Baisong Mei, MD PhD
Chief Medical Officer @ City Therapeutics
About
• An experienced and passionate executive leader, physician scientist and drug developer with 25 years of experience in pharmaceutical/biotech industry in several disease areas including hematology, neurology, ophthalmology and other diseases • Responsible for Clinical Development, Drug Safety, Clinical Operation, Biometrics, Regulatory, Medical Affairs and Patient Advocacy • A change agent who transforms company strategy, revitalizes execution, changes and grows organizations • A key leader in the company transformation from research/early clinical stage company to late clinical stage company; from a scientific company towards a drug development and commercial company • A key leader in external engagement with investors, investment analysts, bankers and media • An excellent track record in bringing novel medicines from discovery to clinical development and regulatory approval, including Alprolix®, Elocate®, Jivi®, Onpattro®, Altuviiio® and Qfitlia® • Inventor of two globally approved drugs, Jivi® and Altuviiio® • Led clinical development for multiple new molecular entities (gene therapy, siRNA, protein, and small molecule), from first in human to Phase 3 studies, and global approvals in US, EU, Japan, China and other regions • Leadership experience covering the entire drug development cycle, from Discovery Research, to CMC and Clinical Development, and Regulatory approval • Led successful external strategic partnership collaborations resulting in 2 globally approved drugs • Contributed in BD and M&A activities resulting in acquisition of a public company
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United States
Pharmaceuticals
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Experience

Executive Vice President and Chief Medical Officer
Cambridge, Massachusetts, United States
• Led clinical research and drug development for the Company’s pipeline across all therapeutic indications, including hematology and ophthalmology as well as oncology and other rare diseases • A change agent in the executive leadership team with enterprise vision, transforming the company’s strategic direction, changing the culture and improving the execution of clinical programs • Led the company’s drug development governance and chaired the Development Review Committee; established drug development processes in target identification, clinical / regulatory plans, unmet medical needs, and commercial opportunities • A key leader in executive communications with investors, investment analysts, bankers and media about company strategy and execution • Built a high-performance organization, including Clinical Development, Drug Safety, Clinical Operation, Biometrics, Regulatory, and Medical Affairs and Patient Advocacy • Revitalized the execution of clinical programs such as accelerating patient recruitment, establishing medical monitoring and GCP process. • Led successful engagement with FDA and reached critical alignment on development plan (e.g. reached alignment with FDA to convert a Phase 1 study to a seamless Phase 1/2/3 study for BLA filing) • Led culture change to build a learning organization to improve organizational effectiveness • A key leader in business development activities, both in licensing and out licensing

VP Senior Global Project Head, Rare Diseases and Rare Blood Disorder Clinical Development
Cambridge, MA, USA
• Accountable for end to end Clinical Development • Led a group of Sr. medical directors, medical directors and clinical scientists for Phase 1 to Phase 3 studies • Led a strategy partnership with Alnylam for siRNA clinical development of multiple rare diseases • Led Qfitlia® program (siRNA for hemophilia A and B, with and w/o inhibitors) from Phase 1 to Phase 3 development, including adult and pediatric studies, and completed 3 Phase 3 studies all with positive results • Oversaw collaboration of Onpattro® clinical development (siRNA for Transthyretin Amyloidosis) • Led early stage programs in Rare Disease Therapeutic Area, include SCD, hemophilia, complement-mediated diseases and kidney diseases • Engagement with US FDA, EMA (incl. PDCO), Japan PMDA and China NMPA, including pre-IND, end of Phase 2 meetings, revision of Phase 3 clinical program • Participated due diligence and in licensing activities, including acquisition of a public company • Worked closely with Research, Commercial, Market Access and Medical Affair on program/franchise strategies

Therapeutic Area Head, Hematology, Clinical Development
Cambridge, MA
• Therapeutic area head for non-malignant hematology clinical development, including molecules in early and late stage clinical development programs on hemophilia and hemoglobinopathy (sickle cell disease and thalassemia) • Therapies under development included biologics, gene therapies, and small molecules; Clinical studies in adult and pediatric populations • Critical leadership for global approvals of Alprolix®and Eloctate®, and design of first in human study for Altuviiio® • Led a group of medical directors from establishing clinical development plans to preparation of study protocols, medical monitoring, clinical study reports and regulatory filings • Led medical monitoring partnership with CRO Medical directors for clinical studies • Led clinical development programs by working with a matrix team including clinical operation, statistics, regulatory, medical affair, commercial and market access • Extensive experience in BLA/NDA filings and approvals in US, EU, Japan, Canada and other regions • Worked closely with Research, Medical Affair and Commercial on pipeline development • Developed and coached medical directors and other colleagues within and outside the group • Clinical lead for external partnership on joint clinical development program

Director, Discovery Research
Waltham, MA
• Founding director for the department, responsible for molecular discovery, cell line development, protein expression, purification and analytics for hematology research projects • Led research collaboration with external partner, which resulted in programs in clinical and preclinical development • Co-inventor of Altuviiio® (a FVIII fusion protein) approved in US, EU and globally • Reviewed/prepared CMC sections of IND/IMPD and BLA filings (US, EU and Asia) • Reviewed/prepared clinical documents for BLA filing • Participated due diligence and in licensing activities

Head, Expression Technologies
Berkeley, CA
• Directed the department responsible for protein expression system, cGMP and research cell line development, cell line evaluation and protein production in bioreactor, cGMP cell banking and support of production of marketed products • Led a hemophilia drug discovery program and delivered program from concept design, CMC development to IND • Co-inventor of Jivi®, a PEGylated FVIII, approved in US, EU and globally • Led global CMC process development teams for Phase I and Phase III clinical manufacture processes, completed Phase I clinical manufacture (DS and DP) at in-house cGMP pilot facilities
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