WuXi STA and WuXi TIDES Forum
Accelerated Pharmaceutical Development

On March 11, 2025, the WuXi STA & WuXi TIDES Forum on Accelerated Pharmaceutical Development in San Francisco brought together industry leaders to discuss one prevailing theme: preparation and partnerships lead to success. The event underscored the critical role of Chemistry, Manufacturing, and Controls (CMC) in the pharmaceutical and biotech industries, highlighting strategies to navigate challenges and accelerate development timelines.

The Importance of Strong CMC

Dr. Xiaoyong Fu, Executive Vice President and Head of WuXi STA, welcomed the Bay Area pharma and biotech audience with a powerful message on the necessity of robust CMC strategies. He emphasized that great molecules require great CMC support to translate into successful therapies.

Keynote speaker Heow Tan, Chief Technical and Quality Officer, Biomea Fusion LLC, captivated the audience with insights drawn from more than 40 years of CMC experience. Tan underscored the importance of meticulous planning, hard work, and strategic partnerships in overcoming manufacturing pitfalls. He highlighted his long-standing collaboration with WuXi STA, which has spanned more than 14 years, and credited their expertise and capacity for successfully producing over 200,000 kg of an oncology therapeutic on an increasing truncated timeline. His message was clear: CMC surprises are inevitable, and readiness is key. He concluded his presentation with a quote from General Colin Powell: “There are no secrets to success. It is the result of preparation, hard work, and learning from failure.”

Tackling Molecular Complexity in Drug Development

Dr.Jling Chen, Senior Vice President and Head inof Pharmaceutical Development and Manufacturing at WuXi STA, illustrated the company’s ability to navigate increasing molecular complexity in therapeutics. She shared two compelling case studies:

• Accelerated NDA Submission: WuXi STA supported the development of a challenging Proteolysis Targeting Chimeras (PROTAC) oncology drug candidate with poor yields and bioavailability, successfully improving purification and crystallization to surmount these challenges, achieving an aggressive 12-month NDA submission timeline.
• Scaling Oligonucleotide Therapeutics: The team optimized a hepatocyte-targeting siRNA-GalNAc conjugate, overcoming poor yields and a three-step purification utilizing on resin click chemistry to improve yield, purity, and scalability.

These examples reinforced WuXi STA and WuXi TIDES’ expertise in solving complex drug development challenges through experience, innovation, and efficiency.

Panel Discussion: The Role of CDMOs in Modern Pharma

A distinguished panel of experts, including Dr. Xin Linghu, Vice President and Head of CMC at IDEAYA Biosciences; Dr. Michael Martinelli, Vice President, Exelixis; Dr. Sri Mudumba, Chief R&D Officer at PYC Therapeutics; and Heow Tan, engaged in a dynamic discussion on speed, quality, risk mitigation, and supply chain challenges. The panelists agreed that the days of pharmaceutical companies investing heavily in commercial manufacturing infrastructure are over. Instead, outsourcing to Contract Development and Manufacturing Organizations (CDMOs) like WuXi STA and WuXi TIDES has become the industry norm due to their unparalleled speed, experience, cost efficiency, and quality.

Looking Ahead: Our Commitment to Industry Advancement

The event concluded with inspiring remarks from Yu Lu, Senior Vice President, Head of WuXi TIDES and Head of Business Operations at WuXi AppTec, who reaffirmed the company’s commitment to expanding its facilities and capabilities to meet industry demands. Amid an evolving global landscape, the organization remains dedicated to driving quality solutions for global pharmaceutical development.

The FAST Forum made one thing abundantly clear: preparation and partnerships are the foundation of success in pharmaceutical development. As the industry continues to evolve, collaboration with trusted CDMOs like WuXi STA and WuXi TIDES will be instrumental in bringing life-saving medicines to patients worldwide.