Product Cycles in the Pharma Industry and How to “Shorten” Them – Part 1

A few weeks ago I commented on what may be the fundamental limit on a stable Pharmaceutical industry — products have to be on the market for at least as long as it takes to replace them.  Cash flow significant enough to fund serious research only lasts as long as a drug has market exclusivity. Thus, to first approximation, a firm has to develop a new drug before it runs out of cash from sales of existing products.

Thinking about it a little further, I realized that it already takes an unsustainably long time to develop new products completely from scratch, but that the overall academic/startup/existing firm ecosystem has developed (or in some instances is in the process of further adapting) to enable these long product development times.

First of all, the very basic biomedical research needed to create a key enabling technology (say monoclonal antibodies), or to discover a promising drug target or pathway takes a lot of time — so much time that that research can’t actually be part of a conventional product development cycle.  Fortunately, the scale can be small, and there are a lot of interesting scientific discoveries to be made — all of which is a good fit for academic laboratories.  Much of this basic research that can later lead to commercial applications is in fact funded through government or foundation-sponsored grant money.  Such academic research follows it’s own funding cycle, and it has it’s own reward system that focuses on the production of trained scientists and significant research results, manifested as published papers (and patents).  Papers have a much shorter “development cycle” than marketed drugs!

Later, more applied research (which requires larger numbers of people and significant funding increases) is often spun off in the form of a start up company, funded through seed money, angel investing, venture capital, etc.  Here the funding cycle and system of reward is based on increasing valuation derived from estimates of future profitability as the firm develops its (as yet unmarketed) products. At the end, the company can go public or be bought by a larger existing firm.  In either case, all that early product development work typically occurs prior to, and almost completely uncoupled from, product sales.  Of course the true overall cycle time wasn’t really shortened, it’s just that parts of development were structured in ways that had their own sustainable cycle of funding and reward.

The net effect is that an existing drug company can either buy a startup company or launch an internal project based on collaborations (or published research) with a significantly shorter effective development time (at least as experienced by the existing firm).  Needless to say, this relationship holds for all sorts of science and technology companies, where government- or foundation-sponsored basic research can take place on a long time scale that is not constrained by the need for short term profits.

Getting back to Pharma, an important implication is that a pharmaceutical firm can benefit if it can apply this sort of decoupling or otherwise off-load development from it’s own internal R&D portion of the overall product development cycle.  I have some thoughts on that, which I will put in another post…

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Nightfall in Winter

Lehigh County, Pennsylvania

20140206-124324.jpg

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Cell Turns 40

The prestigious scientific journal Cell turns 40 this year.  Check out this cool interactive timeline of landmark articles published 1974-1984.

Additional timeline segments mapping many of the incredible discoveries in cell biology over the past 40 years will be published throughout 2014.

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Hitting the fundamental limit of the drug industry?

After a banner year in 2012, the number of FDA Drug approvals dropped back to 27 for 2013, a number more in line with the average rate of approvals for the last few years. As many observers have commented, the cost of developing a new drug has skyrocketed (see, for example, this analysis by Matt Herper).

However, I wonder if there isn’t a more fundamental limit on the sustainability of the drug industry in aggregate: By many estimates, the time it takes to develop a new small molecule drug has become longer than the length of market exclusivity. According to data from the Pharmaceutical Benchmarking Forum, it takes 12.5 to 13.5 years from initial screening to final drug approval (as reported on this web site; other sources give similar numbers). Even assuming a new molecule isn’t patented until 2-3 years after the project begins, that leaves 10 years or fewer on the market.

Think about the implications of this fact. A pharmaceutical firm generates high gross margin cash flow (the kind of money needed to fund extensive R&D) for only as long as its products have market exclusivity.* This means that for a pharmaceutical company’s business to be sustainable, in aggregate the firm must develop a new product within the length of time it generates cash from an existing product. But how can the firm do that, if on average it takes longer to develop a new product than an existing product is on the market? It can’t. No matter how many projects are conducted simultaneously, no matter what the overall success rates, at steady state you have to develop a new product in less time than the amount of time you have it available for sale. Otherwise, revenues will decline as a company struggles to replace lost products — behavior strikingly like what we’re seeing today for quite a few firms.**

Clearly, I’ve simplified the story somewhat; there are other ways of financing product development besides free cash flow — loans, venture capital, co-investing, buying assets from other firms, etc. Of course, some individual firms may fill their pipelines faster than they lose products — whether due to better management or just plain good luck. But as a system, I don’t see a way around this fundamental limit of having to replace products faster than they disappear.***

I’d love to hear comments from readers.

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* Being much harder to copy (at least under current law), biologics are a different story. Market exclusivity can be maintained for a longer period.

** Note that in comparison to existing firms, a brand new company looks like a winner, at least for a while. A new product comes on market, revenues skyrocket, stock price leaps, etc. It’s only 10 years later when a replacement fails to come along.

*** Actually, I can see a theoretical way out of this — lots of early stage R&D funded by very patient investors (think long term venture capital), who sell their assets to pharma firms. An individual pharma firm could then accumulate new assets faster than existing products go off market. But the early investors would have to endure negative cash flow for a long time.

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Why build a house when you can print it?

Extrapolating the 3D printer trend one step further, researchers are working on systems that can “print” large scale structures made of concrete.  Like a house, for example –printed in only 24 hours.

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Rigid stack ranking of employee performance and pharmaceutical research is a bad combination

Microsoft’s recent decision to abandon employee stack ranking is just the latest example of the growing skepticism around stack ranking performance management schemes, especially ones that force bottom 5-10% distributions.  Sadly, some pharmaceutical firms still use the method.

The major arguments against stack ranking and forced bottom distributions (especially bad for industrial scientific research) are the following:

  • Intrinsic motivation is a much more powerful force than monetary rewards based on stack ranking.  As popularized by Dan Pink, what really motivates people is Autonomy, Mastery, and Purpose. “Challenge and mastery, along with making a contribution are what drive people —  how else do you explain Wikipedia, Linux and other open source software?”
  • People are exquisitely tuned to perceived fairness in compensation, but above that money isn’t as motivating.
  • Large monetary rewards can actually undermine performance in tasks requiring cognitive skills.
  • In scientific research, performance quality can be very hard to measure objectively, and outcomes are not necessarily dependent on worker skill and motivation.
  • Research has shown employee skills & performance can be Pareto-distributed, not Gaussian.
  • While forcing 5-10% of employees in to a bottom rank may work better for engineering or other fields where performance is more easily quantified, it still creates a culture that undermines the teamwork required for highly collaborative work.
  • In companies undergoing layoffs, stack ranking sets off a cycle of demotivation as even very talented employees are given poor rankings.
  • Punishment does not work as a motivating force for knowledge workers.

Here is Daniel Pink’s 2010 presentation to the Royal Society for the Advancement of Arts, Manufactures and Commerce, Drive:  The Surprising Truth about What Motivates Us

Of course, in the real world, it’s too easy for researchers — even highly motivated ones — to pursue projects that don’t align well with corporate needs.  Pharma research scientists should be paid fairly, held accountable for meaningful objectives, and their professional development should be supported by managers.  Stack ranking at the end of the year could be used to keep people honest, but it should be a relatively modest determinant of compensation.  To keep alignment with corporate goals, it’s preferable to link bonus amounts more closely to company or group performance.  And there should never be a forced 5-10% at the bottom.

More Reading

Yahoo’s Latest HR Disaster: Ranking Workers on a Curve – Business Week

“Basically, many people have lost faith that ranking employees works, and some research suggests that employee performance doesn’t follow a bell curve at all. Instead, most people are slightly worse than average (PDF), with a few superstars. And while a bit of pressure can motivate people, constantly pitting employees against one another is terrible for morale. In a company that is going through layoffs, this gets worse over time (PDF), wrote several MIT professors in a study of forced rankings in 2006. “As the company shrinks, the rigid distribution of the bell-curve forces managers to label a high performer as a mediocre. A high performer, unmotivated by such artificial demotion, behaves like a mediocre.”

Papers cited: The Best and the Rest: Revisiting the Norm of Normality of Individual Performance and Punishing by Rewards: When the Performance Bell-curve Stops Working For You

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Microsoft kills its hated stack rankings.  Does anyone do Employee Reviews Right?

 Three Myths of Management – HBS Working Knowledge

Forced Ranking is as bad for Yahoo as it was for Microsoft – Forbes

Should I rank my employees? – Management – WSJ.com

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Boston is a Global Financial Center – #7 Actually

Most people think of Boston as a global center for research and teaching, especially in the biomedical sciences.  (or perhaps as a center of excellence in American professional sports…).  Say “financial center”, however, and the word “regional” comes to mind next.  Not so.  The most recent Global Financial Centres Index, published by the Z/Yen Group, ranks Boston as the #7 global financial center.  Based on surveys of financial professionals as well as a host of quantitative data, the ranking algorithm analyzes 102 factors in 5 categories of competitiveness: Business Environment, Financial Sector Development, Infrastructure, Human Capital and Reputational Factor.

Here’s their top 10 list of global financial centers:

(1) London, (2) New York, (3) Hong Kong, (4) Singapore, (5) Tokyo, (6) Zurich, (7) Boston, (8) Geneva, (9) Frankfurt, (10) Seoul.

At #7 in 2013, Boston was up 1 place from 2012, putting it ahead of cities such as Shanghai, Geneva, Frankfurt, Seoul, Dubai, San Francisco and Chicago and, well, everybody else.  Being a world financial center probably doesn’t hurt when entrepreneurs are deciding where to found and grow a new business.

Read the report. There’s a lot of interesting information there.

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Did You Know? 2013 – Technology Impact on Society and Business

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Amazing Images from the Cassini Mission

SaturnFollowing up on the space exploration theme in yesterday’s post (and one from a while back), here is a link to Nadia Drake / Wired Magazine’s summary of discoveries from the Cassini spacecraft’s mission to Saturn.

One of my favorites is the incredible hexagonal storm system on the North Pole that — like the great spot on Jupiter — seems to be a stable structure.  If you look closely, you can see the light green hexagonal storm on the image above.

Another really neat image is this view of five moons, aligned near Saturn’s rings:

SaturnMoonQuintet

As Nadia Drake said, one of the greatest space missions ever.

(Image source: NASA and JPL-Caltech)

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To Infinity… and Back!

SpaceX launches its first geosynchronous payload

Yesterday SpaceX launched its first satellite payload into geosynchronous orbit, at a price 75% lower than currently charged by other commercial launch providers.  Even more impressive is the fact that SpaceX has been steadily developing the required technology to slow down and return first stage boosters back to earth, which would even further decrease costs.

Watching this take off and landing test of the SpaceX Falcon 9 rocket reminds me of Buck Rogers:

 

(image & video source: SpaceX)

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