Jeong Sae-Im writing for Korea Biomedical Review reports that a recent conference in Korea, BIO KOREA 2019 at COEX, brought together prominent speakers from a variety of Korean research institutions. Some observations from the conference:

  • Korea may be pulling ahead of Japan in the gene therapy market
  • Korea is lagging behind Japan in the cell therapy market—due to the fact that Japen invests $175.3 million
  • Koreans were first to publish a paper focusing on gene editing in ophthalmology focused on macular degeneration
  • Gene therapies face challenges including astronomical prices. For example Luxturna gene therapy for treatment of Leber’s congenital amaurosis costs about $790,146 for both eyes.  A single treatment, theoretically can cure the disease but in reality the article points out a treatment would be needed very decade.
  • Costs  are a real factor for gene therapies
  • Other challenges include “unintended genetic modification” and more accurate off-target effect detection tools are in development
  • FDA is easing its regulatory stance over gene therapies which will accelerate clinical programs—the FDA based its decision on the fact that it is “impossible to check all the risks related to gene therapies during clinical trials before a review.”
  • FDA now considers chemistry, manufacturing and control information the most important when it comes to gene therapy now.
  • The U.S. NIH now is abolishing preliminary guidelines for gene therapy products
  • Professor Kim Yeon-Soo of Hanyang University Chemistry Department noted “the U.S. is seeking various changes, such as allowing conditional approval for gene therapy on rare and intractable diseases, to help gene approval for gene therapy on rare and intractable diseases, to help gene therapies quickly arrive in market.” He also noted “many clinical trials using genetic editing are progressing worldwide and these technologies will lead to gene therapies.”
Source: Korea Biomed

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