• 25 years of clinical development experience in pharmaceutical / biotech industry in support all phases of clinical development, regulatory submissions and approvals, and life-cycle management. • Extensive experience in a dynamic small biopharma company providing biometrics leadership including strategic direction and operational excellence of biostatistics, statistical programming, and data management and providing a critical contribution in bringing a first drug to the market. • Therapeutic experience includes liver diseases, multiple sclerosis (MS), multiple rare diseases, age-related macular degeneration (AMD), parkinson’s disease, chronic kidney disease (CKD), hemophilia, infectious disease, cell and gene therapies, and osteoarthritis (OA) • Expert in novel study designs and statistical methodologies. • Extensive knowledge of regulatory guidance and industry standards.
Qifeng Yu is a highly experienced professional with 25 years of clinical development experience in the pharmaceutical and biotech industry. He has a strong background in supporting all phases of clinical development, regulatory submissions, and approvals. Qifeng Yu has held leadership positions in a dynamic biopharma company, providing biometrics leadership and statistical programming. He has expertise in novel study designs and statistical methodologies, and has extensive knowledge of regulatory guidelines and industry standards. Qifeng Yu has worked in various roles, including Vice President and Head of Biometrics at Editas Medicine and Albireo Pharma, Inc.
On March 2, 2023, Albireo was acquired by Ipsen, strengthening Ipsen’s rare disease portfolio with promising therapeutics for pediatric and adult rare liver diseases. Albireo Pharma is a rare disease company focused on the development of novel bile acid modulators to treat pediatric and adult liver diseases. Albireo’s lead product, Bylvay, was approved by the U.S. FDA as the first drug for the treatment of pruritus in all types of progressive familial intrahepatic cholestasis (PFIC), and in Europe for the treatment of PFIC. Bylvay is also being developed to treat other rare pediatric cholestatic liver diseases with a completed Phase 3 trial in Alagille syndrome (ALGS), an ongoing Phase 3 study in biliary atresia, as well as Open-label Extension (OLE) studies for PFIC and ALGS. The Company has also completed a Phase 1 clinical trial for A3907 to advance development in adult cholestatic liver disease, with IND-enabling studies progressing with A2342 for viral and cholestatic liver disease. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com.
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Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics. With approximately 7000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.
Durham,North Carolina,United States
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