Three Successful Late-Stage Lifecycle Management Tactics

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

When a drug first hits the market, lifecycle management (LCM) teams have a host of weapons in their arsenal to increase market share.  As that same drug approaches patent expiry, the choices become more limited. But all hope is not lost! Here are three late-stage lifecycle management tactics highlighted in our new report with a track-record of success:

  • Pediatric exclusivity
  • Strategic pricing
  • Medical publications

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Hey, Clinical Sites! Are You Prepared to Work with Companies Using Risk-Based Monitoring Strategies?

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

Ever since the FDA and EMA each released separate position papers, sponsors and CROs alike have been focused on implementing risk-based monitoring (RBM) strategies, rather than performing traditional monitoring for each of their clinical trials. And why not?  A look at the costs and benefits of traditional site monitoring activities shows that these two metrics do not always align favorably.  According to an article published in Perspectives in Clinical Research, clinical site monitoring accounts for “30% of total clinical trial cost.” However, the same article estimates that the source data verification (SDV) that CRAs conduct during these in-person site visits account for “less than 3% of data changes performed after CRA visits.”  If there’s no discernible benefit for sponsors and CROs to visit sites more often, it follows that companies would look to reduce the number of in-person site visits they schedule by using risk-based monitoring strategies instead. Continue reading


Balance Geographic Responsibilities to Strengthen Pharmaceutical Call Center Structure

Victoria Cavicchi, pharmaceutical medical affairs researcher
By Victoria Cavicchi,
Research Analyst

As life sciences companies cultivate a more global reach, the medical information function must also grow to span worldwide operations.  For many companies, this means maintaining a number of medical information groups — including both a global function and localized teams, in addition to a more established call center system. The ways in which these global, regional and country-level teams work together drive team activities and also determine pharmaceutical call center structure. Continue reading


Pharmaceutical Divestitures Are Reshaping the Pharma Landscape

Jacob Presson, pharmaceutical portfolio management researcher
By Jacob Presson,
Senior Research Analyst

One of the interesting trends over the past few years for those of us watching the pharmaceutical industry is how companies are turning increasingly to specialization within their portfolios. Pharmaceutical divestitures are continuing at breakneck pace as companies look to shed products that fall outside primary business interests and scour the market for products or pipelines that match up with development priorities.  So why is this happening now and how will it further shape the industry? Continue reading


Build Cross-Functional Support for Medicaid Pricing Activities

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

According to a Cutting Edge Information study, attaining favorable Medicaid pricing remains a key factor in life science companies’ market access preparations.  Broadly, government payer acceptance often sets the precedent for whether private payers will reimburse company products or not. Unsurprisingly, private payers are less likely to support products that fail to meet government approval. As one market access advisor explained, “Failure to receive Medicaid coverage is like a kiss of death for company products.”  Subsequently, market access teams work diligently to ensure that drugs attain Medicare and Medicaid reimbursement. Continue reading


Mitigating the Risks of CER Clinical Trials

Natalie DeMasi, clinical trial and comparative effectiveness researcher
By Natalie DeMasi,
Research Analyst

One of the best ways to prove a product’s worth is to quash a competing product in comparative effectiveness research (CER) clinical trials.  Conversely, one of the best ways to harm a product’s market success is to be crushed in a comparator trial.  Of course, most CER clinical trials are not this definitive, but there are always risks of unexpected negative revelations.  Despite this, many life sciences companies look to comparative effectiveness findings to aid market access and commercialization efforts. Continue reading


Risk-Based Monitoring Strategy: Embrace Centralization Technology to Save Resources During Clinical Trials

Victoria Cavicchi, pharmaceutical clinical trial researcher
By Victoria Cavicchi,
Research Analyst

Risk-based monitoring (RBM) has recently emerged in the pharmaceutical industry as a way to reduce the costs of clinical trials while maintaining, or even improving, site protocol compliance and communication. In traditional trials, sponsors visit clinical sites frequently — often every four to eight weeks. However, these in-person site visits and monitoring strategies account for a large percentage — a suggested 30% — of clinical trial costs.  A risk-based monitoring strategy — especially when combined with in-person visits — conserves time and staffing resources while still enforcing good clinical practices. Continue reading


Setting the Pace for Clinical Publications, One Step at a Time

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

The foresight necessary to produce clinical publications is similar to preparing for and running a marathon. Before the race begins — or before a product launches — a lot of hard work goes into ensuring that the final outcome matches the desired result.  Runners may train for weeks, months or even years to prepare themselves for an upcoming competition. In similar fashion, dedicated publications teams spend a lot of time ensuring that products will receive ample clinical publications support both before and after product launch. Continue reading



Staying in the Loop: Pharmaceutical Call Center Audits

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

Pharmaceutical companies medical information groups often use outsourced call centers to support their activities.  As such, keeping close track of the performance of these vendors has grown in importance.  Many medical information groups have a set list of performance indicators paired with internal goals that must be met to ensure a consistent experience for callers.  Pharmaceutical call center audits, in their various forms, allow companies to monitor vendors with the same level of detail that they would be able to do for an in-house team. Continue reading