Huichen Liu, Clinical Pharmacology, Aerospace Center Hospital: 60 Second Interview
With increasing emphasis on implementing effective early phase trial strategies in Asia, companies are looking to reduce approval timlines, risks and costs from first-in human through proof of concept. Huichen Liu, Director, State Clinical Pharmacology Research Unite, Peking University Teaching Hospital - Beijing Aerospace General Hospital , joined Pharma IQ for a 60 second interview ahead of the 2nd Annual Early Phase Clinical Trials Asia 2012, to discuss understanding regulatory timelines and approval process for early phase trials in China.
Pharma IQ: What emerging trends are you witnessing in early phase clinical trials in China?
H Liu: In recent years, INDs have been encouraging to be developed. So more and more earlg phase clinical trials need to be conducted, and more and bigger challenges should be faced.
Pharma IQ: In your opinion, what has been the single biggest shift in the way clinical trials are conducted?
H Liu: More and more attention is being paid to the quality and standards of clinical trials.
Pharma IQ: What are the latest challenges in the field you are seeking to overcome?
H Liu :How to predict and reduce the risk of fist-in-human studies.
Pharma IQ: Do you feel more emphasis is being put on running early phase trials in China?
H Liu: Yes.
Pharma IQ: What are the most visible changes in clinical trials regulatory guidance at present?
H Liu: Much more emphases are put on the quality of clinical trials, and the role and responsibility of sponsor is being highlighted.
Pharma IQ: What would be your top 3 strategies for managing timelines and approvals in China?
H Liu: Know the related policies and technological requirments. Communicate with SFDA and its CDE. Communicate with the PI chosed or to be chosed and understand each other.
Pharma IQ: What are your predictions for the Pharma landscape in 2020?
H Liu: Pharma can play a real important role in improving the left quality of the older population.
Pharma IQ: Looking at the Chinese pharmaceutical market, in your opinion what therapeutic area will show the biggest opportunity in terms of growth?
H Liu: Cancer. Firstly, the incidence of cancer is high, secondly, most cancers cannot be cured and thirdly most anticancer drugs are expensive.
Pharma IQ: What are you looking forward to about the 2nd Annual Early Phase Clinical Trials Asia Summit?
H Liu: Sharing more imformation with other experts from Asia and the World.
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