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A Web MD: Paul Bleicher Reflects on Phase Forward


Bleicher talks about Phase Forward’s acquisitions, milestones, and what’s next.

By Kevin Davies

March 24, 2009 | Last November, Paul Bleicher stepped down as chairman of Phase Forward, a leading e-clinical software company that he founded more than a decade ago. Bleicher remains a director of Phase Forward, but these days can be found occupying a small office in a new health care informatics start up, where he serves as chief medical officer. (Details of that venture should emerge in due course.) Kevin Davies caught up with Bleicher, who reflected on a decade at the helm of a leading player in clinical technology. (This is a slightly edited version of Bleicher’s remarks: see the full video interview at: www.bio-itworld.com/lsw/paul_bleicher)

Bio-IT World: You trained as an oncologist and immunologist. What did you see about the role of the Internet in clinical trials back in the mid 90s?
Bleicher: I actually took a long journey out of Harvard Medical School… and found my way into the pharmaceutical / biotechnology industry, because I thought that was the place where progress in basic science got translated into progress for people and for disease mitigation. At that time, as I began to get into it, both as an investigator at Mass General and then at a CRO and at a biotechnology organization, I learned that there was a lot of inefficiency. A lot of things had been tried involving laptop computers, even large computers, but with the emergence of the Internet and the ability to be able to view this through a web browser, I saw a new opportunity and was at the right place at the right time.

What was the original mission of Phase Forward when you launched in 1997?
The mission was to solve two of the problems I thought had plagued me in the various clinical trials I’d run before. First, we needed to get real-time clinical trial data … and make that actionable, both from a safety perspective and from all perspectives, making sure that data was in house and high quality as soon as possible, which was consistent with the best practices of science.

The second was all the operational information—about who did what, when, where—was so important to someone who was running a clinical trial, to make sure these resources were appropriately spent and managed and that the trial could be done on time. It was those two things that I saw were the opportunity and became our mission at Phase Forward—to create a high quality, regulatory compliant, complete application for the management of clinical data and for the management of the operational aspects….

Has the industry complied or are there unresolved issues?
A little of both; obviously, that’s not unexpected… Certainly one always dreams as an entrepreneur to be highly successful, and it did to my wildest expectations. It started a trend that changed the industry. It’s something that’s been adopted by a large percentage of pharmaceutical companies, and is in use in at least half of the clinical trials by best estimates… On the other hand, a lot of the efficiency that can be obtained… both from operational aspects and from a variety of process changes, etc. haven’t been perfected at this point. They haven’t gotten to the point where we as an industry have made best use of them.

As you say, 50% of trials are still not performed electronically. Where is the problem?
I actually don’t think it’s a problem at all. It’s following a standard technology adoption curve that’s been known since the 1950s and was popularized in Crossing the Chasm… but the pace at which different industries do technology adoption is different. The pharmaceutical industry clearly, a number of years ago, crossed the chasm... and adoption at the 50% level is at the peak of the technology adoption curve… Compare that to the industry I’m working in now—electronic health records. That started at a very, very low percentage, very similar to where clinical trials were in 1997. By best estimate is in the 12-14% range, as compared to the 50% range [for clinical trials], so I’d say we’re quite successful in that regard. Some companies are still waiting for more feedback, more evidence of successes from others, and some applications may lag. It’s my belief that, for whatever reason, [e.g.] academic clinical trials, specialty clinical trials, some very small clinical trials from companies trying to preserve their funds of whatever, there are going to be some clinical trials that will always be done on paper.

Phase Forward went public in 2004. What were your key acquisitions along the way?
Lincoln Technology has a very important place in the safety arena and in the standards arena as well. It brought a lot of expertise and experience that has gathered over the years in that company. Safety, pharmacovigilance, and the ability to identify safety signals, both in clinical trials and reported data, was something that was very important to us, especially with the acquisition (before going public) of ClinSoft and the ClinTrace product. So [we’ve] been able to bring together the safety aspects of the ClinTrace product with Lincoln Technology’s expertise and products in pharmacovigilance and in clinical trial safety, and it’s made a very powerful suite, that combined with our technologies in clinical trial data management, makes an even more compelling argument.

Green Mountain Logic added a workflow aspect to phase I clinical trials, which every phase I unit needs to manage the labs and activities in a phase I clinical unit. That’s very important, and I think will grow. Thirdly, the Clarix acquisition, which is in both the typical IVR systems and interactive web response systems, allows us to get randomization, more clinical trial and supply management, allows us to basically complete the loop with adaptive clinical trials. We now have everything that is necessary to do adaptive clinical trials and can offer that together to our customers in an integrated form, ready to go.

Where do you see Phase Forward’s future opportunities?
…I think the company has been quite public about its interest to go to technologies and technology service providers for clinical development for post-launch safety. The idea of an end-to-end solution, technology-enabled services, actually is where the company should be focusing. There are still a number of opportunities that are available to help the company continue to consolidate and provide a one-stop shop integrated solution.

Can Phase Forward and other companies make the cost of bringing a drug to market more affordable?
Absolutely, that’s been my belief all along. You’re always dealing with time, quality, and cost, that triangle. Phase Forward has been able to reduce all of those, to make that triangle smaller. Each company, each clinical trial has its own interest—sometimes time is of the essence, sometimes quality, sometimes cost. The suite of techs has made it possible for companies to choose or focus on all three of them. As pharmaceutical companies get better, using that data they’ve collected, at data mining, looking for connections, there will be even more opportunity… That being said, the concept of ROI in EDC in general, it’s almost past that point… Now people are focused on, what’s the best way for my company to make this an enterprise-wide solution.

What can you tell us about your new health care venture?
Not a whole lot! We are still in stealth mode, as it’s called. But I learned a lot, took a lot of principles from what we did in the pharmaceutical industry. The next challenge is the health care industry… I’ve joined a company that has a really dramatic advantage, both in skills and in concept, in health care informatics... I joined as CMO, it gives me an opportunity to use a lot of things, a lot of skills in being an entrepreneur, it allows me to bring some of those principles I learned in developing Phase Forward to bear in the early days of designing and formulating a product that hopefully will change some aspects of health care the same way that EDC was enabling, and Phase Forward, was enabling for the pharmaceutical industry.

Do you think the new Obama administration will be a partner?
I do. The new Obama administration is anxious to make changes in the health care system. The current economic climate may make it difficult to make the kind of sweeping changes people are looking for, but the one thing Republicans and Democrats shared in common in their platform as they were running was electronic health records (EHRs)—connectivity through electronic data management and actually driving quality and safety of patient care through electronic data management. So I believe, if I’m reading the tea leaves right, the Obama administration is planning on making one of their infrastructure investments in high technology, in enabling EHRs and interconnectivity through electronic data. If that turns out to be correct… you heard it here first! 


This article also appeared in the March-April 2009 issue of Bio-IT World Magazine.
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