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This is Hubwonk. I’m Joe Selvaggi. Welcome to Hubwonk, a podcast of Pioneer Institute, a think tank in Boston. How does government funding drive breakthroughs in university research, turn into valuable products for consumers, and cultivate a thriving high tech economy? The framework that establishes the synergy between our university research system and high tech consumer product firms is largely defined in the 1980 Bayh Dole Act, which protects the rights of private firms to license patented university technology, whereas before the Bayh Dole Act’s passage, Many potentially useful breakthroughs were left untouched, but in the past 25 years, it is estimated that the law has generated 6. 1 trillion dollars for the U. S. economy and more than six and a half million American jobs. Recently, however, the Biden administration has proposed changing Bayh Dole to include price controls by giving lawmakers power to take patent license protection back from those firms deemed to be charging unreasonable prices for their products.
While the desire to control prices can be politically appealing, such provisions would put at risk the profits from any products derived from university patents, and all but eliminate incentives to invest in products yet to be developed. How do current laws encourage technology companies to harness university patents, and how might the proposed changes in the law put those incentives at risk?
My guest today is Senior Fellow and Director of Pioneer Life Sciences Initiative, Dr. Bill Smith, who has written extensively on the importance of intellectual property protection for new product development, particularly in life sciences. Dr. Smith will share with us how the 1980 Bayh Dole Act serves to cultivate the synergy between university research, High tech product production and discuss his concerns That proposed amendments to control the prices of patent derived products could reduce or eliminate incentives for firms to refine ideas into valuable consumer goods.
When I return, I’ll be joined by Pioneer Institute’s Senior fellow, Dr. Bill Smith. Okay, we’re back. This is Hubwonk. I’m Joe Selvaggi. I’m now joined by a Hubwonk listener favorite, senior fellow and director of Pioneer Life Sciences Initiative, Dr. Bill Smith. Welcome back to Hubwonk, Bill.
Dr. William Smith:
Joe, my pleasure. Great to be here.
Okay, Bill, it’s good to have you back. I framed our conversation for today’s podcast in the intro as being something about the relationship between university research and the many high tech companies that we see all around us. And of course, the valuable consumer products that they produce this by Dole Act is really the framework around which all those firms thrive. The university thrives. So let’s start our show off by helping our listeners understand what is the Bayh Dole Act?
Dr. William Smith:
So Joe, we’ve always had a very vibrant university research community, right? Harvard, MIT have been around a long time. They’ve done a lot of very interesting research. But in this 70s. Mostly they were coming through with all these breakthroughs. Some of their research was funded by the government the national science foundation has been around since 1950 NIH has been around since 1880 So and the defense department has funded research so a lot of university research is funded by the government and the problem with that is that If they make a discovery and they put a patent on it The government owns the patent.
Prior to 1980 the government and commercial companies were reluctant to partner with universities on some of these discoveries and patents because they were afraid the government was gonna actually take away their product or the invention and deny them the use of it. So the environment in the use university research community was not akin to commercialization.
That was the problem. And I think Senators Bayh and Dole recognized that. And in 1980, they passed a law basically saying that a university patent Even if it was funded by the government could be licensed to a commercial company and they encouraged this to happen through a variety of statutory changes.
They encouraged universities to commercialize their patent and what happened was a boom of commercialization and I believe Personally, that, the ecosystem, the the ecosystems of life sciences that have grown up around Stanford and MIT and Harvard and places like that, largely developed because of the Bayh Dole Act, because university discoveries could suddenly be thrown out into the commercial marketplace and companies started popping up around these universities.
All right. There’s a lot to unpack in what you just said. And for the benefit of our listeners, you say, okay, in the past, again, MIT, I think Harvard’s been around, what is it? 1639. So it’s been a while, coming out with great ideas and in the past, before this act, those ideas would perhaps sit in the lab, or be patented and they exist in this, in the world, but they might just stay there in the lab. Why would a the ability for a private company to capitalize or commercialize and make money on that government research creation? Why would that move a great idea from a lab into a, into products you and I can use?
Dr. William Smith:
Again, prior to Bayh Dole, it wasn’t clear who owned the patent, right? It was clear that the government owned the patent, but if a company wanted to go get an invention that had been invented in a university lab, that had been funded by the government, it wasn’t clear that they could take that product to market.
And the government could step in at any point and say, wait a minute, that’s our patent. You can’t make money on that. Bayh Dole changed all that. And Bayh Dole said. When a university makes a discovery, even if it’s funded by the government, they own the patent, the university does, and they are allowed to license that patent to a private company who wants to turn it into a product and, royalty deals like that are allowed Suey Generous.
You got to look at them and find out how important was the university discovery to that product. And the more important it was to discovery, the more royalty should be. And if it’s just a minor discovery that helped a product get to market then maybe the royalty shouldn’t be as much. You have to look at all of these deals to see how valuable they are to the taxpayer.
Let’s take a step back and talk about patents. You and I have talked about the value of patents. But for our listeners, when I invent something, the government effectively gives me a legal patent. It reviews the technology. I have to lay it out for the government and say, this is what I’ve invented.
I can’t remember the criteria. It has to be novel, not been around. It has to not be obvious that somebody else is likely to have invented it, and it has to be useful. And after that, it’s been deemed useful to patent, but effectively the government gives me the exclusive right effectively in a monopoly exclusive right to sell this product to and no one else can make this product.
Why is that valuable? Why? Why in a free market? Shouldn’t everybody? Why shouldn’t information and products just go out into the world and to everyone instantaneously?
Dr. William Smith:
It’s very simple. And I think James Madison understood this when he put the patent clause into the constitution. No inventor is going to spend a lot of time and money seeking an invention.
If that invention, the moment it’s put on the market can be immediately copied by somebody else and sold by somebody else. It just there’s no incentive to innovation when you’re when your discovery can be immediately stolen and so Madison said in the constitution Patents can be granted for useful inventions for a limited period of time.
He didn’t want monopolies to be everlasting. He wanted them to be limited. And when it comes to biopharmaceutical products, the patent life is 20 years. Congress has decided that 20 years is the acceptable limited period. And many times, the molecule that’s under consideration to be a drug is patented early in the R and D process.
So they’re not even selling it yet. It might be in the R and D process for 10, 12 years. And that company might only be able to sell it under a patent for 8, 10 years.
Okay so imagine a university then does develop a, let’s say a new molecule, again your expertise and our conversation usually focus on medical therapy.
So we have an important breakthrough, we’ve got a new molecule, and it’s sitting on the shelf with a patent. Now it’s a decision of a commercial firm to say, okay, I can do two things, I can ignore this. Or I can license that or have that license to me. I can pay for all the trials that go into it, and make sure it actually works in the real world, and then commercialize it.
And then, but even though the government has essentially funded the creation of this thing, I can make You know, a fair amount of money if I take it to market. Without that protection, what you’re saying is, because I don’t have the opportunity to make money, I’m not going to go through the trouble of giving it the test.
So it will remain on the shelf and not in the hands of consumers that could otherwise use it. Is that fair?
Dr. William Smith:
That’s fair. And, the companies that commercialize a product that comes from a university need to pay royalties and those royalties should be fair and, you have to look at specific deals to decide what is fair and what is not fair. But basically the university does make money when patents that they discover, discoveries that they patent end up in the marketplace.
Now we’re going to get a little more technical into the provisions in Bayh Dole that do say, look, if you if we effectively pay for this research you, Mr. Person who wants, firm who wants to use our patent, our technology for commercial uses, there are some provisions in Bayh Dole that allows the Government to, I’ll use their term or it seems like a universal term, march in and take back the patent or in a sense where the patent exists, the government doesn’t just essentially relinquish all rights and allow a commercial enterprise to do what it likes with that patent.
And there are provisions to march in, say more about conceptually, what does march in mean?
Dr. William Smith:
There are, but that provision was actually put in there to encourage commercialization. So the authors of Bayh Dole said, you know what, if you invent something useful at a university and it’s sitting on a shelf and not being commercialized, the government can march in.
Take that discovery and license it to somebody in the commercial marketplace to make money the marching provisions were designed to actually force universities to commercialize now we’ve never had to use them the government’s never marched in and taken a patent and licensed it. Because it was sitting on a shelf largely because there’s so much incentive for commercial companies to come in and commercialize patents university discoveries.
It’s not a provision that’s been used. But it sits there and the government, if there was a, gigantic discovery, for example, that would change cancer research or change cancer therapies, and the university was not commercializing it, the government could step in and say, you know what, you got to give this patent to Genentech so they can create a cancer product.
So even though this exists the fact that no one’s marched in and the government has not marched in and taken the patent because again, if it’s valuable, the private or the commercial sector will recognize it’s important. Will find it. Yes. Absolutely. And they’ll find it. By the time the government figures out it’s useful, it’s either not useful or, somebody’s already done it.
Exactly. Though a margin provision exists. It has not been exercised yet. Now we’re coming up to current times and a very good paper thought piece or white paper you’ve authored at Pioneer talks about this being reconsidered. These marching provisions being expanded to allow for the government to march in, not because it’s sitting on the shelf, but rather it’s being used and perhaps being used improperly.
Describe for our listeners why what are the changes in the margin provisions being contemplated by the current Biden administration?
Dr. William Smith:
And by the Senator from Massachusetts, Elizabeth Warren, but basically because this march in provision exists, they want to use it to essentially march in and take the patent from a patented drug that’s being sold as a branded product.
Give that patent to a generic company to sell it more cheaply. So they want to use march in rights to strip intellectual property from inventors.
Okay, again, you said it so succinctly, I want our listeners to understand. We’ve established that a, Product A was developed with public funds at a university and patented.
A commercial enterprise deems this valuable, pays royalties, develops the product, sends it to market, and charges what it charges, what the market will bear, right? It’s rules to make money on this. And what we’re talking about, what we’re contemplating with our own Senator Elizabeth Warren, would be you can do all those things. We’re great with that, except. If you charge too much, we want to reserve the prerogative to come in and not take the patent, but effectively take the patent, give it to a generic so that somebody can compete with you and charge nothing. So effectively wipe out your patent, your legal monopoly.
And essentially your profits that were expected would effectively go to zero. Do I have that about right?
Dr. William Smith
Yes, you do. The only word I quarrel with that you used is a monopoly. There’s this myth that drugs that are under patent have a monopoly. And just from someone who’s been at Pfizer and been in the trenches of competition, I know that patented products… have enormous competition. They don’t have a monopoly. So Lipitor was the best selling cholesterol lowering drug in the world, but it had enormous competition from Merck’s Zocor, from all sorts of other branded patents. So patents don’t eliminate competition. They only prevent people from copying your exact invention and reselling it.
And that’s, that should be clear because the statin market, and this was true to some degree with hepatitis C drugs, branded drugs compete like crazy. That’s one of the reasons television advertisements for drugs because they’re competing with other branded products and they’re trying to get market share.
And the competition for the statin class when I was at Pfizer was vicious. They were, everybody was trying to discount rebate and provide discounts to get their preferred statin onto a health plans formulary. So it’s a myth that patents create monopoly pricing. It’s just not true.
Okay, I think conceptually, I was just talking about the idea of a particular drug, not a drug class, again, I’m over my head here talking about the difference between a drug and a drug class.
So yes, every drug has competition. So what we’re talking about here, and also, I think it’s important to know, and we have talked about this in earlier podcasts, that patents aren’t eternal, they are limited in their time. And by the time they go through the gauntlet of approval, by the time we can buy it in the store and pay list price, that patents, seven years in the in the future.
So it is an eternal it’s brief. And as you mentioned, there’s always alternative to any drugs, but let’s return to the idea which is to say that if the government and it doesn’t I don’t think contemplate what it expects producers to charge reasonable prices. And that’s when my my spidey sense starts to tingle here.
When the government starts to decide what prices are reasonable and which are not, of course, we can always have lively rhetorical flourishes about the middle class getting hammered and price gouging and all kinds of corporate greed. But once the government says, that price is too high, it’s not reasonable.
And like the sword of Damocles, they can walk in, and if they deem reasonable, you’re charging too much, we’re going to take your right to charge. Effectively anything away from you on at our whim. Am I being, too.
Dr. William Smith
No, that’s right. And it’s I am concerned personally, that intellectual property is not as well respected as it was a few decades ago. Some of the legislation that happened in the 1980s, not just by Dole, but the Orphan Drug Act and the Hatch Watsman Act. Those legislators on a bipartisan basis understood how intellectual property worked, how they could incentivize innovation, and when it comes to the Hatch Waxman Act, how they could encourage generic drugs to get into the marketplace faster and make drugs cheaper for consumers.
So there were, legislators were very sophisticated back in the 1980s about intellectual property, and I’m concerned that our contemporary legislators aren’t as sophisticated. They’re willing to strip intellectual property from inventors very quickly and almost whimsically.
Yes. And to me, again I’m not sure Senator Warren has a firm grasp of how the economics of Bayh Dole work, but we do have, of course, a natural experiment.
We say we, we knew what the world looked like before we had Bayh Dole. We know what we have now. And we probably know if we were to effectively invalidate its value, which is to say, yes, you can have a patent unless we decide to take it back. We could then predict what’s in the future that I read an important research paper that was talking about estimating the value of Bayh Dole, which is to say what would without Bayh Dole, these great products would have sat on a laboratory shelf and not been commercialized.
It estimates that in the last 25 years Bayh Dole has contributed 1. 9 trillion to the U. S. economy and created six and a half million jobs. So the inverse of that is that if we weaken Bayh Dole, which is to say if we make patents so fragile that a government may decide that the person who’s commercialized or the firm that’s commercialized it is charging too much, effectively, there is no Bayh Dole Act.
No one would, in his right mind, right? I don’t want to put words in your mouth, but if my patent is at risk, in other words, I’m going to do all the technology, I’m going to commercialize this product, and if somewhere down the road the government decides I’m charging too much for it and takes away my patent, all my plans are gone.
Dr. William Smith:
And if you’re a biotech investor, why are you going to continue to invest in biotech? Why not go to energy or some other sector? If the government someday is going to step in and strip away your patent and destroy your commercial product. And by dole, in part helped create these, as I said, life sciences ecosystems that exist around universities.
And it’s, University researchers, medical schools foundations, and commercial companies all collaborating on life sciences breakthroughs. It’s an amazing thing that’s been created, and the government can mess it up very quickly.
I don’t want to keep beating the same dead horse, but I again the same paper estimated that before Bayh Dole, there was nearly 28,000 patents inventions gathering dust on government shelves.
And before 1980, when Bayh Dole was passed, only 5 percent of patents based on federally funded research were ever used in the private sector, meaning 19 out of every good, 19 out of every 20 good ideas never saw the light of day. And so what we’re doing is we’ve come into the light of Bayh Dole and with perhaps well intentioned changes, we may go back into that dark space whereby no one in his right mind would do this.
I we, you and I always talk about pharma biotech. It’s vital to our world here in Boston, you just have to look across the river at Cambridge and all the big, beautiful new buildings and all the prosperity we see in our region. And of course, as we mentioned, we have ear to ear with schools they’re everywhere.
And that wonderful synergy between research and commercialization of these products that frankly, create. Vaccines that, the world can use all that is at risk, not just our health, not just our country, but certainly our region where we, this synergy, this one plus one equals three, all this good stuff happens locally.
Why would our Senator or our, we have a, delegation even consider such a thing that would, you know, to, to me, a lay person would put it all at risk.
Dr. William Smith:
I can’t. I’m not a politician, so I can’t look behind her eyes. She must know how damaging it would be to the Massachusetts economy if the government started marching in and taking the right, the patent rights of biotech companies away.
But I suppose it’s a trade off and she thinks that voters who care about drug prices and what they’re paying that for their drugs out of pocket are more important than the bioscience sector in the state. I, that’s the only trade off I can think of politically. But it’s damaging because, you’re going to see fewer and fewer innovations if these things start to happen if the government starts to take away patents.
Now, let me just I can imagine a listener on the other side saying, okay, listen, guys this technology wouldn’t exist, but for our taxpayer research, look, these government, these private companies are making billions of dollars on something.
We, the taxpayers invented. Why shouldn’t the government at least be able to reserve the prerogative to say, if you use our technology to create millions and billions of dollars worth of wealth, why shouldn’t there be some provision, some sort of tool in the toolkit to ensure you’re not quote, unquote, price gouging and taking it to the same consumers who fundamentally. Underwrote your basic research. Why speak to our listeners who don’t get it.
Dr. William Smith:
Yeah, I think what they fail to understand is that typically the government funded or university research, they make important breakthroughs. But for example, they might discover there’s a certain enzyme that creates pain.
Great. That’s a great discovery to know. And a biotech or a pharmaceutical company, when they find out that an NIH researcher at Harvard has figured out which enzyme causes pain. What do they know? They know that they have to block that enzyme. How do they block that enzyme? They need to find a molecule that will block that enzyme.
And then they need to do clinical trials to prove that it’s limiting people’s pain. And so, the company will end up spending billions of dollars because yes, the government funded research provided a certain insight into how the human body works, but they didn’t do trials. They didn’t invent a molecule that’s going to solve a person’s pain problem.
They basically just provided an insight, which is valuable and which we want, but it’s not, the NIH budget, for example, is about 40 billion. The biopharma industry spends 200 billion on R& D. What’s spent by commercial companies dwarfs what is spent by universities and by the government. And those universities and the government funded agencies do make important breakthroughs that help inform how to come up with a new therapy, but they don’t discover new therapies, generally.
So that’s great insight, essentially the basic research is the spark and then the flames are flamed by, private industry and ultimately to us, make it available to us, the consumer we keep talking about pharma. I know it’s your expertise and something we focus on regionally, but Bayh Dole doesn’t just… limit or doesn’t create or potentially create a fragility in these patents just for pharma. This is for everything. It could be computers, it could be energy, it could be transportation. We are focusing on pharma, but if I build a better mousetrap or I invent a technology for a battery that could, double the range. It might just sit there in the lab because nobody can scoop it up and put it in a real car. Is that right?
Dr. William Smith:
Absolutely. Absolutely. For example, quantum physics. There are going to be breakthroughs in quantum physics that are going to make computers 10,000 times faster than the computers we have now. And so you want Breakthroughs in quantum physics to be commercialized by the Microsoft’s and the Apple’s and the computer makers because you want these high speed computers to analyze data and do a million valuable things and Bayh Dole allows Commercial companies, computer companies to go into a quantum physics lab at Harvard or MIT and say, “hey, this patent you put on this is going to be very valuable in us building a super fast computer. Will you license it to us?” Yes, it’s not just biotech and pharma that Bayh Dole encourages commercialization. It brings useful products in any field.
So you the reason I know anything about this is you’re good enough to write a paper Which leads to another paper and has a couple of good links to more research I went on a deep dive into this I think perhaps for many of our listeners this is the first time they’ve heard of Bayh Dole or the how it works where research public research or publicly funded research finds its way into private markets into consumers hands.
Where can our listeners learn more about what your work and just this whole Bayh Dole issue so that they’re well informed and perhaps might engage with their elected representatives?
Dr. William Smith:
They should look for a paper that we’re about to put out sometime in the next two weeks on intellectual property that explains a lot of these issues.
If they really are interested in this, I would recommend the Congressional Research Service. Which their products are available online to anybody in the public now. And You can search Bayh Dole and Congressional Research Service, you can search Hatch Waxman and the Congressional Research Service and it’ll give a history of the legislation and explain the issues that the legislators were dealing with, how they were trying to protect innovation, but also get cheaper drugs to consumers.
And I find, I found it very interesting when I was doing the research for the paper because I found these legislators. To be particularly sagacious and particularly concerned about protecting inventions and innovation in a way that I don’t see contemporary legislators acting.
Indeed, like the people, it was Bob Dole who ran for president, he was a presidential nominee and by, these are two senators that, when reading this thought piece behind this act, really understood its value.
As you say it’s saddening that we’ve lost our way. I thought an interesting feature that you brought up in one of your papers was that, they deliberately contemplated having some sort of provision whereby publicly developed research was commercialized. They thought about putting some provision in it that would have, explicitly allow the government to step in if that product were priced too high, and they deliberately decided that was not something they should have. They didn’t forget it. They said, we could do it, but we think it’s a bad idea. Let’s go out on why they thought it was a bad idea.
Dr. William Smith:
Because I think they understood, which a lot of legislators now don’t understand that the government is a very blunt instrument and sometimes an objectively wrong instrument when they try to make market based decisions about prices and things that exist in the commercial marketplace.
They’re just, the government’s just not good at that. and anybody who’s been to the DMV or has had experience with the government knows that they’re not going to be the ones to efficiently get a product to market and price it appropriately. All right, Bill, we’re talking about the way the government potentially can distort markets if it has the ability to come in and take away a patent because of, it thinks a firm is charging an unreasonable price.
This reminds me a little bit about an earlier conversation you and I had about provisions in the Inflation Reduction Act that took away some patent protections for small molecule drugs. We haven’t talked about that in a while. Do you see similarities, potential similarities, if we were to make these changes proposed in the Bayh Dole Act.
Is it similar to what you saw as distortions, potential distortions in the inflation reduction acts regarding small molecules?
Dr. William Smith:
Yeah, the Inflation Reduction Act provides an enormous disincentive for companies to invest in small molecule research. And there’s a lot of small molecule research in oncology and neurology, two very important fields.
And the price control process on a small molecule can start seven years after approval. So many of these molecules may even be under patents. When the government steps in and ratchets down the price, essentially stripping the patent away. Now, they’re not stripping the patent away, but it is de facto stripping the patent away if you knock down the price of a drug 80 percent by government fiat.
So it’s very problematic when the government gets involved in stuff like this.
So since that happened again, some people have been happy, but they were committed to reducing again. Reasonableness was the criteria they just like Bayh Dole. They were going to take the 10 most expensive drugs. And as you say, not take away the patent, but mandate a price that is lower than would otherwise be. How is that working? You and I haven’t talked about this in a while.
Dr. William Smith:
Yeah they’ve already announced which 10 drugs will be subject to price controls. They created that list and made it publicly available.
And interestingly, the 10 drugs that they selected were not the 10 most expensive drugs, the 10 most costly drugs for the Medicare program. They selected the 10 drugs that were heavily used by seniors, not the ones that cost the most for the federal government. No economist likes price controls, but at the very least, you can say if they’re reducing the deficit, there’s a silver lining a little bit in this program, but they selected 10 drugs that aren’t even going to reduce the deficit.
In a maximal way, because they wanted to select drugs that are heavily used by senior citizens who are important voting block. So you know, this, the government tends to make decisions in a political way that’s not always the good policy. And I think this inflation reduction act is shaping up as being one of those examples.
So to map it into Bayh Dole, if we were to say which of the firms might have the government come in and, deem their price unreasonable and essentially give their patent to a generic firm, effectively wiping out any potential for profit, that might not be guided by the government. Some economist determination of reasonable or rather either political vendetta or to appease the demands of the loudest voters who want a particular drug for free.
Dr. William Smith:
So exactly, they might not make the decision based on the fiscal impact of price controlling that drug. They might say this is going to please the most voters if I knock down the price of this particular drug. So it’s a very arbitrary process and we just don’t want to go down this road.
One that would make it particularly it would seem to me the drug firm that was thinking about a particular product and using that patent licensing the patent god forbid it is wildly successful and everyone uses it that would provide a huge incentive for the patent to be taken up.
Dr. William Smith:
Generic, when you’re making decisions about R& D projects, you might say, you know what, a lot of seniors are going to use this drug. Let’s not go down this path. Let’s work on a rare disease drug.
The temptation to make it generic would be overwhelming for politicians looking to exactly these voters.
Yeah, so and the end result isn’t that the drug is cheap, it means the drug doesn’t exist, because no one decides to commercialize it, right? So, we’re all poor for this, perhaps well intentioned, but woefully misguided program.
So yeah, we agree. Find your work at least which will point them in the right direction.Where can we read more?
Dr. William Smith:
Pioneerinstitute.org is our website, and you can go on our life sciences section and see all the stuff we’ve put out. And again, the intellectual property paper is not out, but it’s being edited and formatted and finalized as we speak. So, it will be out within 10 days or so is my guess.
I appreciate your work in this field again. You opened my eyes. I hadn’t no knowledge of this particular feature, but always wondered how the, the interaction between government research and private commercialization worked and you’ve opened my eyes. So, thank you very much for being a guest on Hubwonk once again, Bill, you’re a great asset.
Dr. William Smith:
My pleasure, Joe. My pleasure.
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Joe Selvaggi talks with Pioneer Institute Senior Fellow Dr. Bill Smith about the benefit of the Bayh-Dole Act’s protection of intellectual property rights for university research patents and the risk posed to the nation and the local economy from recent efforts to consider price controls on products developed from patented discoveries.
Dr. William S. Smith is a Senior Fellow and Director of Pioneer Life Sciences Initiative. Dr. Smith has 25 years of experience in government and in corporate roles. His career includes senior staff positions for the Republican House leadership on Capitol Hill, the White House Office of National Drug Control Policy, and the Massachusetts Governor’s office where he served under Governors Weld and Cellucci. He spent ten years at Pfizer Inc. as Vice President of Public Affairs and Policy where he was responsible for Pfizer’s corporate strategies for the U.S. policy environment. He later served as a consultant to major pharmaceutical, biotechnology, and medical device companies. Dr. Smith earned his Ph.D. in political science with distinction at The Catholic University of America.