence are opaquely understood and often the result of unconfirmed hypotheses.
When thinking of product design for Pharma, I often ask myself: WWND? (What would NASA do?). Due to NASA’s environment of operation, products cannot be modified after launch and, hence, must be perfectly designed, planned and implemented in order to be considered viable! In addition and analogous to Pharma, they have very little materials to work with and must account for many unknowns within their post-launch environments. When developing a new part for its space shuttle, or space-craft (now that the shuttle program has been discontinued) there are limited materials that can be used due to the exacting demands of space-travel (weight, durability, size, etc…). To get around this issue NASA develops new materials but, more importantly, heavily tests and reuses its existing ones. It is, in fact, the recycling of existing materials that is often the most economically viable and suitable option.
Similarly, the limited number of safe molecules within Pharma’s portfolios is something that companies need to leverage more aggressively. Although it would be optimal to find the perfect solution for a problem (whether the problem is located in space or within ourselves), this solution is either physically impossible to manufacture or the current knowledge does not support its creation. Given that it is most often the latter, I wonder why do we regularly grasp at this limited knowledge and use it to, speculatively, restrict the potential alternative development options for a molecule? After all, we have seen several diseases and pathways seemingly unrelated, upon further investigation, be interrelated. It would be, then, negligent for Pharma to frequently come out of the phase I gate with products forgetting that what they have are in fact, molecules. Molecules are regularly turned into a single product and all the potential around that wheel of product-possibilities is locked without deeper consideration for what the molecule may otherwise become. Keeping in mind the lessons from NASA and recognizing our limited knowledge, we should strive to invest additional efforts into, at least, considering (if not testing) alternative products based on a single safe molecule?
We have all been privy to the prophecy biding “big Pharma” to decline and in many respects this prediction may be founded on solid pillars. Still, this prophecy may fail to place enough consideration on the importance of a broad portfolio. Coming back to the idea that the hardest thing to develop are safe and efficacious molecules, although small companies are more nimble in their approaches to the market, they lack the breadth that big Pharma’s pipeline has. Considering the pre-clinical development attrition rates and the costs associated with getting a molecule to Phase II, it is a grave shame that we are not habitually pausing to explore (or IDEAte on) a molecule’s product-possibilities. In fact, I would argue that if big Pharma were to extensively exploit the breadth of their pipelines, it would be difficult for small companies to compete. In the end, what I truly believe will separate successful big pharmaceutical companies from the rest is their ability to plan, design and more importantly leverage their latent pipelines.