2016 ANNUAL REVIEW Ministry of Science and Technology

involving AstraZeneca (AZ) and AstraZeneca Taiwan (AZT). In this project, AZ and AZT provided research funding and compounds, and the three parties called for new indications or other preclinical research proposals involving innovative drugs against forms of cancer prevalent in Asia, such as lung cancer, breast cancer, stomach cancer, and liver cancer. (f) The program arranged for the signing of an international technical service contract between the Japanese firm SAI and the Synchrotron Radiation Research Center in December 2016. Under this agreement, the Synchrotron Radiation Research Center began providing TPS machine experiment technical services to SAI during the latter part of December. Apart from establishing linkage between domestic academic and research organizations and international industry, this service cooperation will also enhance Taiwan's service capabilities as a whole through the accumulation of international market experience. (6) Ethical, legal, and social implications (ELSI) group a. This group is assisting TCTC in resolving technical and legal issues connected with trials at different stages, and continuing to implement joint ethical review mechanisms (NRPB-IRB), enhance the efficiency of multi-center clinical trial proposal review, reduce waste due to the redundant production of review documents, and lessen the time needed for transmission of review documents. As of the end of December 2016, 21 hospitals had joined NRPB-IRB, 29 NRPB-IRB applications had been received (12 from companies, 17 from principal investigators), 28 applications had been submitted to reviewing hospitals, and the reviewing hospitals had completed review of 25 cases. The average time needed to review each case was 14.6 days (from passing administrative review to completion of review). Because the National Research Program for Biopharmaceuticals will come to an end, relevant services have been handed over to the Center for Drug Evaluation (CDE). b. After completing a sample "multicenter clinical trial contract" the group provided "contract- signing guides" to 30 hospitals in an effort to boost contract-signing performance, promote cooperation between hospitals, and boost the effectiveness of clinical trials. c. The group revised the "Should I Participate in a Clinical Trial?" handbook, which explains to the public the implementation of clinical trials and IRB protection mechanisms in order to establish a basis of mutual trust. d. The public participation group completed the "Public Attitude toward Human Specimen Studies" telephone survey and in-depth interviews. After interviewing biomedical researchers, IRB members, representatives of human rights group, legislators, and government decision-makers, the group completed 31 in-depth interviews. The group also conducted a nationwide telephone survey at the start of 2016, and held a panel discussion on public attitudes on November 26, 2016; the biomedical researchers, scholars, and members of patient groups and the general public invited to this event discussed this issue and shared their research results. e. The group held three training classes, two next generation sequencing (NGS) round-table experts' conferences, and a public forum on the topic of "public attitudes toward human specimen research". C. Research Results of the National Synchrotron Radiation Research Center The Taiwan Photon Source (TPS) synchrotron accelerator successfully completed commissioning, and achieved a storage current with the design value, during 2016. President Tsai Ing-wen presided at the TPS' inaugural ceremony held on September 19, 2016, and took part in a push-button start- up ritual with various other dignitaries. Following the completion of commissioning, TPS' beamline experiment facilities were formally made available to users who completed application procedures, allowing domestic and foreign research teams to use TPS' advanced experimental facilities. TPS will lend new vitality to Taiwan's S&T development, and may develop into a world-class scientific research center. Apart from operating TPS and actively constructing beamline experimental facilities, the National Synchrotron Radiation Research Center (NSRRC) is also maintaining the high-efficiency operation of its existing Taiwan Light Source (TLS), and providing high-quality, advanced radiation services to domestic and foreign research teams engaging in basic and applied scientific research. 1. Accelerator Facility The TLS and TPS accelerator light sources have continued to operate stably 24 hours a day. The accelerators had an operating efficiency of 98.2% (TLS) and 99.9% (TLS) in 2016, and were able to maintain an electron beam stability index ( △ I 0 /I 0 , beam strength fluctuation ratio) of less than 0.2% for 99.9% Support for Academic Research Ministry of Science and Technology 55

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