What Are IDEAs Made Of: Enemy of innovation – The TPP
The industry has a well-recognised problem. There is a prevailing view that developing drugs is hard, and that attrition is natural. Most observers accept that this is broadly true (despite the widely-varying rates between companies). To then go on to say that one in four to one in five drugs that launch do not go on to cover their own R&,D costs is not, however, the statistic of a healthy industry. Failures in development may be largely unpredictable, failure to launch a successful product is less forgivable. Launching products that the market wants and will pay for can be an exercise in rational foresight and creative insight. However, despite declining numbers in registration, this figure has not changed – fewer drugs may be launching, but the proportions of successful drugs are not rising. The industry has a problem, and that problem lies in the continued reliance on things that don’t work.
Innovation is what you launch. Innovation that reaches the patient is productive innovation. A ‘culture of productive innovation’ is one that identifies and then successfully launches products that deliver value in the marketplace – that is, they uniquely meet the wants and demands of payers, patients and physicians at a price that is considered worth paying.
The problem in pharma isn’t to put more products into the top of the hopper – it is to identify system losses that can be stemmed, and turned into productive innovation. Ask yourself the question: out of the 9,999 drugs investigated that didn’t make it to market, what are the odds that at least one wasn’t potentially the blockbuster the other 1 didn’t become?
“Ask yourself the question: out of the 9,999 drugs investigated that didn’t make it to market, what are the odds that at least one wasn’t potentially the blockbuster the other 1 didn’t become?”
One of the key enemies of innovation, the TPP, is described here.
The Target Product Profile (TPP) is the opposite of possibility. It says ‘hit these targets and we have a drug.’ That is fine, if the targets are creatively derived, against a clear-cut opportunity. Two problems: TPPs are almost never creatively derived against a clear-cut opportunity 5 to 10 years hence, instead being (in many cases) a best guess as to what the drug will do in the clinic (so the TPP becomes self-referential). Also, failure to hit a TPP doesn’t make a drug a failure. It may well have just shown a profile that produces another, different opportunity. Companies that do well in Productive Innovation have mechanisms to evaluate a drug for what it might be, rather than what it is not. Like the many record labels that turned down The Beatles because they weren’t ‘the right fit’, rejecting drugs that don’t hit a predefined wishlist puts an awful lot of faith in the wishlist being exhaustive and predictive.
Many recent successful innovations have resulted from the harnessing of serendipity. Molecules have possibilities – yet from Phase I onwards, there is often little evaluation of ‘what else’, only a single-minded pursuit of a registration. What is not known at any point from that decision is ‘if we don’t hit this TPP, is the product still potentially of value as something else?’
“Molecules have possibilities – yet from Phase I onwards, there is often little evaluation of ‘what else’, only a single-minded pursuit of a registration.”
Without a concept, an IDEA, to prove, there should be no Proof of Concept. Tight, working concepts can be proven. ‘Preventing or delaying progression in RA’ is a concept, ‘blocking an immune pathway that may or may not be involved in RA’ is not a concept. Proving the latter may provide clues to the former, but it is not Proof.
When you only have one option you have no choice: Carry on, or kill. The problem of sunk cost is then apparent – the greater the momentum behind the option (clinical evaluation, market analysis), the lower the likelihood that any alternative options will be considered – there is too little information, too little time, too much emphasis on delivery, rather than ‘what else?’, too little ‘maximise this option’ versus ‘is there a different way, with a higher potential?’ The desire to avoid failure of a project then makes companies lower technical hurdles, leading to lower probability of regulatory and commercial success.
‘Keeping options open’ is efficient only at one stage in development. Parallel studies versus sequential studies is a consideration (for most companies) only at Phase I, and Phase IIa.
The TPP’s rise in the industry has coincided with declining productivity. Coincidence? Not on the evidence so far.
About the author:
Mike Rea is a Principal with IDEA Pharma, who enjoys taking a look outside the industry to learn how it can think differently. For direct enquiries he can be contacted on firstname.lastname@example.org and for more information on IDEA Pharma please see http://www.ideapharma.com/what/default.htm.
Do TPPs hinder productive innovation?