Mike Li ｜ 李作斌简介
- 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.
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
Responsible for process development, instrumentation and control, equipment specifications, piping and sizing, material and energy balance, etc.
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