With over 25 years in global and European pharmaceutical and biotech industries, Ming brings extensive experience in strategic regulatory affairs, managing full lifecycle activities and successfully leading agency interactions across multinational, SME, and start-up environments.
Product Development
Extensive experience leading end-to-end development of innovative therapies, including gene and cell therapies, biologics, and combination products. Ming has overseen clinical and regulatory aspects of multiple AAV and lentiviral vector programs, including early research translation, IND/CTA preparation, and first-in-human studies. Skilled in defining target product profiles, development plans, and integrated strategies to enable accelerated progression from concept to clinic.
Regulatory Strategy
An expert in designing and executing global regulatory strategies that support expedited development and approval pathways, achieving RMAT, PRIME, Breakthrough Therapy, and Orphan Drug designations while managing scientific advice, PIPs, and global agency interactions. Provided strategic leadership across development programs to anticipate regulatory trends and adapt to evolving guidance frameworks.
Technical Expertise
Deep understanding of cell and gene therapy platforms, vector manufacturing, and device integration. Adept at applying evolving regulatory science to real-world development challenges for ATMPs and complex biologics.
Compliance
Proven track record of ensuring regulatory compliance throughout all phases of development, manufacturing, and commercialization. Responsible for preparation and maintenance of clinical trial applications, marketing authorizations, and substantial amendments. Supported post-approval compliance activities, naming reviews, and promotional material evaluations to uphold global regulatory and ethical standards.
Business Strategy
Strategic contributor to corporate planning and product portfolio decision-making, aligning regulatory opportunities with business objectives. Provided insights into competitive intelligence, regulatory trends, and market access implications to inform investment and development priorities. Collaborated with executive teams to integrate regulatory considerations into overall company growth strategies.
Project Management
Effective leader of global, cross-functional teams and vendor partnerships. Skilled at driving collaboration across clinical, manufacturing, and regulatory functions to deliver milestones on time and to the highest standards.
