There is a strong push from regulators worldwide for pharmaceutical companies to first report and then justify physician payments. This push includes all compensation for activities such as scientific speaking, journal publications and clinical trial operations. Authorities are looking for greater transparency, and that starts with fair-market value reporting. But for the most part, life science companies have been left without concrete guidance on how to calculate FMV around investigator compensation. Continue reading “Using Per-Patient Visit as Basis to Compensate Investigators” »
There is a surge in portfolio management activities going on in big pharma right now. Several CEOs have announced plans to refocus their investigational pipelines and divest marketed product lines that no longer fit the new company strategy. Some companies, such as Bayer AG, have sought to strengthen the core business through large-scale mergers. (Bayer purchased oncology specialist Algeta in December for $2.9 billion). Some of the biggest companies, however, are using divestitures and asset swaps to accomplish their goals. Continue reading “Pharmaceutical Leaders Seek Focused Product Portfolios” »
A common theme running through a lot of what we at Cutting Edge Information learn while conducting research on the pharmaceutical industry is the need for more consistent and productive communication between internal groups, ranging from regulatory affairs and clinical development to marketing and medical affairs. However, simply saying “communicate better” falls far short of actually helping companies operate more efficiently. A framework needs to be in place that allows for such communication. Groups also need to be reminded of the value of working closely with other parts of the organization for the greater good. Continue reading “Provide a Framework for New Product Planning Groups to Influence Clinical Trials” »
Roche’s recent announcement about the failure of its schizophrenia drug, Bitopertin, highlights two hot topics within pharma: clinical trial transparency and patient-reported outcomes (PROs). The drug failed to meet primary endpoints in two Phase III trials designed to test Bitopertin’s efficacy in reducing negative symptoms in schizophrenia patients. The decision to announce the failure indicates a growing trend by pharma towards increased transparency of clinical trial data results. In an effort to improve pharma’s reputation among an increasingly distrustful patient and physician population, companies are increasingly deciding to publish both positive and negative trial results.
Continue reading “Roche’s Bad News Emphasizes Clinical Data Transparency and Patient-Reported Outcomes” »
This blog has previously discussed in detail how pharmaceutical companies are turning to advisory boards to inform their clinical trial strategies and increasingly to provide assistance when conferring with payers about the value and effectiveness of new products. However, research from Cutting Edge Information shows that one of the traditional uses of pharmaceutical advisory boards continues strongly into the modern life sciences landscape. Continue reading “Advisory Boards Put the Marketplace in Your Conference Room” »
In this age of blockbuster drug patent cliffs, pharma has focused its attention on optimizing drug lifecycle management. Companies are adding dedicated LCM teams and cross-functional committees to better plan and execute LCM strategies. Tactics are aimed not just at prolonging exclusivity at the end of the lifecycle, but at maximizing sales while still under patent protection. Companies surveyed in an upcoming LCM report explain below how to embrace an LCM strategy this February 14th. Continue reading “Lifecycle Management: A Love Story [Infographic]” »
By Christie Shilling,
Teams within medical affairs often have substantial trouble gaining management buy-in and, as a result, don’t often receive the resources that they need. Although most marketing and sales functions can use hard numbers to prove their value to the company, medical affairs is often completely barred — whether legally or by company policy — from tying their work to financial gain. Most medical affairs functions need to turn to soft performance metrics to demonstrate value and obtain the resources they need. Medical publications teams were no different — until recently. Continue reading “Performance Metrics Not Useful for Medical Publications Team Valuation” »
Digital marketing is a growing strategy for pharmaceutical companies seeking to get in touch with more patients. Through digital marketing, companies invite patients to become a part of the conversation. Successful pharma apps deliver rich content and can provide important, innovative solutions to common issues that deter patients. These benefits have the potential to further patient education, increase adherence rates, facilitate trial recruitment, inform patients about new developments and promote companies and brands. Continue reading “Mobile Apps Fight Patient Non-Adherence” »
Clinical data transparency has become one of the hottest issues for pharmaceutical and biotechnology clinical development and regulatory teams. From new disclosure policies at PhRMA and the EFPIA to working with the AllTrials initiative, many companies are determined to become proactive when it comes to data disclosure.
Over the past decade, various patient advocacy and regulatory stakeholders have pushed for greater clinical data transparency. Under the FDA Amendments Act of 2007, companies in the US have until 21 days after the first patient is enrolled to register their clinical trial on ClinicalTrials.gov. These teams also have up to one year after their clinical trials conclude to post results. More recently, in Europe, the EMA released an updated version of the European Clinical Trials Database (EudraCT) which aligns its summary results with those already found on ClinicalTrials.gov. Continue reading “Planning Ahead to Meet Clinical Data Stakeholders’ Expectations” »