ProImmune Ltd, a global leader in immunological reagents and services, announced the launch of Mastering Immunity 2026 - Shanghai, an inaugural symposium in China providing practical, real-world guidance to help drug developers manage immunogenicity risk. Taking place at the Oriental Riverside Hotel in Shanghai, the event will convene leading scientists, industry executives, and regulatory professionals from around the world.
Immunogenicity, the potential for biologics to trigger unwanted immune responses, remains a decisive factor in determining safety, efficacy, and regulatory and commercial success. When immunogenicity is poorly understood or assessed inadequately, development programs face clinical failure, costly redesigns, and significant delays. In some cases, these risks can lead to the loss of entire programs, representing financial impacts in the hundreds of millions or even billions of dollars, as well as extended timelines required for additional studies or reformulation.
Presentations will cover modality-specific insights based on real world examples for emerging therapeutic platforms and perspectives on evolving global regulatory expectations presented by speakers from leading companies and regulators with experience of bringing successful drugs to market, including:
- Dr. Zuben Sauna (Director, Center for Biologics Evaluation and Research, FDA)
- Dr. Sophie Tourdot (Immunogenicity Sciences Lead, Pfizer)
- Dr. Balaji MR (Vice President and Head - Non Clinical, Dr. Reddy's Laboratories)
- Dr. Daniela Verthelyi (Former Chief, Laboratory of Immunology, Office of Biotechnology Products, FDA)
- Dr. Tim Hickling (Former Head of Immunosafety, Roche, Quasor)
- Dr. Kanthikiran Varanasi (Global Head of Clinical Affairs, Galencium)
- Andreas Hollenstein (Senior Principal Scientist, Immunosafety, Roche)
- Dr. Nitinkumar Dobaria (Associate Director, Injectables Product Development, Lupin)
- Dr. Anuj Saini (Global Head-Global Clinical Management, Dr Reddy's Laboratories)
- Prof. Yoonjoo Choi (Professor, Department of Microbiology and Immunology, Chonnam National University Medical School)
This meeting is a pivotal moment, bringing together global leaders to tackle the urgent challenge of immunogenicity risk and drive better patient outcomes. This is a must-attend event for anyone committed to shaping the future of biotherapeutics."
Dr. Juhao Yang, Toxicology Project Leader, China Innovation Center of Roche
Dr. Nikolai Schwabe, Chief Executive Officer, ProImmune, added: "Licensing activity and clinical trials are at an all-time high in China's biopharmaceutical industry, but the regulatory landscape is still evolving. By connecting immunogenicity leaders from around the world to share experiences including development and regulatory best practice, ProImmune is playing a critical role in helping developers manage the risk around immunological effects and ultimately accelerate the development of successful therapeutic products."
For event details and registration, including early-bird, visit: https://www.proimmune.com/mastering-immunity-2026-shanghai
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