Every once and a while we get a clear example of the gulf between those battling over important public policy issues and can understand why the public and policy makers are confused by resulting charges and counter charges. Last week was a good illustration.
The Washington Post reviewed a study by the Tufts Center for the Study of Drug Development in its story titled Does it really cost $2.6 billion to develop a new drug? As the title implies the claims of huge costs and risks undertaken by drug developers are summarily dismissed by their critics. The story fairly presents both sides of a debate with vastly different worldviews.
The Tuft’s study estimates that the costs of drug development have doubled from $802 million in their 2001 study to $2.6 billion today. The causes include:
Every once and a while you get a reminder that lives are literally at stake in some R&D partnerships. Last Wednesday was one of those days. I was privileged to moderate a panel for the Congressional Technology Transfer Caucus on innovative partnerships fostered by the National Center for Advancing Translational Sciences (NCATS) the newest center/institute at the National Institutes of Health. It was anything but a run of the mill tech transfer session.
We often hear that $2 billion to $5 billion are required to commercialize a new drug, with 14 years or more required for development and a 95% chance of failure. Less well known is that for thousands of serious diseases plaguing humanity only about 500 have FDA approved treatments available. Stark as that seems it’s downright cheery compared to rare or neglected diseases. Of more than 6,500 such ailments only 250 have treatments. While these may be “rare” diseases for many of us, to millions of our friends, families and neighbors each morning brings another day of suffering desperately hoping that someone, somewhere is working on a cure.
Editorial Note: This month’s column from Joe Allen comes from his plenary address to the Eastern regional meeting of the Association of University Technology Managers, which took place in Baltimore, Maryland, on September 18, 2014. CLICK HERE to view his PowerPoint presentation, which includes facts and figures that support the positions taken in this article.
They say when speaking that you should repeat your message at least three times. Here’s the first: Bayh-Dole has succeeded beyond anyone’s wildest imagination. It was not created to benefit universities but the American taxpayer. You are the stewards of a public trust and have an obligation to defend and protect the law in the same way as the Founders of AUTM protected it for you.
Research universities are now recognized drivers of our economy and your discoveries improve lives around the world, but that wasn’t always the case. The reason is the Bayh-Dole Act which gives certainty and predictability to the ownership and management of publicly funded inventions so they can move from the lab into the marketplace.
Last week I was speaking in Brazil which adopted a technology transfer law to spur university-industry partnerships. Unlike Bayh-Dole theirs is full of uncertainty which is undermining its impact. I explained that having clearly stated rules is an essential ingredient for success because companies are undertaking a tremendous risk when turning university technologies into useful products. The time and expense of development is borne by the business—not the government or the university. Companies cannot justify this effort when the bureaucracy inserts itself between a university and its industry partner. That was the situation in the US before enactment of Bayh-Dole and it caused the benefits from billions of dollars of taxpayer supported research to go right down the drain.
Entrepreneurship is hard anywhere. It’s especially difficult in government where all too often agency lawyers, committees and bureaucratic procedures smother promising new ideas under reams of red tape. This makes a partnership between the National Cancer Institute (NCI), the Avon Foundation and the Center for Advancing Innovation boosting new treatments in the fight against breast cancer all the more remarkable. That this initiative was conceived and launched in a large federal agency in just a few months illustrates the difference that a few inspired people can make.
A critical factor not stressed enough in technology commercialization is the need for a passionate commitment to success. Taking early stage discoveries from the lab to the market is a long, arduous, daunting journey. Without an all-consuming passion to overcome all obstacles and keep getting back up after repeatedly being knocked down, the chances of success are remote. This is hard enough at best. Yet too many times entrepreneurs in large organizations face additional cultural barriers that doom their efforts before they ever get started. Effective leaders recognize this trap, insuring that internal processes and procedures support product development, not thwart it.
There’s a famous Chinese curse “May you live in interesting times” which certainly applies now. It seems that every cornerstone we’ve relied on has slipped, creating instability in all aspects of modern life. As humorist Ogden Nash remarked: “Progress might have been all right once, but it has gone on too long.”
We live in a world where seemingly everyone has a cell phone —and a rifle. Every day we learn of breathtaking scientific discoveries and atrocities straight from the Dark Ages. Thanks to technology images of beheadings travel instantly around the world.
Debates rage over hot button topics widening divisions in society. One is over the merits (or demerits) of the patent system. That’s really a subset of a larger question: does innovation lead to prosperity for most people or does it merely widen the gap between the haves and have not’s?
What, if anything, should be done to correct “income inequality” is a point of contention in our political system. President Obama says that growing income inequality and a lack of upward mobility is “the defining challenge of our time.” Sen. Elizabeth Warren (D-MA) ads: “Trickle down (economics) doesn’t work. Never did.”
~ When your enemy’s making mistakes, don’t interrupt him. Billy Beane (General Manager of the Oakland A’s) in Moneyball
~ Can’t anybody here play this game? Manager Casey Stengel in anguish over his 1962 New York Mets. The team went 40-120– the most losses by any team since 1899.
As an avid baseball fan nothing makes me crazier than seeing my team lose because of dumb unforced errors. And anyone who follows the Pittsburgh Pirates has seen more than their share of these (like on Friday the 13th under a full moon when our pitchers walked 6 batters in the 9th inning blowing a comfortable lead). Countries, like sports teams, make inexplicable unforced errors leading to loses that are a lot more significant than just losing a game. Two recent articles and one anecdote caution that if the US loses its technological lead it could be because of our own blunders rather than what our competitors are doing.
The first article illustrates the significance of one of our greatest resources: our unequalled system of publicly supported R&D. Patents as proxies: NIH hubs of innovation published in the June edition of Nature Biotechnology documents the tremendous potential federally-funded inventions have to help move the life science industry forward. Of course, potential is a double edged sword: every day teams with more potential lose to those who play the game smarter, avoiding unforced mistakes.
Patents as proxies looks at medical innovation which employs one million Americans, generates $84 billion in wages and salaries and $90 billion in exported goods and services. The U.S. biomedical industry dominates the world largely because of successful partnerships between our public and private sectors. Taxpayer supported inventions made in universities and federal laboratories are licensed under the Bayh-Dole Act to the private sector for commercial development. The article notes the resulting impact as universities created 1.7 new companies per day and 657 new products from their patent licensing in 2010 alone. It estimates “that approximately 30% of the total value of NASDAQ has roots in academic research.”
“When I use a word,” Humpty Dumpty said in a rather scornful tone, “it means just what I chose it to mean- neither more nor less.” ~ Lewis Carroll
Humpty Dumpty with Alice, from “Through the Looking Glass.”
Far be it from me to criticize anyone’s skills in using a foreign language as my greatest challenge in getting out of college was the requirement to learn one. I did OK when we talked about French, Spanish or German culture and history—but those discussions were in English. The problem began when the instructor insisted that we try to talk in the other language. My brain immediately went numb. I used to sit in the very back of the class sweating bullets that the clock would finally tick down before the professor could call on me. I can still recall the terrified feeling as our German class wound down to the last 5 minutes and the kid next to me was speaking. “Please, talk slow,” I prayed. If that failed, I went to my “prevent defense” asking the professor to repeat the question as seconds slowly ticked off. When that failed, I was in deep kimchi (one foreign word I can say successfully, but that didn’t get me any points in French, Spanish or German).
Perhaps my greatest academic achievement was finding a degree that didn’t require learning a language. Otherwise, I’d be like Zonker Harris in the comic strip Doonesberry who’s been in college for 40 years. You have to wonder how much he owes in college loans by now, but that’s another story.
After seeing how the federal agencies intend to implement the recommendations from The White House Lab to Market Summit the difference between product and process oriented people really hit home.
Product people burn with a passion to get the job done. Process people focus on rules and procedures to minimize risk. Thus, product people are like the accelerator and process people are the brakes. You need both in your car, but if the brakes run the show you’ll never get out of the driveway. Similarly, whenever deal makers are subservient in a system to process people, frustration is sure to follow.
Last year the White House put together its Lab to Market Summit and asked Diane Palmintera and me to co-chair a panel of external experts to review several innovative agency technology transfer programs and come up with “transformational, not incremental” ideas to increase the commercialization of $140 B of federally funded research.
Steel yourself, gentle reader. This month we go hunting the living dead: arguments that keep climbing out of the grave to bite and infect the unwary.
Four months after NIH rejected the latest attempt to misuse the Bayh-Dole Act to control drug prices zealots have risen from the crypt claiming the law should be used to haunt drug developers. March-in rights were designed to force universities to issue additional licenses if effective efforts are not being made to commercialize a federally funded invention; if the licensee cannot meet national health, safety or regulatory needs; or if the licensee fails to make the product in the U.S. despite a pledge to do so.
Critics claim there’s another trigger: if they don’t like the price of a drug. While the cost of new drugs is a concern, their solution sucks the life blood out of a system leading the world in protecting public health. It’s time to drive a stake through that spectre.
This month’s column is based on my remarks to the Association of University Technology Managers (AUTM) at their annual meeting in San Francisco.
First of all, congratulations! You made TheWashington Post and they even spelled your name correctly. Unfortunately, AUTM was specifically called out in an article titled Patent Trolls Have a Surprising Ally: Universities.The name of another article appearing at the same time Patenting University Research Has Been a Dismal Failure, Enabling Patent Trolls: It’s Time to Stop while long winded speaks for itself. And two innocuous sounding reports from the Brookings Institution Building an Innovation Based Economy and University Start-Ups: Critical for Tech Transfer say that Congress should amend the Bayh-Dole Act to give the federal government control over whether you can grant exclusive licenses, that you have been unsuccessful as most technology transfer offices are not self-supporting, that your business orientation conflicts with the mission of a university and your alleged model of “licensing to the highest bidder” has failed. The New York Times accurately summarized the intended message in its headline Patenting Their Discoveries Does Not Pay Off for Most Universities.
For a profession that keeps a low profile and goes out of its way not to antagonize people, you may wonder what in the world’s going on that you are gaining such notoriety. The answer is that you are in the sights of several groups who do not wish you well. Some want to weaken the patent system for their short term benefit, some believe society would be better off if inventions were freely available without patents; some don’t think it’s moral for universities to work with industry, and others believe they should determine who reaps the rewards of innovation. While operating on diverse belief systems, they all have one thing in common: they don’t like you.
The report makes some good recommendations for increasing support for start-up formation, but implies that most university technology transfer offices (TTO’s) are not worth their cost because they are not self-supporting through patent licensing income. As Brookings acknowledges, universities spend the vast majority of their licensing revenues rewarding inventors or funding new research, not in supporting technology transfer operations. Brookings recommends that universities shift focus from patent licensing to start-up formation.
Ironically, recommendations from a preceding Brookings study would make both start- up formation and patent licensing more difficult.
Baseball is a good analogy for politics, which is why political talk shows have names like “Hard Ball.” A defining moment for any hitter is realizing that a 95 mile an hour fastball has just been deliberately thrown at your head. Pitchers throw the “beanball” is to see if a batter has the courage to play the game knowing that the risk of serious injury is literally an inch away. As former Dodger pitcher Sandy Koufax said: “Pitching is the art of instilling fear.”
A similar challenge is delivered to those who get in the way of well-funded lobbyist’s campaigns. An equivalent of the beanball is the attack article in the Washington Post, the paper of record for the political class. So it should not be surprising that as soon as universities announced that they could not support the House patent reform bill in its current form that a beanball was immediately headed their way.
“The pitcher has to find out if the hitter is timid. And if the hitter is timid, he has to remind the hitter that he’s timid” said Don Drysdale, a pitcher who built a career successfully intimidating batters. In baseball and politics the message behind the pitch is the same: “Kid, are you sure you want to take me on?”