Patients Can’t Answer? Look to Clinician- or Observer-Reported Outcomes!

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

Because of patient-reported outcomes implications for market access and reimbursement success, many pharmaceutical organizations include these endpoints during clinical trials.  However, these clinical outcomes assessments are not always an option for clinical teams. Certain patients — typically small children and, sometimes, patients suffering from illnesses such as Alzheimers disease — are unable to manage their own outcomes reporting during trials. In these cases, clinical teams can look to caregivers or clinicians to submit observer-reported outcomes (ObsROs) or clinician-reported outcomes (ClinROs) to provide patient-centric insights. Continue reading

New Product Planning: Taking the Extra Step Now May Mean a Leap in Commercial and Reimbursement Success Later

Sarah Ray, pharma new product planning researcher
By Sarah Ray,
Senior Research Analyst

When it comes to lifecycle management, providing adequate pharma new product planning support can represent a tall order.  According to the Journal of Medical Marketing, drug development takes between 12 and 15 years. Considering that patents generally only guarantee exclusivity for 20 years, companies have only 5 to 8 years of patent protection if the product makes it to market.  The same Journal of Medical Marketing article suggests that the odds of a compound in pre-clinical development ever reaching the marketplace are only 1 in 10,000. Continue reading

Signal Detection: The Key to a Sound Pharmacovigilance Strategy

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

Thanks to a mixture of recent regulations and negative media coverage, pharmacovigilance remains a hot topic across the life sciences industry. Pharmas, biotechs and device companies alike continue to take an active interest in leveraging new technologies to uncover, assess and mitigate safety concerns associated with the products they develop.  For example, in an effort to streamline the adverse event reporting process, several teams — surveyed for a recent Cutting Edge Information study — have established strong, external-facing social media platforms. Still other organizations have instituted customized adverse event databases to help them track and analyze the adverse event reports that their dedicated teams receive. Continue reading

What’s In A Name? How Functional MSL Titles Encompass the Role

Ryan McGuire, lifecycle management tactics expert
By Ryan McGuire,
Research Analyst

The MSL role should be an easy to define. But if that’s the case, why do MSL titles vary so widely across the pharmaceutical industry? Besides medical science liaisons, there are also regional medical liaisons, clinical science liaisons and regional scientific liaisons.  Independent of their actual title, they all perform the same essential duties — bridging the gap between pharmaceutical companies and the medical community.  On the surface, the definition of an MSL is quite logical; however, once you take into account all of the typical responsibilities, the MSL role begins to look quite complex. Continue reading

Document Like the Romans: Maintaining Regulatory Knowledge

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

If anything could be said about the ancient Romans, aside from their insatiable drive for conquest and glory, it was their proclivity for documenting everything that happened around them.  The fact that we know so much about the Romans comes down to the sheer level of documentation that survives from their time.  When pharmaceutical companies are looking at their own documentation priorities, preserving regulatory knowledge and the associated protocols should be close to the top of the list. Continue reading

Coordinating Lifecycle Management Techniques: Involving the Right Functions at the Right Time

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

Orchestrating lifecycle management (LCM) techniques can be a complicated, and — as with any strategic operation — different players contribute to the process over time.  Life sciences companies optimize lifecycle management by involving the right functions at the right time throughout development and commercialization.  For example, R&D is far more important in the early years of product development.  On the other hand, market access plays a major role closer to product launch. Continue reading

Medical Advisory Boards: Refreshing Companies Clinical, Marketing and Market Access Strategies, One Meeting at a Time

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

Medical advisory boards take a number of forms across life science companies clinical, marketing and market access teams.  Although recent legislature limits how companies interact with the physicians and other key opinion leaders (KOLs) who most commonly staff these boards, they do not decrease the importance of these institutions. When leveraged appropriately, medical advisory boards — which combine members’ expertise and unique insights — are a huge asset to the industry as a whole. Continue reading

Pharmaceutical Call Center Management: Evolve to Respond to Better Informed Customers

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

Lets face it, Google makes us smarter.  Well…not really.  But it certainly gives us a window into all kinds of information that used to be held only by professionals.  The healthcare industry has certainly seen an uptick in customer knowledge over the last several years.  Patients and healthcare providers alike can now use their search engines to do fairly deep dives into diseases state information and treatment options.  This access has a big impact on pharmaceutical call center management teams.  Patients and health care providers can answer many of the questions that they formerly asked of medical information groups with quick internet search.  Medical information teams are also receiving additional, more complicated questions than in the past. Continue reading