Cutting Edge Information recently conducted research among pharmaceutical medical affairs groups that looked at physician-interaction database ownership. The research revealed that ownership of these databases varies among the surveyed companies. Global groups at 60% of companies report responsibility for these internal databases. Companies that do not report global groups’ responsibility for an internal database (40%) may consider their use of Excel spreadsheets or Outlook to track physician interactions as internal database. Other global medical affairs teams allow country-level groups to document physician interactions according to local regulations. Still other companies may be in the process of either developing a new database platform or transitioning from an existing one. Continue reading “Driving KOL Engagement Efficiency through Physician-Interaction Databases” »
Melanoma is the deadliest form of skin cancer. Although the World Health Organization estimates that melanoma accounts for only 5% of skin cancer cases — or 132,000 annual cases globally — it accounts for 75% of skin cancer deaths. However, compared with other cancer types, melanoma remains a small area of study. ClinicalTrials.gov shows that, over the past 10 years, excluding studies of unknown status, there have been approximately 1,070 melanoma clinical trials. According to Biopharm Insight, 15 approved drugs exist to treat melanoma, with another 49 active drug programs in Phase 3. Continue reading “New Clinical Trials Offer Promise for Melanoma Treatments” »
Drug companies’ increased pharmacovigilance activities highlight the importance of both clinical data and adverse events reporting. The World Health Organization (WHO) estimates that adverse drug reactions (ADRs) represent between the fourth- and sixth-leading causes of death in the US. The global organization cites that in the UK, among patients aged 16 and older, those experiencing adverse drug reactions at any given time may account for the occupancy of seven 800-bed hospitals. Continue reading “Pharmacovigilance: Databases Support Adverse Event Reporting” »
The pharmaceutical industry has begun to dabble in online business communication, especially around speaker programs aimed at informing healthcare providers of new research and medicines. Of course, pharmaceutical speaker programs have existed for a while in the form of presentations, dinners and round-table discussions. New technology has recently expanded speaker programs into the online world, allowing one-way and interactive webcasts. Even some web-based teaching programs using principles of self-driven learning have been emerging as well. Continue reading “Don’t Ditch the Tech If You Want Successful Speaker Programs” »
Staying on schedule with planned timelines is both essential to maximizing a product’s potential and monstrously difficult to achieve. New data that we’ve compiled in a recent study (see Figure 1) show an average of more than five months’ difference between planned and actual trial duration. It’s clear that most of these delays are during patient enrollment, whether from low enrollment rates alone or amendments that companies end up making to the study protocol. The exact problems that a clinical trial team runs into depend on the therapeutic area, the locations and abilities of the study sites. But the clinical team should not discount the potential of its own expectations and communication methods to cause problems. Continue reading “Minimize Phase 1 Delays through Early and Open CRO Communication” »
Pharmacyclics Inc. recently announced that the FDA granted an additional Breakthrough Therapy designation for its investigational oral agent ibrutinib as a monotherapy to treat patients with chronic lymphocytic leukemia or small lymphocytic lymphoma with deletion of the short arm of chromosome 17. For those keeping score at home, this is ibrutinib’s third breakthrough therapy designation. In February 2013, the FDA granted breakthrough designations for ibrutinib’s use in relapsed or refractory mantle cell lymphoma (MCL) and Waldenstrom’s macroglobulinemia (WM). Continue reading “Promising Oncology Drug Receives Third Breakthrough Designation from FDA” »
According to the American Hospital Association, hospitals nationwide remain liable for up to $41.1 billion in unpaid healthcare costs annually. This cost is up from the recorded amount of outstanding costs in 2010 ($39.3 billion). Currently, Jack Hadley, senior health services researcher at George Mason University, estimates that the government ultimately foots the bill for up to 75% of hospitals’ uncompensated care costs. Continue reading “Projected Impact of ACA Legislation on Unpaid Hospital Bills” »
Direct-to-consumer (DTC) advertising in the pharmaceutical industry is changing. From 2011 to 2012, money spent on DTC ads by pharmaceutical companies declined by 22% to $3.1 billion, according to Cegedim Strategic Data. Companies are shifting their marketing mix to include more Internet advertising, resulting in a decline in TV and print ads. Pharma is realigning its marketing messages in response to public and regulatory backlash. Continue reading “DTC Ads Persuade AND Educate Consumers” »
Although marketing and market access functions may not support a developing drug until Phase 2 or even later, companies need to coordinate between several different teams as products move through different development stages beginning in the pre-clinical stage. Understanding the science behind the product is increasingly important for market access functions as payers increasingly require comparative effectiveness research and health outcomes data. Continue reading “Product Development Stage Dictates Medical Affairs Spending Patterns” »
Within companies’ medical affairs groups, medical information subfunctions disseminate information quickly across consumer and healthcare practitioner audiences alike. However, US companies rely on different-sized medical information teams to fulfill these roles. Figure 1 shows the disparity across surveyed US companies’ medical information staffing teams. Groups range from less than a single FTE up to 20 FTEs at one surveyed large pharmaceutical company. Continue reading “Technology’s Role in Enhancing and Expanding Medical Information Teams’ Capabilities” »
