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

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Pranhitha Reddy, Ph.D.

Prin. Consultant

Biologics & Viral Products, Expression Systems, Cell Banking,  Technology Transfer, Regulatory Submissions

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Marc Better, Ph.D.

Prin. Consultant

Cell & Gene Therapy, CMC Strategy, Product Development, Regulatory Submissions

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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

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Jay Stout, Ph.D.

Prin. Consultant

Cell Therapy & Biologics, Process Development, Validation, Commercial Manufacture, Regulatory Submissions

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Edward N. Pedersen

Process Architect

Facility Design, cGMP Programming, Feasibility Layouts, Equipment Space Testing, Containment Design, Facility Gap Analysis

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Barbara Unger

Sr. Consultant

GMP Audits, Data Integrity, PAI & GMP Inspection Prep, GMP Gap Assessment & Remediation, GMP-Intelligence

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Steve D. Hughes, Ph.D.

Sr. Consultant

Cell Therapy, Product Development, Risk Assessment, Regulatory Submissions, Project Management

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Patt Taylor

Consultant

Quality Assurance, Quality Agreements, Validation, SOPs, Change Control, Deviations, Data Review

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Richard Blackmore, Ph.D.

Sr. Consultant

Biologics, Biologics Process Design, Statistical Data Analysis, Statistical Design Of Experiments

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Gaya Ratnaswamy, Ph.D.

Sr. Consultant

Biologics, Formulation, DP Development,  Lyophilization, Analytical Development, Comparability, Characterization

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Subir K. Basak, Ph.D., MBA

Sr. Consultant

Biologics, Due Diligence for M&A, Downstream Development, Program Management

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Thomas W. Arroll, Ph.D.

Sr. Consultant

Bioassay & Potency Assay Development, Transfer & Qualification, QC Implementation, Biological Characterization & Comparability, Biosimilarity