News Details

News Details

The 43rd session of the Tongxiyi Forum, “Project Management and Incremental Innovation,” was held as scheduled in Wuhan.

Category: Company News

Release Date: 2016-04-29

Summary: The 43rd session of the Tongxiuyi Forum, hosted by Qirui, came to a successful close on March 31, 2016, on the shores of East Lake in Wuhan—the “River City.” Nearly thirty presenters and attendees engaged in lively discussions on “Project Management and Incremental Innovation,” with insightful perspectives exchanged and debated throughout the event.

　　The 43rd session of the Tongxiuyi Forum, hosted by Qirui, came to a successful close on March 31, 2016, on the shores of East Lake in Wuhan—the “River City.” Nearly thirty presenters and attendees engaged in lively discussions on “Project Management and Incremental Innovation,” with insightful perspectives exchanged and debated throughout the event.
　　
　　The four-day forum was divided into two sessions. The first session, “Project Management in Accordance with International Technical Standards,” focused on how to file dual IND applications for innovative drugs in both China and the United States, with particular emphasis on clinical trial design and process management under international standards. The second session, “Improved Innovation and Pharmaceutical Differentiation,” directly addressed the pervasive issue of severe product homogeneity plaguing the entire pharmaceutical industry and provided a thorough interpretation of the 505(b)(2) pathway. A distinguished panel of experts—including senior new-drug review officials and patent examiners—delivered meticulously prepared presentations; all speakers were leading practitioners in their fields, and all presentations were highly practical and actionable, resulting in a fully packed venue.
　　Developing medicines created in China to prescribe powerful solutions for the world—sharing the presenter’s insightful perspectives:
　　
　　Zhang Mingping, former CDE review expert
　　Pharmaceutical submission information for innovative drugs should be comprehensively evaluated based on factors such as the phase of clinical research, the number of subjects and duration of the study, the novelty of the drug’s structure and mechanism of action, the dosage form and route of administration, as well as known and potential risks.
　　Guo Ming, President of Jiangsu Yasheng Pharmaceutical
　　For projects with a defined lifecycle or critical (life-or-death) milestones, time is more valuable than money—for example, the patent term (exclusive marketing period) of an innovative drug.
　　Chen Tingting, Deputy Director of the Lizhu Pharmaceutical Research Institute
　　Meticulous management must be reflected in every detail—every minute counts, and every day saved is a day gained. When personnel lack the necessary skills and experience, compensate with robust processes; when communication is inadequate, supplement it with standardized forms. In short, we must ensure that every task has a designated person in charge and that every activity is properly documented.
　　Huang Zexiong, Senior Partner at Bang & Xin Yang in Beijing
　　Interaction between technical experts and patent attorneys can help optimize innovation. A piece of advice for pharmaceutical companies: invest more in patent-related activities and build a robust internal think tank.
　　Chen Hong, Vice President of the Yiling Pharmaceutical Research Institute
　　Serve as the chief commander on the front lines of drug R&D by building a multifunctional, specialized team; break down project milestones into granular components while maintaining macro-level control over R&D progress; foster a sense of ownership; standardize and streamline project workflows; and enhance capabilities in analysis and problem-solving.
　　Zeng Xueming, Founder of Huacheng R&D Management Consulting
　　A project manager should be adept at assessing the capabilities of team members: for those who are highly competent, avoid overburdening them with a single task—do not treat a “thousand-mile horse” as a mere mule; and for those who are less capable, do not abandon them overnight. Remember that 90% of success is rooted in hard work.
　　Shen Xiaohang, former Executive Director of the Bioanalytical Department at WuXi AppTec
　　Announcement No. 722 embodies rigorous standards, stringent regulation, severe penalties, and strict accountability.
　　Zhang Zhenqing, Researcher at the Academy of Military Medical Sciences
　　The development of combination drugs should aim to enhance patient adherence, improve clinical outcomes, and increase drug safety.
　　Fu Weiming, Vice President of Fangen Pharmaceutical
　　The FDA’s 505(b)(2) pathway covers: new indications; new combinations containing an active ingredient that has already been approved; new dosage forms or new manufacturers; changes in dosage form, strength, route of administration, or dosing regimen; changes in the active ingredient (e.g., a different salt); or the addition of a new active ingredient or an increased amount of an existing active ingredient.
　　Alan Liss, former Director of the U.S. FDA
　　The key to successful new-drug development is to clearly define your management objectives and promptly integrate them into your thinking, planning, and execution.
　　Liu Ping, President of R&D at Shenzhen Aosa Pharmaceutical
　　Our R&D talent must learn, think, and innovate, while aspiring to a lofty goal: to develop medicines that are truly “Made in China” and to prescribe bold, transformative solutions for the world.
　　Tian Shuyan, Director of the Yiling Pharmaceutical Research Institute
　　The integration of traditional Chinese medicine into the international pharmaceutical landscape is an inevitable trend and a natural outcome of current developments. Document No. 44 issued by the CFDA in 2015 underscores that the ultimate goal of China’s pharmaceutical industry is globalization—specifically, aligning with the standards and practices of developed countries in Europe and North America.
　　Lu Xianping, CEO of Shenzhen MicroCore Biotechnology
　　The success of an innovative drug should be grounded in addressing specific clinical needs, offering irreplaceable or complementary therapeutic options, achieving differentiated product positioning, and implementing a successful market strategy.
　　Lü Qiang, Vice President of Yuheng Pharmaceutical
　　Focusing on a distinctive R&D pipeline requires meticulous and targeted development. This entails in-depth exploration of therapeutic areas to identify recent technological breakthroughs and target products that are either not yet on the market or appear to face significant hurdles.
　　Zhang Hui, Product and Solutions Expert at Thomson Reuters
　　In 2015, 55% of new compounds approved by the FDA were granted marketing authorization through the 505(b)(2) regulatory pathway. Of the 46 new drugs approved via this pathway, approximately 87% involved new formulations, new dosage forms, or new combination products, while the remainder included new molecular entities and modifications to the active ingredient, among other categories.
　　Wang Qingsong, General Manager of the Strategic Development Department at Xiansheng Pharmaceutical
　　New dosage forms represent a crucial step in the internationalization of China’s innovative drugs. Concurrent global development is the indispensable path for Chinese new drugs to gain international recognition.
　　Liu Yuanxia, CEO of Beijing Zhiyuan Tongchuang Intellectual Property Agency
　　Domestic enterprises should implement strategic patent portfolio management; prior to the launch of generic drugs, a comprehensive search of the originator’s patents is essential; where avoidance of an existing patent is not feasible, an invalidation action may be initiated, as such an invalidation challenge serves as a powerful defensive countermeasure in infringement litigation.
　　Lü Donghao, former Senior Reviewer at the FDA
　　Many pharmaceutical products can be submitted either as an NDA/NME application, an NDA/505(b)(2) application, or an ANDA/suitability petition. The choice of submission pathway can have a significant impact on a company’s interests and entails different requirements for the product development process.
　　Li Jing, Founder of YaoDu Jingwei
　　New drug development should be driven by emerging commercial opportunities, with greater investment in discovery rather than profiling.
　　Gan Yong, Researcher at the Shanghai Institute of Materia Medica, Chinese Academy of Sciences
　　Chinese pharmaceutical companies are currently undergoing profound industry-wide transformation and restructuring, urgently requiring technological or business-model innovation to drive this transition and overcome existing challenges. Innovation-driven, clinically demand-oriented improved formulations represent one of the key opportunities for the future.
　　Li Shoufeng, CEO of Shanghai Aokeda Biotechnology
　　Start-up biotechnology companies often complement the capabilities of large pharmaceutical firms and achieve unexpected success in direct competition with them. Moreover, for Chinese pharmaceutical companies, the 505(b)(2) pathway represents a highly effective avenue for innovation.
　　Xie Yuli, Director of the CMC Office at WuXi AppTec
　　The core of this round of pharmaceutical reform is to return to clinical value. The reform must and will be steadfastly pursued. Opportunities for products that are unrelated to their intrinsic quality and clinical value—yet, due to regulatory and policy changes, or through opportunistic or deliberate manipulation in processes such as approval and market access, pricing, and inclusion in the national medical insurance formulary—to secure exclusive market positions and carve out premium pricing margins, thereby becoming favored by sales channels driven by financial incentives, will no longer arise. The public will never accept this. Without prioritizing R&D and respecting technical personnel, there is no future.
　　Ren Guobin, Vice Dean of the School of Pharmacy, East China University of Science and Technology
　　Research on pharmaceutical polymorphism is closely linked to intellectual property protection; polymorphic patents are secondary patents with exceptionally strong exclusivity, second only to compound patents. Whether in the development of new drugs or in achieving patent breakthroughs for generic drugs, polymorphic research offers unparalleled advantages and significance.
　　Zhao Buzhen, Senior Partner at Bang Xinyang in Beijing
　　The “Tinib explosion” underscores the need for companies to understand the general patterns of the patent lifecycle in product development, to closely monitor the emergence of patent barriers, and to comprehensively weigh risks against opportunities when selecting which products to develop.
　　Zhong Bohua, Researcher at the Academy of Military Medical Sciences
　　With the advancement of medicinal chemistry and the continuous improvement of human health, increasingly stringent quality requirements have been imposed on pharmaceuticals: shifting from a sole focus on high efficacy and low toxicity to the optimization of pharmacokinetic properties.
　　Yang Jin, Professor at China Pharmaceutical University
　　In the development of innovative drugs, clinical pharmacology experts must be involved early and provide continuous oversight throughout the entire process. Modeling and simulation can support decision-making, but they are only one of many tools in the clinical exploration strategy; it is essential to have a deep understanding of their functions as well as their strengths and limitations, and to employ them flexibly based on a top-down design approach. For some drugs, modeling and simulation play a critical role, whereas for others they are virtually ineffective.

Keywords: The 43rd session of the Tongxiyi Forum, “Project Management and Incremental Innovation,” was held as scheduled in Wuhan.

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