Drug Complexity Drives the Importance of Medical Affairs
Joseph B Laudano, BS Pharm, PharmD
JOSEPH B LAUDANO
BS Pharm, PharmD
When you look at almost any medical conference during the past decade, one thing stands out: pharmaceuticals are becoming more complex. The small molecules that became blockbuster drugs no longer drive the industry. Instead, biologics and complex molecular medicines are the engines researchers count on to deliver life-saving therapeutics.
Some of these new medications go beyond addressing the symptoms of the illness to mediate the underlying causes of disease; a few even promise a cure. Discussing what makes them different from traditional medications requires an understanding of biochemistry, molecular biology, immunotherapy, metabolomics and genomics to name a few areas. It’s not simple. Communicating the science behind these inordinately complex medicines accurately requires years of medical and scientific training, it requires Medical Affairs.
A Crowded Field
Molecular medicine affects virtually every field of therapeutics. Oncology accounts for the lion’s share of biologics in development, but molecular approaches also abound in cardiology, immunology, and all the other areas of study. And, increasingly, developers are taking a systems biology approach that further increases awareness of the many interconnections within the body, which increases the complexity of analyzing any therapeutic approach.
This rapid pace of innovation makes for a very crowded field, and it’s becoming more crowded as companies strive to introduce first-in-class treatments. For example, ClinicalTrials.gov reports, as of March 7, 2019, there are currently 49,614 clinical trials actively recruiting subjects for study globally. Some of these involve combination therapies while others are monotherapy. With so many agents undergoing investigation and countless others in development, stakeholders – thought leaders, prescribers, payers and patient advocates – need the help of Medical Affairs Professionals to keep track of the new innovations and accompanying data.
Staying Up to Speed
Tracking the data includes (among other things) staying up to date on results from a plethora of clinical trials, knowing where specific therapeutics and approaches are developing, understanding the relative merits of alternative approaches and identifying the leading players in multiple niches. Perhaps most importantly, it includes the ability to put all that data into perspective for prescribers who, increasingly, are accessing information in snippets. Medical Affairs professionals, therefore, are a growing source of information, communicating critical data to healthcare providers, prescribers and payers.
To do all that, Medical Affairs professionals need an efficient, comprehensive way to track gargantuan quantities of data and chart the frequent changes in those data. That the system must be automated goes without saying. Advanced analytics are at the heart of any robust Medical Affairs activity. Web crawlers, for instance, can track topics in papers and at scientific congresses, updating databases without the delays inherent in paper-based publication. Consequently, Medical Affairs professionals can access current, comprehensive data quickly and easily.
Harnessing new and emerging analytics engines with robust processing power is the only option for tracking new developments in a timely manner. Now, and going forward, a comprehensive, data and analytics driven Medical Affairs team is critical for success!
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