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Tuesday, May 20, 2014

BioKorea 2014 - A focus on cell therapy and regenerative medicine



I am pleased to be working this year with BioKorea and the Korean Global Stem Cell and Regenerative Medicine Acceleration Center (GSRAC) to host a full-day regenerative medicine track during the BioKorea conference at the end of May.   

The Korean Ministry of Health and Welfare and regenerative medicine industry are blazing an innovative trail in terms of the commercialization of cell-based therapies which the world is watching with increasing interest. The Korean approach to and pace of product approvals has attracted the attention of investors, entrepreneurs, and regulators alike. On the Korean side, companies with commercial products are eager to expand into other markets. This involves technology transfer, securing partnerships, and subjecting their products to different types of regulatory requirements and clinical testing. 

Companies outside of Korea are increasingly interested in identifying and how to involve Korea in their product development plans if it means an expedited pathway to commercial approval. This would likely involve identifying a Korean partner (or investors) and establishing a deep understanding of and relationships with the Korean regulators and industry.

In order to satisfy the needs of the industry both within and outside Korea it is critical to establish a closer working relationship between industry organizations, facilitate a better mutual understanding of the different markets, and create mechanisms for companies to further their goals by helping them identify partners, understand regulatory differences, establish critical relationships, find investors, etc.

This event is intended to create the initial framework for enhanced international collaboration between Korean and the global regenerative medicine industries.

Attendees will:
  • gain a more in-depth understanding of the opportunity and challenges in transferring a commercial product from Korea to other markets
  • hear case studies of collaborations between pharma and regenerative medicine companies
  • learn about the unique advantages and challenges of commercializing regenerative medicine products in Korea
  • learn about the perspectives of the pharma industry on regenerative medicine including cell-based therapies
  • have opportunity to establish contacts with international pharma executives, regenerative medicine companies, and potential partners and investors
  • have opportunity to identify companies from other markets potentially interested in (a) finding a partner, and/or (b) seeking to license and/or partner with Korean companies to take their product(s) into other markets
  • participate in networking activities with representatives of the global and Korean regenerative medicine industry
  • have opportunity to showcase the Korean biotechnology industry and capabilities to members of the global industry

The focus of the session is to facilitate increased collaboration between Korean and international regenerative medicine companies by creating a forum for exploring a better understanding of the Korean regenerative medicine industry and the potential for creating partnership, licensing, and investment opportunities emerging out of and interested in going into Korea.  

We are pleased to have a full day of exciting content from both Korean and international speakers from multinational pharmaceutical companies, Korean representatives, and regenerative medicine companies from around the world.  

In addition to the full-day program, we are also facilitating partnership discussions, networking events, and meetings (if requested with the Korean Ministry of Health & Welfare (formerly the KFDA).

BioKorea will be held May 28-30 at the KINTEX Exhibition Center in Goyang city near both Seoul and the Incheon International Airport. BioKorea, is organized by the Korea Health Industry Development Institute, KHIDI, as a government (Ministry of Health and Welfare)-affiliated organization and Chungcheongbuk-do Province, which is the center of Korean biotechnology, life sciences, and healthcare.  The annual event first started in 2006 and is expected this year to attract 13,000 participants and over 260 exhibiting companies.

Track 3. Stem Cell and Regenerative Medicine: Thursday, May 29
This track aims at facilitating international cooperation and global commercialization
among companies in the stem cell and regenerative medicine, and will serve as a forum of discussion and deliberation for domestic and foreign business enterprises.

The applicants will have opportunities to take part in the following:
   Session I: Introduction to the current status of domestic and foreign markets
and industries of stem cell and regenerative medicine
   Session II: Case studies on technology licensing out between regenerative
medicine companies and large-scale companies
   Session III: Publicity for domestic and foreign regenerative medicine companies
and their products
   Partnering: For those companies which seek opportunities, a meeting place will be provided for their matching commercialization needs.

To help give a little more flavor to this event and the state of the industry in Korea, I had the opportunity to interview Professor Bryan Choi, who is Vice-Director of the GSRAC and has been much of the energy behind making the event a reality.

Welcome, Bryan. Can you start by telling us a little bit about the Global Stem Cell and Regenerative Medicine Acceleration Center (GSRAC) and how you yourself got involved in regenerative medicine?

GSRAC is a government commissioned strategic center that helps the Korean government (a) establish appropriate policy and regulations, (b) facilitate the translation of research to the clinic, and (c) assist RM companies accelerate market entry of their products.  I, myself, am a researcher in regenerative and happen also to be involved in the management of the GSRAC. 

Give us a sense of the state of the regenerative medicine sector in Korea. 

RM is one of hottest areas of interest in the biomedical and pharmaceutical field and is being supported a lot by the Korean government. At the same time, we are also struggling to move forward with some of the technical and commercial aspects of these products. 

How many cell therapy products are commercially approved in Korea to-date and how many are in pivotal trials? 

I know approximately 18 cell therapy products have been launched in the Korean market and 3 of them are stem cell products.

In the past couple years, the world has been watching the development and commercialization of regenerative medicines, especially cell-based therapies, in the Republic of Korea with considerable and growing interest. This is largely driven by a number of cell therapies (including stem cell products) approved for commercial distribution by the Korean Ministry of Food and Drug Safety (MFDS) (formerly the KFDA) and the perception that the regulatory pathway to commercial approval appears to be more proactive and expedited than what exists in the United States and Europe. Can you comment on this?

I cannot say it is exactly proactive but it could be fairly perceived as relatively ‘expedited’ (compared to many other jurisdictions) due to the fast but not abbreviated process of MFDS. MFDS has similar principles to those of the US and Europe for the approval of cell therapy products. A final decision for a submitted product is case dependent. 


We hear rumor that there are changes being considered to the regulation of cell therapies in Korea, can you comment? 

We are currently talking about the need for a new, revised regulation that fits better for RM products but it is not yet formalized. 

What is the level of interest or activity among Korean investors or large life science companies in investing in Korean regenerative medicine?  Are you seeing any growth of interest in entering the Korean market from regenerative medicine companies outside Korea?

Recently they are getting more interested in RM. Some investment deals have been done recently between RM companies and Korean pharmaceutical companies. Where we have yet to see any notable activity is that of foreign investment or interest in the Korean RM market – even by the large multinational firms. 

Tell us about BioKorea and your plans for a regenerative medicine track at this year’s conference. What do you hope to accomplish with this event?  

In BioKorea 2014, we have a RM track (Track 3) which deals with business development and partnering in the RM industry. We invited more than 10 speakers of RM experts or from RM companies to talk about business models in regenerative medicine and partnering opportunities particularly between Korean and foreign RM companies.
     
How can people find out more about the event and what are the ways they can participate?

Please refer to the following websites: www.biokorea.org and www.gsrac.org.  

Will representatives of the Korean Ministry of Food and Drug Safety (MFDS) be at the conference and available for participants to interact with if they wish?

MFDS representatives may be at the conference but we are also planning a separate meeting with MFDS for those interested. 

Will there be opportunity for companies from outside Korea to identify and speak with potential Korean partners that might be potentially interested in in-licensing or out-licensing products?

It is always welcomed. You can participate in the business partnering any time before the end of BioKorea 2014, and may also give an introduction of your company in the session III of the RM track, if a slot is available. Please contact us (bryan [at]gsrac [dot] org) for the availability. 


Thanks Bryan.  I am very much looking forward to the event.