By Amanda Beaster, Ph.D., Research Associate
Soon after graduation, I, like many other young researchers, found myself trying to choose from an ever-narrowing pool of opportunities in academic research. Low funding rates and an increasing number of investigators meant that during my seven grueling years spent pursuing an advanced degree, I watched while seasoned investigators, merit award winners, and departmental chairs lost funding. In addition to a growing trepidation about ever receiving funding on my own, I was left with this haunting question: Who was I helping?
I believe that basic research is a noble pursuit, and that the majority of great scientific advances have had their roots in such research. However, I went into science hoping to help the sick and suffering, wanting to play a role in providing new treatments, new therapies, and new cures. Unfortunately, despite the best efforts of many, I found that there is often an immense gap between the bench-top and the bedside.
So what should I do? The answer soon made itself apparent: I would write for the pharmaceutical industry. This industry consistently offers an opportunity to do what I have wanted to do: contribute to the understanding and potentially new treatments, new therapies, and new cures for the sick and suffering. I decided to use my knowledge of science and technical writing to try to help complete the steps needed when moving a compound from an investigational product to a new drug.
The transition has been surprisingly painless, made easier by the training program at MMS Holdings Inc. I have learned more about word processing in the last month than I did in the previous decade, and I am constantly amazed by the amount effort that goes into every syllable of the documents produced here. Although the day-to-day aspects of the job are completely different such as business dress instead of lab coats and pens instead of pipettes, I am finding that many of the traits I learned in the lab are equally necessary here. Relentless attention to detail, consistency, and the ability to apply the scientific process are just a few of the laboratory-acquired skills that I have already employed in my short time in medical writing.
I owe a lot to academic research, it was my proving grounds and taught me how to be a scientist, but now, typing away in my cubicle, I know that the effort I put forth in using all of my education will result in improving the health and happiness of others.
THE CHALLENGE: Compile a Briefing Book for an Aggressive FDA Deadline
A biologics pharmaceutical company was in need of a advisory committee briefing book to present to an FDA Advisory Committee. However, the deadline for submitting the book was too close for the company to pull together the necessary information using only their internal resources. To turn the project around quickly and to meet their rapidly approaching deadline, they brought MMS on board to provide additional expertise.
MMS SOLUTION: Assemble a Rapid Response Team to Quickly Get the Job Done
As part of our Adaptive Parallel Processing approach, MMS put together a Rapid Response Team to generate the briefing document. Consisting of experienced and skilled experts in the various areas related to the project, the team immediately began work on the book in conjunction with supporting slide decks and an external mock-panel. The goal was not only to develop a briefing book in the allotted timeframe, but to also ensure that it reflected the latest organizational thinking and complement the slide deck and associated arguments.
THE OUTCOME: Briefing Book Completed and Delivered On Time
Despite the aggressive deadline and a blizzard that essentially halted the company’s operations for three days, MMS delivered the briefing document in advance of the deadline with full quality checks. The company successfully presented the book to the FDA Advisory Committee on time, avoided spending additional time and money on would-be delays, and their drug was ultimately approved.