As I write this, it is the 30th of December, 2019. As we ramp up for 2020, let’s remember that it’s a leap year. That extra day gives us about 1/1,300th of an additional year’s worth of time to make things count this year. How best to not squander our time? Develop plans for your strategic approaches for the new year. Keep yourself honest by devising metrics that will indicate if you are on-track or off-track through frequent check-ins with your plan throughout the year.

Plan for Success
In the planning world, there are lots of opinions, and most are wrong. But probably the most correct one is my favorite of Dwight Eisenhower’s quote, “The plan is nothing. Planning is everything.” Many groups whom I’ve discussed this with have an incorrect or inadequate appraisal of the content of this quote. Where the value actually lies in this quote is the lexical play of the noun versus the verb usage in the quote. The “plan” as Eisenhower referred to it is the paper-and-pencil document (the noun) that is the output of the verb of “planning.” Holding in your hand a ‘plan’ for what your organization should be doing is the component which is nearly useless. As soon as the group adjourns, and even before the ink is dry (only an analogy if it’s actually written in pencil or printed via laser printer), it is aging. That’s right: The fruits of your planning, which exist in this written document, are aging day-by-day, and most likely, they’re aging in a way that makes them more and more inaccurate. This is due simply to stochasticity in the external environment in which you work and the financial markets which are at play. This is simple economics fact.


However, the activity which led to the document is one in which success lies. The activity (verb) of planning is what gets your teams to sit around and discuss latent and emerging issues, risks, to conterintuit, to play ‘what-if’ scenarios, to look at unintended consequences. The amount of ‘future histories’ which can come out of this are essentially infinite, but very much bounded by the practical experience of those who you involved in the process. Groups who operate like this, and can avoid the negative and dysplastic elements of groupthink tend to outperform every other method of forecasting that’s currently available. And that includes most types of Machine Learning which currently exist.

The Market In Some Sense Drives The Industry
What I mean by this is the Financial Markets, whose overall impact to the drug development lifecycle can neither be understated nor underestimated. When boundary-breaking therapies come up upon our current horizon through which they will, by definition, break, the financial markets take notice. That is because behind each is a potential economic windfall, not only for that current therapeutic modality or idea, but for all of the technological advancements it undoubtedly represents and ushers in with it. Every single new groundbreaking type of drug (and medtech) therapy has created new approaches to thinking about disease and disease management, as well as approaches to supply chain, patient communication, drug safety reporting, and so on. The markets are to some degree sensitive to this, even if they’re not aware of it fully (to anthropomorphize the markets into an entity, anyway). The economics of this situation drives innovation, R&D spend, regulatory approval approaches, and basically reshapes the entire industry. These cycles have been occurring in intervals of about 4-9 years, but are themselves shaped or assisted by additional changes which derive from changes to regulations and regulatory guidances, such as new revisions to FDA’s Code of Federal Regulations Title 21 (CFR) and the International Council for Harmonisation’s ([…of Technical Requirements for Pharmaceuticals for Human Use], i.e., ICH) semi-frequent updates.

On the Horizon – Scenario Planning
Forecasting for the year 2020, and hopefully with visual acuity also of 20/20, is a very difficult endeavor.

Cell Therapy and Gene Therapy
Cell therapies and gene therapies will continue to rise, tempered by safety and efficacy empiricity—how the data actually look from the clinical trials—and the public’s ever-fickle tolerance for innovation and risk versus benefit.

Manufacturing
Manufacturing will continue to drive to outsourcing and CRO/CDMO/CMO
offerings, which gives smaller startups the ability to innovate with venture capital, and not have to be disintegrated by the burdens of manufacturability overhead. We’ve seen in 2019 that cell therapies have presented some novel and potentially nuanced challenges with respect to manufacturing, and so solving these modern challenges will continue in 2020. These are problems that we didn’t fully predict in the past, and to paraphrase Albert Einstein, “the significant problems we face (now) cannot be solved at the same level of thinking that we were at when we created them.” We create a new future, one in which we now all reside, and the associated problems that came with it are where we have to dedicate our resources to respond to next.

Expansion or Contraction of the Anti-Vax(?)
The past decade has brought with it an almost unheard-of level of scrutiny and rejection of basic scientific principles. Among them, people around the world have been so successfully healthy with our current medical treatments, that they had started, inexplicably, to reject the very immunizations that have led to the reduction or elimination of so many terrible diseases. I’ve seen some conflicting signals here: On one hand, the anti-vaxxers are operating as vociferously and science-rejectiony as ever, but now, very interestingly and paradoxically, those who are interested in fact-based opinions are becoming more vocal, and there seems to be signals in the data suggesting younger people at the moment—younger than the anti-vaxxer demographic, which used to represent a younger cohort in society than the general public of vaccine-adherents—are rejecting the anti-vaxxers nonscientific propaganda, and attempting to support the notions of vaccines and herd immunity.

How I read this signal is that it’s a retrocycle reminiscent of how rejection of smoking came as a result largely attributable to younger generations rebelling against those things that their parents found to be fashionable or signs of the times. These retrocycles and their associated tipping points are hard to pin down, except in hindsight. So I’ll leave this one optimistically as suggesting that anti-vaxxers will lose overall ground in 2020. With big confidence intervals. I think this view is optimistic both for the charge of science, as well as for the health of the population, where vaccines for measles, mumps, rubella, tetanus, polio, diphtheria, influenza and human papillomavirus are available widely and have demonstrated incredible successes and safety.

Even on the ebola front, there has been a flurry of activity which has led to a predominately-effective immunization, however caution is warranted because the overall sample size totals within which it’s been trialled have been relatively small.

In addition, the idea of a ‘universal’ flu vaccine has also gotten a bit more traction lately. It used to be that in the vaccine circles which I would frequent, the colloquialism was that a universal flu vaccine would be available “in 5 to 10 years,” which was understood industry code for a moving time horizon (that was moving faster forward than actual time) which meant, in effect, “never.”

To develop a universal flu vaccine requires that certain aspects of the virology of influenzaviridae, which are less likely to genetically shift and drift are the ones used in development of the immunization. This would confer protection, then, against a very broad range of influenza types and subtypes, without having to worry about yearly re-immunizations. There are also those who have been worried about exposure to RNA fragments in vaccines and adjuvants, so to reduce the overall number of immunizations required would be welcome by the public.

What you can do in 2020
First, for your work within your organizations, if you jumped right to this conclusion in the article, go back up to the ‘Plan for Success’ section and read that first. It will lead to tremendous opportunities for process and programmatic improvements.

If there’s anything we can all do as an industry together, to move our interests forward, support each other, and help humanity in the process, it’s to bring back science to the public’s vernacular. Real, verifiable, empirical science. Educating friends, neighbors, and the public that what they usually read about healthcare and medical treatments and pharmaceuticals is almost exactly wrong. By bringing this clarified lens of objectivity to discussion not only could help teach many in the public where they can seek out relevant and factual information to help maintain or improve their overall health, but the same approaches can also help sharpen your internal organizational meetings. Opinions and ‘gut feel’ can be just as wrong as right (or more so) and their effects can go unnoticed until they’ve caused a lot of unmitigated damage. Plan (as a verb), refine your plan with fresh data as often as possible, ask others to do the same, and cut away activities that are robbing you of your time and productivity where it really matters. 

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Ben Locwin

Ben Locwin is an author, a speaker, and advises on future forecasts for pharmaceuticals, medical devices, and healthcare policy. He is an ardent philanthropist for technologies and causes which benefit health outcomes, and participates on a variety of advisory boards.