An international forum was held discussing the true aspect of regulatory science across all stages of drug development, which could satisfy the thirst of researchers putting forth their best efforts to develop new drugs

The Global New Drug Development Forum was held from May 31Jun 1st for two days at the Seoul Imperial Palace Hotel, sponsored by the KDDF (CEO Dongho Lee) and KoNECT (President Sang-Goo Shin).

The event began with greetings by Hee-Sung Lee (Commissioner, KFDA), Do-Geul Ahn (Director, Health Industry Policy Bureau, Ministry of H&W), and Amy Jackson, President of AMCHAM. More than 300 invitees participated and the meetings proceeded smoothly.

 A speaker from the KASBP, engaged directly in the field of new drug development in the US and a large number of Korean scientists serving in the FDA, participated in lectures and discussions, providing practical information on global new drug development.

In her opening speech at the forum, Ms. Amy Jackson, President of AMCHAM, stated, “Many American bio-pharmaceutical companies want to build partnerships with Korean companies. This is due to the innovative promotion policy by the Korean government, which is based on specific support policies including outstanding human resources”. She said that she hoped to have continued exchanges through these types of forums in the future. 

At the forum, the keynote speech was provided by CEO Lee with the theme “The Efforts of Government to Globally Develop New Drugs”. Subsequently, plenary lectures were given on the following topics: ▲Science-based Decision Making: Drug Development and Regulation (Hae-young Ahn, FDA), ▲ New Trial Designs in Oncology (Young-ju Bang, SNU College of Medicine).

Dr. Hae-Young Ahn, who works for the FDA in the US as an expert in clinical approvals, in her lecture ‘Drug Development and Regulation’ said that, “New drug development is neither the work only for pharmaceutical companies nor only the FDA. It requires a stable government role as well.” She emphasized cooperation and said, “All of this is possible only if all entities cooperate.”

Dr. Ahn also said “ The clinical approval trend of the FDA in the United States is to use biomarkers to maximize the effect of the drug or to incorporate features into the design that are highly effective for patients with specific genetic mutations.”

Subsequently, 4 sessions were held corresponding to the order of all phases of new drug development. First, a discussion concerning pre-clinical pharmacology/toxicology, led by Suk-Yun Yun (Center Chief, DGMIF) and Sang-jun Lee (President, Safety Assessment Institute), followed by discussions on: CMC, led by Yong-jik Kim (Deputy President, Celltrion); clinical pharmacology, led by Kyeong-su Kim (Prof. at the Catholic University, School of Medicine); and regulation, led by Yon-sung Chu (Executive Director, LG Life Sciences).

KFDA researcher, Yun-jung Jang, through her presentation concerning the implementation of ICH guidelines in Korea, commented on active support by the government, saying that, “The local permit system has corresponded with that of the international permit system, and thus excess preparatory work targeting foreign approval for new drug permits is no longer required, which was a huge advantage in saving time, quality improvement, and the promotion of exports.”

A senior researcher at the FDA, Mr. Sang-mok Jung, in his speech ‘Tips for Success in FDA Regulatory Meetings’, conveyed the importance of communication in the drug development process.

He said, “Many institutions or companies knocking on the FDA’s door have failed, because they present only pre-NDA data,” and he recommended that, “Sufficient information can’t be obtained from materials lacking a bridge. Knock after you have what you need and you know exactly what you’re asking for”.

Dr. Dongho Lee, CEO of the KDDF, the co-sponsor of this event, said “This has been a very meaningful opportunity, allowing us to listen and discuss valuable experiences with Korean-American officials and researchers in America in various fields,” and conveyed his expectation that “In line with recent brilliant growth concerning research capability and infrastructure support for the development of new drugs in Korea, there are now being implemented scientific and innovative government regulations with the  hope of establishing Korea as a pharmaceutical power house”.

This global new drug development forum is an opportunity to examine the role of government and its support for the stimulation of new drug development, with a sub theme “Focusing on Regulatory Science”, where attention was focused on the practical discussion that highlighted the ‘regulatory science’ of each session covering entire phases.

Specifically, participants appreciated the fact that the whole process was treated from the perspective of the FDA reviewer currently active in their post.

A participant from the school sector said “This is a very impressive opportunity to be able to learn about all phases of new drug development in one location”, and proposed to extend the period of the forum to 3 days, from the current 2 days. also suggesting that the forum be held on a continual basis.

Another participant also said, “This forum was very helpful to me because presentations were made focusing on practical examples of new drug development by many speakers having lots of experience related to new drug development”, and a participant from one company implementing foreign clinical testing said, “This forum was very useful in that it gave me the opportunity to listen to the FDA staff directly”