Drug Development Workshop Recap

Date: April 27, 2024 @ 9:00 am – June 27, 2024
Location: Hanhai Biolabs

Clinical trial studies are essential for new drug development. To stay updated on the latest trends, the Chinese American Biopharmaceutical Society (CABS) organized a Clinical Development Workshop on April 27, 2024 in Foster City, California.  The event was sponsored by Novotech Inc.  Over 80 participants attended the workshop which exceeded its full capacity. Trainings were provided by leading industry experts, including Dr. Wei Dong, Dr. Wen Liu, Dr. Jing Yi, Harry Liu, and Angela Wang.

Over 80 participants attended the Clinical Development Workshop

CABS President Dr. Jessica Sun first kicked off the workshop with opening remarks. She reviewed the history of CABS, highlighted its past achievements and featured events. She proudly noted that CABS was certified by the “President's Volunteer Service Award Organization.”

CABS President, Dr. Jessica Sun, presenting at the opening remarks

Dr. Wei Dong began the workshop with an overview of the clinical development life cycle, emphasizing the importance of a "begin with the end" mindset when preparing Common Technical Documentation for a New Drug Application.  

Dr. Wei Dong introducing the drug development process

Next, Dr. Wen Liu, Ph.D., provided a training on the regulatory aspects of drug development and approvals. She first introduced various regulatory roles and functions, and then described different types of regulatory applications such as Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA), corresponding to different stages or stages of drug development. Dr. Liu explained the traditional, accelerated, and emergency use authorization approval pathways, elaborating on the accelerated approval pathway with successful examples. She last provided insights into current trends in oncology drug development, including cell therapy, precision medicine, tissue-agnostic drugs, and combination/bispecific therapies.

 Dr. Wen Liu providing regulatory insights on drug development 

Dr. Jing Yi presented “Statistical Considerations in Clinical Trials Designs.” She covered topics such as clinical studies in US package inserts (USPI) and EU Summary of Product Characteristics (SmPC), phases of clinical trials, clinical trial development and statistical analysis plans. She emphasized the importance of selecting appropriate endpoints and controlling Type I errors using methods like Alpha Split or Hierarchical Testing to minimize the risk of false positive claims in clinical trials study design. 

 Dr. Jing Yi presenting "Statistical Considerations in Clinial Trials Design"

Harry Liu, an expert in clinical sciences, presented “Clinical Development Highlights – Clinical Science Priorities and Responsibilities.” He outlined the key roles and responsibilities of the clinical science function, which includes clinical study strategy development, clinical operation and trial oversight, publication, etc. He provided an overview of the clinical development process, detailing the objectives and design strategies of Phase I, II, and III clinical trials. He illustrated this with a real-life example of clinical development using evorpacept (ALX-148) in treating head and neck squamous cell carcinoma (HNSCC).

Harry Liu on “Clinical Development Highlights – Clinical Science Priorities and Responsibilities”

Subsequently, Dr. Wei Dong provided a training in drug safety. Her topics included definition of drug safety and pharmacovigilance, languages and tools used, drug safety regulation, as well as best practices in drug safety.  

The last presentation was by Angela Wang, Commercial Director at Novotech Inc. She provided an overview of the company's services, including clinical operations, clinical strategy development, and project and program management.

Angela Wang introducing NovoTech Inc.

The workshop was concluded with a lively Q&A session. The expert panel addressed various questions such as challenges in drug development and future trends.   

* We thank Novotech Inc. for its generous sponsorship.  Drs Jessica Sun, Wei Dong and Yan Wang for organizing the event, and CABS volunteers who dedicated their time to make the event successful.   

                     Recap by Taras Bai