"The Prius is a bit small," I said, "but as a hybrid it averages 48 miles to the gallon. And some people even get 55 mph or more!"
"But you wouldn't be one of those people," he replied. "When I drive your car, I get 34 mpg, but you only get 29."Dismayed, I asked for tips to improve my mileage. He told me to accelerate slowly, spend more time in a cruising gear (even if that sacrifices a little power), and watch traffic further down the road, to avoid braking and then speeding up repeatedly. In other words, I needed to smooth out my changes in speed.
My gas guzzling habits, I realized, arise from my desire to reach my destination quickly. The funny thing is, my husband can drive anywhere in less time than I do. This was a reminder that not only does haste make (fuel) waste, but it may not even make things faster.
Some people in the pharma industry, however, are way ahead of me in learning this lesson. One of them is Nick Warne, PhD, director of formulation development at Pfizer (formerly Wyeth), in Andover, Massachusetts. At this fall's AAPS conference, he gave a talk on how the Andover group has developed a platform to accelerate drug product development. Many companies use platforms, of course, but one particular aspect of the Andover approach intrigued me: They doesn't go for all-out speed.
A year or so ago, the group reduced the development timeline, from gene to IND, to 17 months (and have since shortened that further). "This is not the fastest possible," Warne said. "But time is not the only important factor. It is also about reproducibility and robustness."
The chosen platform, he explained, not only allows the team to hit its deadlines consistently, but also ensures consistent quality (e.g., low levels of high molecular weight species) and the production of sufficient drug quantities (e.g., for toxicology, clinical trials, stability testing). "For example, I know that at a prescribed week, the purification group will give me 4.5 g of drug to test," he said. In other words, they are smoothing out the changes in speed, and getting better returns overall.
This approach also balances speed and resource investments. "Industry statistics teach us that 90% of these products will likely fail in the clinic," Warne reminded the audience. "Not only does this platform get products into the clinic faster, but by standardizing our approach, we also avoid overinvesting in processes and formulations for products that will never reach the market."
The classic project development triangle says that of the three key elements—time, cost, and quality—you can only get the desired result on two out of three. Applied to pharma manufacturing, where you clearly can never sacrifice quality, this paradigm instructs you to choose between saving money or saving time.
Warne's results, however, like the driving example, seem to say that by balancing things right, you may not be able to reach the extremes of low cost or high speed, but you can get pretty close to your goals on both—reaching your endpoint faster, with the same or fewer resources—while maintaining quality.
Laura Bush is the editor in chief of BioPharm International, [email protected]