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

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."

Her central role in the workshop may have changed Yang's career plans also, she said. She has applied for a pharmacy residency after earning her PharmD degree in May. However, she said, "Now, because of the workshop and particularly from Dr. Polli's influence [workshop lecturer James Polli, PhD, an SOP professor] about regulatory science, I may want to go into that area."

The South Korean delegation included employees of Green Cross Corp., Dong-A Pharm Co. Ltd., Daewoong Pharmaceutical Co. Ltd, GL Pharm. Tech. Corp., Celltrion Inc., HanAll BioPharma Co. Ltd.—each holds a top 10 pharmaceutical market share in South Korea; three professors from South Korea's Chonbuk National University Medical School; and a physician from the Kyungpook National University Hospital Clinical Trial Center.

Professor Soo-Wan Chae, MD, PhD, of Chonbuk University attended the workshop with a strong interest in locating "a presence" for his university at the University of Maryland BioPark. Chonbuk University officials visited the BioPark last year and again last month, meeting with Jane Shaab, UM assistant vice president for economic development.

Chae said, "We plan to enter the Park after ironing out some legal and financial regulations. We will also bring employees and will want to work with the School of Pharmacy students. Being at the BioPark will support our business relations, and the students will help in translating and liaison with the School."

Mohamed Al-Ibrahim, MB, ChB, FACP, president and chief medical officer for SNBL Clinical Pharmacology Center at the BioPark, met with several of the companies. "The Koreans benefited with a look at the drug development process in the United States for two reasons," he said. "First, we are still the biggest market in the world for pharmaceuticals. Second, a number of Korean pharmaceutical companies now have a footprint in this country." There are seven South Korean-owned pharm or biopharma companies in Maryland, according to Bradley Gillenwater, Asia regional manager at the Maryland Department of Business and Economic Development.

Al-Ibrahim said that the visitors took an interest in SNBL's clinical trial capabilities. "They are also interested in exchange of drugs; there are a number of U.S. companies, CROs [contract research organizations], that are in South Korea doing early-stage clinical trials." Al-Ibrahim said the SNBL business development group is reviewing collaborative possibilities raised by the South Korean delegation visit.

"This effort was just great. I take my hat off to the School for the conference," he said.