보건복지부 영문홈페이지

National R&D investment has begun in earnest in stell cell and regeneration medicine to overcome rare and incurable diseases

 

- Finalization of ‘2012 stem cell/regeneration medicine R&D implementation plan’ and the contest for research and development program -

-33.0 billion won investment in total in R&D for development of stem cell cure 2012 --

- The investment that has remained at the level of supporting the basic research so far will be expanded to R&D area for commercialization.

 

 

□ Ministry of Health and Welfare (Minister Rim, Chae Min) announced that it would invest 33.0 billion won, four times greater than the amount of investment made in 2011 (8.7 billion won) as the R&D budget for stem cell/regeneration medicine in order to develop new treatment in rare and incurable disease early and make Korea leap forward into a global power in the area of stem cell industry..

 

*45.9 billion won when the budgets of KCDC (operation of stem cell bank, etc), and KFDA (safety management, etc ) included.

** the government budget (6 ministries/agencies) related to stem cell in 2012: 100.4 billion

 

 

○ With the expanded investment resources, the government plans to invest in the commercialization R&D for verification of efficacy and safety of stem cell-based treatment technologies, moving beyond the previous investment area of basic research*.

 

* Basic/source research regarding the control of physiological functions of stem cells and the identification of stem cell mechanism. 

 

 

□ Regeneration medical technology* using stem cells provides the potential for fundamental treatment of rare/insurable diseases that cannot be cured by current medicine. Thus, the technology is drawing keen attention from the general public and harbors great industrial value as a core future technology.

 

* (Regeneration medicine) Technological area to restore certain functions of the human body by treating, replacing or regenerating tissues and organs that were damaged due to aging, disease, accidents and congenital defects.

 

** (Size of global stem cell market) $32.4 billion in 2012, growing at 24.2% on yearly average. 

 

○ In particular, Korea’s stem cell/regeneration medicine is currently in the top ten band worldwide, which gives us rosy prospects that Korea can be a top global competitor if efficiently supported by the government’s investment. 

 

< Korea’s R&D competitiveness in stem cell/regeneration medicine > ‣ 3 stem cell therapies obtained approval for the first time in the world. * (Hearticellgram-AMI) a stem cell treatment for acute myocardial infarction/ autologous  adult stem cells(July 2011), FCB Pharmicell * (Cupistem) a treatment for anal fistula in Crohn's disease/ using patients' own stem cells from fatty tissue (January 2012), Anterogen * (Cartistem)  a stem cell treatment for damaged cartilage/ stem cells taken from same species developed from newborns’ umbilical cord blood (January 2012), MEDIPOST   ‣ Korea ranks 7th in terms of paper publication and patent application in the field of regeneration; 9th in terms of the ratio of research in regeneration medicine to the overall bio research; 10th in terms of the quality of research papers.      ‣ The number of clinical tests for stem cell therapies is 22 by 7 companies. * Clinical tests for human embryonic stem cell therapies were approved for the second time in the world. (November 2010)

 

 

□ (Focal areas) The new investment in R&D for commercialization of stem cell/regeneration medicine will be made mainly in the following areas. 

 

①    Areas in which investment is imperative for the sake of public good.

 

- For rare diseases which is difficult to expect development treatments by the private sector in a voluntary manner; and for incurable diseases, i.e. damaged spinal cord, which cause permanent impairment due to the lack of cures at the moment.

 

②    Areas with relatively high technological competitiveness which has the potential to advance into the global market

 

- Investment in frequent, chronic diseases such as arthritis and other musculoskeletal system disorders, diabetes, cardio-cerebrovascular disease, etc. has high industrial value as the market demands the development of various treatments for those diseases.

 

 

□ (Core Programs) The following three R&D programs will be implemented with priority under the strategic goal of developing future-oriented cutting-edge stem cell/regeneration technologies and commercializing them at an earlier stage.

 

①    “Inter-Ministrial Intermediate R&D Program” established for better connection between basic and higher-level research

 

- Government investment thus far has been characterized by weak connection between basic research (done by Ministry of Education, Science and Technology) and intermediate/clinical research (done by Ministry of Health and Welfare), which served as an impediment for the outcome of basic research to advance towards commercialization.

 

- In this regard, the “Inter-Ministerial Intermediate R&D Program” was set up to facilitate the connection between the outcome of basic/source research gained in R&D projects conducted by MOEST or others and commercialization efforts.

 

* ‘Core Technology Intermediate Research’: Application can be made on condition that precedent research was conducted. KRW 0.5-1 billion/year, in 3 years. 

 

②    “Investigator-initiated Clinical Trial Program” expanded to build clinical basis

 

- As stem cell/regeneration medicine is a new arena of technology (or product), there have been a significant number of cases where approval for clinical trial and commercialization was difficult to achieve due to the lack of previous clinical research and database.

 

- Therefore, investment budget for “Investigator-initiated Clinical Trial Program” was dramatically expanded to promote creative research by investigators to facilitate the accumulation of clinical database required for commercialization. 

 

* ‘Clinical Research for Basis Building’: KRW 0.3-0.7 billion/year, in 2 years (scheduled to be provided in 2H 2012)  

 

③    “Business-led Consortium Clinical Research Program” through pre-planning competition

 

- So far, the target of government investment was confined mainly to investigators at colleges and universities, limiting the use of potential research competencies and skills possessed by private companies and hospitals. 

 

- To realize such research potential, R&D projects led by venture or pharmaceutical companies with an aim of commercialization will be pursued in the following approach.

            First, select subsidy recipients through competition early in the research planning phase.

 

            Second, form a business-hospital consortium for higher chance of commercialization.

 

            Third, impose royalty fees regarding the outcome of commercialization. The government reinvests in R&D.

 

* ‘Consortium for Commercialization’: Up to KRW 3 billion/year, in 2-3 years, final selection will be made by evaluating the research plan by phase. (cost for planning will be provided, KRW 30 million, 3 months)

 

□ Ministry of Health and Welfare finalized the “2012 Stem Cell/Regeneration Medicine R&D Implementation Plan” containing the aforementioned, and opened a contest for R&D projects. 

 

* Advertisement of the contest can be found on the websites of MOHW or Korea Health Industry Development Institute (www.mw.go.kr, www.hpeb.re.kr).

 

○ To help interested companies and researchers have better understanding, program presentation will be provided on 13 April, 2:30 pm. in Korean Federation of Science and Technology Societies (KOFST) located in Yeoksam-dong.

 

○ The presentation will include “the introduction of MOST stem cell R&D project” (in association with MOST and KFDA) and “the information about stem cell treatment approvals that researchers and developers should know”.

 

□ Ministry of Health and Welfare set out its intention to open up new paths forward for the treatment of rare/incurable diseases by making investment in earnest, and to pave the groundwork for making stem cell/regeneration medicine a high-value added, core growth engine.