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 Expert  724018

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


Available for your Consulting and Expert Witness Needs

Massachusetts (MA)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

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.
 • 

drug

 • 

prescription drug

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

drug clinical trial

 • 

drug development

 • 

new drug

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

drug product 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.
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drug labeling requirement

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.
 • 

drug regulation

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Food and Drug Administration regulation

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

investigational drug

 • 

investigational drug procedures

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

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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drug safety testing

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

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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prodrug


Show Secondary and Basic Areas of Expertise
Localities:
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;  and Providence, Rhode Island.

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

Work History:
Years   Employer   Department   Title   Responsibilities

2008 to 2012

 

Sanofi-Aventis

 

Medical Affairs, Oncology

 

Sr. Medical Director

 

working with marketing/brand team on marketing strategies. working with internal clinical team for clinical studies. working with KOL for medical education.

2004 to 2008

 

Otsuka (Taiho Pharma)

 

Medical Affairs

 

Director, Medical Affairs and Drug Safety

 

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

2000 to 2004

 

Merck (Schering-Plough)

 

Clinical Development

 

Clinical Scientist and Project Leader

 

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.

1997 to 2002

 

Tample University Hospital

 

Cardiology

 

Fellow

 

Cardiovascular research in heart transplantation patients

1993 to 1998

 

Temple U. Sch. of Med

 

Physiology

 

Research Assistant

 

Research in gene therapy, immunology and molecular cardiology

1998 to 2000

 

Covance

 

Clinical Services

 

Medical Associate

 

Medical monitor for clinical studies. keep client relationship. Study manager for clinical study team.

1990 to 1993

 

Tianjin First Central Hospital

 

Surgery

 

Attending and Instructor

 

General surgery, surgical oncology. Urology, cardiac surgery experience

2012 to

 

(Undisclosed)

 

Clinical Development

 

Sr. Medical Director

 

Oncology: NSCLC, Breast Cancer, Colorectal Cancer, Prostate Cancer, Gastric Cancer, Hepatocellular Carcinoma, Renal Cell Carcinoma, Leukemia


Career Accomplishments:
Associations/Societies

American Society of Clinical Oncology

Licenses/Certifications

medical license

Awards/Recognition

fellowship and scholarship awards

Medical/Professional Internships

general surgery and surgical oncology


Publications:
Publications and Patents Summary

8 publications in peer review journals

Selected Publications and Publishers  
 - Journal of Heart and Lung Transplantation  
 - Transplantation  
 - Clinical Cancer Research  

Consulting Services:
Selected Consulting Examples:
  • Participated drug evaluation meeting for in-licensingand safety monitoring committee.
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.

Expert Witness:
Recent Litigation Client Requests:
  • Drug expert needed for consulting on AVELOX drug litigation.
  • FDA labeling expert for consulting on FDA labeling compliance.
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.

International Experience:
Country / Region   Summary
China   He worked as a surgeon in teaching hospitals in China

Language Skills:
Foreign Language  
Chinese  

Market Research:
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.

Additional Skills and Services:
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.

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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