Dr. John Zhong serves as the Vice President and Head of Biometrics at REGENXBIO Inc., a leading biotechnology company specializing in gene therapy. With over 25 years of experience in biostatistics and biometrics, Dr. Zhong has significantly contributed to the advancement of innovative treatments for severe diseases.
Professional Journey
Before joining REGENXBIO in September 2019, Dr. Zhong held pivotal roles in several prominent biotechnology firms. At Biogen, he served as the Biostatistics Group Head, leading teams that provided statistical strategies and support for early development, immunology, and rare diseases across all phases of clinical development. He also led the Innovative Analytics group, playing a critical role in implementing innovative statistical methods and trial designs across multiple assets.
Prior to his tenure at Biogen, Dr. Zhong was a Senior Director at Human Genome Sciences, where he was responsible for statistical strategies and support throughout all phases of clinical development in autoimmune and infectious disease areas. His work has been instrumental in bringing multiple new treatments to patients with serious unmet needs.
Contributions to Statistical Innovation
Dr. Zhong is renowned for actively promoting statistical innovation in drug development and representing the industry’s perspective in regulatory advancements. He served on the FDA’s expert panel for the public meeting on “Promoting the Use of Complex Innovative Designs in Clinical Trials,” significantly influencing the design of the FDA’s Complex Innovative Designs Pilot program. Currently, he serves as a Rapporteur at the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), leading the E20 Expert Working Group to develop an international regulatory guideline on Adaptive Clinical Trials.
Academic Background and Publications
Dr. Zhong earned his Ph.D. in Mathematical Statistics from the University of Maryland at College Park. Throughout his career, he has coauthored over 50 manuscripts in peer-reviewed medical and statistical journals and has delivered more than 100 presentations, contributing significantly to the body of knowledge in his field
Role at REGENXBIO
In his current role at REGENXBIO, Dr. Zhong leads the biometrics division, overseeing the application of statistical methodologies to support the company’s gene therapy programs. His expertise ensures the integrity and validity of data analysis, which is crucial for the development and regulatory approval of innovative gene therapies.
Impact on Gene Therapy Development
Dr. Zhong’s extensive experience and leadership in biostatistics have been instrumental in advancing REGENXBIO’s mission to develop and commercialize gene therapies for severe diseases. His contributions to statistical innovation and adaptive clinical trial design have enhanced the efficiency and effectiveness of clinical development programs, ultimately benefiting patients with unmet medical needs.
Conclusion
Dr. John Zhong’s role as Vice President and Head of Biometrics at REGENXBIO underscores his significant contributions to the field of biostatistics and gene therapy development. His leadership and expertise continue to drive innovation in clinical trial design and statistical methodologies, facilitating the advancement of treatments that have the potential to transform patients’ lives.