What We Heard at Partnerships with CROs


Applied Clinical Trials

Here are some of the things we took away from IIR's 17th Annual Partnerships with CROs and Other Outsourcing Providers Conference.

In the "Advancing Supplier Diversity in Clinical Trials" session, Sylvester Wilkins from GlaxoSmithKline noted that one of the main reasons people frequently outsource to China and India is that there are not enough engineers graduating in America to support pharma...it's not just because of cost.

In the session, "Enhancing the Public's Perception of Clinical Trial Participation," an audience member brought up this scenario as a major issue: Too often, trials get cut off because they have garnered all the necessary information, and patients are left out in the cold without access to the medicine they were being provided because it is too expensive or not available.

Also, in the "Enhancing the Public's Perception of Clinical Trial Participation" session, there was a lot of discussion about the "Everyday Medical Heroes Campaign," where market research was done in order to find out why people would or would not participate in clinical trials. The idea of the "everyday medical hero" came about because a lot of respondents saw trial participants not as guinea pigs, but rather as everyday people who were doing something very important.

ClearTrials, not an EDC vendor, not a CTMS vendor, hits the industry at the operational/planning and analysis apex with Clinical Trials Operations Planning and Strategic Sourcing. The latest version of its software for clinical operations, outsourcing, finance, and project management was unveiled at Partnerships.

Having come from a 20-year engagement at IBM, which included heading up its life sciences business, Caroline Kovac, now managing director at Burrill and Company, offered this industry insight: Just as the IBM mainframe was threatened by distributed computing and the Internet, the blockbuster drug model is threatened today by numerous factors. And there are still mainframes around today; they just aren’t the dominant form of computing.

The “Human Capital Management: Attracting and Retaining Industry Talent in a Changing Environment” keynote brought together four executives from CROs and sponsors in an open format. The panel members included Daniel M. Perlman, chief executive officer & chairman of RPS; John Hubbard, president of Icon Clinical Research; Mark Bach, vice president, clinical operations worldwide, Merck; Ira C. Spector, vice president and vice chief of clinical operations, Wyeth. These were some observations:
From the audience: “There are no female members on the panel.”
In response, Spector: “Seventy percent of Wyeth employees are not male. We should have a woman on the panel.”

Perlman: “There is no shortage of talent. Maybe a shortage of talent that wants to work for you.”

Bach: “Employees need to have a good relationship with their boss. And money is key.”

Hubbard: “People are in this industry because they care about healthcare and they care about what they are doing.”

Bach: “We have spent the effort to have consistent titles in our own company, and that was difficult.”

Hubbard: “It is an industry-wide responsibility to hold the line.” (of those companies who choose to wholesale-upgrade a title or person from CRA II to an associate director).

Spector: “Give them [employees] opportunities to shine.”

Just like a good movie, presenter Sherry Lansing, the first female to head a movie studio in Hollywood, entertained and inspired while making a point: The movie industry and pharma have something more in common than blockbusters. Both need partners to survive because of their industry's high risks and costs and low success rates (only 5% of scripts and 11% of investigational drugs make it out of the pipeline to market, reportedly). Lansing referred to it as a sharing the risk philosophy, which early on was criticized harshly. But it's what every studio does today, she said.

Karen Gotting-Smith, AstraZeneca's vice president of U.S. clinical development and the conferences' first speaker, said pharma needs to look to other industries if it's going to change. In the case of Hollywood, the lesson is outsourcing. According to Gotting-Smith, outsourcing certain activities frees up pharma so it can focus its attention on investing in science (biomarkers, translational medicine), trial design (models and simulations, adaptive), and technology. "We have a much higher bar in innovation and we need to look at ways to partner around the world," she said, "because we can't do it ourselves."

Ex-NBA great Earvin Magic Johnson plans to join the effort to get more minorities involved in clinical research. During his speech on the patient perspective, he said his plans include learning more about the trial process and then going out to minority communities, where he is already heavily involved, and educating them on the importance of clinical trials. It has to be a minority who educates them, Johnson made clear, since many in the urban community still mistrust the industry because of past ethical violations like Tuskegee. The messenger is as important as the message, he said.

Catch phrases: Every conference seems to have one nowadays. And at this year’s Partnership’s conference it was “The world is flat”-a reminder that we are now all working in a globalized industry no longer separated by oceans or great distances.

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