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