Drug Development Strategies in China
In the podcast, Kent Thoelke, Executive Vice Presdient, Scientific & Medical Affairs for PRA, discuss parallel drug development strategies in China, the nuances of the regulatory market there, as well as best practices.
Drug approval strategies for China have fallen into one of two camps over the past decade. On one side are a number of sponsors that started doing business in China in the 1990s and even earlier. These early adopters know China well. They know its relationship-based culture, they know its regulatory climate and nuances. This insider knowledge allows them to develop domestic Chinese approval strategies in conjunction with their global strategies and do well on both sides.
But most pharma and biotech firms are relative newcomers to the Chinese market and aren't aware that the regulatory climate has changed dramatically in recent years. Companies that do not have a physical presence in China may not have noticed, but SFDA approval times for Clinical Trials Approvals have dropped to between seven and nine months for small molecules. The 12-month approval that was once a miracle of speed has now become the limit of acceptability.
There are also opportunities in China for sponsors that have not yet completed Phase II trials to create a similar parallel approval strategy. They may not have the final details such as the final dosing to be used, but it is possible to file a CTA for Phase III based on the most current early phase results. This more limited parallel submission strategy can shave several months from the final approval time in China.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Phase III Trial Data Show Subcutaneous Pembrolizumab as Noninferior to IV Keytruda
March 31st 2025Subcutaneous administration of pembrolizumab with chemotherapy demonstrated a nearly 50% reduction in patient chair and treatment room time while maintaining efficacy and safety endpoints compared to intravenous Keytruda.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
