Yoomin Jeon and Yuchae Jung attended the 15th Annual Pharmaceutical IT Congress in London (UK) 27-28 September, 2017 and presented two posters that detailed the core concept and framework of P-MATCH (Precision-Machine Learning AssisTed Clinical Trial Eligibility Assessment using Health Record) and chatbot service to find the most appropriate clinical trials for patients. Their works were extremely well received. 

The Congress was well attended by >200 delegates from world renowned academic institutions, hospitals, global pharmaceutical organisations and leading biotechnology companies. Yoomin and Yuchae also actively participated in 40 other presentations and case studies focusing on the key developments in Big Data and analytics, lab informatics, collaboration, digital health, wearable technologies, blockchain technology, and artificial intelligence in drug development.  

For more information about 15th Annual Pharmaceutical IT Congress, please click this link. 

In addition, you may want to contact Yoomin or Yuchae for their posters.

 

There are several points to consider when granting extrapolation for biosimilars across different indications, for which the biosimilar was not tested in humans. Dr. Howard Lee, one of the pioneers in the regulatory issues pertaining to biosimilar as exemplified in his well-received paper, was invited to speak at the 37th Annual Scientific Meeting of the Korean College of Rheumatology, where he challenged extrapolation of the safety and efficacy data in one indication to another for biosimilars unless backed up by strong scientific justification. Dr. Lee concluded that the regulatory agencies need to exercise caution before granting extrapolated indications to biosimilars. Watch the full presentation below.

The regulatory agency should evolve into a science agency, followed by a public health agency and, finally, a visionary leadership agency according to Dr. Howard Lee at the 35th Annual Meeting of the Korean Medical Association on June 30, 2017. Dr. Lee emphasized the importance of self-identity by the regulatory agency, which has to balance between the two seemingly contradicting roles: protecting the public from hazards while advancing the public health by introducing innovative new medicines. He also warned the risk to rely exclusively on a specific discipline such as statistics when making an important regulatory decision in drug approval without paying balanced attention to other competing disciplines including mechanistic exploratory modeling analysis. Dr. Lee’s presentation slide deck can be downloaded here.