Drug companies are reaching beyond specialists when targeting medical leaders to further develop their existing products. Among 36 companies recently surveyed, nearly four-fifths targeted multiple types of key opinion leaders (KOLs): from specialists and subspecialists to primary care providers, preventative medicine practitioners and nurses. The takeaway? Companies’ understanding of the movers and shakers in the healthcare community is growing and no longer bound by the traditional understanding of who holds the most sway in the medical community. Continue reading “Companies Broaden KOL Targeting, Found Recent Cutting Edge Information Study” »
For companies that don’t have an in-house diagnostics development program, especially those not focusing on therapeutic areas optimized for companion diagnostic (CDx) development, outsourcing to a diagnostic firm is a great solution. There are many reasons why a drug manufacturer may need to outsource biomarker development. A companion diagnostic (CDx) program is a valuable asset for any pharmaceutical or biotech company seeking to improve health outcomes and ensure that their products are provided to patients who are most likely to benefit from them. Continue reading “CDx Partnerships: What You Want and What You Don’t Want” »
The American Society of Clinical Oncology’s (ASCO) annual meeting is fast approaching, scheduled for May 31st to June 4th in breezy Chicago. One of the many to present data this year is Advaxis, a biotechnology company that develops cancer and infectious disease immunotherapies. The company’s keystone product, ADXS-HPV, is based on technology developed at the University of Pennsylvania and is currently being tested in five clinical trials. The product targets HPV-related diseases, including cervical, head and neck and anal cancer. The company will give presentations on two Phase II trials of the drug next month: one in the treatment of recurrent/refractory cervical cancer in Indian women and the other in the treatment of persistent or recurrent cervical cancer. Continue reading “Advaxis’ Cervical Cancer Treatment Comes to ASCO” »
Over the past several years, we have seen a slow shift among regulatory affairs and compliance groups in the pharmaceutical industry as these groups move under medical affairs oversight. This hasn’t been a surprise among many industry observers, but it hasn’t been a complete shift either. Fewer than 40% of surveyed companies in a recent Cutting Edge Information study put compliance functions under the medical affairs department’s supervision. Continue reading “Regulatory and Compliance Functions Within Medical Affairs Teams” »
Pharma has been quick to take up its share of social media — companies have already staked out their space on Facebook, Twitter and even Pinterest. Television ad spending is down as drug companies have increased their use of these new platforms to interact with patients and doctors. Mobile health (mHealth) apps are on the rise. And with an estimated 3.4 billion smartphone or tablet users with access to mobile health apps by 2017 (according to Research2Guidance), this market represents an enormous opportunity for pharma. The market will continue to increase as smartphone use spreads into developing countries and as baby boomers age, two groups that could particularly benefit from improved healthcare information and access. Continue reading “FDA Closer to Regulating Dr. Smartphone” »
Marketing and commercial teams get a lot of the credit for a successful product launch, but medical affairs teams are typically buzzing with activity in the months (sometimes even years) preceding drug approval. As the official communication channel between a pharmaceutical company and the scientific community, the medical affairs department plays a critical role in successful product launches. Each of the medical affairs subfunctions plays its own unique part to play to properly support a new drug. Continue reading “Product Launch: A Busy Time for Medical Affairs Teams” »
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” »
