Dr. Cynthia N. Brysch, PhD, is an award-winning global expert in Quality Assurance and Regulatory Affairs, specializing in AI-enabled clinical development, regenerative medicine, and advanced therapeutics. As Vice President and Chief Operating Officer at Devine Guidance International (DGII), she leads global QA/RA strategy, clinical quality oversight, and regulatory remediation across biotech, pharmaceutical, and medical device programs. With over 20 years of experience and more than 500 product development campaigns, Dr. Brysch is known for translating complex innovations—including cell and gene therapies, CRISPR technologies, and AI-integrated clinical systems—into compliant, inspection-ready programs. An FDA Lead Assessor, ICH committee member, ISO accrediting authority, and CAP Inspector, she is recognized for her “science-to-compliance” approach, enabling safe and globally harmonized therapeutic advancements.