First Korean/U.S. workshop on drug regulation and marketing

Published on April 6, 2013 at 7:33 AM · No Comments

Getting more and better drugs to market for patients was the ultimate goal of the University of Maryland School of Pharmacy's (SOP) first Korean/U.S. workshop on drug regulation and marketing from March 18 to 22.

In the meantime, each participating group—pharmaceutical company executives, faculty, students, and food and drug regulators from both countries—said they benefited greatly from the unique opportunity of the workshop, which was largely made possible by a new Korea-U.S. Free Trade Agreement reached a year ago.

Visiting executives from six South Korean companies—each with a top-10 share of the pharmaceutical market in that country—became more familiar with the U.S. drug regulatory system and approval processes, plus key elements of the workings of clinical trials in this country, through the workshop.

They attended 13 lectures by SOP professors on topics ranging from U.S. medication regulatory laws to clinical trial design in this country. And they heard lectures from three U.S. Food and Drug Administration (FDA) officials, two University of Maryland School of Medicine professors, and executives of two U.S. companies.

The SOP faculty—those presenting and others in attendance—got their own firsthand 'course' on the South Korean pharmaceutical industry by fielding questions and comments from the visitors in session and socially.

SOP Dean Natalie D. Eddington, PhD, FAAPS, FCP, said, "We are really excited about the opportunities and the partnership possibilities. I hope that every spring we will bring a contingent from South Korea so this will be an annual conference."

Workshop organizer Wonro Lee, executive director of the State of Maryland Business Office for South Korea located at the JG Business Link International in Gaithersburg, Md., said, "The workshop was like a course in U.S. regulatory processes with topics that matched well with the diversity of expertise represented by the Koreans' interests."

The workshop was scheduled during the School's spring break. Yet, 10 South Korean and Korean-American students—many fluent in the Korean language—took opportunities throughout the week to converse with South Korean company executives, thus enhancing their future career options.

Third-year SOP student Hae Jin Cho said "though I had learned the workshop contents in class through my pharmacy education, the Korean Delegation Visit has provided me an opportunity to learn the similarities and differences of the U.S. and the Korean FDA regulations and their drug development processes."

Regulatory comparisons were also a keen interest of South Korean businesswoman Bo-Ram Lee of the department of clinical operations management at Celltrion Inc. Three months ago, the company marketed in South Korea a biosimilar version of the Johnson & Johnson medication Remicade, which is indicated for rheumatoid arthritis. Lee and company colleague Kyungmin Park said they are planning to apply to the FDA to start the process for marketing the biologic product in this country.

Lee said, "The lectures were very informative and beneficial, especially from the FDA officials." She appreciated the direct communication with FDA officials and her interaction with Frank Palumbo, PhD, JD, executive director of the SOP's Center on Drugs and Public Policy, and with other faculty, "considering the more complex development process necessary for a generic biologic medication than for [marketing] a pill composed of a molecular compound," she said.

Wonro Lee commented that because Bo-Ram Lee's Celltrion is one of the leading edge companies in South Korea in the biologics field, "Other [Korean] companies are waiting with bated breath to see how they do [with the FDA]. They have had more international experience in biologics than most in Korea."

Fourth-year SOP student from Korea, Seojin Yang, who volunteered as a special liaison to communicate announcements and other information in the Korean language, said she had been excited to see Dean Eddington's email request for student volunteers. "Wow, I can do something for my country, too," said Yang. "It is good to know the regulatory information in both Korea and the U.S. When there is a drug to market in Korea, it will help [U.S. drug makers] to know the Korean system and for the Koreans it will help them to know the FDA regulation process to market in the U.S."

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