Nearly 100 innovative drug experts and leading talents from the Greater Bay Area attended this grand event, including Zhu Shaoxuan, Executive President of the Guangdong Association for Biomedical Innovation Technology; Dr. Liu Feng, Chairman of Guangzhou DiQi Pharmaceuticals Co., Ltd; Dr. Wang Tingchun, Chairman of Boji Pharmaceutical; Dr. Wan Zhihong, former Cellular Immunotherapy Review Expert at the regulatory review department and Chief Scientist at Boji Pharmaceutical; and Dr. Li Xinxu, former Chief Statistician at the regulatory review department and Chief Statistician at Boji Pharmaceutical. The salon was hosted by Xie Songping, Commercial Director of Boji Pharmaceutical's South China Region.
At the outset of the conference, Zhu Shaoxuan delivered the opening remarks on behalf of the organizers. She noted that in recent years, Guangdong Province has placed significant emphasis on the development of the biopharmaceutical industry and has made considerable progress, particularly in the rapid advancement of industrial chain construction. However, objectively speaking, there remains a certain gap compared to Jiangsu and Zhejiang provinces at present. How Guangdong can adapt to the situation, build momentum for future growth, and cultivate a biomedical innovation ecosystem has become a shared mission for industry peers. She called on biomedical enterprises, universities, and social organizations across the Greater Bay Area to join hands, foster mutual connections, and collectively advance the development of the region's biomedical innovation ecosystem.
In recent years, advanced therapies such as cell therapy and immunotherapy have garnered significant industry attention, with related clinical trials in these fields drawing considerable interest. As an expert reviewer in the field of cellular immunotherapy, Dr. Wan Zhihong's presentation, “Review Considerations and Challenges in the Clinical Development of Immune Cell Therapy,” immediately captured the audience's focus from the outset.
Dr. Wan Zhihong provided a detailed analysis of the current landscape of immune cell clinical trials, covering aspects such as the definition and characteristics of immune cell therapy products, the status of research and development, relevant technical guidelines, subject recruitment and selection, and dose exploration. She also analyzed the advantages and challenges of single-arm trials and randomized controlled trials.
As the lead statistical reviewer for the original review department, Dr. Li Xinxu delivered a presentation titled “Exploring Common Statistical Issues in Communication.” Drawing on his personal experience, he shared insights on topics including sample size estimation and test thresholds in clinical trials, issues of multiplicity in clinical trials, adaptive trial designs, interim analysis in clinical trials, bridging studies in clinical trials, and the evaluation of Chinese subgroups in global MRCTs. Additionally, he illustrated and analyzed communication review challenges encountered in various scenarios, providing attendees with valuable insights.
The development of long-acting formulations has emerged as a key industry focus in recent years. Dr. Liu Feng shared his insights on this topic with attendees in his presentation titled “Development Strategies for PLGA-Based Long-Acting Formulations: Innovation or Imitation?” He emphasized that, after comprehensive consideration of multiple factors, innovation remains the optimal development strategy for long-acting formulations. Dr. Liu cited the successful case of Green Leaf Pharmaceutical's recently launched innovative long-acting formulation, Risperidone Microspheres for Injection. He analyzed the global market landscape for long-acting formulations, combined with the development trajectory of China's long-acting formulation industry, concluding that the domestic market for long-acting formulations holds vast potential!
Taking PLGA-based extended-release formulations as an example, the presentation then compared and analyzed the risks associated with innovation versus generic development for such formulations. This comparison covered aspects including carrier formulations, manufacturing processes, equipment, clinical studies, R&D timelines, funding requirements, clinical risks, and indications. The session also shared successful case studies of modified extended-release formulations, earning enthusiastic applause from attendees!
The forum continued until nearly 6 p.m. that evening. After the event concluded, many attendees lingered at the venue, eager to engage in in-depth discussions with the speakers about the future development of the Greater Bay Area's biopharmaceutical industry.
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