MSL Selection: Expertise, Knowledge and A Certain Je Ne Sais Quoi

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

Medical science liaisons (MSLs) are often a key ingredient of life science teams’ medical strategy.  For some teams, the MSL hiring process can be arduous as companies focus on qualifications that they believe will make prospective MSLs successful at their organization.  To help them recruit and retain well-suited MSL candidates, companies may look to individuals that balance expertise with enthusiasm. Continue reading


Shape Up Your Key Account Management Team Engagement Strategies

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

The role of pharma key account management (KAM) is growing.  Throughout the life sciences industry, KAMs act as the voice of the company for major commercial accounts – including physician networks, hospital systems and even payer organizations.  Because a large part of the key account management team role is working directly with these accounts, KAMs may also need to coordinate their visits and discussion topics with other outward-facing teams across the organizations.  In fact, many companies would prefer that KAMs act in a strategic role to shape the organization’s account communication. Continue reading



Loi Bertrand Update: Conseil d’Etat Prescribes a Healthy Dose of Vitamin C

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

Ever since its inception in 2011 and eventual adoption in 2013, the French Sunshine Act or Loi Bertrand has created a fervor.  Like its US counterpart, the French version aims to shed light on the life science industry’s interactions with “covered recipients” by requiring manufacturers to disclose any cash or in-kind benefits they provide to these individual and group organizations.  In the US, covered recipients refer to physicians and teaching hospitals.   In France, covered recipients include even organizations on the periphery of healthcare—organizations like publishing companies and prescription and dispensing software editors. Continue reading



Determining Trial Master File Management Staffing Levels

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

The trial master file (TMF) incorporates every aspect of a clinical trial, so TMF management will similarly include people from all parts of a clinical trial’s operations.  These groups include everyone from clinical development to data management, regulatory affairs and contract management — just to name a few.  Cutting Edge Information’s report about TMF management collected benchmarks for the number of FTEs responsible for TMF from different groups. Continue reading


Leverage Standalone Groups to Coordinate Drug Safety Activities

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

As part of its 2013 pharmacovigilance research, Cutting Edge Information determined that just under half of surveyed life science teams had standalone groups dedicated to drug safety. More specifically, the survey found that 28 of 57 surveyed pharmaceutical, biotech and device teams (49%) had a standalone drug safety group in place.   Remaining teams relied on other groups, like regulatory and medical affairs, to coordinate both pre- and post-launch drug safety activities. Continue reading


Medical Device Development: Choosing Partners to Drive Product Commercialization

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

Medical device companies require substantial resources to move their products to market.  For many firms, these resources—whether technology or personnel—already exist in-house.  However, not all medical device developers are equipped to manufacture or commercialize their products without outside support.  In many cases, partnerships can drive commercialization initiatives.  Partners can assist these smaller firms by contributing either personnel, manufacturing space or financial resources necessary to drive further medical device development and commercialization efforts. Continue reading


Resolve Increasingly Complex Physician and Patient Requests by Involving All Medical Information Teams

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

Medical information teams fulfill multiple roles within companies’ medical affairs functions.   These teams may provide an internal resource for sales teams and medical science liaisons (MSLs).  For example, medical information groups may develop medical responses that field force teams can use in their interactions with physicians and other healthcare audiences. Additionally, medical information teams may also resolve medical queries received directly from external audiences. A Cutting Edge Information study found that about 94% of surveyed life science teams respond to unsolicited requests for information from physician and patient audiences alike.  Continue reading