What is Study Group?

A study group usually consists of a small group of people who are interested in a research topic and want to gain deeper knowledge on the topic. Members of the study group are required to meet frequently and actively participate in discussions.

So far, CBA has organized a few study groups that are well received, such as biomarker study groups, Clinical and regulatory affairs study groups. 

Open enrollment - Biomarker and Companion Diagnostics Study Group

Organizing Committee Members:

杨宏钧(Harry Yang),  余红(Judy Yu),  朱培轩(Peixuan Zhu),  邢传华(Julia Xing)

Precision medicine is a focal point of attention worldwide and the future of medicine. It involves precision prevention, companion/complementary diagnostics, targeted treatment, and prognosis. The essence of precision medicine is to treat the right patient, with the right drug, at the right time, in order to improve the effectiveness of the treatment with minimal side effects and to improve the quality of life for the patients. Along with the progress of molecular-targeted cancer therapy, biomarker and companion/complementary diagnostics have become a new area of importance and rapid growth. Precise diagnosis is the foundation of precision medicine. It plays an instrumental role in various aspects from the screening of healthy people, early diagnosis and prognosis of diseases, to aiding optimal targeted treatment decisions, and monitoring for recurrence, etc. The widespread use of biomarkers, combined with the digital pathology and artificial intelligence based on big data on genomic, proteomic, and metabolomics information, will drive new developments in precision diagnostics. We believe it will be soon the prime time for the rapid development of precision diagnostics. This group therefore is established to strategize and represent the future direction of medicine.

CBA’s mission is to bridge biopharmaceutics between the US and China, utilizing the political, economic, academic, research, talents, and geographic advantages in the greater Washington DCregion. It is proposing the formation of the Biomarker and Diagnostic Study Group. The main purpose of this group is to strengthen and advance scientific discussion and communication in area of biomarker and companion/complementary diagnostics among the experts, interested members, and the Biopharmaceutical community.

The activities of this group will mainly focus on research advancements, technology improvements, clinical trial development, guideline updates, HEOR studies, and regulatory policy changes in the area of biomarker and companion/complementary diagnostics related to precision medicine. We plan to enlist 15-20 CBA active members (personal, industrial, and lifetime) to participate, meeting up to 2 times a month to discuss and explore representative events related to the above topics. For example, discussions may include the review of key publications, guidelines,policies, and hot topics of key conferences. In addition, the group may also provide recommendations and participate in the planning of CBA organizational level events and annual meetings. Once formed, the group plans to provide CBA with its annual activity plan and end-of-year report, in order to facilitate the future development of this group. This group will obey all CBA operational, management, and development policies, principles and mission, especially strictly follow intellectual property policy and regulations.

ESTABLISHMENT AND RECRUITING OF THE CBA-USA CLINICAL AND REGULATORY AFFAIRS

After discussions and preparations by the past presidents of the Chinese Biopharmaceutical Association, USA (CBA-USA), and experts in related fields among members, the CBA Clinical and Regulatory Affairs Study Group (CCRA) was established on November 23, 2019. This group will focus on the deep learning and discussion of clinical trials and regulatory affairs related knowledge and regulations in pharmaceutical research and development settings. This is the second thematic study group led by CBA. It will inherit the experience of the first CBA Biomarker group that was established in 2017 and successfully run for one and a half years, and held a group meeting with one related topic on a monthly basis. Beyond studying and discussing, this group is also planning to write annual review reports, organize annual symposiums that will open to the public, etc. The establishment of this group will be a great opportunity for professional career development and networking. Based on the principle of “small and refined” with full participation, from now until December 14th, 2019, CCRA will recruit and admit 20 members on a demand and merit basis. You are welcome to apply for membership if you are majored in or working in the following field: clinical development, clinical practice, medical writer, pharmacovigilance, regulatory affairs, statistics, etc. 

Welcome to consult and sign up: frankli@cba-usa.org or yixing.han@cba-usa.org

 

CBA membership

Become a CBA member to receive the latest news about new study group information and free access to insider knowledge on the latest topics.

Learn more about our Membership Programs.