The Value of Medical Affairs Lies in Its Ties to Patient Care

Elio Evangelista, physician fair-market value expert
By Elio Evangelista,
Senior Director

A theme that emerged at World Congress Second Annual Summit on The Evolving Role of Medical Affairs and Thought Leader Engagement in an Era of Transparency, held in Philadelphia from May 20 to 21, is that medical affairs teams face universal challenges — regardless of whether theyre housed within large Top 50 drug makers, small specialty biotechs or medical device companies. The greatest challenge to these teams is not necessarily the effects of new transparency regulations, but rather, the same internal obstacle that these teams have faced for decades: how to prove their value to senior leadership.

The presentations delivered by some of the industrys most experienced medical affairs leaders highlighted several key themes that underscore common challenges Continue reading

Basing Fair-Market Value on Physicians Salary Data Isnt Enough Anymore

Elio Evangelista, physician fair-market value expert
By Elio Evangelista,
Senior Director

Medical Marketing and Media published an article recently stating that 46% of the highest-paid physicians (orthopedists at $413,000 annually) are unsatisfied with their pay. This is a telling metric given the discussions that compliance executives throughout the pharmaceutical industry are having around determining fair-market value (FMV) for the physicians their companies work with.  Continue reading

The Global Expansion of Medical Science Liaisons

Significant changes to medical science liaisons’ roles and expectations in the past 15 years have underscored the value MSLs bring to their organizations. MSLs not only provide access to highly influential physicians and medical researchers, but they also bring exposure to key healthcare decision-making bodies, such as payers. Our latest research into MSL operations found that the payers’ role in healthcare decisions is one factor fueling MSLs’ global expansion. Continue reading

Accelerating Phase 4 Clinical Trials a Matter of Improving Enrollment

Phase 4 clinical trials not only serve to gather valuable data surrounding drugs’ safety, tolerability and real-time effectiveness, but also to test potential new indications, develop stronger marketing profiles, gain payers’ favor and prove superiority over competitors’ products. While many phase 4 trials are conducted at the requirement of regulatory agencies, many are conducted simply to help boost products’ profiles. Needless to say, these trials can be particularly pertinent to the success, or failure, of a product regardless of the reason. Continue reading

The Widening Talent Gap in Regulatory Affairs is a Problem for Small Pharma

By Casey Ferrell,
Senior Research Analyst

In sports, payroll tends to have a big impact on the quality of a roster. Though it doesn’t always equate to Stanley Cups or World Series rings, the rule is pretty simple: more money equals better players equals more wins.

In pharmaceutical regulatory affairs, the same is increasingly true. To the detriment of smaller players and the benefit of bigger ones, talented regulatory affairs personnel are in high demand; this seems to be driving rapidly growing salaries. Companies with deeper pockets are snatching up the best and brightest regulatory affairs professionals working, creating a talent gap in the industry, the ripple effects of which are numerous and consequential. Continue reading

Purdue Plans Big DTC Campaign for Intermezzo

By Jeremy Spivey,
Senior Research Analyst

Advertising Age reports that Purdue Pharma is planning a major DTC ad campaign for its new product, Intermezzo. Although Intermezzo is based on the same active ingredient molecule as Ambien, a sublingual administration and a lower dosage allows Purdue to target this formulation as better suited for the treatment of early awakening. Unlike Ambien, Intermezzo is approved for this indication, and can be taken with as little as four hours of sleep time remaining.

The $100 million budget Continue reading

New White Paper: Five Key Trends in MSL Program Management

By Stephanie Swanson,
Strategic Marketing Manager

The CEI research team is launching two new benchmarking studies that will explore the value proposition, Return-on-Investment and performance measurement of the Medical Science Liaison function. Early results from these studies highlight several trends in medical science liaison (MSL) program management, particularly the changing responsibilities of MSLs within pharmaceutical and biotechnology companies and how their role is expanding worldwide. “Key Trends in MSL Management,” is a complimentary resource providing insights from the new data. The findings in our new white paper are signposts to help managers and executives understand how life science companies operate their MSL programs. Continue reading