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


What Level Executive Should Lead Your Medical Science Liaison Team?

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

Organizing medical science liaison teams can be a struggle.  At Cutting Edge Information, we have interviewed numerous MSL leaders and each interviewee’s team is unique.  Some teams focus on interteam communication worldwide, and others operate in smaller silos.  Some teams handle multiple products in one therapeutic area, and others manage one product with multiple indications.  Many teams do not even use the “medical science liaison” moniker.  Among these differences, MSL teams are also split about the title of their MSL head. Continue reading


Medical Publications Teams Begin Activities As Early As Pre-Clinical

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

Medical publications groups are the forerunners of product success.  The clinical development team spends years testing a potential product and collecting data about its efficacy and safety.  But, the medical publications team has the privilege of formulating these findings into articles and disseminating them via journals.  In fact, medical publications teams are so vital that surveyed global medical affairs teams allocate an average 14% of their budgets to medical publications. Continue reading


The Next Medical Affairs Innovation: Patient-Centricity

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

Over the last decade, medical affairs has been transitioning from an offshoot of marketing into an independent function that is vital in its own right.  As a part of this transformation, medical affairs teams have found ways to innovate — going above and beyond to bring the most value to healthcare stakeholders and the internal organization.  Cutting Edge Information’s new medical affairs report uncovered many new medical affairs innovations, and one of the most exciting trends is a drive towards patient centricity. Continue reading


Medical Science Liaisons: Case Studies for Promoting Interteam Communication

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

Medical science liaisons (MSLs) have all types of interesting, difficult and/or successful encounters with healthcare providers (HCPs).  MSLs can learn from hearing each other’s stories and together create best practices for overcoming challenging situations — and not just MSLs that are on the same team but MSLs throughout the entire company.  Despite the benefits of these conversations, 39% of surveyed MSL teams face challenges with internal communication (Figure 1). Continue reading


Leverage Dedicated Medical Publications Teams to Maximize Annual Output Levels

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

According to an earlier Cutting Edge Information report, life science organizations report an array of medical publications team alignments—both in terms of team numbers and team types.  Some life science companies have dedicated medical publications teams.  Others supplement their lack of a dedicated medical publications team with the expertise of non-dedicated medical affairs FTEs. Continue reading


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