【药时代智库】Mike Li

【药时代智库】Mike Li

Mike Li | 李作斌简介

SUMMARY OF QUALIFICATIONS:

  • More than 36 years pharmaceutical experience in the development of pharmaceutical products for various dosage forms (injectable, oral and transdermal).
  • Extensive hands on experience in preformulation studies, analytical/formulation development, process development and scale up manufacturing.
  • Experienced in development of drug products and regulatory requirements from IND-enabling studies to phase 3 and commercialization.
  • Supported bioanalysis for preclinical and clinical studies.
  • Prepared Chemistry, Manufacturing and Controls (CMC) documentation for two NDAs, more than 30 INDs and many ANDA submissions.
  • Expertise in contract manufacturing and testing including vendor qualification, technology transfer and contract manufacturing for CRO/CMO in US and foreign countries.
  • Played critical roles in helping three companies IPO and established licensing opportunities.

PROFESSIONAL EXPERIENCE:

 Independent CMC Consultant                                                                                 1/06 – now

  • CMC development of early and late stage pharmaceutical products in various dosage forms or delivery systems.
  • Selection, qualifying and managing CROs or CMOs for analytical development, bioanalysis, product and process development, manufacturing and distribution of clinical trial materials.
  • Preparation of CMC documents for regulatory filings (INDs) or due diligence purposes.
  • Performing GMP gap analysis, establishment of SOP and documentation systems.

 

Threshold Pharmaceuticals, Redwood City, California                         3/03 – 1/06

Sr. Director of Product Development

Responsibilities included product, process and analytical development, manufacturing drug substance and drug product, QC/QA and documentation.

  • Technology transfer and contract manufacturing of oral tablet and lyophilized drug products.
  • Establishing API and DP specifications working with testing laboratories for release and stability testing.
  • Packaging/labeling and distribution of clinical supplies
  • Assembling CMC documents to support regulatory submissions
  • Setting up documentation and SOP systems in compliance of cGMP requirements.

 

Matrix Pharmaceutical, Fremont, California                               1990 – 2002

Director of Advanced Product & Process Development

Responsibilities included Quality Control, Manufacturing (1990-1992) and development of three anticancer drugs in parenteral dosage forms.

  • Developed collagen-base semisolid injectable products and process to support clinical studies and enabled two NDA submissions.
  • Transferred technology, analytical methods to QC/Manufacturing and contract manufacturers.
  • Prepared technical and CMC reports to support IND and NDA submissions.
  • Responsible for Pre-approval inspection (PAI) for R&D group.

 

Quad Pharmaceutical, Indianapolis, Indiana                                1987 – 1990

Manager of Formulation Research.  Responsible for development of parenteral generic drugs (small molecules and protein/peptides) in liquid, lyophilized and suspension dosage forms.

  • Conducted preformulation and formulation studies.
  • Process development, scale-up and manufacturing under GMP.
  • ANDA submissions and response to FDA inquiry.

 

Bausch & Lomb, Rochester, New York                                        1986- 1987

Pharmacy Specialist in R&D Formulation Group.

Responsible for formulation research of lens care and eye care products.

  • Evaluated ingredients and conducted preformulation studies.
  • Developed and scaled up process for liquid and semisolid products.

 

LyphoMed Pharmaceutical (Fujisawa), Melrose Park, Illinois.               1983 – 1986

Development Chemist, Group Leader

Responsible for development of parenteral generic drugs (small molecules and protein/peptides) in liquid, lyophilized and suspension dosage forms, supporting ANDA submissions and commercial manufacturing

 

Austin Company, Des Plaines, Illinois                                         1982 – 1983

Process Engineer

Responsible for process development, instrumentation and control, equipment specifications, piping and sizing, material and energy balance, etc.

 

EDUCATION:

M.S. Chemical Engineering, University of Illinois at Chicago, 1982

M.S. Chemistry, Eastern Illinois University, Charleston, IL, 1979

B.S. Chemistry, Tunghai University, Taiwan, 1975

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