My Journey: The Transition from Lab to Regulatory Affairs

By October 1, 2014Biotechnology, Featured

by: Astha Jaiswal

My name is Astha Jaiswal and I am pursuing Masters in Biotechnology (concentration in Regulatory Affairs) from Johns Hopkins Krieger School of Arts and Sciences. I completed my undergraduate degree in Biotechnology from India. My background includes a mix of three years of bench experience as well as market and product research for pharmaceutical clients as an analyst. Currently, I am conducting oncology research at the Johns Hopkins School of Medicine.

While I have always enjoyed biological sciences, I found my calling when I first took an introductory class in regulatory affairs during my undergrad and understood what really went into getting a drug approved from a regulatory agency. I saw myself fit into a role where I could witness the translation of science into a marketable drug product that has undergone multiple phases of research and clinical studies. While I have the requisite science background, I decided that an advanced degree in regulatory affairs will help me transition in the field and hence, I came to Hopkins. As a tip to all aspiring regulatory professionals, I recommend attending Advisory Committee meetings that are frequently conducted by the FDA (and yes, admission is free to general public!). One such meeting that I recently attended remains a captivating experience for me. It is one forum where you understand the depth and breadth of the science that goes into a drug approval. It is an experience to witness the interaction between the FDA, a sponsor and patient representatives, all coming together for the benefit of public health.

This summer, an opportunity to intern at MedImmune proved to be an invaluable experience for me. Working with the Science Submission Management group, I was involved with the nonclinical regulatory submissions of molecules in different therapeutic areas across the pipeline. A major responsibility of the role was to assist research scientists in authoring regulatory compliant documents for Investigational New Drug (IND) submissions. It was interesting for me to observe how regulatory writing for IND research reports is very different from authoring of research articles, although the content that goes into it is very similar. Aside from my primary role, it was a great opportunity for me to interact with various research scientists, clinical experts, manufacturing experts, and technical writers, all of whom contribute their expertise in various aspects of drug development. In terms of therapeutic areas, oncology remains my area of interest, not only because it is the surging field right now, but also I see a myriad of approaches being adopted by groups to find therapeutic options for diseases, such as testing different combinations in clinics, and exploring different disease pathways.

I have been following Hopkins Biotech Network over the past year and I believe it is an excellent way to network with industry professionals being in academia. As a volunteer writer with HBN, I hope to pen down some interesting articles for readers on current issues and trends in biotechnology. For any questions or comments, please feel free to reach out to me at ajaiswa1@jhu.edu.

 

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