Caution When Traveling Full Speed Ahead

January 2, 2007
Pharmaceutical Technology
Volume 31, Issue 1

The closing presentation was perfectly pitched to bring a lump to our throats and have us cheering for fast-track drug development. I and 30 other journalists had spent the day touring a Big Pharma plant, and now sat shoulder to shoulder in a warm conference room, awaiting the final speaker.

The closing presentation was perfectly pitched to bring a lump to our throats and have us cheering for fast-track drug development. I and 30 other journalists had spent the day touring a Big Pharma plant, and now sat shoulder to shoulder in a warm conference room, awaiting the final speaker.

Kaylynn Chiarello-Ebner

The meeting was focused on bringing new, more efficacious cancer therapeutics from the bench to the market. By taking advantage of fast tracking, the company claimed it could slash the time patients must wait for new treatments: within 5 years from when they are first synthesized.

And so, we waited for the closing speaker to arrive. A bustle of excitement flowed through a pack of event organizers huddled at the podium. "Ladies and gentlemen," one said coming forward, "We have a special surprise guest." The doors opened, heads whipped around, and in walked the speaker—tall, graceful, and completely bald.

She spoke about her battle with ovarian cancer. The disease was ugly, but she described the fight as "beautiful." The ordeal taught her much about herself and was lucky, she said, to have received the fast-track drugs that saved her life. She graciously thanked the company for its efforts, hugged some senior scientists, and brought a tear to every eye.

The presentation worked well. I felt like hugging the researchers, too.

But then, I remembered a conversation with an interviewee for this month's special report. Accelerating trials—by combining phases of trials, for example—makes it difficult to compile as much formulation data as companies had in the past. Companies may tweak a formulation for a clinical trial without having complete data about how it works. And when the drug is on the fast track, they have less time to scale up and fine tune production, a process that should be a key strategic factor considered throughout drug development.

Speeding a drug's time in the clinic can be advantageous for patients. But, do we risk paying for early success in the long term with processes that are difficult to control and products that aren't as good as they might have been?

Kaylynn Chiarello-Ebner is the managing editor of Pharmaceutical Technology, kchiarello@advanstar.com