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


Supporting Investigator-Initiated Trials: Develop IIT Management Team Numbers In-Line with Centralization Practices

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

Investigator-initiated trials (IITs) are developed and executed under the direction of third-party clinical investigators.  However, life science teams often require ample in-house teams to support these activities from start to finish. Dedicated teams handle tasks such as managing online investigator portals and reviewing IIT submissions. Continue reading


Female Key Opinion Leaders Receive Smaller Percentage of Research Funding, Finds Recent Cleveland Clinic Study

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

Over the past few years, the industry has paid close attention to the Sunshine Act’s physician payment reporting requirements.  Ideally, publication of payment data will usher in a new era of transparency regarding how key opinion leaders (KOLs) interact with life science teams.  However, while many healthcare consumers may welcome Sunshine Act reporting, some physicians and industry groups remain apprehensive that consumers will take financial information out of context.  Moreover, previously released physician payment data already demonstrates that individuals may not always receive equivalent compensation for the same types of work. Continue reading



Pharmaceutical KOL Disclosure Requirements: Global Transparency Trends

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

Often, life science companies elect to partner with industry experts or pharmaceutical KOLs to support their medical affairs activities.  However, companies may struggle to determine the appropriate physician fair market value (FMV) rates to provide these external experts.  For industry teams in the US, the knowledge that physician remuneration will become public knowledge — in-line with Sunshine Act reporting requirements — contributes to this perceived challenge.  Continue reading


IIT Approval: The Stanley Cup of Investigator-Sponsored Research

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

Like NHL playoff teams vying for the Stanley Cup, investigators submitting IIT proposals are also competing with one another — and the competition is fierce.  In its Investigator-Initiated Trial Management study, Cutting Edge Information found that surveyed life sciences teams received an average of 108.7 IIT proposals in 2014.  Of these proposals, companies evaluated an average of 99.2 of combined concept and protocol submissions and approved an average of 43.5. Continue reading


Proving MSL Team Value: Best Practices from ExL’s MASS East 2015

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

Proving value is a constant challenge for medical science liaisons (MSLs).  Like many medical affairs subfunctions, MSL teams are developing key performance metrics (KPIs) to illustrate their productivity levels to senior management.  Some teams begrudge this task, not wishing to condense MSL’s activities to mere numbers that may or may not reflect the quality of their work.  Still, many teams are building robust, outcomes-based, multifactorial KPIs that get closer to the heart of MSL value.  Continue reading


The Sunshine is Spreading: Physician Payment Reporting Obligations Have Become a Global Affair

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

The US Sunshine Act is probably among the more well-known regulations governing the life science industry’s interactions with physicians and other healthcare community members.  However, when it comes to physician payment reporting obligations, the United States is not the only country with a little sunshine to spare. Many other countries have also recently drafted or enacted physician payment disclosure requirements of their own. Continue reading


Top 3 Criteria for Selecting Investigator Initiated Trials to Fund: Strategy Alignment, Scientific Merit and Strong Investigator Credentials

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

There are many different names for investigator sponsored trials (ISTs), such as investigator initiated trials (IITs), investigator sponsored studies (ISS), investigator initiated research (IIR) and a number of other variants of those titles that you can think of.  IITs – or whatever sobriquet you prefer – vary in budget, patient population, phase and research goals even more than they vary in name.  But one thing does not change about investigator sponsored trials: the need to carefully select which trials are worth funding and which ones are not. Continue reading


Upholding Physician Fair-Market Value: It All Starts with a Formal Rate Card

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

Developing competitive rates, to recruit key industry experts has never been the easiest of tasks for life sciences companies.  Add in the additional complexity associated with Sunshine Act reporting requirements and the recruitment process become even more difficult.  In this heightened regulatory environment, recruiting top-tier physicians and other thought leader types means that companies must balance their desire to remain competitive with adhering to rates that do not fall too far astray of physician fair-market values. Continue reading