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In this issue, you’ll see a new department in Pharmaceutical Commerce: Clinical Operations. And it would be very reasonable for you to have the reaction, “So what? Why should what Pharmaceutical Commerce chooses to publish make a difference?” Well, we’re here to make a case that it will.
When Pharmaceutical Commerce began publication, the logic—which still holds today—was to focus on everything that happens after a product comes off the manufacturing line: how it is packaged (and the branding and dispensing of that product based on its packaging); how it gets physically distributed, via various channels, into the marketplace; how it gets marketed and sold (and the necessary information that flows both out into the market, and back from the market for analytical purposes); and how it gets reimbursed. Add to that IT, regulatory compliance and overall financial management—all necessary to running a successful business in life sciences—and you’ve got a reliable how-to manual for “business strategies for bio/pharma success” (I know this is true because it says so right on the cover!)
Noticeably, there is little to nothing on biopharma R&D. This choice is not because of a perceived lack of significance of R&D; but rather, because it gets covered extensively in academic and other journals where scientists and research directors talk to each other. Very early on, however, we recognized that there is no bright-line distinction between R&D and the pharma business—for example, the thinking that goes into post-approval trials; the more recent development of risk evaluation and mitigation strategies (REMS); and the back-and-forth experimentation/commercialization of drugs for rare diseases. Many other examples can be cited.
As we’ve covered more pharma R&D activities, we noticed how the clinical trials activity mirrors a commercial market: there are valued service providers (clinical research organizations, clinical development and manufacturing organizations, clinical trial logistics providers) for one thing; for another, the IT requirements—a true Big Data instance—have become essential services, as has the need for negotiating complex legal and regulatory frameworks. Today’s movement toward health outcomes research and value-based medicine only amplifies this R&D/commercial interplay.
Going forward, we hope to apply the same thinking we have in pharma’s commercial operations—reducing costs and complexity in pharma distribution, marketing and reimbursement—to the challenges of running the clinical trials “business.” One timely example of this is a “clinical syringe package,” said to potentially cut 18 months out of the drug-development process for injectables. We’re also covering innovation in monitoring refrigeration systems in laboratory settings—the front and tail ends of the cold-chain logistics processes we’ve covered extensively in the past. (By the way, please note our overview of the 2014 Biopharma Cold Chain Sourcebook)
These are just a few examples of innovation going on in the clinical operations arena. We hope to be covering many more.