We’re diving back into our notes from the Clinical Trials Congress (CTC). That would be a 10,000-word, 53-page monster document. Whew. But every time we take another peek, there is more strong material to post. We’re going to tackle some fascinating material from Novartis tomorrow and Wyeth (with luck) on Monday.

For today, it’s MedImmune’s John Whalen, VP of clinical development operations. A physician, he put in time at Merck and Scirex before joining MedImmune, which has three marketed products, including FluMist. The company’s growth curve has taken it from 100 employees to 2,300, Whalen said.

He reviewed charts and trends that other speakers also presented—noting $40 billion worth of drugs coming off patent by 2010, citing higher costs of research and lower numbers of new chemical entities. His company’s perspective is that a new era of fewer resources for research is already here. The challenge of the hour, then, is picking the partners or technologies that help a sponsor of clinical trials survive what may be a grim environment. In MedImmune’s case, it has 40 compounds at various stages of the research or development process.

“There is no way to escape what our industry is facing and what the challenges are,” Whalen said. “There will be less money coming through the door that all the rest of us will have to spend on drug development.”

Tufts Metrics

Whalen lauded a recent report from the Tufts Center for the Study of Drug Development, an analysis showing how more efficient companies are killing about half of their drugs in Phase I, not letting them clog the pipeline in later phases. That discipline, on average, slices more than a year out of the time a compound spends in Phase I-III. Inefficient companies, Tufts found, only have the stomach to kill about a third of the candidates in Phase I.

Whalen spoke at length about biomarkers. The company isn’t waiting for the Critical Path program to show the way; it already sees biomarkers as a way to do drug development more quickly.

MedImmune also works closely with contract research organizations (CROs). “It’s important that you use established and experienced CROs,” he warned. “A failure with a CRO is extremely costly.”

Financial Models

Even with a strong relationship with a CRO, MedImmune still looks closely at what the costs for each trial should be. He briefly mentioned a company new to us, ClearTrial, praising it. The idea is to know what the trial should cost, but not push too much. The company does financial modeling of all trials.

“We know how costs are built up. Many people at MedImmune used to work at CROs,” he said. But MedImmune is not in the habit of squeezing its CROs to the point where a supplier’s finances are in peril. “We don’t negotiate to the absolute lowest cost,” Whalen noted. “We want our CRO to be financially sound.”

Whalen offered a full endorsement of technology. In a few sentences, he sketched the basic landscape: an Oracle Clinical data management system, the Impact clinical trial management system, SAS. An electronic time sheet program, he said, has proved invaluable in helping to see when some people are overburdened or extra help may be needed.

ROI for EDC

The company is just now beginning to use electronic data capture (EDC). He did not name any companies it is using in that field. Said Whalen: “We’ve made a late commitment to convert to EDC. We’re getting there. A lot of people would say a company of our size should have been there a few years ago.” To plot the transition, MedImmune hired Campbell Alliance. MedImmune and Campbell studied which processes would have to change, spending $3 million on the process.

“We did vendor assessments, process redesign, pilot studies,” Whalen notes. “It’s a substantial investment. But we believe we will achieve a return on investment.” As MedImmune studied EDC, it found that a few assumptions (eliminating one data monitor visit out of seven, for example) could create a return on its investment.

In closing, Whalen stressed the scientific and business imperative of efficiency. “It is imperative that we be cost effective in all aspects of clinical development,” he said.