By Paul Thomas, Managing EditorDavid Pulman, president of Global Manufacturing and Supply at GlaxoSmithKline, began his rousing keynote address at the recent ISPE Annual Meeting in Phoenix with modest challenges for his audience of pharmaceutical engineers and professionals: Find cures for cancer, congestive heart failure and HIV/AIDS. Bring affordable medications to the third world. And do so within the next 25 years.It’s not going to be easy, Pulman admitted, especially given the current costs and regulatory constraints of doing business in pharmaceutical manufacturing, and the dismal public perception of the industry. R&D expenditures continue to rise as the number of NCEs approved for commercialization fall, he noted. Meanwhile, public opinion polls place the pharmaceutical industry in the company of tobacco and banking as the least respected industries. “And it’s going to get worse before it gets better,” he admitted.But it will get better, as manufacturing comes to the fore and is truly viewed by companies as a strategic asset. While manufacturing will get more attention, it won’t get get more money, Pulman said. Costs must be dramatically reduced, Pulman said, because consumers will refuse to pay more for their medications. “The price issue is not logical nor is it rational,” Pulman said. “Even people who have money don’t want to spend their retirement funds on drugs. We’re going to have to live with this dynamic.”'We must be aggressive
Manufacturers should not take a “slash and burn” approach, Pulman said. “We have to do this without putting risk in,” he believes. Any cost savings must then go to R&D if manufacturers are to fill their pipelines with enough novel drugs to remain competitive in the marketplace.GSK’s approach to reinvigorating its manufacturing operations has been to build quality into its organization and processes from discovery through manufacturing — what the company calls “quality by first intent.” “GSK is looking at quality holistically,” Pulman said. “The vast majority of costs of goods originate in the development phase.”Other manufacturers, too, must “institutionalize quality,” Pulman urged, and they must be diligent in doing so. “You’ve got to do it every day, every week for years,” he said.For GSK, institutionalizing quality begins with aggressively developing the leaders and engineers of the future, giving more responsibilities and rewards to those with grounding in science, and retraining employees that have the ability and willingness to do so.As for those employees who can’t adapt? “We’re telling our [staffing] people, ‘Don’t be sympathetic about Bob who you’ve known for 20 years,’” Pulman said. To put it another way, “If you’re not current, you can’t practice,” he added.The industry will need an infusion of talent with technical expertise, and will have to convince younger people that pharmaceutical careers are worthwhile. “We must be aggressive in developing the leaders and engineers of the future,” Pulman said. “This is the critical initiative. The future is about people. We in manufacturing have been the second-class citizens. Our time has come.”
