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Medical Affairs 101

Medical Affairs, what is it? What do you do with it? How does it work? What do you eat it with? These might be some of the questions that pop up in your mind if you are outside of the medical affairs profession wanting to know more.

The trend in biotech is the small startup. Many small startups produce one or 2 molecules or have a limited pipeline. For a new company that’s just taking its first steps in the field, or a mid-size company developing and globalizing its departments, you may want to know how to best operationalize

for compliance and effectiveness. For me, as a recent graduate student intern, who is learning about the pharmaceutical industry and its departments, understanding medical affairs and what good looks like within its walls is a project I was willing to research.

Medical Affairs is a key division found in Pharmaceutical/Biotech companies with the overall responsibility to explain the information about their marketed products. The data, can be disseminated in many ways, and used by health-care providers. Their Objective is to educate the use of therapies developed by the company for managing better treatment and care for the patients who used said products. This division is made of other subdivisions or departments and employ medical and scientific personnel (PharmD, MD and PhD, generally) that help run the operational functions. For example, you can find sections for patient advocacy and diagnosis, Medical Information, and Medical Communications, Publications and Post-Marketing Clinical Research to name a few. Those sections are made up by team holding various titles and functional responsibilities medical officers, medical managers, directors, and advisors.

Medical Affairs is involved in oversight of medical activities and roles, such as, Field Medical Teams, Post-launch clinical trials, Medical-Information services, Medical Communications, Medical education, Medical strategic activities and sometimes Health economics and outcomes-research activities. You must be thinking, as I did, “What? they do all that!” The answer is yes, they do and much more. Now the vision that surrounds a Medical Affairs department for its company involve around:

  • Patient access to the ideal medical treatment

  • Embracing healthcare.

  • Facilitating the direction and integration of different medical data and types of Disseminating a medical information I response to unsolicited inquires.

  • Obtaining and evolving the talent for cultivating and building a strong, multi-faceted Medical Affairs organization for the future healthcare scene across the globe.

While researching this post, I found another article that was written by a clinically based PharmD that gives a very similar point of view. The author was taking the approach of looking at the industry from the outside in to further understand the Medical Affairs scene within the Industry. If you enjoy reading this feel free to take a look at the ACMA post titled “Why I Became a Board Certified Medical Affairs Specialist (BCMAS) By Christine Megalla, PharmD, BCMAS.

I hope that Medical Affairs world now seems less complex to you but if you still have any questions, contact us. Feel free to click on the Discovery call button, located on the home page if need help for the development or organization of your Medical Affairs operational departments.

Author: Jamie Arvizu, B.Sc., Biotechnology; Post Baccalaureate Intern

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