By: Chris Lowe Some of our iJOBS participants have been able to complete industrial internships during their PhD studies. We recently had the chance to sit down with Dharm Patel, a 5th year PhD student in Biochemistry, to learn about his internship experience and see what advice he would offer other students looking to transition into industry. This post is part 1 of our 2 part interview with Dharm. Q: Where did you complete your internship and what was your role while you were there? Dharm: I completed my internship at Leo Pharma, a specialty pharma company from Denmark. They’ve had a presence here in the United States for about six years. I was in their Medical Strategy and Scientific Affairs (MSSA) group as an intern. The company just started this internship program so they had one person in each department. I was doing a couple of different projects with various groups within MSSA, including Pharmacovigilance (PV), Health Economics and Outcomes Research (HEOR), Medical Information (Med Info), and the Medical Science Liaison (MSL) team. So with each of the groups, I did one to two projects that had already been outlined for the intern position or some of them I came in and said I wanted to explore a little bit more and they found something for me. Q: Can you give us an example of what your responsibilities were for some of the projects you did? Dharm: So maybe I’ll define one project for each area within MSSA. For the Pharmacovigilance group, when you have a new product out on the market, you have to do Pharmacovigilance on it for adverse events (AEs) that may occur from use of the product. The product that they had was for Actinic Keratosis, which is a pre-cancerous lesion on the skin. The FDA requires that you submit a Periodic Adverse Drug Experience Report (PADER) about all of your adverse events reported over six months or a yearlong period. In the PADER, the company needs to discuss some of the reasons why the adverse events may be a valid signal, or perhaps this is something new that should be explored, or if this could actually be an issue with the specific lot of the drug. One of my responsibilities for the PADER was writing up narratives for the cancer related AEs. I would go through submitted adverse event reports, look at exactly what was happening, and then write a summary about the cases. What were the commonalities of the cases? Is this something that was expected? Is this something that has already been defined in the literature? For Health Economics and Outcomes Research, I was focused on compiling clinical data on approved therapies for psoriasis for input into a Budget Impact Model. Many stakeholders want to see that your drug is efficacious and economically feasible compared to other treatments. For HEOR you want to show those who are paying for your product (payers), basically insurance companies, Medicare/Medicaid, CMS in general, why they should have your product in their formulary and have it covered at a specific tier along with other drugs that may be used for the same indication. Medical Information was the one I did the most amount of work in. One of the contrasts between industry and academia is that in academia, we can basically get access to any paper we want through the university library. In industry, you have to pay for every single paper you get, which is not a problem we generally encounter in academia. So to limit costs and create a central repository, I helped reorganize an existing repository and made it more user-friendly. I utilized an Elsevier product QUOSA, a scientific information management software they had, and compiled all the articles and put them into this virtual library, organizing them so that they could be easily found. Lastly, with the MSL team, I went out and shadowed an MSL in the field, going to health-care providers (HCPs), talking about the drug, certain clinical trials that were of interest to the HCPs, and any issues the doctor was facing in prescribing this product. It was great to learn the nuances of regulations on how MSLs should engage with healthcare professionals. For example, you cannot discuss a clinical trial with a healthcare provider; they have to initiate a discussion with you. It shouldn’t seem that companies are sharing clinical trial data so that a physician would start using that information prematurely for a new indication. However, if a physician asks what is in the pipeline, then you can discuss ongoing clinical trials. Having the chance to experience those regulations regarding MSL conduct in the field firsthand was very valuable. Stay tuned on Thursday for more of Dharm's internship interview and to hear what his takeaways were!
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