Bridging US and China to Conquer Cancer

September 1, 2012
Lingjie Guan

,
Wancai Yang

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-09-01-2012, Volume 21, Issue 9

During the annual ASCO meeting in June, the US Chinese Anti-Cancer Association (USCACA) held its fourth annual meeting to discuss the emerging role of China in global clinical development of novel anti-cancer drugs.

During the annual ASCO meeting in June, the US Chinese Anti-Cancer Association (USCACA) held its fourth annual meeting to discuss the emerging role of China in global clinical development of novel anti-cancer drugs. Approximately 200 ASCO attendees from pharmaceutical industries, cancer research organizations, and universities joined the meeting. Topics that were discussed included: oncology translational research and early development capabilities in China; novel chemical entity development and partnership with Chinese companies; and the increase in Chinese-based pharmaceutical companies participating in global oncology drug development.

The mission of the USCACA (http://www.uscaca.org) is to facilitate collaborations among Chinese and American professionals in the field of cancer research, treatment, and prevention; promote knowledge and information exchange between the professionals in the United States and China; and provide educational information to serve cancer patients, their families, and the community. According to Wei Zhang, President of USCACA, the organization has made significant achievements in the past two years. First, it collaborated with the Chinese Society of Clinical Oncology (CSCO) in organizing two international conferences "Early Oncology Clinical Development Forum and Translational Research" and "Biomarker Summit" in 2011. In the era of molecularly targeted cancer therapy, implementation of biomarkers in early phase clinical trials is essential to understand the mechanism of targeted therapies and to achieve the ultimate goal of personalized medicine. During the meeting, Yi-long Wu, MD, President of CSCO, updated the audience on the USCACA-CSCO initiatives in forming the CSCO Biomarkers and Translational Research Committee to standardize, coordinate, and prioritize biospecimen collection and resources in order to maximize the clinical utilities of biomarkers in anti-cancer drug development in China.

Through collaborations between USCACA, South Texas Accelerated Therapeutics (START), and Fudan Cancer Hospital in Shanghai, China, the first internationally integrated Phase I clinical research center in China, START Shanghai, was founded in September 2011.

Partnerships and development

Many Chinese pharmaceutical companies have gradually evolved their business from manufacturing generic drugs to discovering and developing novel medicines, over the past 10 years. Hua Mu, MD, Senior Vice President, Clinical Development of Hutchison MediPharma, a prominent Chinese pharma engaged in novel anti-cancer drug research and development, presented a case of collaboration with AstraZeneca to develop a novel and selective c-MET kinase inhibitor.

Lianshang Zhang, President, Global R&D of Hengrui Pharmaceutical Co., introduced Hengrui's promising pipeline with a strong interest on partnership for co-development of novel chemical entities in China and worldwide.

Further in the area of partnership and dedicated development in China, the first USCACA Distinguished Partner Award was presented to Pfizer and PharmaNet/i3, in recognition of their partnership and support to USCACA's mission as well as to oncology clinical research in China. Mace Rosenburg, MD, Senior Vice President and Global Head of Clinical Development and Medical Affairs of Pfizer Oncology, and Dalvir Gill, President of Phase II to IV Services of PharmaNet/i3 accepted the awards on behalf their companies.

A panel discussion focused on the key issues around China's emerging role in global clinical research and development of novel anti-cancer drugs featured oncology experts including: Pablo Cagnoni, MD, Senior Vice President, Oncology Clinical Development of Novartis; Jorge Puente, MD, President of Asia Pacific and Canada of Pfizer Oncology; Eric Rubin, MD, Vice President, Oncology TA Head of Merck; Gerd Stehle, MD, Vice President, Oncology of Boehringer Ingelheim; Michael Vasconcelles, MD, Senior Vice President, Oncology of Millennium: The Takeda Oncology Company; Jason Jin, MD, CEO of Shanghai Bio; Shou-ching Tang, MD, the Founding President of USCACA; and Christopher Ung, President & COO of Cistrogene. The panelists shared their opinions on how to address these critical issues in order for US companies to conduct translational clinical research in China, recommended possible solutions for biomarker tissue sample handling and analysis, as well as the IND review process by the State Food and Drug Administration (SFDA) of China. Joanne Jiang, a founder of Fountain Medical Development Co., said that more clinical Phase I research centers are being established and the SFDA has recognized the issues around the IND review process and is making an effort to shorten the review period.

—Wancai Yang, MD, is a Professor at Xinxiang Medical University, Xinxiang, China, and an Adjunct Associate Professor at the University of Illinois at Chicago. Lingjie Guan is a Scientist with Ingenuity Systems, Redwood City, CA.

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