Historically, clinical development sponsors — along with trial sites and CROs — have struggled to recruit sufficient numbers of patients for their studies. In some cases, this challenge owes to a sudden influx of trials that target the same patient groups. For example, more than one pharmaceutical executive has worked with sites that are running concurrent studies — each with similar enrollment criteria. In others, problems recruiting sufficient participants boils down to an inability to cater patient recruitment strategies to patient perspectives. Continue reading
No thought leader management team is complete without a process for medical science liaison training. Medical science liaisons (MSLs) tweak their knowledge and practices in response to constantly evolving compliance regulations and continuous clinical research. But, MSLs don’t go it alone. Companies offer MSLs training to help them keep up with the latest regulations and research. Perhaps most importantly, medical science liaison training allows a company to standardize MSL processes across its widespread teams. Continue reading
In Research Triangle Park, fall is already here. The leaves are falling, there’s a chill in the air and the holidays are right around the corner. Inside the Cutting Edge Information office, the team is busy turning out new pharmaceutical benchmarking studies. But outside, we’ve taken on the age-old challenge: The Annual Cranberry Sauce Beanbag Toss.
Three rounds. Four beanbag tosses. One victor. Continue reading
When medical device companies — especially smaller start-ups — begin developing new products, it’s all hands on deck. Most medical device commercialization teams expect their new products to face some competition in the US market; in fact, Cutting Edge information found that just over 30% of surveyed device firms expect high competition levels at launch. To ensure successful medical device commercialization, companies call on the expertise of stakeholders throughout the organizations to contribute to strategic planning and market research. Continue reading
In recent years, regulatory policies dictate that life sciences companies must pay physicians fair-market value (FMV) payments. But, regulatory guidelines offer no rule book for how to calculate FMV. This situation — however dire it may seem — actually offers companies a tabula rasa for establishing the best methods for FMV calculations. While pharma continues to build its own guidelines for FMV, there are three broad steps for determining FMV investigator compensation: Continue reading
One of the major organizational challenges presented by health economics groups is the fact that they need data from the clinical and scientific side of the organization in order to make an effective case for payers that may be used to speaking with the commercial side of the company. This issue is part of why many health economics groups report into medical affairs so that they can preserve their scientific expertise and credibility while bridging the gap to payers as needed. Continue reading
Pharmaceutical lifecycle management strategies have changed in the past decades. In the old days of industry lore, companies could roadblock generic market intrusion by conducting clandestine laboratory tests and sending letters to FDA pointing out flaws in the generic’s bioequivalence – just to list one colorful example. But those days are past. Today, pharma companies will have better success countering generics with strategic pricing techniques.
Generics often toll the death knell for branded drugs because of their low price. Since companies can’t beat generic prices, they might as well join them by lowering the price or offering rebates of their branded drugs at the entrance of generics. A recent study by Cutting Edge Information found that 40% of surveyed companies with strategic pricing utilized these strategies to slow market share decline after exclusivity loss (Figure 1). Continue reading
Well over a year ago, the industry group TransCelerate released its original risk-based monitoring (RBM) position paper. The paper provided a series of insights regarding off-site monitoring approaches. Each of these strategies hinged upon the concept of quality by design (QbD) in which trial designers leverage efficient risk identification, monitoring and mitigation practices to uphold patient safety and data quality in each of their clinical studies. Ultimately, TransCelerate leveraged its paper to emphasize the flaws in companies’ existing risk monitoring strategies — from the lack of sufficient risk-characterization tools to companies’ extensive use of source data verification (SDV). Since May 2013, the industry has been abuzz with the best ways to implement RBM and overcome stigmas associated with not conducting 100% SDV. Continue reading
In a recent study, a sampling of pharmaceutical companies participating in social media rated Facebook and Youtube as the most impactful social media channels. Survey takers were asked to rate the level of impact of various social media outlets on their pharma digital marketing efforts. Ratings were measured on a scale from one to five, with five representing the largest impact. As the accompanying figure shows, both Facebook and Youtube received average ratings of 3.8 out of 5. Continue reading
Medical publications remain an important consideration for companies’ dedicated and non-dedicated medical affairs staff. Earlier this year, Cutting Edge Information conducted a study examining companies’ guiding medical publication strategies and their annual output patterns.
Figure 1 shows that the highest percentage of surveyed companywide, business unit and country-level teams ranked the following as extremely relevant publication goals: Continue reading