It’s interesting to contemplate that all the things that led to the development of our modern society also nurtured the jump, from animal to human, the pathogens that threaten it today. In his Pulitzer-prize-winning book “Guns, Germs and Steel,” Jared Diamond noted that germ evolution was supported by a given microbe’s ability to elicit symptomatic responses from the host, ultimately facilitating its transmission from infected to healthy. Fortunately, human biology kept pace, evolving the immune system to suppress biology’s little terrorists — but only to a point.
True to our knowledge-sharing, tool-creating natures, humans put a new spin on the whole affair when Jenner observed, theorized and acted, inoculating his gardener’s son with the cowpox virus, effectively externalizing the battle and launching the biopharmaceutical industry.
And look how far we’ve come. According to the Centers for Disease Control & Prevention’s table “Impact of Vaccines in the 20th and 21st Centuries,” current morbidity rates for once-common diseases have decreased nearly 100%. Nevertheless, biopharma still has plenty of germs to fight. But the industry is also facing its fair share of challenges. From the patent cliff to cost-generating process bottlenecks, the pessimist’s outlook is not all that rosy.
Optimists are out there, however: In a Chain Drug Review OpEd, John Castellani, PhRMA’s president and CEO reminded the industry that “In reality, the prospects of the biopharmaceutical sector … are bright and promising … the biopharmaceutical research sector remains one of the most innovative and productive sectors in America’s health-care system and its economy.” According to a recent PhRMA report, a total 5,408 medicines are currently in development, with more than 70% comprised of potential first-in-class candidates.
The biopharmaceutical industry has not lost sight of its life-saving mission. But the economics have to be right, and attention must be paid to improving process and production efficiencies to win commercially. This month’s cover story “Process Efficiency Dominating the BioManufacturing Landscape” (page 22) by BioPlan Associates’ Eric S. Langer, provides insight from 450 global experts who generally agree process efficiency is a key, common driver.
Technical innovation is gaining real momentum, too, reaching the “autocatalytic” state Diamond described in his book. A recent paper from MIT “Polymer multilayer tattooing for enhanced DNA vaccination,” published in the journal Nature Materials recently, highlights the autocatalytic effect at work. In essence, MIT researchers discovered that a transdermal patch featuring a microneedle array and a multilayer DNA vaccine coating is the perfect way to administer DNA-based vaccines. Meanwhile, advanced data analytics, single-use systems, process analytics and other advancements continue apace, creating new weapons to fight disease.
It’s exciting to be part of the pharmaceutical industry, and I am thrilled to be giving new voice and editorial leadership to Pharmaceutical Manufacturing. As I jumped into covering the industry, my eyes were opened to an incredibly dynamic manufacturing environment — and what I saw, I liked: Protein Sciences new trivalent flu vaccine approved by the FDA. Flublok is the world’s first recombinant vaccine for the prevention of influenza made using the company’s egg-free BEVS technology. It’s a game changer, and I wanted to hear more about its mass produceability — so I called Executive Chairman Daniel D. Adams. He shared with me a dramatic tale of the effort and persistence it took to bring Flublok to market. He also told me something that I will bring to work with me every day: “I’m in this business to save lives. And I’ll even tell our people when I open company meetings that I get up every morning and come to work to save lives. If that’s not why you come to work, you won’t succeed here. It’s not about making money or taking companies public. Our business is saving lives.” That’s how I see it, and I hope it’s the same with you, dear readers.
Steven E. Kuehn, Editor in Chief
Published in the March 2013 issue of Pharmaceutical Manufacturing magazine