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Expert in Clinical Trial and Drug Safety in New Drug Development and Marketing/Commercialization
Available for your Consulting and Expert Witness Needs
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Summary of Expertise:
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Listed with other top experts in: |
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Expert has a working knowledge of ICH guidance related to patient protection and relevant US laws.
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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.
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Expert is an expert in drug clinical development from planning to protocol design, conducting and reporting.
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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.
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Drug approval regulation is complexed processes. Expert has years of experience in working on all requirements related to drug approval.
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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.
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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.
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Expert is working with many investigational drugs in clinical phase of development. He is an expert in the evaluation of new compounds.
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Expert has been leading the efforts to file NDA for several drugs involving all the clinical aspects of the program.
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Expert has been working on a number of pro-drugs in clinical development with experience in special requirements in regulations and clinical development.
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Show Secondary and Basic Areas of Expertise | Localities:
Expert may consult nationally and internationally, and is also local to the following cities: New York, New York;
Yonkers, New York;
Newark, New Jersey;
Jersey City, New Jersey;
Paterson, New Jersey;
Elizabeth, New Jersey;
Bridgeport, Connecticut;
Stamford, Connecticut;
Philadelphia, Pennsylvania;
and Allentown, Pennsylvania.
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Degree |
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Subject |
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Institution |
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1986
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MD
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Medicine
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Tianjin Medical University
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1998
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PhD
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Cardiology and Immunology
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Temple University School of Medicine
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Employer |
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Department |
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Title |
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Responsibilities |
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2008 to
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(Undisclosed)
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Medical Affairs, Oncology
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Sr. Medical Director
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working with marketing/brand team on marketing strategies. working with internal clinical team for clinical studies. working with KOL for medical education.
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2004 to 2008
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Otsuka (Taiho Pharma)
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Medical Affairs
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Director, Medical Affairs and Drug Safety
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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
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2000 to 2004
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Schering-Plough (Organon)
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Clinical Development
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Clinical Scientist and Project Leader
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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.
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1997 to 2002
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Tample University Hospital
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Cardiology
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Fellow
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Cardiovascular research in heart transplantation patients
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1993 to 2002
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Temple U. Sch. of Med
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Physiology
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Research Assistant
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Research in gene therapy, immunology and molecular cardiology
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1998 to 2000
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Covance
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Clinical Services
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Medical Associate
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Medical monitor for clinical studies. keep client relationship. Study manager for clinical study team.
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1990 to 1993
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Tianjin First Central Hospital
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Surgery
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Attending and Instructor
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General surgery, surgical oncology. Urology, cardiac surgery experience
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1986 to 1990
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Tianjin First Central Hospital
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Surgery
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Resident and chief resident
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General surgery, GI, endocrinology, immunology experience
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Associations/Societies
American Society of Clinical Oncology
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Licenses/Certifications
medical license
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Awards/Recognition
fellowship and scholarship awards
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Medical/Professional Internships
general surgery and surgical oncology
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Publications and Patents Summary
8 publications in peer review journals
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Selected Publications and Publishers
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- Journal of Heart and Lung Transplantation
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- Transplantation
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- Clinical Cancer Research
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| Selected Consulting Examples: |
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Participated drug evaluation meeting for in-licensingand safety monitoring committee.
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Click the green button above to contact
Expert for a free initial screening call regarding your expert consulting needs.
Expert is available for consulting to corporate, legal and government clients.
Remember, your initial screening call to speak with
Expert is free.
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Recent Litigation Client Requests:
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Drug expert needed for consulting on AVELOX drug litigation.
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FDA labeling expert for consulting on FDA labeling compliance.
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Click the green button above to contact
Expert for a free initial screening call regarding expert testimony,
litigation consulting and support, forensic services, or any related expert witness services.
A few litigation needs include product liability, personal injury, economic loss, intellectual property
(patent, trademark, trade secret, copyright), and insurance matters. Remember, your initial screening
call to speak with
Expert is free.
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| International Experience: |
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Summary |
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China
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He worked as a surgeon in teaching hospitals in China
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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
Click the green button above to contact
Expert for a free initial screening call regarding your marketing research, industry research, and company
research needs. For research needs involving multiple experts or secondary research,
a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker
and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.
Remember, your initial screening call to speak with
Expert is free.
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| Additional Skills and Services: |
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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.
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Supplier and Vendor Location and Selection select CRO for central lab, clinical monitor, medical writing, pharmacovigilance,
select clinical investigators and experts committee, safety monitoring board
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Education
