Next-Gen Drugs Offer Companies High Yield Pharma LCM Solutions

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

Pharmaceutical companies have no shortage of options when looking for line extension strategies. Many turn to new formulations, new indications or combination drugs to boost their brand’s lifespan. However, for those companies that have to capital to invest in pharma LCM solutions, next generation drugs may be their best bet.  This particular strategy yields the highest returns, but also takes the largest investment. Continue reading


Investigator Sponsored Trials: Structuring Evaluation and Approval Committees

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

There are many key elements to running a successful investigator sponsored trails (ISTs) program, such as:

  • Evaluating IST proposals efficiently
  • Only approving ISTs that have high scientific merit and align with corporate research objectives
  • Maintaining compliance with fair market value (FMV) and milestone payments

The investigator sponsored trials evaluation committee is at the heart of many of these processes.  A company’s IST team runs the program, but the IST committee is responsible for evaluating the submissions. Continue reading



No Risk-Based Monitoring Team? Look to Clinical Operations Groups Instead

Victoria Cavicchi, risk-based monitoring team researcher
By Victoria Cavicchi,
Research Analyst

As risk-based monitoring techniques gain footing in the clinical space, life sciences companies are looking for the best way to implement these processes.  Often, RBM responsibilities fall to clinical operations groups.  These groups already have a thorough understanding of a company’s scientific procedures and expectations.  However, dedicated risk-based monitoring teams may be more able to ensure that RBM strategies are applied and leveraged throughout clinical trials. Continue reading


MSL Salary Changes: Large Pharma Overtake Small Companies as Most Competitive

Sarah Ray, MSL salary changes researcher
By Sarah Ray,
Senior Research Analyst

By comparing pharmaceutical companies’ reported 2012 and 2014 medical science liaison salaries, Cutting Edge Information found that large and mid-sized pharma teams have replaced small company teams in offering the most competitive average MSL salaries.  Back in 2012, Cutting Edge Information found that small companies offered MSLs the highest average annual salaries (Figures 1 and 2). However, soon-to-be-published research shows that MSL operations have evolved in the past two years. Continue reading


Medicaid Drug Rebate Program Stipulations Shape Companies’ Pricing Strategies

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

So far, over 600 drug manufacturers report participating in the   Medicaid Drug Rebate program. Each of these life sciences companies have individually contracted with the Secretary of the Department of Health and Human Services (HHS) via national rebate agreements. Such agreements stipulate that state Medicaid agencies cover most of enrolled companies’ drugs in exchange for routine product and pricing data updates. Specifically, life sciences companies must use the Drug Data Reporting for Medicaid system (DDR) to submit information regarding any new covered outpatient drugs they market.  These companies must also notify states of each new drug’s coverage. After states agree to cover companies’ products, contracted companies are responsible for paying Medicaid rebates, on a quarterly basis.  Once paid, state and Federal governments share these payments, to help offset the overall expenditures of prescription drugs under the Medicaid Program. Continue reading



Developing Successful Patient Recruitment Strategies Means Never Underestimating the Value of Market Research

Sarah Ray, clinical trial patient recruitment strategies researcher
By Sarah Ray,
Senior Research Analyst

Historically, clinical development sponsors — along with trial sites and CROs — have struggled to recruit sufficient numbers of patients for their studies. In some cases, this challenge owes to a sudden influx of trials that target the same patient groups. For example, more than one pharmaceutical executive has worked with sites that are running concurrent studies — each with similar enrollment criteria. In others, problems recruiting sufficient participants boils down to an inability to cater patient recruitment strategies to patient perspectives. Continue reading


Medical Science Liaison Training: Keeping Up with New Research and New Regulations

Natalie DeMasi, medical science liaison training researcher
By Natalie DeMasi,
Research Analyst

No thought leader management team is complete without a process for medical science liaison training.  Medical science liaisons (MSLs) tweak their knowledge and practices in response to constantly evolving compliance regulations and continuous clinical research.  But, MSLs don’t go it alone.  Companies offer MSLs training to help them keep up with the latest regulations and research.  Perhaps most importantly, medical science liaison training allows a company to standardize MSL processes across its widespread teams. Continue reading