Expert Details

Expert in Clinical Trial, Biomarker, Clinical Development, Drug Safety, Medical Affairs, Commercialization

Expert ID: 724018 Massachusetts, USA

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As a prescribing physician and a physician in drug development for many years, Expert has expertise in drug mechanism of action and clinical data, and clinical use.

Expert is an expert in drug clinical development from planning to protocol design, conducting and reporting.

Drug approval regulation is complexed processes. Expert has years of experience in working on all requirements related to drug approval.

Expert has developed drug labels from draft to 1st approved label on all medical and safety related sections. He has been maintaining label updates on safety and new indications.

Expert has a working knowledge of regulations in US and EMEA is key to be successful in this field. He keeps up with all related regulations (updates) and applies those to the development programs.

Expert is working with many investigational drugs in clinical phase of development. He is an expert in the evaluation of new compounds.

Expert has been leading the efforts to file NDA for several drugs involving all the clinical aspects of the program.

Clinical drug safety is his primary focus in clinical development. Anaylsis safety information from clinical studies are part of his rountine daily life. He is leading signal detection and risk management efforts.

Expert has a working knowledge of ICH guidance related to patient protection and relevant US laws.

Expert has been working on a number of pro-drugs in clinical development with experience in special requirements in regulations and clinical development.

Participated drug evaluation meeting for in-licensing
and safety monitoring committee.

Expert may consult nationally and internationally, and is also local to the following cities: Boston, Massachusetts - Worcester, Massachusetts - Springfield, Massachusetts - Lowell, Massachusetts - Cambridge, Massachusetts - Brockton, Massachusetts - New Bedford, Massachusetts - Hartford, Connecticut - Manchester, New Hampshire - Providence, Rhode Island

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Education

Year Degree Subject Institution
Year: 1986 Degree: MD Subject: Medicine Institution: Tianjin Medical University
Year: 1998 Degree: PhD Subject: Cardiology and Immunology Institution: Temple University School of Medicine

Work History

Years Employer Title Department Responsibilities
Years: 2008 to 2012 Employer: Sanofi-Aventis Title: Sr. Medical Director Department: Medical Affairs, Oncology Responsibilities: working with marketing/brand team on marketing strategies. working with internal clinical team for clinical studies. working with KOL for medical education.
Years: 2004 to 2008 Employer: Otsuka (Taiho Pharma) Title: Director, Medical Affairs and Drug Safety Department: Medical Affairs Responsibilities: Head of medical affairs and drug safety departments. Plan, design and conduct of clinical trials. Drug development strategic planning, drug evaluation of in/out licening, manage CROs and external experts, responsible for publication, drug labeling, training materials. In charge of safety pharmacovigilance. Attend FDA meetings
Years: 2000 to 2004 Employer: Merck (Schering-Plough) Title: Clinical Scientist and Project Leader Department: Clinical Development Responsibilities: In charge of drug development team. design protocol, analysis results and IND/NDA filing. Clinical team leader for timelines, budgets and present to higher management.
Years: 1997 to 2002 Employer: Tample University Hospital Title: Fellow Department: Cardiology Responsibilities: Cardiovascular research in heart transplantation patients
Years: 1993 to 1998 Employer: Temple U. Sch. of Med Title: Research Assistant Department: Physiology Responsibilities: Research in gene therapy, immunology and molecular cardiology
Years: 1998 to 2000 Employer: Covance Title: Medical Associate Department: Clinical Services Responsibilities: Medical monitor for clinical studies. keep client relationship. Study manager for clinical study team.
Years: 1990 to 1993 Employer: Tianjin First Central Hospital Title: Attending and Instructor Department: Surgery Responsibilities: General surgery, surgical oncology. Urology, cardiac surgery experience
Years: 2012 to Present Employer: Undisclosed Title: Sr. Medical Director Department: Clinical Development Responsibilities: Oncology: NSCLC, Breast Cancer, Colorectal Cancer, Prostate Cancer, Gastric Cancer, Hepatocellular Carcinoma, Renal Cell Carcinoma, Leukemia

International Experience

Years Country / Region Summary
Years: to Present Country / Region: China Summary: He worked as a surgeon in teaching hospitals in China

Career Accomplishments

Associations / Societies
American Society of Clinical Oncology
Licenses / Certifications
medical license
Awards / Recognition
fellowship and scholarship awards
Medical / Professional
general surgery and surgical oncology
Publications and Patents Summary
8 publications in peer review journals

Additional Experience

Training / Seminars
Oversee the publication strategy. Review training materials for national sales meeting and communication to regulatory authorities and media. Organize expert meeting, CME symposiums, and advisory broad meetings.
Vendor Selection
select CRO for central lab, clinical monitor, medical writing, pharmacovigilance,
select clinical investigators and experts committee, safety monitoring board
Marketing Experience
Expertise in new drug development and product commercialization in oncology. Leading experience in new drug development stratagy, drug safety evaluation, clinical study conduct, CRO management, FDA regulations, IND-NDA filings, scientific publications. Follow up the trends in development and commercialization for global and US marketplace for oncology products. FDA pre-NDA meeting, end-Phase I-II meetings. hands-on experience in drug development plan, medical safety evaluation of compound for in-licensing, drug safety evaluation, protocol, data, report review and approval, patient enrollment, advertising, project budgeting

Language Skills

Language Proficiency
Chinese

Fields of Expertise

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