The RDPAC R&D Working Group (WG) held its 2023 annual meeting in Shanghai on 7 December at which Vivian Bian, RDPAC Executive Committee member and CEO of Roche Pharma China, and Renaud Gabay, RDPAC Managing Director, delivered opening speeches. Nearly 70 participants, including over 30 R&D heads of RDPAC member companies, attended the meeting in person, with an additional 60 colleagues from the R&D, Regulatory Affairs (RA), Human Resources and other RDPAC member company departments attending online. This meeting brought the WG together face-to-face after a hiatus of three years due to the pandemic. Furthermore, several pharmaceutical industry experts also attended the meeting, at which all participants had thorough discussion and interaction on a range of topics.
Science is the cornerstone of the pharmaceutical industry and its source of innovation, with innovation being the topic at the forefront for RDPAC member companies and their respective head offices. In their speeches, Vivian and Renaud acknowledged the effort and contributions of the RDPAC R&D WG to promoting innovative regulatory policies and enhancing innovation capacity across the industry, including initiatives such as its advocacy of Human Genetic Resources (HGR)-related policies and the promotion of consensus on ICH E17, initiatives which have improved the quality of clinical studies at the same time as optimizing processes and shortening timelines for clinical trial applications in China. It was noted that positive feedback has been received from the headquarters of various RDPAC members in response to these initiatives. We are now entering a critical stage during which regulatory policies in China are being adjusted and optimized, with opportunities for improvement in abundance. The significance of the RDPAC R&D WG advocacy lies in its ability to find opportunities to promote the key nodes of China's drug development, improve innovation capacity in China, make China's innovation more beneficial to patients in China and even globally, and to allow China to harness its resources for global drug development.
In terms of promoting simultaneous global R&D, the RDPAC R&D WG has proven successful in 2023
Promoting simultaneous global R&D, registration and review of innovative drugs is key to fostering China’s pharmaceutical innovation system and is a top priority for the RDPAC R&D WG, as stated by Zhang Kezhou, Chair of the RDPAC R&D WG and Corporate Vice President, Clinical Development, Medical & Regulatory Affairs and Quality Assurance of Novo Nordisk China. Efforts to further China's integration into the global innovative drug R&D system and to incorporate China into the global development plan at the early study stage are designed to foster the development of global innovative drugs that can bring expedited benefits to Chinese patients earlier, help China's innovative drugs to benefit global patients faster, ensure the high-quality and sustainable development of the pharmaceutical innovation sector, and continuously enhance China's role and influence in the global pharmaceutical R&D innovation ecosystem.
In 2023, the RDPAC R&D WG fostered significant breakthroughs across multiple work priorities. For example, the Blue Book for ICH E17 Implementation project organized by the R&D WG’s Statistics Sub-WG was successfully completed. Zhu Chao of Eli Lilly, Chair of the Statistics Sub-WG, noted that the project helped the industry to reach consensus on the implementation of ICH E17 in China by enhancing its understanding of ICH E17 and by refining the pooling strategy methodology, consistency evaluation, and extension strategy for risk-benefit balance. The project team received strong support from colleagues in the fields of clinical pharmacology, safety assessment and regulatory affairs, among others.
Breakthroughs were also made with respect to the optimization of clinical operations under the guidance of the Clinical Operations (CO) Sub-WG. In 2023, a series of regulations and guidelines were released, such as the Rules for the Implementation of Regulations on Management of Human Genetic Resources which clarified and focused on management scope, with the aim being to optimize management processes to promote the efficient initiation of clinical trials. Julia Wang of Eli Lilly, Co-chair of the CO Sub-WG, stated that in addition to further advocating the optimization of HGR management, the CO Sub-WG has also been cooperating closely with clinical institutions to accelerate the signing off of clinical trial contracts and to promote prior Ethics Committee review to further expedite the initiation of clinical trials. Meanwhile, the report of the international comparative study on decentralized clinical trials (DCT) provided an overview of the status quo in China measured against international experience, laying a solid foundation for future implementation of DCT-related modules in China and ensuring the quality of clinical implementation.
The annual meeting commended more than 40 people across five R&D WG project teams and two government-assigned task teams for their outstanding contributions in 2023, as well as acknowledging the efforts and contributions made by the R&D teams of seven member companies, namely, Eli Lilly, Pfizer, Bayer, Roche, Boehringer-Ingelheim, Novo Nordisk, and Abbvie, in fostering China's pharmaceutical innovation sector during 2023.
R&D Heads from Multinational Pharmaceutical Companies (MNCs) Discuss Both the Current Landscape and Future Opportunities offered by the Pharmaceutical Innovation Microenvironment
RDPAC, with the assistance of McKinsey & Company, has conducted an “RDPAC Annual R&D Survey” during each of the past five years, with it providing a comprehensive insight into the concerns and prospects of MNCs in China in relation to R&D. Among the 28 companies surveyed in 2023, more than 30% expect to have over 70% of their registration applications over the next three years to be submitted simultaneously globally (a simultaneous submission is defined as a Chinese NDA having been submitted prior to the world's first NDA approval), a 10% increase on last year. Of the multiple registration-enabling clinical studies conducted in China over the past three years, more than 15% have joined global phase I and II clinical trials, a proportion with increase over before, and about 65% have participated in global Phase III international multi-center clinical trials. Respondents were positive about China's participation in pivotal early-stage global studies. Although China's participation in global Phase I clinical trials faces many challenges such as timelines, capabilities and resources, attendees maintain that MNCs in China need to break through capacity barriers and strengthen early-stage study capacity building. With strong support from acceleration channels and other regulatory policies, China’s goals of joining, and even leading, global early studies and of becoming the world's leading pharmaceutical R&D engine and a pharmaceutical power are well within reach.
At the same time, collaboration with local innovators has also provided the impetus for an improvement in China's overall innovation capacity. In recent years, with an increasing number of local innovative compounds having found their way onto the global market, there has been a trend for innovative talent to move from MNCs to local companies, allowing those companies to strengthen their position within the industry and to build a healthy pharmaceutical R&D innovation system, a trend which has resonated with all R&D heads at the meeting. Shen Hong, a core member of the RDPAC R&D WG and SVP, Head of Roche’s China Innovation Center, invited representatives of PharmCube team to provide attendees with an overview of the policy, capital, and R&D support being provided to the innovative Chinese biopharmaceutical industry currently, and into the future, and what they saw as China's local innovation strengths. The PharmCube team identified China's local innovation strengths as “from 0 to 1” potential player engaging in first-in-class (FIC) drug R&D, or strategic enterprises that maximize the efficiency of flexible strategy with faster global target R&D progress, and “from 1 to 10” enterprises that have achieved differentiated competition through technological innovation and platform optimization. PharmCube added that all of these enterprises may become competitors of MNCs in terms of innovative pharmaceutical R&D, or alternatively, they could be viewed as high-quality partners jointly contributing to the enhancement of China's influence and voice in the field of innovative global pharmaceutical R&D.
“Human Effort Is the Decisive Factor” - Innovative R&D Talent Is the Driving Force Behind Continuous Innovation in the Industry
MNC R&D teams across the world view talent diversity and stability as keys to innovation. So, a special R&D Talent Forum with the theme of ‘letting people make people decisions’ was convened at the annual meeting. Wang Lin, core member of the RDPAC R&D WG and General Manager, Vice President of Takeda Research and Development and Head of Takeda Development Center Asia, shared the results of RDPAC's talent survey. The survey showed that 56% of respondents were satisfied with the overall supply of R&D talent in China, with technical skills and learning agility being seen as the top two strengths thereof. However, respondents believe there is still a significant shortage of talent in fields such as translational science, program leadership, and clinical research. The survey showed that a favorable organizational culture, professional development opportunities, and flexible work arrangements are the biggest drawcards by which MNCs can attract R&D talent. Maintaining the long-term stability of talent, there being a limited pool of qualified candidates, and competition from biotechnology companies and high-quality innovative local enterprises were noted as challenges being faced by MNCs. Enhancing the ability to influence key stakeholders and program leadership capabilities, having global experience and a complementary mindset, and providing opportunities for Chinese R&D talent to play key decision-making roles in global projects are seen as the priorities when it comes to building China's R&D talent capacity. To provide attendees with a more diverse perspective on talent, Gladdy He, Founder and CEO of Become Consulting, was invited to share her in-depth insights garnered over years of having engaged talent in the pharmaceutical industry. Subsequently, in the panel discussion, Jessie Chen, General Manager of Pfizer (China) Research and Development Co., Ltd., and a core member of the RDPAC R&D WG, Di Jianing, Head of the China Compound Team Leader Unit at Janssen, and Lisa Tang, Roche P&C Business Partner, provided their perspectives on R&D heads and senior HR business partners, with in-depth discussion being held on a wide range of topics including how to define R&D talent, how to view talent mobility within the innovation ecosystem (growing together with study teams, partner institutions, and regulatory teams) and how to help talent better understand their position and motivation within organizations.
The RDPAC R&D WG 2023 Annual Meeting closed amid lively discussion and exchanges. As summarized by Wang Li, Co-chair of the RDPAC R&D WG, Eli Lilly Corporate Senior Vice President and Head of Eli Lilly China Drug Development & Medical Affairs Center, the RDPAC R&D WG is committed to becoming a trustworthy and leading scientific partner for all stakeholders, and to fostering cooperation between government, industry, academia and institutes to drive simultaneous global R&D. In 2024 and beyond, the RDPAC R&D WG will maintain its focus and further strengthen its communication and exchanges with local government with the aim being ongoing improvement in the quality and efficiency of clinical studies and China's R&D capabilities. Sara Wang, Executive Director/VP of RDPAC Science & Regulatory Affairs, stated that in the future, RDPAC would also strengthen cooperation with international associations, working with them to promote simultaneous global R&D and China's integration into simultaneous global R&D framework. RDPAC and PhRMA will jointly host the 5th International Pharmaceutical Innovation Forum (IPIF 2024) on 22 March 2024, bringing together experts from regulatory affairs, the pharmaceutical industry and academia, as well as researchers, etc. to explore the opportunities and challenges that face China as it strives to further integrate into the simultaneous global R&D system to provide patients with more advanced therapy options. In the future, RDPAC will continue to work with member companies and the whole industry to move towards a simultaneous global R&D system for innovative drugs, doing so by analysing the innovation system, and addressing concerns about simultaneous global R&D and expectations for China to join such a system.
