Rare Disease Center Sponsors Internships in Washington, DC
Three Keck Graduate Institute students are gaining invaluable field experience this summer through internships sponsored by KGI's Center for Rare Disease Therapies. Sonali Talele and Aditya Kelkar are interning at the Food and Drug Administration in the Office of Orphan Products Development (OOPD) in Washington, DC, while Brent Thompson is working in Scientific & Regulatory Affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA), also located in the capitol.
Dr. M. Ian Phillips, the center's director and Norris Professor of Applied Life Sciences at KGI, says the internships are one way to improve the effectiveness of the center's mission. "The goal of the Center for Rare Disease Therapies is to increase awareness of the problems faced by patients with rare diseases in obtaining treatments," Phillips explains, adding that approximately 25 million people in the United States have been diagnosed with a rare disease.
"We want to increase the number of therapies available to these patients," he says, noting that the center partners with government agencies, the pharmaceutical industry, patient organizations and academic researchers to achieve its goals.
The internships at OOPD and PhRMA put KGI students at the center of activity relating to the field. The OOPD administers the major provisions of the Orphan Drug Act, enacted in 1983 to provide incentives to companies to develop products to treat rare diseases. PhRMA represents the country's leading pharmaceutical and biotechnology companies, advocating for public policies that encourage discovery of new medications.
In her prior training to become a medical doctor, Talele says she learned how to prescribe the proper medications for patients, but wanted to gain more insight into how new drugs are discovered as well as the regulatory aspects governing their entry into the market.
"This internship has given me a deeper understanding of the clinical and regulatory scenario of the drug industry, and particularly rare diseases," adds Talele. At OOPD, she is assisting with a project that "involves searching the FDA internal database for a certain group of rare diseases, then finding the products that received orphan designations and approvals for that condition and the status of clinical development of these products." The project also involves tracing the trend of approvals for these products over time as well as analyzing the products.
Fellow OOPD intern Kelkar is working on two projects: the analysis of all orphan products approved since 1983 and helping update the FDA databases. The aim of the first project is to look for trends in orphan product approval in the past few years, in comparison with all other FDA approvals.
Regarding the second project, Kelkar says: "There are different databases within the FDA that record the data for drugs and biologics approved in a calendar year. The aim of the project was to compare these records and find out if there were any discrepancies between the different databases so that appropriate changes can be made by the concerned authorities." In addition, Kelkar attends grant application meetings, educational seminars and even FDA advisory board meetings.
Both Talele and Kelkar are supervised by Tim Coté, director of OOPD and a member of the Center for Rare Disease Therapies' advisory board.
Just as their time at the FDA is enhancing Talele and Kelkar's understanding of the drug industry from the regulatory side, Thompson says his internship at PhRMA has given him a broad understanding and behind-the-scenes look at the many aspects of the industry side.
"My primary responsibilities are related to a new rare and neglected disease initiative approved by the executive board in mid June," explains Thompson, who is working with PhRMA's senior vice president of scientific and regulatory affairs, David Wheadon, MD. "A large amount of my time has been spent putting together a landscape analysis of this space and determining to what extent PhRMA's member companies are involved in this initiative. I've also had the opportunity to attend several conferences and meet with influential people in this area."
All three students, who are currently seeking their Master of Bioscience degree at KGI, agree the experience gained in Washington will be invaluable to their future careers.
- By Susan Wampler
Educating the future leaders of the bioscience industry, Keck Graduate Institute (KGI) offers an interdisciplinary graduate education through its Master of Bioscience (MBS) degree program and its PhD program in Applied Life Sciences. Using team-based learning and real-world projects, KGI's innovative curriculum seamlessly combines applied life sciences, bioengineering, bioethics and business management. KGI also has a robust research program concentrating on the translation of basic discoveries in the life sciences into applications that can benefit society. KGI is a member of The Claremont Colleges, located in Claremont, California.
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