Doranne Frano
Seasoned Regulatory and Quality Assurance Executive
Professional Overview
Doranne Frano is an accomplished regulatory and quality assurance leader with extensive expertise in the pharmaceutical and biotechnology industry. As the Vice President of Regulatory and Quality Assurance at Intensity Therapeutics, Inc., she is responsible for overseeing the company's regulatory compliance, quality management systems, and strategic initiatives to ensure the development and commercialization of safe and effective therapies.
Current Role
In her current role as VP of Regulatory and Quality Assurance at Intensity Therapeutics, Inc., Doranne is instrumental in guiding the company's regulatory strategy and quality assurance efforts. She is responsible for managing the submission of Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs) to global regulatory agencies, ensuring seamless interactions and timely approvals. Doranne also leads the implementation and maintenance of robust quality management systems, driving continuous improvement and compliance with industry standards.
Career Progression
Doranne Frano has a distinguished career spanning over two decades in the pharmaceutical and biotechnology industry. Prior to her current role at Intensity Therapeutics, Inc., she held various leadership positions, including Senior Director of Regulatory Affairs at Acme Pharmaceuticals and Director of Quality Assurance at BioMed Innovations. Throughout her career, Doranne has consistently demonstrated her ability to navigate complex regulatory landscapes, optimize quality processes, and contribute to the successful development and commercialization of innovative therapies.
Academic Background
Doranne holds a Bachelor of Science degree in Biological Sciences from the University of California, San Diego, where she graduated with distinction. She also earned a Master of Science degree in Regulatory Affairs from the University of Southern California, further strengthening her expertise in the regulatory aspects of the pharmaceutical and biotechnology industries.
Areas of Expertise
Doranne's areas of expertise include:
- Regulatory affairs and compliance
- Quality management systems and cGMP implementation
- Strategic planning and project management
- Cross-functional collaboration and stakeholder management
- Leading high-performing teams and driving organizational change
Professional Impact
Doranne's contributions to the industry have been recognized through her involvement in various professional organizations. She is an active member of the Regulatory Affairs Professionals Society (RAPS) and the American Society for Quality (ASQ), where she has presented at conferences and contributed to the advancement of regulatory and quality best practices. Doranne's deep understanding of the evolving regulatory landscape and her ability to navigate complex challenges have made her a respected thought leader in the industry.
Conclusion
With her extensive experience, strong technical expertise, and proven track record of successful regulatory and quality initiatives, Doranne Frano is a valuable asset to Intensity Therapeutics, Inc. and the pharmaceutical and biotechnology industry as a whole. Her strategic leadership, commitment to quality, and focus on driving organizational excellence position her as a trusted advisor and strategic partner in the pursuit of bringing innovative therapies to patients worldwide.
