Our Team

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

Ali R Siahpush, Ph.D.


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

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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

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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

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Patt Taylor


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


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

Quality Assurance, Supplier Quality Management, Validation, Change Control, CAPA, Project Management

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Merrill S. Goldenberg, Ph.D.
Sr. Consultant

Drug Delivery, Sustained Release (proteins, peptides, small molecules), High Concentration Formulations, Viscosity/Rheology, Biomedical Polymers Subcutaneous Injections, AAV Characterization