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Our Team
Meet the Pharmefex team and put our experience to work for you.

Ali R Siahpush, Ph.D.
President
Cell Therapy & Biologics, Technology Transfer, Validation, Technical Investigations, Regulatory Submissions, Strategy

Pranhitha Reddy, Ph.D.
Prin. Consultant
Biologics & Viral Products, Expression Systems, Cell Banking, Technology Transfer, Regulatory Submissions

Marc Better, Ph.D.
Prin. Consultant
Cell & Gene Therapy, CMC Strategy, Product Development, Regulatory Submissions

Greg C. Flynn, Ph.D.
Sr. Consultant
Quality By Design, Product Characterization, Analytical Development, Regulatory Submissions
Tom Boone
Prin. Consultant
Protein Engineering, Mammalian & E. coli expression, Formulation, Refolding, Downstream Development, Analytical Development , Strategy

Thomas W. Arroll, Ph.D.
Sr. Consultant
Bioassay & Potency Assay Development, Transfer & Qualification, QC Implementation, Biological Characterization & Comparability, Biosimilarity

Edward N. Pedersen
Process Architect
Facility Design, cGMP Programming, Feasibility Layouts, Equipment Space Testing, Containment Design, Facility Gap Analysis


Barbara Unger
Sr. Consultant
GMP Audits, Data Integrity, PAI & GMP Inspection Prep, GMP Gap Assessment & Remediation, GMP-Intelligence

Steve D. Hughes, Ph.D.
Sr. Consultant
Cell Therapy, Product Development, Risk Assessment, Regulatory Submissions, Project Management

Steven L. Cockrill, Ph.D.
Sr. Consultant
Characterization/Comparability, Method Lifecycle Management, Regulatory Submissions, Quality Control Operations, Technical Documentation

Richard Blackmore, Ph.D.
Sr. Consultant
Biologics, Biologics Process Design, Statistical Data Analysis, Statistical Design Of Experiments

Gaya Ratnaswamy, Ph.D.
Sr. Consultant
Biologics, Formulation, DP Development, Lyophilization, Analytical Development, Comparability, Characterization

Subir K. Basak, Ph.D., MBA
Sr. Consultant
Biologics, Due Diligence for M&A, Downstream Development, Program Management

Karen Benson
Consultant
Quality Assurance, Supplier Quality Management, Validation, Change Control, CAPA, Project Management

Brandon Vail
Sr. Consultant
CDMO Selection, Due diligence, Process scale-up, Tech transfer, Process Engineering, Downstream optimization

Patt Taylor
Consultant
Quality Assurance, Quality Agreements, Validation, SOPs, Change Control, Deviations, Data Review
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