JHU Montgomery County Campus Welcomes New Regulatory Science Coordinators
Emil Wang and Jonathan Helfgott aren’t new to Johns Hopkins University, but they are new to the Montgomery County Campus. Wang and Helfgott are the new, part-time program coordinators for the Regulatory Science program, a master’s degree program offered by the Krieger School of Arts & Sciences Advanced Academic Programs. The Regulatory Science program exposes students to advanced topics in the regulatory approval processes for global and domestic biotechnology products. (more information about Regulatory Science program)
Both Wang and Helfgott bring with them degrees from Johns Hopkins and years of experience with the U.S. Food and Drug Administration. Hopkins Happenings talked to them about their backgrounds and what they hope their students learn in the Regulatory Science Program.
Wang received his undergraduate degree in biomedical engineering from Johns Hopkins in 1993. While a student in that program, he was a teaching assistant for a professor who worked for the FDA. That connection served a starting point for Wang to work for the government agency. Now, he is a senior adviser for manufacturing and regulatory policy for the FDA’s Center for Tobacco Products, Office of Compliance and Enforcement. That means he is involved in regulating the design and manufacturing process of tobacco products, including cigarettes, electronic cigarettes and smokeless tobacco products.
Recently, he has been handling issues surrounding nicotine leaks and exploding batteries from e-cigarettes.
Wang has been teaching for the JHU Regulatory Science Program since 2010, mostly teaching online. Now, he teaches Food and Drug Law; Medical Device and Combination Product Regulation; and International Regulatory Affairs. He regularly holds office hours on the Montgomery County Campus.
“I would consider myself a longstanding member of the Hopkins community,” Wang said. “It’s an interesting perspective to see some of my youthful enthusiasm in my students. I really enjoy working with the students and mentoring students.
“It’s coming full circle, giving back to Hopkins in terms of sharing that experience and sharing insights with the students about career opportunities in this industry,” Wang continued.
Wang, who received his Juris Doctor degree from the University of Maryland School of Law, said he hopes his students learn how the FDA regulates medical products and how industry can develop and commercialize these products. He hopes students understand how products go through the FDA approval process.
“This program is an area where Hopkins has a leadership role,” Wang said. “It serves as a very credible platform to bring together scientists, industry and government. It’s that environment that helps make the program what it is.”
Helfgott was part of the very first graduating class of the JHU program, back when the degree was the masters in Bioscience Regulatory Affairs. (He graduated in 2007.) He took most of his courses in person at the Montgomery County Campus while working full time at FDA’s Center for Devices & Radiological Health.
“The insights I had learned in the classroom proved to be invaluable for my professional career, both inside and outside the FDA,” said Helfgott, who spent nearly a decade at the FDA before a recent transition to private industry. Helfgott now works for Stage 2 Innovations, a Michigan-based company, and he focuses on supporting global medical product development and commercialization.
Like Wang, Helfgott gets a kick out of teaching at the school where he was a student. He’s been teaching at JHU since 2011. He teaches Clinical Development of Drugs & Biologics; International Regulatory Affairs; Validation in Biotechnology; and Biomedical Software Regulations. He holds office hours at the Montgomery County Campus.
“This perspective allows me to help students understand and appreciate all the benefits and keys to success within the program,” Helfgott said. “Whether it is navigating through the options of amazing courses, figuring out the best sequence of classes to take for convenience of schedule or looking to expand the scope of one’s skill set to grow professionally, I have extensive real-life experience to draw from.”
Helfgott can’t overstate the importance of regulatory affairs. He considers it perhaps the most essential aspect of the entire product development life cycle. A company may have found a cure for cancer, but if that company doesn’t know how to navigate through the regulatory maze and obtain approval for the product to be used in the marketplace, patients won’t benefit.
“I hope my students will learn to appreciate how critical regulatory affairs is to product development, which includes everything from the lab to clinical trials to post-market development and even promotion and advertising compliance,” Helfgott said. “Students should always remember to take full advantage of all the resources within the Regulatory Science program. Whether students are seeking professional advice, want to know how to best network with their fellow classmates or want to grow their careers within the regulatory affairs/ biotech space, JHU’s world-class faculty are always there to help students out any way they can.”