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Tufts study predicts challenge for drug cos. to control R&D costs

BY DSN STAFF

BOSTON —While consumers probably won’t feel the pain, the increasing complexity of clinical trials will make it harder for pharmaceutical and biotechnology companies to keep the costs of developing new drugs under control, according to a new study.

The study, conducted by the Tufts University Center for the Study of Drug Development, found that the median number of medical procedures conducted per clinical trial increased by 49% between 2000 and 2003 and between 2004 and 2007, while the total effort put into the procedures increased by 54%. The study is an update to one conducted two years ago that the CSDD said provided the first quantitative assessment of the effects of protocol design, meaning the planning of trials’ methodology, on clinical trial performance.

The most rapid growth in the number of medical procedures and burden to execute them between 2002 and 2007 occurred in trials of drugs for cancer, autoimmune disorders and central nervous system disorders—areas that many big drug makers have sought to target as they transition into the manufacturing of high-cost specialty drugs. At the same time, growth in complexity and execution burden saw the slowest growth in late-stage, phase-3 trials, due to companies’ looking to contain costs by gathering more data in phase-1 and phase-2 trials.

“More complex and burdensome protocols are extending study cycle times, increasing costs and challenging patient recruitment and retention,” Tufts CSDD senior research fellow and lead study author Ken Getz said. “Wide observed differences in complexity and execution burden by phase and therapeutic area indicate that pharmaceutical and biotechnology companies can target their efforts to improve protocol design and improve clinical trial operating performance.”

Getz said an increase in the number of criteria for eligibility to partake in studies resulted in a decline in volunteers enrolling in trials, and once they did enroll, the larger number of medical procedures for each protocol dissuaded them from staying in trials to the end.

Therapeutic area with the greatest complexity and work burden for phase-2 protocols, 2002-2007

Source: Tufts Center for the Study of Drug Development
Therapeutic area Total procedures (median) Growth in total procedures Investigative work site burden (median units) Growth in work burden
Hematology 233.3 119.4% 45.6 144.6%
Immunology 193.1 -23.3 43.9 9.6
Dermatology 182.2 26.0 48.9 93.3
Oncology 178.6 7.6 53.4 52.1
Anti-infectives 165.5 -10.0 49.4 16.9

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NACDS puts a new spin on Meet the Market

BY Michael Johnsen

SAN DIEGO This year the National Association of Chain Drug Stores introduced two new features to its Meet the Market format. First, NACDS hosted a Meet the Market Presentation Template webinar twice prior to Meet the Market, in which NACDS introduced a meeting template that succinctly captured all of the information retailers typically use to evaluate a new product or company.

Also new to Meet the Market were the booths of 10 service companies — trade media and professional education, merchandising consultants and marketing/media information companies — which afforded an opportunity for new and smaller suppliers to meet with these organizations.

“New companies have a need not only to meet with retailers, obviously, they have a need for their business,” noted Jim Whitman, NACDS SVP meetings and conferences. Another ongoing improvement is the productivity within each meeting, Whitman added. “We keep refining the match, the appointments,” he said.

This year, the Meet the Market format — in which smaller and new suppliers have 10-minute meetings with their category buyers — represented more than 8,000 face-to-face pre-arranged appointments.

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Retail clinic growth slowing down? Not a chance

BY Antoinette Alexander

WHAT IT MEANS AND WHY IT’S IMPORTANT The news that Target is looking to expand its retail-based clinic business this year is yet one more indicator that reports of the demise of retail clinic growth have been greatly exaggerated.

(THE NEWS: Target to expand its retail clinic presence. For the full story, click here)

As the article states, Target, which opened its first clinic in 2006, is looking to open up eight new locations this September. It already operates 28 locations in Minnesota and Maryland.

It wasn’t so long ago — April to be exact — that CVS Caremark’s MinuteClinic indicated that it could double its current number of clinics in five years.

Why the growth? Well, aside from the aging population and a shortage of primary care physicians, a major catalyst is healthcare reform, which will mean that 32 million people who currently are uninsured will have healthcare coverage. With emergency rooms already overflowing, and primary care physicians already over-extended, having a retail clinic nearby where patients can receive convenient, quality and affordable health care will only become increasingly important.

Meanwhile, RediClinic, which has 22 clinics in H-E-B stores in Houston and Austin, Texas, is cranking up its marketing efforts and has tapped former Duane Reade executive Jeff Thompson as VP marketing. Thompson will be responsible for RediClinic’s consumer and partner marketing activities, including developing and implementing strategic customer acquisition/retention programs, new product delivery and brand strategy.

Thompson most recently served as VP marketing for Duane Reade.

Clearly, there continues to be significant growth opportunities for clinics — both in terms of the number of clinic locations and the scope of services offered within the clinics. As mentioned earlier, there are 32 million reasons why the growth will be quite dramatic.

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