Proactive Communication Key to Managing Challenging Regulatory Agencies

David Richardson, pharmaceutical commercialization and launch expert
By David Richardson,
Director of Research

Dealing with regulatory agencies to earn product approvals can prove quite difficult for life sciences companies.  Some representatives can be quite passionate about their therapeutic area which can affect their judgment, for instance.  In other instances, one investigator can simply prove more difficult than others.

To respond, pharmaceutical and other life sciences companies use several strategies to handle working with difficult regulators, according to Cutting Edge Information’s conversations with regulatory affairs executives.  Open communication with the regulator assigned to a product is absolutely essential — and should begin early in the development process. By openly communicating with agencies early on in the development process, companies can seek input from the individual responsible for reviewing the product. This communication ensures that there are no surprises on either side and that potential misunderstandings can be addressed promptly. Continue reading


Staffing Oncology Trials: An Ode to the CRA

Sarah Ray, staffing oncology trials researcher
By Sarah Ray,
Senior Research Analyst

As investigational drugs and devices move into larger and more complex trials, a growing variety of roles are involved in ensuring that clinical trials continue to run smoothly.  Cutting Edge Information’s oncology trials report focuses on how companies’ staffing roles — including data managers, statisticians and regulatory staffing — evolve to provide key clinical support.   Although each role is significant, the importance of the clinical research associate (CRA) stands out, in the opinion of clinical development executives.  In a word, CRAs are the jacks-of-all trades whose familiarity with trial protocols and previous clinical experience can prove instrumental in the success of a new product’s clinical trials.  Using their knowledge of Good Clinical Practices, CRAs can drive trial progress by facilitating sponsor-site communications and acting in a troubleshooting capacity, should specific challenges arise. Continue reading


Contacting Medical Information Teams: What Channels Are Physicians and Patients Using?

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

It’s no secret that our communication practices continually evolve to match our communication capabilities. Why write a letter when you can make a phone call? Or call when you can send an email or text message? Why not use any number of social channels to reach out to, not just people you know, but the companies that you support?  Medical information teams must now take on the daunting task of meeting customers — both patients and physicians — where they operate, while still remaining compliant.

Many pharma companies’ medical information teams receive requests via a number of different channels, including telephone, email, social media and fax.  Physicians may also submit inquiries through intermediaries such as sales reps and medical science liaisons (MSLs). While traditional channels — telephone and reps — remain prominent, digital channels are gaining traction.  One interviewed call center manager noted, “I’d say that just as recently as 3 or 4 years ago, three-fourths of our medical inquiries came in on fax or letter or phone call. Now I’d say that over two-thirds come in by email.” Continue reading



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 pharma lifecycle management tactics highlighted in our new report with a track-record of success:

  • Pediatric exclusivity
  • Strategic pricing
  • Medical publications

Continue reading


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