Two Ways to Optimize Medical Affairs KPI Tracking: My Conversation with the CEO of kernel

Natalie DeMasi, clinical development and medical affairs researcher
By Natalie DeMasi,
Senior Research Analyst

As we know, medical affairs’ quintessential and ongoing struggle is proving value to the internal organization.  And, we wager the solution for this battle is some combination of medical affairs key performance indicators (KPIs), outcomes measures and medical insights for the internal organization.  I recently spoke with Avikk Ghose, CEO of kernel — a company that develops intelligent mobile software for medical affairs — and he highlighted two main ways that life sciences companies can bring medical affairs KPI tracking to the next level. Continue reading


Medical Science Liaisons: The Unsung MVPs of the Life Science Industry

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Earlier this summer, the Chicago Blackhawks secured their third Stanley cup in six years.  The win also marked the first time the Blackhawks had won at home since 1938.  Pretty incredible, right?  Well sure, but the team could not have won without top-notch plays by Corey Crawford, Patrick Kane, Jonathan Toews, Duncan Keith — and many others.

Basically, just as an NHL team is only as good as its individual members, life science companies’ medical affairs organizations cannot hope to thrive without ample support from talented medical science liaisons (MSLs). Continue reading


Pharmaceutical Brand Marketing: Begin Brand Assessment As Soon As Pre-Clinical Development

Victoria Cavicchi, pharmaceutical social media researcher
By Victoria Cavicchi,
Research Analyst

Life sciences companies rely on brand assessments and market research to form the foundation of pharmaceutical commercialization strategies.  Often, companies begin these activities early in the product lifecycle to prepare for future pharmaceutical brand marketing activities.  In some cases, brand teams begin product assessments and commercial landscape assessments as early as pre-clinical development.  Early assessments allow teams to coordinate support activities across internal stakeholders.  These assessments also guide firms in determining best-fit pharmaceutical launch and marketing budgets.     Continue reading


Recent Rate Card Sampling Shows Life Science Teams Reimburse KOLs at Similar Rates

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Life science teams enact a number of strategies to assure fair market value (FMV) rates when compensating industry key opinion leaders (KOLs).  The rate cards that these pharmaceutical and device teams develop include payment ranges for advisory board and speaker programs, among other medical affairs activities.  In some cases, these rates are determined on an hourly basis.  In others, rates are capped at a pre-determined maximum, flat rate.  Continue reading


Clinical Investigator FMV: Differentiating Research-Driven Costs from Standard of Care Expenditures

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

For trial sponsors, building a budget that anticipates all potential study expenses is one of the more challenging aspects of clinical planning.  A recent Cutting Edge study — targeting clinical investigator FMV — found that clinical trial budgets cover a number of study expenditures.   Many of these trial costs are directly associated with site initialization and sites’ ongoing responsibilities: from enrolling study participants to managing patient retention. Continue reading



Medical Information Call Centers: Establish Clear Processes for Adverse Event Reporting

Natalie DeMasi, clinical development and medical affairs researcher
By Natalie DeMasi,
Senior Research Analyst

Pharma medical information call centers bear a number of responsibilities beyond answering stakeholder questions about products.  For instance, call center agents may recruit for clinical trials and respond to internal literature requests.  Another vital call center role — conducted by 63% of surveyed teams — is reporting adverse events (AEs). Continue reading


Informing Patients Doesn’t Stop with Recruitment: One-on-One Patient Engagement Practices Bolster Patient Retention

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Contract research organizations (CROs) play an ever-present role in companies’ clinical trial practices.  Many sponsors leverage these third parties to support study elements like site monitoring and patient recruitment.   Patient recruitment in particular has always been a difficult task for sponsors, CROs and site teams alike.  To help alleviate the challenge of patient recruitment, some CROs are customizing their approach, to ensure that they can both attract qualified study participants and keep these individuals interested throughout the clinical trial. Continue reading


Medical Science Liaison Core Activities Don’t Change For Pre- and Post-Launch Stages — But the Time Spent on Them Does

Natalie DeMasi, clinical development and medical affairs researcher
By Natalie DeMasi,
Senior Research Analyst

I’ve said it before, and I’ll say it again: Medical science liaisons (MSLs) are one of the superheroes of the life sciences industry.  They fly to the aid of healthcare providers (HCPs) in need of scientific data, and they return to the internal organization with invaluable insights about drug utilization and the patient experience.  These deeds are crucial after a product earns market authorization, but MSL activities are equally as important during pre-launch stages as well.  However, MSL priorities may shift between pre-market and post-launch stages. Continue reading


Some Medical Device Companies Leverage Clinical Trials to Supplement FDA Submissions and Enhance Marketing Messages

David Richardson, pharmaceutical commercialization and launch expert
By David Richardson,
Director of Research

The US Food and Drug Administration (FDA) does not require that all medical device manufacturers file clinical findings along with regulatory submissions.  Companies developing medical devices that are similar to other products in the US market can use the pre-market notification 510(k) submission which requires bench and laboratory data, but not full-blown clinical trials. Continue reading