Can’t Reach Physicians? Time to Implement Customer-Centric Strategies

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

In recent years, pharmaceutical companies’ commercial teams have faced a growing number of challenges in the market.  These organizations have already faced two major patent cliffs, both of which filled the market with a number of generics and biosimilars alongside an increasing contingent of branded competitors.  Now, sales representatives are seeing more and more doctors close their doors to pharma’s commercial forces in response to the Physician Payment Sunshine Act.  In the wake of these challenges, pharmaceutical sales teams have had to evolve their traditionally product-centered commercial models to better meet their customers’ demands. Continue reading


Don’t Call it a Comeback: mHealth Never Went Out of Style

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

Across the life sciences industry, global not-for-profit partnerships and pharmaceutical manufacturers alike have become increasingly active in the mobile health space.  In 2012, projections indicated that the global smartphone application market would reach up to $718 million. Already, mobile technologies had helped pharmaceutical and device teams facilitate heightened medical awareness and encourage patient adherence.  Continue reading


Johnson & Johnson Demonstrate Value of Line Extensions in Lifecycle Management

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

In 2013, Johnson & Johnson announced plans for up to 25 different line extensions for their products by 2017 across all markets.  Looking back now from 2015, we can see that J&J are not only on track to meet this goal, but look set to vastly exceed the stated target.  In 2014 alone the company had 20 new line extensions approved and have another 20 applications in process.  Continue reading


Investigator Initiated Studies: Composing Cross-Functional Evaluation Committees

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

Approving investigator initiated studies (IIS) is a multi-step process that can be both time-consuming and complicated.  Once an investigator submits an IIS proposal, one pivotal step is for the team’s evaluation committee to assess the proposal for scientific merit, alignment with corporate strategies and investigator credentials – as well as budget and compliance aspects. Continue reading


Consider Site Capabilities to Determine Risk-Based Monitoring Strategies

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

Clinical site monitoring is a key consideration for life science companies’ clinical trial timelines and budgets.  Regardless of development phase, the level of planned site visitation — which can take up not only a lot of clinical research associates’ time, but also trial budget — can potentially accelerate or delay trial progress.  While in-person site visits help sponsors identify a number of issues, risk-based monitoring strategies can improve monitoring efficiency and save companies time and money. Continue reading


The Sunshine is Spreading: Physician Payment Reporting Obligations Have Become a Global Affair

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

The US Sunshine Act is probably among the more well-known regulations governing the life science industry’s interactions with physicians and other healthcare community members.  However, when it comes to physician payment reporting obligations, the United States is not the only country with a little sunshine to spare. Many other countries have also recently drafted or enacted physician payment disclosure requirements of their own. Continue reading


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