Effective Utilization of Key Opinion Leader Tiers

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Senior Research Analyst

Many pharmaceutical and life science companies have a three tier system in place for determining key opinion leaders’ fair market value.  Companies also typically have an “exceptional” tier for those that go beyond a tier 1 level of influence.  Among those participating in our research, almost 20% do not have rates or procedures in place for the exceptional tier, sticking with the 3 tiers, typically in order from tier 3 at the local level to tier 1 at the global level of influence.  Continue reading


Investigator-Initiated Trial Budget Changes for the Coming New Year

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

Investigator-initiated trials (IITs) are one of the pillars of company-thought leader interactions and trust-building.  Alongside company-sponsored Phase 4 studies and collaborative research, IITs are an integral part of a product’s continuing research.  Plus, they foster corporate goodwill and relationships with key opinion leaders (KOLs).  As such, companies should not be stingy in resourcing investigator-initiated trial teams. Continue reading


Defining Appropriate Fair Market Value for Specific KOL Activities

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

Collaboration with physicians and top thought leaders is key to many life sciences operations.  From speaker programs to clinical trials, key opinion leaders (KOL) take on critical tasks to help pharmaceutical and medical device companies develop the best possible products and educate the healthcare audience.  However, life sciences companies must take a number of factors into consideration when determining fair market value for specific KOL activities.  In addition to a doctor’s geography and sphere of influence, companies should also consider the type of tasks that they are asking KOLs to perform. Continue reading


Increasing REMS Program Awareness, One Alliance at a Time

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

In an effort to mitigate associated product risks and reduce patient safety concerns, the US created new legislation in 2007.  Under the Food and Drug Administration Amendments Act (FDAAA) the FDA can require life science teams operating in the US to develop Risk Evaluation and Mitigation Strategy (REMS) programs in situations where products have serious potential or known safety risks.  All REMS require a timetable for submission of assessments—typically around 1.5 years, 3 years and 7 years after a product launches.   REMS may also include medication guides, communication guides, elements to assure safe use (ETASUs) and implementation systems.  Continue reading



Exploring Geographic Trends in Fair Market Value Compensation Rates

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Senior Research Analyst

One of the biggest challenges when determining what constitutes fair market value (FMV) rates among healthcare providers is understanding the geographic differences that occur around the world.  While there will always be some variation between therapeutic areas and for different types of activities, there are some broad trends in these geographic shifts that we will explore here. Continue reading


Medical Affairs and Postmarketing Studies Go Together Like Peas and Carrots

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

Postmarketing studies help companies expand their product knowledge, even after the launch window has passed.  For example, dedicated or non-dedicated postmarketing study teams may leverage Phase 4 research to gather additional safety data as a condition of regulatory approval. Or, companies may develop postmarketing studies to evaluate the impact of long-term product use.  Still other life science organizations may generate late-stage studies as a way to demonstrate cost-effectiveness.  Regardless of their end goal, companies can gather information to fulfill these diverse objectives through prospective interventional or observational studies or through retrospective data collection methods. Continue reading


Medical Affairs Firewalls: How Far Is Too Far?

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

Compliance can be medical affairs’ worst enemy.  In fact, our new medical affairs report found that compliance and perceived overregulation were the most commonly-reported concerning trends among surveyed industry experts.  Compliance concerns include managing off-label discussions and fair market value payments to physicians.  However, internal firewalls between medical affairs teams and commercial teams can also be a point of contention at many companies. Continue reading


Criteria for Establishing Fair Market Value Rates

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Senior Research Analyst

As companies begin to build documentation for fair market value rates, there are four main variables that they must take into account when establishing what rate is appropriate for a specific activity.  The primary criteria are the country, the activity, the tiering of the thought leader, and the specialist involved.  Successful application of FMV rates requires accounting for all four variables. Continue reading


Upholding TMF Document Quality Part One: Initiate Quality Control Activities Early to Avoid Herding Cats

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

From clinical development to product launch, TMF quality control activities remain an important consideration for life sciences teams.  In the wake of drug supply chain interruptions, many companies have taken increased care to uphold the integrity of their manufacturing and drug delivery processes to assure patient safety.  But, what about upholding the quality of the clinical trial documents that not only help companies’ products receive marketing clearance but also effectively outline products’ development pathways? Continue reading