Carol L. Fisher

BioPharm International is about to embark on another new beginning. You'll remember the magazine (along with the primers, supplements and media kit) had a drastic new beginning in February of 2004 when we launched the major redesign. There were other new beginnings in the past two and one-half years, like five new columns (StreetTalk, Operations Excellence, BioPartnerships, Compliance Briefing and Final Word.) You'll even see a sixth column about legal issues in 2006.

Idon't have many colleagues who react with joy when management announces strategic planning meetings. Do you? After all, it means hours, nay days, of discussion and debate while your day-to-day obligations lag woefully behind.

Hurricane Katrina is slamming into the Gulf Coast of the US at the moment, with wind gusts of up to 140 mph. As many as 10,000 residents of New Orleans, LA have taken shelter in the city's Superdome, while others obeyed the mandatory evacuation order and fled to safer ground earlier.

Shortly after London's ordeals, I heard of a new piece of intelligence suggesting that a large pharmaceutical company is on a short list of possible Al Kaeida targets. Since I'm sure all pharmaceutical facilities are securely buttoned up, I wonder more about our industry as a whole becoming a focus of attack by these maniacal extremists.

One of the very last sessions on the very last day of BIO 2005 drew quite a crowd. It was titled, "The Five Worst Mistakes You Can Make When Creating a Collaboration or Strategic Alliance."

Reading about the sophisticated advances in biotechnology is now a common, enlightening occurrence. But the field certainly has taken its lumps over the past three decades, creating doubts in the minds of investors and periodically striking fear in the hearts of the public. Take the late-night sci-fi thriller I awoke to one evening, where an army of diseased and highly intelligent rats was infiltrating a stalled subway car filled with terrified passengers. Of course, the animals were sick, smart, and reproducing offspring with similar attributes because of an experiment-gone-awry in a biotech lab — they'd been treated with some kind of therapeutic grown in a rare plant — which was now abandoned after its occupants received one too many warning letters from "a regulatory agency." THAT woke me up real fast.

Despite the ringing of two stray cell phones disrupting the quiet, all eyes and ears were glued, almost reverently, on New York City's former Mayor Rudy Guiliani at INTERPHEX when he presented the day's keynote address. First, he thanked the audience for providing the therapeutic options that allowed him to successfully defeat prostate cancer awhile back. Next came his imitation of James Gandolfini in the hit TV show "The Sopranos," as he reminisced about his duties as NYC's former chief prosecutor. Once he had our full attention, close to 1,000 of us, he shared what he felt are the most valuable leadership attributes and how they will successfully get you through challenging and uncertain times.

You don't really care what people say about you (the biopharm industry) behind your back, do you? According to a recent survey of 670 BioPharm International subscribers, conducted by Derek Ellison from Eden BioDesign, some of you care very much about the public's perception of the industry.

This was the week for awards. The Academy Awards, which honored the film industry, captured the eye of millions worldwide. They were followed midweek by The Fourth Annual Top 25 Direct-to-Consumer (DTC) Marketers of the Year Awards. Sponsored by USA TODAY and DTC Perspectives magazine, these awards celebrated the accomplishments of 2004's most talented DTC pharmaceutical marketers.

You don't need me to tell you how bad the news has been for the pharmaceutical industry in the last two months. First, it was antidepressants for children, then Vioxx. It took maybe 48 hours before the first tort request hit the airwaves, asking to hear from those who'd experienced heart attacks or strokes after taking the drug. Celebrex came next, followed by NIH announcing it put the kibosh on a study of naproxen.

Idon't know about you, but I found Senator John Kerry's assertion that President Bush was to blame for the US flu vaccine shortage quite laughable, but only until it became clear Kerry intended to continue railing about it throughout his final campaign thrust. As political tactics would have it, of course there was no mention of the Comprehensive Child Immunization Act of 1993, back-door price controls, and the resultant US dependence on external vaccine suppliers.

Let's be frank. Love doesn't make the world go round —money does, especially if you're developing a promising technology but you're facing ten or fifteen more years of bench time and clinical trials before you can unveil a marketable product.

American patients are more educated about health issues than any prior generation, thanks to the Internet. I read somewhere that doctors, from family physicians to specialists, are amazed at how well prepared their patients are when they show up for an appointment — with documentation in tow after researching conditions, medications, and treatments. So much so that the doctors are stressed out from trying to answer all their questions, complete their exams, and get everyone out the door in the amount of time the insurance companies say is "reasonable."

What were you doing on the evening of July 20, 1969? If you are at least a baby boomer, you were probably watching Neil Armstrong take "one small step for man, one giant leap for mankind." Sputnik aside, the birth of that monumental achievement probably began with the same question that sparked so many other great feats: "What if?" Where would civilization be if someone periodically hadn't had the imagination and the courage to ask that question, whether their field of expertise was aeronautical engineering, architecture, or biotechnology?

It may take take more than a decade to bring a new drug to market, but it's still a race from the bench to the shelf. It's easy to think of the race in terms of a sprint, like a six-second dash from one end of the pool to the other, especially during crunch times when you're rushing to meet deadlines. However, developing a biologic drug is a much longer race, more like a 400-meter medley. If you've ever competed in one, you know it's a test of endurance that requires a long-distance mind-set, strategic thinking, and a complex combination of skills.

Welcome to the inaugural issue of the new BioPharm International. We are pleased to unveil our new logo and redesign after collaborating for four months with award-winning designer Virginia Dickens of Vision Advertising. One of our redesign goals was for the magazine to reflect the same innovative, cutting-edge qualities that are characteristic of the evolving biopharm industry. Probably more important to you is how the new format will better accommodate the expression of your day-to-day challenges.

There are pressures on biopharma to grow up — and to grow up fast. Although we still hear references to its "infancy," I think we're well past that stage and already confronting the awkward — and sometimes painful — experience of adolescence.

Working with a contractor reduces time-to-market, risk, and debt, while providing expertise, equipment, and flexibility - but those benefits accrue only if you plan and communicate with your outsourcing partner.