About

Senior Vice President, Head of Regulatory Affairs

Raj Dhodda, PhD, is responsible for the Company’s Global regulatory affairs and the development of regulatory strategies, interacts and negotiates evidence with FDA, EMA and other global regulatory authorities across all therapeutic areas. Dr. Dhodda received her integrated PhD in Molecular Biochemistry from University of Madras, India, and University of Wisconsin-Madison and completed a postdoctoral degree at University of Wisconsin-Madison, USA. She has earned a second advanced Masters certificate in Regulatory Affairs – Oncology at San Diego State University, USA.

Dr. Dhodda’s career includes regulatory leadership roles with increasing responsibilities at Abbvie, Takeda, Sumitomo Pharma Oncology (Sunovion), Covance, and PPD. She has led teams as a key regulatory expert and an adaptive strategist over her 23 years and has a track record of developing and implementing successful global regulatory strategies leading to NDA, BLA approvals in multiple therapeutic areas.

Dr. Dhodda is a well-recognized leader and a standing mentor and chair at the Healthcare Businesswoman’s Association Midwest chapter.

Vice President, Biostatistics

Huanyu (Jade) Chen, PhD, is Vice President of Biostatistics at Fortvita Biologics, where she leads biostatistical strategy and activities across global drug development programs. She brings deep expertise in oncology drug development gained through leadership roles in the pharmaceutical industry and regulatory experience at the U.S. FDA.

Before joining Fortvita, Dr. Chen served as Head of Oncology Biostatistics at Ipsen, where she directed pivotal submission efforts, securing FDA approval for Onivyde in first-line PDAC and multiple ex-US approvals for Cabometyx across several indications. Her prior industry experience includes roles at Regeneron and Bayer, where she contributed as a project statistician in immuno-oncology development across diverse tumor types. Earlier in her career, Dr. Chen spent over a decade at FDA/CDER as an Expert Mathematical Statistician supporting oncology product reviews. In this role, she advised on study design and statistical analyses for IND and NDA submissions, participated in multiple ODAC meetings, the Avastin public hearing, and oncology-focused regulatory workshops. She co-authored several FDA draft guidance documents and led the development of Oncology CDISC Therapeutic Area User Guides (TUAG) for colon, lung, and prostate cancers as FDA’s Biostatistics representative.

Vice President, Clinical Pharmacology and Pharmacometrics

Su Liang, PhD, leads Fortvita Biologics’ Clinical Pharmacology and Pharmacometrics functions, overseeing strategies that translate scientific insights into therapies optimized for the right patient at the right dose. He brings extensive experience across all phases of drug development, leveraging biology and translational tools to accelerate the discovery and development of novel therapeutics.

Prior to joining Fortvita, Dr. Liang gained regulatory experience at the U.S. FDA and held roles of increasing responsibility at Genentech, Regeneron, and Immunovant. He has founded and directed Clinical Pharmacology, Pharmacometrics, and Translational Medicine organizations, contributing to senior leadership teams to shape strategy, manage risk, and drive cross-functional alignment.

Dr. Liang’s expertise spans nonclinical and clinical development, including study design, regulatory authoring, and successful product registrations. He has built and mentored high-performing teams, delivering advancements in global regulatory submissions and compliance.

Vice President, Quality Assurance

Jeffrey Ouano leads Fortvita’s Quality Assurance operations, overseeing the development and management of global quality systems that ensure compliance across all phases of product development, from discovery through commercialization. He brings over 25 years of leadership experience in Quality Assurance, with a strong record of building scalable systems that support regulatory compliance and product success.

Prior to joining Fortvita, Jeffrey served as Vice President of Quality Assurance at CG Oncology, where he established and optimized the company’s quality infrastructure, supporting its successful FDA inspection in 2022.

Earlier, as Senior Director of Quality Assurance at SillaJen, he led US and Korea-based Quality teams in harmonizing systems for a late-stage viral oncolytic program. From 2006 to 2014, Jeffrey oversaw Quality Assurance for the cabozantinib (Cometriq®) program at Exelixis, managing compliance from discovery through regulatory approvals in the United States and European Union. He also served as audit host for the company’s first FDA Pre-Approval Inspection, which contributed to product approval in 2012.

Jeffrey began his career in Quality Assurance with roles of increasing responsibility at PDL, XOMA, Aviron, and Chiron. He holds a Bachelor of Science in Molecular Biology and Chemistry from San Jose State University.

Senior Vice President, IT & Data Sciences

Michael Zhang, PhD, leads Fortvita Biologics’ IT and systems infrastructure, overseeing initiatives that streamline operations and support R&D activities. He brings over 25 years of experience in pharmaceutical R&D, clinical operations, quality and compliance systems, data science, and IT.

Before joining Fortvita, Michael served as Vice President of IT & Data Sciences at Brii Biosciences and Senior Director of Development Operations Systems at Gilead.

He holds a PhD in Chemistry from the University of Houston and a B.S. in Chemistry from Beijing University.

Vice President, Fortvita US Office

Leah Tong leads Fortvita Biologics’ US office, overseeing operations, research teams, and strategic partnerships. She brings over 25 years of experience in biotechnology, with deep expertise in oncology research, cell biology, and analytical techniques.

Before joining Fortvita, Leah held roles at UCSF and Exelixis and spent more than two decades at Gilead Sciences, advancing from Senior Research Associate to Research Scientist. In her current role, she manages operational strategy, team leadership, and regulatory compliance for the US office.