Standing the Test of Time - Pharmaceutical Technology

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Standing the Test of Time
Thirty years ago, the world was a very different place; so was the pharma industry.


Pharmaceutical Technology


Michelle Hoffman
1977—Orlando Bloom was born, and Elvis Presley died. Jacques Chirac was elected mayor of Paris, Indira Gandhi resigned her post as India's prime minister, and Jimmy Carter pardoned most of the Vietnam draft evaders. It was the year in which Rocky won the Academy Award for Best Picture, Star Wars debuted, Jay Leno appeared for the first time on Johnny Carson's "Tonight Show," and the last episode of "The Mary Tyler Moore Show"aired. The Oakland Raiders beat the Minnesota Vikings, 32-14 in Superbowl XI, and the Concorde began regular passenger service between New York and Europe. Studio 54 opened its doors for the first time. That year, before Rosalyn Yalow shared the Nobel Prize in Physiology or Medicine, and after Roots premiered on TV, the first issue of this magazine was published.

1977 was a time when the medical research community felt especially confident about its ability to vanquish infectious disease; the United Nations had declared that smallpox had been officially eradicated worldwide one year prior. The emergence of HIV and AIDS, which would shake that confidence, was, of course, still a few years away. The war on cancer raged, and a new technology on the horizon filled many in the drug-development field with a great sense of possibility. Monoclonal antibodies had been discovered a couple of years earlier, and researchers set out almost immediately to demonstrate how these highly specific molecules might be used to attack cancer cells with near-surgical precision. Most of those efforts were met with disappointment, and by the 1990s, many had become skeptical that mono-clonal antibodies would provide the much hoped for "magic bullet." Had that technology panned out, the revolution in biopharmaceutical manufacturing may have happened a bit earlier than it did—and more publicly. But as it was, the genetic revolution snuck up on the industry.

In 1974, investigators learned how to splice together unrelated pieces of DNA, but because they were working with lowly bacteria, the revolutionary nature of their accomplishment wasn't immediately apparent. Perhaps, more people took notice in 1976 with the incorporation of Genetech, the world's first biotechnology company, which was founded to commercialize the pharmaceutical inventions that came out of those obscure splicing experiments. We are just now—30 years later—seeing the fruits of the genetic revolution. In 2006, two biological products entered the world's top 10 bestseller list for the first time.

To accommodate these new technologies, new manufacturing procedures are being invented. And with those, come new regulations. As we speak, the US Food and Drug Administration is grappling with the appropriate ways to monitor biopharmaceuticals and the processes used to make them, particularly in the case of generic biologicals.

None of which is to say that the formulation and manufacture of small-molecule drugs has remained stagnant. Far from it. Drug makers now have at their disposal an increased arsenal of tools and techniques with which to address century-old problems of solubility, bioavailability, and drug delivery, to name a few. The methods for grinding, drying, analyzing, and purifying compounds of all stripes have become increasingly efficient—as are the methods for discovering these compounds. Overall, these 30 years have been remarkable for the changes that have come about and the ideas drug developers have for the industry's direction in the future.

But the pharmaceutical industry isn't the only one to evolve these past three decades. The business of publishing has also undergone revolutionary change. I refer, of course, to the invention and widespread use of the Internet. While print hasn't disappeared (yet), the Internet has opened up unimagined possibilities for sharing information. So we at Pharmaceutical Technology, as part of a community of dynamic inventors, are also innovating. This month, we unveil our redesigned website ( http://pharmtech.com/). You can see the fruits of our labors (and imaginations) unfold in the coming months as we increase and improve our interactive offerings and make the website an invaluable companion to the magazine. So, here's to you and us and sharing our mutual quest for innovation and excellence over the next 30 years.










Michelle Hoffman is editor-in-chief of Pharmaceutical Technology,

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