Stanford’s Center for Innovative Study Design, with co-sponsors including the Stanford Center at Peking University (SCPKU), the International Society for Biopharmaceutical Statistics and Tsinghua University’s Center for Hospital Management, held a Forum on Regulatory Science and Biomedical Innovations at SCPKU on March 22, 2017. The event gathered more than 60 leaders from the Chinese Food and Drug Administrations (CFDA), Chinese Association of Preventive Medical (CAPM), universities, professional organizations, and R&D experts from domestic and international biopharmaceutical companies.

Over the last decade, significant progress has been made in medical research, disease treatment and general health and well-being.  The Chinese government has called out innovation as a major national strategy to achieve sustainable growth.  At the same time, to address public health and safety, the country’s regulatory agencies are tasked with implementing relevant laws to ensure the safety and efficacy of new products and services before they’re available to the public. The ability of regulatory agencies, laws and regulations to promote innovation while protecting public health is an important research question.  This forum at SCPKU was designed to facilitate a high-level discussion on this topic by scholars from academia from both China and the US, CFDA leaders, and R&D experts from biomedical industries.

The forum was structured with four keynote talks and two panel discussions. Dr. Ruiyi He, the Chief Scientist at the Center for Drug Evaluation of CFDA, delivered a speech on CFDA’s plan to enhance regulations on drug evaluation to promote the development of new drugs. He highlighted some major initiatives to align with ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use).  In June 2017, China became a member of ICH. Dr. Dechao Yu, founder and CEO of the Innovent Biologics, Inc., gave a talk on opportunities and challenges in innovative biologics in China. He shared his experience in developing Oncorine and Conbercept in China and the needs for regulation reform for innovative new drug applications. Professor Jiqian Fang from Sun Yat-Sen University reviewed the development of the CFDA in the past two decades and called for open, transparent and academic participation in innovative development of drug review and approval regulations. Professor Baoyan Liu, Vice President of the Chinese Academy of Chinese Medicine Sciences, presented innovations in Chinese medicine (CM) using clinical trials and big data, and the regulatory needs tailored for the sciences of CM.

The two panel discussions were focused on the challenges and opportunities in evaluating the safety and efficacy of innovative biomedical products and collaboration in biomedical innovations. Panelists included a CFDA division director, CFDA biostatisticians, several members of the CFDA advisory committee, a vice president of CAPM, and CEOs of several biomedical startups in China.

Attendees were able to exchange ideas in an open and fair environment and many expressed interest in joining future SCPKU-based forums and workshops on this topic.  Forum participants drew the following conclusions:

·   Regulatory science plays an important role in promoting and supporting biomedical innovations.

·   Regulatory reforms should be open, transparent, science-driven, and in alignment with international standards.

·   Low-quality generic drugs should not be supported.

·   Regulatory agencies, academics, and the biopharmaceutical industry should work together on developing science-based policies to make effective, safe and affordable drugs for Chinese patients.

The Center for Innovative Study Design also held a Workshop on Innovative Statistical Methods in Precision Medicine and Big Data at SCPKU on March 23, 2017. Twelve statisticians from the Chinese FDA, Chinese universities and US universities presented their research on advanced clinical trial design, statistical innovations in big data, and applications of machine learning in biomedical data science. More than 60 attendees from local universities (both faculty and graduate students), government, and pharmaceutical companies joined the workshop and had many insightful discussions.