Before I ever stepped into a bioreactor facility, or ever spent time in a clinic calculating absolute risk reduction (ARR) versus relative risk reduction (RRR), I was an astrophysicist. Some of my early heroes were the quantum scientists of the early 20th century, one of whom was Niels Bohr. Bohr’s view of the atom—devised with Rutherford—was the now-classical ‘solar system’-looking model. He is best-known for helping to create quantum mechanics, and his interpretation of it was a philosophical flavor known as ‘The Copenhagen Interpretation’ for its derivation by Bohr and his team of scientists working in Denmark.

Futurism
I have to tell you, I’ve been called a ‘Futurist’ at more than a half-dozen events, and I’m still not sure exactly what it means. We all to some degree think about the future. Those who are depressed seem to have a different perspective on the future, which may be actually implicated in their depression, but the direction of causality still isn’t clear. For the most part, we all live in the past because our concept of the world is based on foundations built from previous experience. We expect the sun to rise tomorrow because it did yesterday. We expect a particular person to react in a certain way because that’s what we have come to be accustomed from him or her—and we’re surprised when it doesn’t happen.

We also, not just metaphysically speaking, actually live slightly in the past because we’re perceiving the world as it was microseconds ago or milliseconds ago, given the transit time of light and sound to our brains and then the subsequent processing. There also has been some interesting research from Ernst Pöppel suggesting that our conception of “now” is a quantum of time that spans about three seconds. It’s about the time it took you to read that last sentence. And now that’s not part of ‘now.’

Richard Feynman, the eminent physicist and Nobel Laureate, realized during his time at Caltech that he couldn’t count off seconds in his mind at the same time as thinking about other things or speaking, which he wrote about in, “The Pleasure of Finding Things Out.” And Ernst Mach—yes, the father of the eponymous ratio of velocity to that of the speed of sound—conducted some experiments which showed that there are no perceived intervals of ‘duration’ if they are less than 40 milliseconds long.

But what of the future? The future of pharma is one of relatively great uncertainty given the past several decades of greater certainty. Drug prices, personalized medicine (pharmacogenomics), rejection of science (antivaccination mindsets). These are all huge issues that never existed decades ago. In fact, in the era of smallpox, polio, etc., if you had systematically rejected the science behind vaccinations, you would have been one of the victims among a group of tens-of-millions.
Here are some notions on the future—and improving the future—of pharma.

Leadership vs. followership
Portfolio diversification is often a good thing to tamp-down wild swings in the market. However, sometimes having a relentless focus in one therapeutic area or mechanism of action can be an asset. Research by Bain & Co. showed, strikingly, that late-stage development programs from category leaders (Relative Market Share > 0.75) were more than twice as likely to result in regulatory approval as similar programs from category ‘followers’ (p=0.01). There are a lot of factors at play, not simply ‘experience’ in a particular category. It could be that regulatory agencies expect category leaders to be more competent, and that expectation drives outcomes via a modification of a phenomenon known as the Pygmalion Effect. This is where the expectation that one will perform at a high level leads to alterations in how they are treated, increasing performance and thus creating somewhat of a self-fulfilling prophecy. Think about your relative market share, and how you can optimize what you do next.

The medicalization of behavior
The last couple years have seen more individuals felled by opioids and other drugs of addiction than any models were predicting, even from five years back. This has led to messy and imprecise therapies amidst an industry and a society that are still deeply split as to whether addiction is a behavioral problem, such as shoplifting, or a biological/biochemical one. As hospitals, Emergency Medical Technicians (EMTs), and police departments find more and more overdose patients, they have taken up the mantel of providing opioid toxicity reversal through rapid treatments like Narcan, where dangerous levels of overdose can be treated such that the victim is less likely to die from depressed breathing and cardiac rhythm anomalies. It seems like tremendous progress in preventing deaths over a short period of time, but consider this: Naltrexone is an addiction treatment so effective that it’s been called a “home run” treatment and it was approved by the FDA in 1994 for alcohol use disorders. That’s 24 years ago. So we’re really just getting to the point where society has come to accept these treatments.

Because exposure to extraordinarily-addictive molecules, such as opioids, that can be a trigger for long-term problems, it has also caused a re-evaluation of other behavioral transgressions. If gambling is a similar trigger for certain genotypes, then addictive gambling behavior, the theory goes, should be considered an illness and not a personal failing. Indeed, it’s listed in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM V); and “Internet Gaming Disorder” has a mention as well as a ‘condition for further study.’ And although surveys of the general public have repeatedly shown that there is a perception that far too many children and adults are diagnosed with ADHD and treated medically, who presumably shouldn’t be, the only real data about this indicates that the reverse seems to be true: That the proportion of children and adults diagnosed with, and treated for, ADHD is considerably less than its actual prevalence in the population.

Patient centricity
What once sounded very touchy-feely and overly-optimistic has now resoundingly become more and more a part of actual healthcare practice. If you’ve been to a hospital or clinic in the past several years, you’ve been guaranteed to be exposed to surveys asking dumb questions like “How was your visit?” Protip: Nobody frequents hospitals for fun and enjoyment. But these surveys are strong leading indicators of what the public cares about—and what the hospitals and clinics are incentivized to be concerned about. Now more than ever, patients come equipped with their smartphones and can doctor- or clinic-shop nearly at-will. In order to be competitive in a social media-democratized healthcare system, fruitbowls, fishtanks, and abstract wall art are more common than ever in healthcare settings.

To this end, patient centricity in pharma takes the form of people looking for treatments that are easier to take, such as smaller dosage sizes for oral solid doses, increased use of novel administration methods such as transdermal patches, sublinguals, implants, controlled release formulations, and self-controlled dosing devices like insulin autoinjectors. Also, don’t underestimate the interest in DTC drug advertising with self-help questionnaires or other simple superficial diagnostics. These take advantage of a concept called ‘gamification,’ where once you’ve triggered engagement with content, like with a pen-and-paper or online set of questions about how you ‘feel’, it tends to be surprisingly sticky. Follow these up with coupons or other cost-saving programs, and prescription-seeking behavior hits levels never seen before in the industry.

Real-world evidence
As we become more networked, connected, and quantified, getting real population-level data from people about their physiological status, health conditions, and drug treatments has almost brought us to a place where polling the zeitgeist for precise healthcare data can be nearly as accurate as controlled clinical trial data. Now, the population-wide statistics are far more noisy, but this is not such a bad thing. One of the issues always encountered with clinical trials and the switch to market release and real-world use is that polypharmacy—combinations of undisclosed drugs that may interact—and human behaviors related to taking prescriptions—missing doses, doubling-up, forgetting to refill—are all there in the Big Data set, as clear to see as the Duchenne smile in the Mona Lisa. The more we can accept that real-world usage stats don’t mirror the clinic, the more accurately we can predict healthcare outcomes.

Vaccines
A recent survey published by The Economist (25Aug18) from The Vaccine Confidence Project asking “Overall I think vaccines are safe,” found that about 42% of respondents in France thought this statement was true—the U.S. respondents similarly agreeing was ~13%. Now, vaccines are relatively low-margin, but ignorance in this field is tremendously costly. The EU had endeavored to ‘end measles’ by 2015. This hasn’t happened yet, and the numbers above don’t give much confidence here. It’s now been reset to the year 2020.

When you can’t succeed just move the goalpost.

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Ben Locwin

Ben Locwin, PhD, MBA, MS, MBB is a widely-acclaimed author and speaker. He has been featured in The Wall Street Journal, The Associated Press, Forbes, and other media. He writes the Clinically Speaking column for Contract Pharma and is a member of several industry Advisory Boards and Boards of Directors.