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 Expert  724881

Expert in Biopharmaceutical Development


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: 

Expert, PhD, is a consultant in the field of BioPharmaceutical Development. He has over 23 years of biotech industry experience in biotherapeutic and diagnostics development, having held senior positions at several biotech companies, most recently, VP of Biologics Development at Biovest International.

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.

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active pharmaceutical ingredient

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analytical biochemistry

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applied biotechnology

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bioanalytical chemistry

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biochemical process development

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biochemical research

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biochemistry

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biotechnology

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bulk pharmaceutical chemical manufacturing

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cancer biology

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drug development

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drug regulation

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enzyme technology

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Food and Drug Administration regulation

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generic drug manufacturing

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hybridoma technology

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immunobiology

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immunochemistry

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protein biochemistry

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protein biology

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receptor biochemistry

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tumor biology

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Chemistry, Manufacturing and Controls

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stem cell


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  
1981   Ph.D.   Biochemistry   University of California  
1977   B.S.   Chemistry   Indiana University  

Work History:
Years   Employer   Department   Title   Responsibilities

2006 to 2007

 

Biovest International

 

Biologics Development

 

VP Biologis Development

 

Directed analytical, process development and immunology departments in support of cancer vaccine and cell culture instrumentation divisions.

2005 to 2005

 

Antigenics Inc.

 

R&D

 

Senior Director, Scientific Services

 

Strategic planning and coordination of project activities between Development, Operations and R&D from discovery through commercialization.

1998 to 2005

 

Antigenics Inc.

 

Pharmaceutical Technologies

 

Senior Director of Pharmaceutical Technologies

 

Managed all aspects of analytical and process development, formulation, product characterization and discovery research for novel cancer vaccines.

1996 to 1998

 

AutoImmune Inc.

 

Operations

 

Associate Director of Biochemistry

 

Directed team responsible for the characterization of proteins and protein-lipid mixtures for the treatment of autoimmune disorders.

1989 to 1996

 

Oncogene Sciences, Inc.

 

Diagnostics

 

Principal Investigator, Diagnostic Research

 

Managed the research and development program for cancer diagnostics.


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:
Publications and Patents Summary

15 peer-reviewed scientific publications and 7 patents.

Selected Publications and Publishers  
 - Methods  
 - BioPharm.  
 - Biochemical Journal  

Consulting Services:
Selected Consulting Examples:
  • 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.
Recent Client Requests:
  • Expert in LEA proteins for paints.
  • Expert for consulting on Large Molecule Biologics
  • Expert for consulting on for developing automated at-line analyzer for biologics.
  • Expert in in biologics manufactory to facilitate process development and optimization for mammalian cell colure.
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:
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.

Market Research:
Extensive background with regulatory issues related to biopharmaceutical development and approval.

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

Validation of Analytical Test Methods for Biopharmaceuticals

Other Skills and Services

Due diligence for the Biotechnology and Biopharmaceutical industry. Oversight of outsourced activities.


 

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