A custom collaboration with: Quintiles
We start where the patients have unmet medical needs, and then try to match that with the science, says Joanne Waldstreicher, chief medical officer at Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD) in Raritan, N.J. In many cases, that science depends on combining technologies with therapeutics. As examples, Waldstreicher mentions biomarkers, imaging and pharmacogenomics. “This will help physicians and caregivers target the right patients,” she says.
As a pharmaceutical company develops new products, it must work with other industry groups. “We interact quite a bit with payers and regulators,” says Waldstreicher. “We get important information from them as to what they see as valuable, and that is a good perspective to have.” J&JPRD experts also work with nongovernment organizations and local health authorities to get their views on unmet needs. “For example, such groups helped us understand the public-health value of our drug in tackling multidrug-resistant tuberculosis [MDR-TB], which is a threat no matter where it is.” In fact, J&JPRD and Tibotec scientists are working on an MDR-TB drug called TMC207, which is in clinical trials.
The mention of clinical trials also leads Waldstreicher to point out that the company takes a value-based approach early on. “We try to incorporate value assessment in research as early as possible, even as early as phase 1 trials in some cases,” she says. This can include, for example, comparing a new compound against existing drugs. “In the past, we were looking more at placebo-controlled trials,” she adds. “Now, we challenge ourselves to set the highest hurdle, to make sure our drugs are differentiated and bring value.”
It’s not always possible to push such value studies into phase 1 trials. Moreover, this approach does not work in every case. “It really depends on the disease as well as the drug,” Waldstreicher explains. “Sometimes, you might be working, for instance, with a new disease where there may not be a treatment.”
Still, Waldstreicher and her colleagues include such assessments whenever possible. “We have limited resources, precious resources,” she says. “If there are other drugs on the market, we want to compare them with ours as soon as possible.”
For example, J&JPRD is partnering with Bayer Schering Pharma on a large phase 3 trial called ROCKET AF. This study compares rivaroxaban—an anti-thromobotic agent—against warfarin for preventing strokes in patients with a common cardiac condition called atrial fibrillation. “This 14,000-patient study will generate hard outcomes data against the current standard of care, and exemplifies the standards expected of new drug developers,” she says.
“The more we can target healthcare to not just single medicines, but to solutions for patients or for public health,” Waldstreicher adds, “the better we will all be.”
The process of developing therapeutics has multiple expense points, which will undoubtedly change as new business models replace old ones. Here is a snapshot of the current major expenditures related to the bench-to-bedside enterprise.
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