Christopher Molineaux is president of Pennsylvania Bio, the only statewide trade association for the life sciences industry whose membership includes medical device, diagnostic, biotechnology, pharmaceutical and research organizations. Prior to joining Pennsylvania Bio in September 2009, he served as worldwide vice president of pharmaceutical communication and public affairs for Johnson & Johnson.

 

Molineaux previously served as vice president of public affairs at the Pharmaceutical Research and Manufacturers of America, prior to which he was vice president, communications and marketing, at the Blue Cross and Blue Shield Association, based in Chicago.

 

MDD: Your organization has undertaken an interesting new initiative by acquiring the Life Science Career Alliance in Philadelphia and planning to transform it into a statewide initiative. Tell me how that came about and your plans for the future.

 

Molineaux: The Life Science Career Alliance was founded in 2002. It was a regional initiative run by the Philadelphia Workforce Investment Board, as a subsidiary of that group. Their mission was to train and develop the workforce at multiple levels within hospitals and health systems – life sciences broadly, but they really were focused on hospitals and other healthcare facilities to provide updated training to keep that workforce current.

 

The Philadelphia Workforce Investment Board recognized that the mission could be expanded beyond the Philadelphia region. We started conversations with them about a year ago on how to work together to expand their mission and their impact. As the only statewide trade association for the life sciences in the Commonwealth, we now have a membership of more than 530 organizations, we have expanded our presence in the Pittsburgh area with more than 60 member companies, and we have members in the Lehigh Valley and in Central Pennsylvania; it seemed like a natural move for the Life Science Career Alliance to go statewide.

 

So we started those conversations, but candidly, we did not have any experience or background in workforce development, so it took some real introspection to make a decision on whether this new idea fit with our strategic priorities and direction. What we recognized after a lot of deliberation was that, as a trade association and as an industry across the state, if we could help create a workforce within hospitals and health systems that ultimately could benefit our industry, whether it's medical devices, diagnostics, biotech or pharma, that would in fact create a pipeline that could feed a supporting cast into industry.

 

When you look across the biopharma space in particular, many of the companies are now outsourcing a lot of their development work. The device companies are doing some of that as well, but it's really obvious on the pharma side. And they're outsourcing that development work to hospitals and health systems in many cases, in addition to contract research organizations and contract manufacturers.

Organizations like Geisinger Health Systems have been doing this for a while, as has the University of Pennsylvania, but our feeling was that if we could help accelerate that capability within hospitals and health systems, that would benefit the new structure of the industry, which is more of a mosaic of outsourced functions.

 

One of the core missions of what is now known as the Pennsylvania Life Sciences Institute is to create a curriculum that will help develop that workforce of the future, a workforce that can help with broadening this mosaic and executing across the state. We'll take that out to Pittsburgh, we'll take it to the Lehigh Valley, so that workforce development for the life sciences industry becomes statewide and takes advantage of the powerful network of companies and resources within our membership.

 

MDD: One of the areas you have cited as being offered by the institute is training for entrepreneurs in the life sciences. From your perspective, what's the state of medical device innovation in Pennsylvania, and in the U.S. in general?

 

Molineaux: The state of innovation is very strong – there are a lot of very interesting projects and products going on within our universities. There is a growing stable of entrepreneurs, and now there also is a growing network of resources to support those entrepreneurs.

 

Just going back to the question about the Life Science Institute, we don't believe that the institute should be directly or uniquely responsible for entrepreneur development across the state. There are tremendously effective organizations already in place – just to name a few: here in Southeastern Pennsylvania, we have the University City Science Center; across Pennsylvania we have regional organizations like the Life Sciences Greenhouses and the Ben Franklin Technology Partners; at the University of Pittsburgh, there's an initiative specifically focused on helping entrepreneurs with a network of mentors to help scientist entrepreneurs get technologies out of the lab and into the marketplace for further development and potential commercialization.

 

There are a lot of entities already doing very effective and important work to support the growing entrepreneurship, so we just want to help raise awareness of the opportunities and resources, and help entrepreneurs tap those different available resources.

 

MDD: One of the biggest problems for entrepreneurs in recent years has been the paucity of venture capital funding for medical start-ups in particular. Do you see that improving, or is the new reality that different forms of funding are the norm today and going forward?

 

Molineaux: It's important to tie together what's happening at the FDA and the importance of gaining a little more certainty and transparency with the agency because that will help open up venture capital and other funding sources, because right now the uncertainty is keeping investors away. So, as we get more clarity around what healthcare reform means, what reimbursement looks like and what the reforms at the FDA look like, I think the money will start to flow again.

 

MDD: I know that when I talk with VCs, they say it's the uncertainty that's killing them. They pretty much say, "We don't care if it's going to be harder; just let us know with certainty what the process is."

 

Molineaux: No one is asking for guarantees of approval, just let us know what the process is . . . and stick to it. Obviously, anyone who is investing in a medical technology wants it to succeed, but if it's going to fail, they want it to fail quickly. There seems to be an institutional delay across the board at the FDA. There is some aversion to risk, which we understand. Patient safety is ultimately the most important thing. Efficacy, right up there with it. But in order to sustain innovation and incentivize investment in innovation, we definitely need more certainty or predictability around the process to which companies and their technologies will be subject.

 

MDD: Device companies are taking a variety of approaches to dealing with both established international markets and emerging markets such as China and India. Are you providing programs aimed at helping your members better understand those markets and how to approach them?

 

Molineaux: We believe Pennsylvania is the most attractive place for companies to open life sciences operations. From a life sciences opportunity perspective, on the southeastern end of the state we're right on what's referred to as the biopharmaceutical corridor that runs between Boston and North Carolina. You have New Jersey, the medicine chest of the world, you have a heavy biotech concentration up in Cambridge, and we have academic research institutions in southeastern Pennsylvania that are churning out technologies and talent.

 

In the western end of the state, around Pittsburgh in particular, is an emerging med-tech corridor, which runs from Toronto right through Pittsburgh to Cleveland, so Pennsylvania sits right at the belt buckle of those two belts, biopharma in the east, medical devices in the west, so we're very geographically desirable from an industry standpoint. Southeastern Pennsylvania also sits right between the financial markets of New York and the regulatory agencies in Washington and Maryland. We've got tremendous talent and technologies coming out of the universities.

 

There's a great ecosystem of life sciences strength right here in Pennsylvania, so we are approached very frequently – I would say two or three times a month – by representatives from other countries looking to open operations in the United States, and they're looking at Pennsylvania. Talk about emerging markets, just last week I had a group of 16 representatives from Russia looking to open operations here.

 

In June 2011, we signed an agreement with Assobiotech, the life sciences trade association for Italy. We sign a Memorandum of Understanding between our two organizations creating an initiative called BioBridge, which is designed to introduce Italian companies to the opportunities here in Pennsylvania and conversely to help facilitate Pennsylvania companies who are hoping to open operations in Europe to do that in Italy. So there are exchanges of contacts for financing, a formalized relationship to help our companies looking to operate in Europe.

 

Similarly, in February of this year I was in Bangalore, India, and we signed an agreement with the government of Karnataka, which is the state in which Bangalore sits, to do a similar initiative called BioSpan, where we're helping Indian companies get connected here in Pennsylvania. And we've introduced Pennsylvania companies to the government in Bangalore, helping them get introduced to the Indian marketplace. At this point it has been more on the contract research organization end of it, but that bridge now exists between those countries and this state.

 

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