On December 18, 2020, the annual meeting of RDPAC R&D Committee was grandly held on the Roche Pharma Shanghai campus. R&D heads from 24 RDPAC member companies attended the meeting, and Hong CHOW, Vice Chairman of RDPAC Executive Committee and General Manager of Roche Pharmaceuticals China, attended the meeting and delivered a speech. An in-depth discussion was conducted at the meeting about the current situation and challenges in clinical development faced by pharma multinational companies (MNCs) in China, with group discussions and opinion sharing on two themes: promoting global simultaneous development and establishing R&D talent training mechanism.
“Now China is in the second tier of global pharmaceutical development and has become one of the top options for global innovative development. The importance of continuously promoting simultaneous development of global innovative drugs, and attracting and nurturing outstanding R&D talents cannot be overstated.” Hong CHOW said. “With the continuous reform of the review and approval system since 2015, the review and approval of new drugs continue to be optimized, and regulatory standards are gradually aligned with the international standards, which has contributed to great improvement in the R&D environment China. Consequently, over 200 new drugs have been introduced to China by RDPAC member companies in the past five years. RDPAC member companies will continue to actively accelerate the delivery of the latest global therapeutic products to Chinese patients, promote the optimization of China's pharmaceutical innovation ecosystem, and contribute to the realization of the Healthy China 2030 vision.”
Sara WANG, Senior Director of RDPAC Science & Regulatory, expressed her welcome to all participants of the annual meeting. Sara shared the RDPAC Science & Regulatory 2020 achievements and objectives in 2021, saying that 2020 was a year of challenges and opportunities. Although the pandemic has led to changes in working ways and adjustments in working priorities, thanks to the rapid response of member companies to changes and interconnection in special periods, and the active contributions as always, we have made lot of progress in many aspects such as facilitating the drug review and approval reform, advancing innovation and development, sharing international experience, and maintaining efficient operation. On behalf of the RDPAC Science & Regulatory Department, Sara Wang thanked all members of the R&D Committee for their positive contributions and looked forward to continued effective interaction and cooperation in 2021.
Subsequently, Kezhou ZHANG, Chair of RDPAC R&D Committee and Vice President of Clinical & Medical & Regulatory, Novo Nordisk China, reviewed the value proposition, work priorities and function setting of RDPAC R&D Committee since its establishment. He said that the RDPAC R&D Committee will continue to accelerate the development of innovative products in China, provide support to develop a coordinated and unified R&D ecosystem, promote China's entry into the first tier of global R&D, and work together to promote solutions to simultaneous global development in China.
Li WANG, Co-chair of the RDPAC R&D Committee, Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs, pointed out that China has become the second largest pharmaceutical market in the world, and pharma MNCs still face challenges in simultaneous global development and simultaneous submission as well as R&D talent training in China. What we should do is to seize the opportunity in the favorable policy environment to further enhance China's position in the global R&D ecosystem and continuously improve the training mechanism for R&D talents. These efforts will enable the global innovations to better benefit Chinese patients, and China's participation in new drug development, as a key direction of future development strategies of pharma MNCs, could greatly contribute to global new drug development.
Launch simultaneous submissions to continuously enhance China's strategic position in the global R&D system
China’s pharmaceutical innovation has entered a new era with the continuous optimization of the policy environment, the government's continued encouragement of innovation, the accelerated introduction of global innovative drugs, and the rapid rise of local innovative forces. After joining ICH, China’s registration regulations are gradually in line with the world and China is increasingly participating in international multicenter drug clinical trials, laying a good foundation for simultaneous global innovation. The implementation of simultaneous global clinical studies will help accelerate the development and registration of innovative products in China and allow Chinese patients to benefit early from global innovations.
Li WANG, introduced in the meeting that according to RDPAC’s internal survey, the proportion of simultaneous submissions in China accounted for less than 10% of global simultaneous submissions in the past three years and is expected to increase to 10-30% in the next three years. The survey showed that MNCs have conducted few global First in Human (FIH) trials in China over the past three years, and this situation is anticipated to improve over the next three years. Only by continuously improving China's innovative R&D ecosystem and harnessing the value of China’s R&D in the overall R&D system of pharma MNCs can simultaneous global innovation be achieved.
The heads of R&D departments of RDPAC member companies attending the meeting mentioned that China's patient pool, i.e., clinical resources, is the major advantage to help improve the efficiency of global R&D, and the global R&D system should pay more attention to the strategic position of China. Achieving simultaneous submission & marketing of new drugs in China and including China in the early stages of development of global breakthrough therapies will facilitate the important role of China in the global R&D system.
The simultaneous global development and submission in China by Pharma MNCs face a number of challenges from the internal and external environment. The main contributing factors for simultaneous submission come from the following four aspects based on the comprehensive discussion and summary of the RDPAC Working Group (WG): 1) whether the pharma MNCs’ headquarter has included China in its global pivotal study program; 2) whether an adequate window for enrolling Chinese patients can be ensured; 3) whether the number of subjects allocated for clinical trials in China could meet requirement for new drug registration; and 4) whether clinical trial monitoring is done in-house or through the CRO(s) to ensure sufficient and high quality registration data.
42% of those surveyed in RDPAC's internal survey believed that the time lag between clinical trial initiation in China and globally remains a major challenge for pharma MNCs, and is the main reason why China is not included in key studies in the global R&D systems. This challenge also affects the achievement of simultaneous submissions. 19% of the surveyed suggested that there are now more new challenges to achieve simultaneous global submissions than ever before. Jing HE, a core member of RDPAC R&D Committee, Senior Vice President of Global Oncology R&D, AstraZeneca and President of Global R&D China Center, pointed out in the meeting on behalf of the WG many realistic problems faced by simultaneous global submission. From the internal view, in order to improve the efficiency of pharma MNCs’ R&D in China, their global headquarters should make a decision early in the phase I clinical studies about whether China will participate in the key studies, and if so, whether a separate clinical trial in China will be conducted, or China will participant in the global clinical trials. Considering the external factors, the implementation of ICH E17 guidelines still needs to be refined; the requirements of the new regulations on human genetic resources management in China need to be fully considered during the stage of study design and implementation plan of clinical trials involving foreign countries, and there is still room for further improvement on clinical trial site system construction and capacity building in China. In addition, now China should train more principal investigators who will be capable of leading international multicenter clinical trials. Therefore, in order to facilitate the simultaneous global submission of innovative products by pharma MNCs, the above-mentioned challenges from both pharma MNCs and the China’s R&D ecosystem need to be overcome as soon as possible.
Strengthen the construction of talent pool, pay more attention to R&D talent training and R&D team investment
Technology and talents are both indispensable in promoting pharmaceutical innovations, thereby allowing global innovations to benefit Chinese patients simultaneously. For both pharma MNCs and China's local pharma companies, R&D talent is also one of the decisive factors in the outcome of new drug development. According to the McKinsey report “Broadening the Bridge to Innovation”, China's local biopharma companies contributed more than 50% to the clinical trials with innovative drugs in China by 2020. Accordingly, as the tide of pharmaceutical innovation in China proceeds, both pharma MNCs and local pharma companies, without exception, have seen a significant increase in the demand for R&D talent, which has intensified the competition for talent resources. In recent years, the overall structure of pharma MNCs and their R&D strategies in China have been adjusted, leading to a particularly obvious trend of local talent flowing between pharma companies, which has become another challenge faced by pharma MNCs for R&D in China.
According to an internal survey by RDPAC, 54% of the surveyed believe that the impact of the talent shortage on pharma MNCs in China will become increasingly prominent. The majority of those surveyed expressed that middle and senior managements in R&D departments opt to left MNCs mainly because of better salary and more considerable autonomy and career advancement space. This is consistent with the results of a research “2021 Talent Report - Healthcare and Life Sciences” by Hudson, which shows that from the R&D talent angle, career advancement opportunities, a great corporate culture, and salary are the three main factors that influence their choice of workplace. By way of example, Hudson reported that the R&D staff turnover in foreign companies has increased from 15% to 23%, and 88% of them have stayed in their new workplace for less than two years. Hence, providing pharmaceutical R&D talents with their expected advancement space and a reliable R&D team is the key for pharma companies to improve R&D efficiency, and it is also crucial for pharma MNCs to promote the marketing of innovative drugs in China.
Jessie Chen, a core member of the RDPAC R&D Committee and General Manager of Pfizer China R&D Center, shared a cross-company salon named “China R&D Future Leaders’ Salon” which aims to promote the high-end R&D leadership training, followed by leading the deep discussion among RDPAC R&D Committee on this topic. Empowerment and feedback from headquarters, opportunities for local R&D talents to lead global or simultaneous development directly so as to extensively enhance the leadership of domestic talents in global R&D projects, and development in competition so as to better adapt to the "war for talent" triggered by the rapid development of local innovation in China, have become major challenges faced by pharma MNCs' R&D teams in China in terms of talent resources. RDPAC WGs, to solve the above issues and improve the overall R&D level and efficiency, recommend that more opportunities should be offered for R&D talents to grow in global development projects and adequate guidance should be given by actively building up an in-house talent development system, and creating a favorable development environment based on the needs of R&D talents. In addition, the value proposition of talent development in pharma MNCs, which is “focus on science, implementation, and culture”, should be delivered from both Chinese and global standpoints.
RDPAC and its member companies, as partners in achieving the goal of Healthy China 2030, have always been committed to the development and introduction of innovative drugs, thereby allowing global innovations to benefit Chinese patients sooner. Sara WANG said, “Next, we will put emphasis on encouraging China to develop a globally harmonized, scientific, transparent and predictable drug regulatory system to accelerate global simultaneous development and innovation, and promote comprehensive monitoring throughout the product life-cycle, eventually to enable Chinese patients to access high quality and safe drugs.”
The RDPAC R&D Committee 2020 Annual Meeting bridged the past and the future. To benefit Chinese patients, we will work together to focus on simultaneous global development and talent development, and contribute to the realization of Healthy China 2030.
