▶  Facing challenges and adapting to changes:

Against the backdrop of economic cycle fluctuations and demographic changes, the pharmaceutical industry must constantly adapt to market demand and update clinical diagnosis and treatment standards. We have witnessed the transition from traditional medicine to targeted therapy, and the evolution from monotherapy to personalized medicine. Dr. Zhu emphasized that the pharmaceutical industry is facing unprecedented challenges under the combined effects of macroeconomic factors such as economic cycles, demographic changes, and geopolitics. This requires the sponsor and project outsourcing agency to quickly adapt to changes in the industry environment and policy orientation during research and implementation.
 

▶  How external pressures can have a downward impact on clinical practice and sponsors:

The applicant is facing unprecedented pressure in project initiation decisions and portfolio strategies. How to ensure the stability of the company's cash flow while ensuring project progress has become a challenge we must face.

Dr. Zhu used popular anti-tumor targets such as small molecules and bispecific drugs as examples to explore changes in competitor data and clinical best practices, how they affect project approval, indication selection and prioritization, and how dynamic adjustments can be made. He emphasized that under the new normal, improving clinical prediction and risk awareness has become a higher requirement for medical staff.

At different stages of clinical research and development, Dr. Zhu used seven vivid cases in the fields of chronic diseases, medical aesthetics, rare diseases, and cell/gene therapy to illustrate how New Leading Medicine actively optimizes trial design to assist applicants in achieving cost reduction and efficiency improvement. He emphasized that under the new normal, applicants need CRO to provide more flexible and professional support from project evaluation to NDA stage. This support is not only based on the professionalism of CRO, but also requires medical personnel to have a broader perspective and more proactive thinking ability.
 

▶  Looking to the future, and keep learning

Dr. Zhu pointed out that the widespread application of main trials, platforms, umbrella and basket trials, as well as the precision of indication design, are reshaping the face of clinical research. The discovery of biomarkers not only provides strong evidence for clinical mechanisms, but also significantly enhances the possibility of the project entering the next stage, laying a solid foundation for the success of phase III clinical trials. The support of real-world data provides more comprehensive and in-depth evidence for drug approval, accelerating the process of new drug launch.

The breakthrough application of artificial intelligence has not only achieved significant results in auxiliary diagnosis, disease assessment, surgical assistance, drug development, patient monitoring and management, but also demonstrated its unique value in the field of imaging evaluation. The innovative application of digital experiments, such as preclinical organs, digital human physiological/disease models, and pharmacological models, is effectively eliminating gray areas in AE/SAE judgments and improving the accuracy and safety of clinical trials.

However, the accompanying question is how professionals in the current field will adapt to this change? How will they find their place in this transformation?

Faced with the rapid changes in the pharmaceutical industry, Dr. Zhu believes that professionals need to continue learning, have an open mind, and collaborate across industries. The future of the pharmaceutical industry is full of brightness, but there are also challenges. Dr. Zhu calls on colleagues in the industry to work together and embrace a new chapter in the pharmaceutical industry with an open mind and innovative spirit, contributing to the cause of human health.