Dr. Kamali Chance Joins Advenchen Biosciences as VP of Global Regulatory Affairs to Lead Drug Registration Strategy
Amador Bioscience, a global leader in translational science and clinical pharmacology CRO services, has appointed Dr. Kamali Chance as Vice President of Global Regulatory Affairs. In this role, Dr. Chance will report to Ms. Chen Xiaomin, Chief Operating Officer of Amador Bioscience. Dr. Chance will lead the company’s regulatory affairs team, providing global pharmaceutical companies with regulatory support spanning from IND-enabling studies through IND submissions to NDA/BLA/MAA filings.
AMADOR BIOSCIENCE’s regulatory registration services leverage the company’s strengths in domestic and international clinical pharmacology, laboratory services, translational medicine, and clinical development teams, along with a quality management system compliant with international standards. By drawing on the team’s extensive experience in interactions with regulatory authorities worldwide, we provide global innovative pharmaceutical companies with comprehensive services including global regulatory strategy, regulatory consulting, clinical development plans, registration pathways, and regulatory negotiations. To date, the AMADOR team has successfully completed over 210 marketing authorization applications (including NDAs, BLAs, and MAAs) for clients both in China and abroad, serving a diverse clientele ranging from leading startup biotechnology firms to multinational pharmaceutical companies.
Dr. Kamali Chance
Dr. Chance has 25 years of industry experience in regulatory affairs, covering the preclinical, clinical, and global market approval stages of various drug development programs. She has facilitated the successful market launch of multiple drugs in the United States, the European Union, Canada, China, and other Asian countries. Dr. Chance has also authored and co-authored numerous articles and book chapters on regulatory practices for innovative drugs and biosimilars. Recently, her article, “Design and Implementation of Successful Regulatory Strategies in Biosimilar Development,” was published in a Springer-published book on biosimilars.
Prior to joining AMADOR BIOSCIENCE, she served as Chief Executive Officer and Executive Consultant at KC Biopharma Consulting, where she was responsible for developing global regulatory strategies and providing U.S. market regulatory consulting and affairs support for rare disease drugs. Previously, she held the position of Chief Regulatory Officer at BioscienceCorp, leading the company’s global regulatory strategy, clinical development programs, and registration pathways for drug/device, mRNA, and cell therapy product development. Dr. Chance spent over 11 years at QUINTILES (IQVIA), serving as Vice President and Head of Global Biosimilar Regulatory Strategy.
Dr. Chance earned her Ph.D. in Nutrition/Nutritional Biochemistry from the University of North Carolina at Greensboro and her Master of Public Health degree from the University of North Carolina at Chapel Hill. She holds a Regulatory Affairs Certification issued by the Regulatory Affairs Professionals Society.
Regarding Dr. Chance’s appointment, Ms. Chen Xiaomin, Chief Operating Officer of AMADOR BIOSCIENCE, stated: “Dr. Chance brings extensive experience in global regulatory affairs and is an exceptional leader. Under her leadership, we are confident that AMADOR BIOSCIENCE’s global regulatory capabilities will be further strengthened, enhancing our service capacity worldwide.”
Dr. Kamali Chance stated, “I am delighted to join Amador Bioscience. My career has been dedicated to regulatory affairs. Amador boasts top-tier experts across various fields and an experienced international management team. I look forward to collaborating with the team to help bring more innovative drugs to market.”
Dr. Wang Bing, Chairman and CEO of AMADOR BIOSCIENCE, stated, “Dr. Chance possesses keen insights into the global regulatory landscape and extensive experience. We are confident that her addition will further enhance AMADOR’s global capabilities in regulatory affairs.”
AMADOR BIOSCIENCE drives new drug development with clinical pharmacology as the core, providing end-to-end clinical development services that meet international standards. This includes clinical development strategies and execution from preclinical stages to market launch, scientifically optimizing dose selection, target identification, and patient stratification, while adhering to global quality execution standards to enhance the success rate of new drug R&D. AMADOR’s end-to-end clinical services encompass Clinical Pharmacology (A2PG), Bioanalysis, and Clinical Research. Its client base ranges from leading startup biotech companies to multinational pharmaceutical enterprises. To date, the AMADOR team has successfully completed over 210 marketing authorization submissions (NDA, BLA, MAA) in Europe and the United States for domestic and international clients.
AMADOR BIOSCIENCE currently operates facilities in multiple locations worldwide, including Pleasanton, CA; Ann Arbor, MI; Germantown, MD; and Richmond, VA in the United States; Hangzhou, Shanghai, and Beijing in China; and Limburg, Belgium in Europe.