Thinking Outside the Lab

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Kathleen Drennan says she “grew up in pharma,” and memories of her first research job conjure a mix of nostalgia and pride. But Drennan, who served on the product development team at Upjohn for 11 years spanning the 1980s and 1990s, also recalls a lack of communication between the R&D group, based in central Kalamazoo, MI, and the promotional division, based miles away in another part of town. “Marketing and R&D were oceans apart,” Drennan says. “We hardly spoke to each other.”

A decade later, she sees the situation changing. Drennan, who works in clinical recruiting, has seen a rise in the collaboration level between brand teams and medical groups within clients. “Pharmaceutical companies are making great strides bridging that gap between science and marketing, but it's still fragmented,” says Drennan, SVP/managing director at Corbett Accel Healthcare Group's Iris Global Clinical Trial Solutions. “Companies are still getting marketing people involved way too late in the game.”

An early brand team

When these two groups do collaborate early in the product life cycle, as clinical trials are underway and during the post-marketing phase, good things can happen—including optimal product positioning and strategy, as well as ongoing synchronization between promotional messaging and clinical trial data. It all stems from better communication. Often the vast majority of this dialogue occurs at the investigational stage, before submission. A cross-functional product team can draw staff with expertise in research, medicine, marketing, safety, epidemiology and health economics to develop strategy for the development of the product.

These sub-teams often begin talking very early in the life cycle. For instance, right after scientists at Novartis established proof of concept for the firm's new once-daily oral renin inhibitor, Rasilez (aliskiren), an early brand team was formed to participate in international cross-functional dialogue about the compound, which is being developed for treating hypertension.

As aliskiren moved into the clinical-trial phase, the brand team was ready to look at the data being generated and determine how it fit into positioning. The frequency with which this brand team met, and its size, increased as the drug moved from phase IIa along the development cycle. (Rasilez, first in a new class of high blood pressure drugs, was accepted for filing by the FDA in April.)

“When you start developing a product, you do it because you perceive there's an unmet medical need to be addressed,” says Marjorie Gatlin, MD, Novartis VP, cardiovascular and metabolism, US clinical development and medical affairs. “That vision needs to be refined as you develop the profile of your product and as the world around you changes and medical practice changes.”

“Going steady”

R&D and marketing speak about how the product is likely to be used, patient perceptions, and the trade-off between efficacy and side effects in different populations. They also work together to do market research and understand how doctors perceive various unmet medical needs. “We like to go steady,” Gatlin says. “We talk very frequently … working to educate our marketing colleagues around the science of the product.”

No courtship is complete without a chaperone. Medical advertising agencies can fulfill this role, facilitating collaboration for established products and prompting brand teams to request more trial data from R&D in response to changes in the physician marketplace. “We know what might be compelling to physicians and what might be helpful to combat competitors,” says Anthony Mastrangelo, PhD, VP, medical director, Integrated Communications Corp.

It's not always prudent to pull data just to counter a competitor's promotional messaging, says one agency chief. But if prescriptions start moving in response to another drug's positioning—a signal of marketplace acceptance—that could prompt such a request. “The vast majority of what we do is about addressing new scientific challenges and answering new scientific questions,” Gatlin says. “It's not so much defensive positioning. We're out there trying to generate positive science that will help physicians develop positive treatment choices.” To that end, subteams must keep up with the literature, maintaining close contact with researchers and thought leaders on what is available to help provide important information to practitioners.

Although R&D endeavors to work closely with the marketing brand team to understand the desired product positioning, some jobs are not shared. Designing trial protocols and selecting investigators is the sole responsibility of medical and remains independent of marketing.

Toward a “cohesive continuum”

In contrast to the fragmentation that characterized Drennan's first pharma job, drug companies are evolving to place more emphasis on internal communication. They have to, with the drug development process averaging 10 years and upward of a billion dollars. The expectations of the marketplace, practitioners, and payers and patients are that there is going to be data on which to base decisions. The market does not tolerate me-too drugs, and companies with a commitment to innovation and quality medicine and science must incorporate innovative communication.

But is it happening across the board? “From a clinical trial perspective, I'm seeing more marketers sitting on a clinical team early on and then a clinical person involved in trials sitting on a brand development team so that there's more didactic discussion about how this drug has evolved through the life cycle,” Drennan observes.

But she also sees companies waiting until mid–phase III trials to start “ramping up the launch,” though it would behoove them to start earlier. According to her, the old divide between science and marketing persists in some firms. “In the old days, it was segmented and fragmented,” Drennan says. “It was us and them. We're moving into a more cohesive continuum. But it has a ways to go.” The more cognizant marketers are about a drug's clinical trials, and the more clinical people understand the promotional challenges of a new product, the better, she says. “It will mitigate the risk of having another Vioxx suit, of having something be misinterpreted, of having something fall through the cracks.”

Moreover, marketers' interest in product development must start earlier. “We forget,” Drennan says, “that the minute that potential new drug for prescription use is ingested by a human, you've just started your brand life cycle.”

Constant communication

Dialogue flows easier for new products but can be more challenging for existing drugs. “When you are launching a new drug, you have to have all your positioning and messaging sewn together before launch,” says Mastrangelo. “Whereas, if a drug has been around for seven to 10 years, the marketing team can almost lose track of what trials are being conducted.”

Keeping current can be a major challenge as medicine continually evolves, especially globally. Whenever Mastrangelo has seen teams where global and US are in lockstep, the process is much smoother. Even for firms where there is little resistance to multidisciplinary communication, it's tough to get all the parts working together. “The hardest thing is making sure we're fully aligned on prioritizing,” Gatlin says.

At Novartis, not only are key people located in the same building, they're situated on the same floor. “That kind of proximity facilitates the dialogue and knowledge exchange,” Gatlin says. “It's the hallway conversations. It's the stopping into each other's office. It's the e-mails. It's constant communication, an ongoing, iterative process.”

These are promising signs for Drennan, who sees a future of more cooperation among pharmaceutical brand team, product development and agency account team members “understanding what it takes to get a drug to the point of launch. We're definitely going in that direction.”  

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