Big Data’s Potentially Big Impact in Medical Affairs Decisions


By Victoria Cavicchi,
Research Analyst

Big data is quickly becoming a big deal in the pharmaceutical industry.  A number of clinical studies — including two from Winship Cancer Institute and NextBio — are leveraging big data to seek out distinct biomarkers across a wide range of patients. The hope is that, through constantly generated data from a variety of sources, there lies the key to better understanding particular disease states or treatment possibilities. But clinical groups aren’t the only ones to take advantage of the influx of big data. Medical affairs groups may also soon embrace this new wealth of information. Continue reading


Medical Affairs Team Structure: Centralized or Decentralized?


By Yanis Saradjian,
Director of Consulting

A medical affairs team’s structure is contingent on a number of determining factors.  The growing complexity of the compliance requirements that pharmaceutical and biotechnology companies must adhere to has greatly impacted their organizational structures, particularly in medical affairs.  But companies must also weigh their portfolio needs in their decisions about how to structure teams.  Furthermore, how the medical affairs team interacts with other parts of the organization impacts reporting relationships and group responsibilities. Continue reading


Advisory Board Functions Expanding in Pharma Industry


By Jacob Presson,
Research Analyst

Advisory boards have been part of the pharmaceutical landscape for a long time, providing companies with valuable expert opinions on topics ranging from ensuring thorough regulatory submissions to clinical trial protocols.  This role does not look to fade anytime soon, as regulatory requirements get tougher and payers look for ever more clinical data and health outcomes to prove the value of products on the market.  Many companies are working to create a cohesive advisory board strategy that encompasses which groups are best suited to handle the responsibility of coordinating advisory boards and how to achieve a useful deliverable out of a board meeting. Continue reading


Companies Increasingly Position Health Economics Teams within Medical Affairs


By Yanis Saradjian,
Director of Consulting

Blockbuster patent expirations are impacting pharmaceutical companies throughout the industry.  Remarkable shifts in corporate earnings send budgetary shock waves through nearly every department of a pharmaceutical or device manufacturer.  Even at some of the largest companies, medical affairs teams — seemingly insulated from spending cuts during the economic crisis in the late 2000s — have been issued a challenging mandate: Do more with less.  Although serving the medical community is an important corporate responsibility, life science companies cannot spend outside their means to do so.  Now medical affairs groups must not only manage their core responsibilities — to generate, package and disseminate medical and clinical information — but they also have been asked to take the lead on other important activities such as health economics and pharmacovigilance. Continue reading


It’s That Time of Year: Crunch Time for Medical Publications


By Jacob Presson,
Research Analyst

In light of the coming American Society for Clinical Oncology (ASCO) annual meeting, many companies are scrambling to get their medical publications out by the conference deadline. One of the biggest contributions a pharmaceutical company can make — beyond the manufacturing of drugs — is to sponsor physicians’ research to further therapies and techniques. This sponsorship represents a valuable component of how pharmaceutical companies engage their thought leaders. Continue reading


Companies Broaden KOL Targeting, Found Recent Cutting Edge Information Study


By Sarah Ray,
Research Analyst

Drug companies are reaching beyond specialists when targeting medical leaders to further develop their existing products.  Among 36 companies recently surveyed, nearly four-fifths targeted multiple types of key opinion leaders (KOLs): from specialists and subspecialists to primary care providers, preventative medicine practitioners and nurses.  The takeaway?  Companies’ understanding of the movers and shakers in the healthcare community is growing and no longer bound by the traditional understanding of who holds the most sway in the medical community. Continue reading


Regulatory and Compliance Functions Within Medical Affairs Teams

Over the past several years, we have seen a slow shift among regulatory affairs and compliance groups in the pharmaceutical industry as these groups move under medical affairs oversight. This hasn’t been a surprise among many industry observers, but it hasn’t been a complete shift either. Fewer than 40% of surveyed companies in a recent Cutting Edge Information study put compliance functions under the medical affairs department’s supervision. Continue reading


Product Launch: A Busy Time for Medical Affairs Teams

Marketing and commercial teams get a lot of the credit for a successful product launch, but medical affairs teams are typically buzzing with activity in the months (sometimes even years) preceding drug approval.  As the official communication channel between a pharmaceutical company and the scientific community, the medical affairs department plays a critical role in successful product launches.  Each of the medical affairs subfunctions plays its own unique part to play to properly support a new drug. Continue reading


Driving KOL Engagement Efficiency through Physician-Interaction Databases

Cutting Edge Information recently conducted research among pharmaceutical medical affairs groups that looked at physician-interaction database ownership.  The research revealed that ownership of these databases varies among the surveyed companies.  Global groups at 60% of companies report responsibility for these internal databases.  Companies that do not report global groups’ responsibility for an internal database (40%) may consider their use of Excel spreadsheets or Outlook to track physician interactions as internal database.  Other global medical affairs teams allow country-level groups to document physician interactions according to local regulations.  Still other companies may be in the process of either developing a new database platform or transitioning from an existing one. Continue reading


Pharmacovigilance: Databases Support Adverse Event Reporting

Drug companies’ increased pharmacovigilance activities highlight the importance of both clinical data and adverse events reporting.  The World Health Organization (WHO) estimates that adverse drug reactions (ADRs) represent between the fourth- and sixth-leading causes of death in the US.  The global organization cites that in the UK, among patients aged 16 and older, those experiencing adverse drug reactions at any given time may account for the occupancy of seven 800-bed hospitals. Continue reading