Cultivate Strong Leadership to Ensure a Strong Lifecycle Management Strategy

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

After a pharmaceutical product has entered the market, managing the brand’s performance requires a combination of foresight and cross-functional support.  An effective lifecycle management strategy combines multiple initiatives to maximize the brand’s impact, performance and longevity.  Though proactive planning and internal collaboration are important, pharmaceutical executives report that these are not the most essential factors to LCM success. Continue reading


Trial Master File Management: Laying the Groundwork for Clinical Success Starts with Innovative Strategies

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

Companies traditionally leverage a master file for each of their clinical trials. These master files help them organize trial documents and, consequently, adhere to regulatory standards.  Generally, Good Clinical Practices (GCP) guides what documents companies elect to include in this file.  Additionally, included documents range from those necessary for trial set-up to documents signifying trial completion. For example, companies would need to include materials as trial protocols, feasibility assessments, patient informed consent documents, to name a few. Continue reading


Get Your Compliance Ducks in a Row By Evaluating IIT Research Grants for FMV

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

Like any medical affairs subfunction, compliance is a major concern for investigator initiated trial (IIT) teams.  Companies have no say in an IIT’s protocol, patient recruitment practices or final publication, so teams need to get all their compliance ducks in a row before giving out an IIT research grant.  One of the most crucial compliance concerns is that the IIT’s proposed budget is fair-market value (FMV). 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


MSL Strategy: Proactive Vs. Reactive

Ryan McGuire, lifecycle management tactics expert
By Ryan McGuire,
Research Team Leader

Medical science liaison (MSL) strategy is a difficult concept to define.  Much of it seems to boil down into two main schools of thought — proactive MSL strategies versus reactive strategies.  Proactive teams pride themselves on initiating meetings and bringing the latest medical research directly to physicians. On the other hand, reactive teams quickly respond to medical inquiries and other scientific requests. Continue reading



The Building Blocks of a Successful Launch Sequence: A Strategic Regulatory Affairs Perspective

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

Developing, refining and coordinating a complex pharmaceutical launch sequence can be a significant challenge for even large global groups.  There are a myriad of market considerations on top of commercial priorities that come into play when setting the launch sequence. Bringing a strategic regulatory affairs function into these discussions is also key in order to keep the license cascade in line with the proposed launch sequence. Continue reading


Working with Pharmaceutical Big Data: What Makes a Good Analyst?

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

We are firmly rooted in the information age, and we all have plenty of it. With the abundance of pharmaceutical Big Data, real-time and real-world data, life sciences companies are ready to put all of these insights to good use. In many companies, Big Data teams are already in place to work with these insights and inform retrospective trials and other initiatives. However, filling these teams with the skilled Big Data analysts can be difficult for organizations. Pharmaceutical Big Data analysts much possess not only a strong analytical background, but also have the industry knowledge to work with insights in a meaningful way. 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


MSLs, KPIs and Value: A Numbers Game That Teams Have to Play

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

Medical science liaisons (MSLs) are invaluable to the life science industry.  Through interactions with thought leaders, MSLs build relationships with physicians, gain competitive intelligence, learn prescribing behaviors and bolster the company’s public image.  Unfortunately, not all of upper management understands the value that MSLs bring to the internal organization.  In fact, 63% of surveyed MSL teams struggle to prove value to upper management, according to a new report by Cutting Edge Information. Continue reading