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PharmaTrax Sales, Marketing, and R&D Trends from Industry Analysts

Scientific Expertise and Good Value Are Important When Choosing a CRO

The primary factors pharmaceutical and biotechnology companies consider when selecting a CRO are the strength of its scientific expertise and the cost/value ratio associated with the study, according to a report, commissioned by Quest Pharmaceutical Services (QPS) and conducted by SCORR Marketing. Industry experts indicate that companies engaged in preclinical development are most interested in a CRO with demonstrated scientific knowledge and technical skills, as well as one that offers good value for its expertise and service. Secondary considerations include the CRO’s timeliness in scheduling, meeting timelines, and executing overall turnaround, as well as its responsiveness in communicating with scientific personnel, business development, and project managers. Decision-makers charged with evaluating CROs clearly articulated the importance of service quality, priority setting, and the ability for rapid, effective problem-solving in service-provider selection. Other important CRO attributes include resources to handle the job, location of laboratories, quality of reports, flexibility as study progresses (and potentially changes), and history of prior relationship. Study Identifies Barriers to Portfolio Management Success More than 60% of global-level industry executives and almost 15% of affiliate-level executives surveyed by Cutting Edge Information cited corporate culture and lack of organizational buy-in as the greatest barriers to portfolio management success in the pharmaceutical industry. “The portfolio management executives with whom we consulted for this study also lamented that their companies simply don’t dedicate enough resources to portfolio management,” says Elio Evangelista, senior research analyst at Cutting Edge Information. “Almost 30% of affiliate-level portfolio managers said their companies allot an inadequate amount of time to overseeing their product portfolios.” The industry’s largest companies are most likely to be understaffed or simply lack the resources needed to manage their product portfolios. Among the survey respondents, 40% of large pharmaceutical and biotechnology companies cited “inadequate time dedicated” as the top barrier to portfolio management success. Other key findings from the report, Pharmaceutical Portfolio Management Strategy, include: • Portfolio management delivers the strongest impact when aligned with corporate strategy. • Midsized companies face the greatest portfolio management challenges as they grow larger. • Data standardization, though difficult to achieve, streamlines portfolio management and makes the decision-making process more effective. • An inverse relationship exists between the frequency of portfolio management team meetings and overall satisfaction with portfolio management success. Blockbuster Life-Cycle Management Best Practices Life-cycle management continues to be a key focus for pharmaceutical executives who understand that extending the life of a blockbuster can mean hundreds of millions, even billions, of dollars more in company revenue. Now, more than ever, as generic drugs stand ready to outstrip branded product sales in the next several years and product pipelines become leaner, brand managers face the daunting task of stretching the lives of their marketable drugs for even longer periods of time. With myriad strategies available — from new formulations, to combination products, to new indications, to over-the-counter switching — choosing the appropriate tactic that best fits a particular drug is especially critical. A Best Practices LLC study reveals that successful life-cycle management (LCM) tactics can: • Gain companies as much as 10 years of additional product life. • Increase the average number of months gained by using LCM strategies from two to 78 months. The study also revealed that 60% of respondents indicated the following as the top five most frequently used and most successful LCM tactics: • New formulations, • New indications, • Publication strategy, • Thought leaders, • Line extensions. Drug Labels Are Prescriptions for Mistakes A new study, To Err is Truly Human: Literacy and Misunderstanding of Prescription Drug Labels, conducted by the Annals of Internal Medicine, found that patients had difficulty comprehending how much and how often a medication should be taken. Misunderstanding was particularly high among those who had lower literacy levels (eighth-grade level or below) and for those who took many prescription drugs. The researchers interviewed 395 English-speaking adults in three states. The five medications identified for the study were two antibiotics (amoxicillin and trimethoprim); an expectorant (guaifenesin); an antihypertensive, channel blocking agent (felodipine); and a diuretic (furosemide). Patient literacy was classified either as low (sixth grade and below), marginal (seventh to eighth grade), or adequate (ninth grade and higher). Study findings included: • Although 70.7% of patients who were evaluated as being at a low literacy level correctly stated the instructions “take two tablets by mouth twice daily,” only 34.7% could demonstrate the number of pills to be taken daily. • The rates of understanding individual labels ranged from 67.1% for the instructions for trimethoprim (“take one tablet by mouth twice daily for seven days”) to 91.1% for the instructions on the label for felodipine (“take one tablet by mouth once each day”). • Patients with low literacy were less able to understand the meaning of all five medication labels than those with adequate literacy. • The majority (51.8%) of incorrect patient responses reflected an error in dosage (e.g., tablespoon vs. teaspoon), and 28.2% stated the wrong dose frequency (e.g., “one tablet each day for seven days” instead of “take one tablet by mouth twice daily for seven days”). • Most patients did not pay attention to the auxiliary (warning) labels (for example, “do not take dairy products within one hour of this medication”) and those with low literacy were more likely to ignore them. The study indicates that currently recommended methods for confirming patient understanding, such as the “teach-back” technique in which patients are asked to repeat instructions to demonstrate their understanding, may be inadequate for identifying potential errors in medication administration. According to health-literacy expert and lead author of the study, Terry C. Davis, Ph.D., chairperson of the American College of Physicians Foundation’s Patient-Centered Health Literacy Advisory Board, medication errors are the most common medical mistakes, and most of the research has looked at the mistakes of healthcare providers. “In looking at patients, we found it was common for them to make mistakes when dosing medicine for themselves, their elderly parents, or their children,” he says. Study Reveals Rapid Global Growth of Online Market Research For the third year in a row, Internet-based market research — once viewed with skepticism by some in the pharmaceutical industry — has leapt ahead of face-to-face and phone interviews to become the world’s No. 1 method of data collection for quantitative physician studies. The rapid gain in acceptance, particularly in the European Union, is one of the most significant findings in the newly released 2006 Medefield Pharmaceutical Market Research Trends Study, which has been conducted annually since 2004. The latest study confirms the dramatic change that is taking place in the industry — where 43% of all quantitative market research globally, and 75% in the United States, is conducted online — and cites the growing pool of physicians, especially those on European panels, who have access to the Internet as the principal factor in reversing long-held attitudes. According to Elys Roberts, president of Medefield America, although the Internet’s time-saving and cost-effective benefits are obvious, convenience and accessibility are additional major reasons for conducting research online. The year-to-year increases are particularly important, Ms. Roberts says, because the growth trends for Internet-based research — conspicuous in the United States for the past few years — are now being played out on a global stage. In Europe, according to the study’s authors, the level of online pharmaceutical research has jumped 27% in the last year alone. Market research: Key Findings Reasons for choosing online vs. phone (2006) Internet Phone Time efficient 76% 33% Cost-effective 68% 55% Convenient for physicians 41% — Accessibility to physicians 41% 33% Global increase in online research year online face to face phone 2004 27% 43% 31% 2006 43% 27% 27% U.S. and Europe increase use of Internet-based market research U.S. Germany France U.K. Canada Spain 2004 45% 22% 16% 24% 19% 16% 2006 59% 35% 32% 32% 29% 26% Note: 2006 study based on 122 respondents, all market researchers from pharmaceutical or biotech companies, including Novartis, AstraZeneca, Sanofi-Aventis, GSK, Pfizer, Merck, BMS, Roche, Amgen, Schering, Altana, and others. Source: Medefield America, New York. For more information, visit medefield.com. Follow up The American College of Physicians (ACP), Philadelphia, is the nation’s largest medical specialty society. For more information, visit acponline.org. Best Practices LLC, Chapel Hill, N.C., is a research and consulting firm that conducts work based on the principle that organizations can chart a course to superior economic performance by studying the best business practices, operating tactics, and winning strategies of world-class companies. For more information, visit best-in-class.com. Cutting Edge Information, Research Triangle Park, N.C., provides research and consulting to the pharmaceutical, biotechnology, and medical-devices industries. For more information, visit cuttingedgeinfo.com. Medefield America, New York, is a provider of e-fieldwork services, with recruiting capabilities in the United States, Canada, Europe, Central and South America, and Asia. For more information, visit medefield.com. Quest Pharmaceutical Services, Newark, Del., is dedicated to helping sponsors meet the challenges posed by the dynamic environment of pharmaceutical research and development globalization. For more information, visit questpharm.com. SCORR Marketing, Kearney, Neb., collaborates with companies to develop next phase growth strategies and a disciplined approach to marketing plans. For more information, visit scorrmarketing.com.

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