Expert Details
Biopharmaceutical Development
ID: 724881
Massachusetts, USA
He has extensive experience in analytical and process development, formulations, QC, and cGMP manufacturing. Expert has developed products derived from natural and recombinant sources for the treatment of cancer, infectious diseases, and autoimmune disorders. He has authored CMC sections for INDs and BLAs, and has been a thought leader in devising unique solutions to regulatory challenges for novel biological therapeutics.
He has advised on bioprocess and characterization issues for monoclonal antibodies and numerous other protein-based drugs. In addition, he has specific experience in the area of personalized medicines and has worked on stem cell therapies.
Provide technical and strategic advice on the development of a protein-based biologic therapeutic drug.Advisor to the investment management community on development, production and regulatory issues for biological therapeutics.Development of physicochemical and bioanalytical methods for the characterization and QC release of protein therapeutics.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1981 | Degree: Ph.D. | Subject: Biochemistry | Institution: University of California |
| Year: 1977 | Degree: B.S. | Subject: Chemistry | Institution: Indiana University |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2006 to 2007 | Employer: Biovest International | Title: VP Biologis Development | Department: Biologics Development |
Responsibilities:Directed analytical, process development and immunology departments in support of cancer vaccine and cell culture instrumentation divisions. |
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| Years | Employer | Title | Department |
| Years: 2005 to 2005 | Employer: Antigenics Inc. | Title: Senior Director, Scientific Services | Department: R&D |
Responsibilities:Strategic planning and coordination of project activities between Development, Operations and R&D from discovery through commercialization. |
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| Years | Employer | Title | Department |
| Years: 1998 to 2005 | Employer: Antigenics Inc. | Title: Senior Director of Pharmaceutical Technologies | Department: Pharmaceutical Technologies |
Responsibilities:Managed all aspects of analytical and process development, formulation, product characterization and discovery research for novel cancer vaccines. |
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| Years | Employer | Title | Department |
| Years: 1996 to 1998 | Employer: AutoImmune Inc. | Title: Associate Director of Biochemistry | Department: Operations |
Responsibilities:Directed team responsible for the characterization of proteins and protein-lipid mixtures for the treatment of autoimmune disorders. |
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| Years | Employer | Title | Department |
| Years: 1989 to 1996 | Employer: Oncogene Sciences, Inc. | Title: Principal Investigator, Diagnostic Research | Department: Diagnostics |
Responsibilities:Managed the research and development program for cancer diagnostics. |
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Career Accomplishments
| Associations / Societies |
|---|
| American Association for the Advancement of Science; American Society for Biochemistry and Molecular Biology; American Association for Cancer Research MASSEP |
| Publications and Patents Summary |
|---|
| 15 peer-reviewed scientific publications and 7 patents. |
Additional Experience
| Training / Seminars |
|---|
| Validation of Analytical Test Methods for Biopharmaceuticals |
| Marketing Experience |
|---|
| Extensive background with regulatory issues related to biopharmaceutical development and approval. |
| Other Relevant Experience |
|---|
| Due diligence for the Biotechnology and Biopharmaceutical industry. Oversight of outsourced activities. |
Fields of Expertise
active pharmaceutical ingredient, analytical biochemistry, applied biotechnology, bioanalytical chemistry, biochemical process development, biochemical research, biochemistry, biotechnology, bulk pharmaceutical chemical manufacturing, cancer biology, drug development, drug regulation, enzyme technology, Food and Drug Administration regulation, generic drug manufacturing, hybridoma technology, immunobiology, immunochemistry, protein biochemistry, protein biology, receptor biochemistry, tumor biology, Chemistry, Manufacturing and Controls, stem cell, biopharmaceutical, biopharmaceutical product development, investigational drug procedures, proteome, industrial biotechnology, antitumor drug, lipid biochemistry, molecular biochemistry, physical biochemistry, enzymology, antigen