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.
Biologics & Viral Products, Expression Systems, Cell Banking, Technology Transfer, Regulatory Submissions
Marc Better, Ph.D.
Cell & Gene Therapy, CMC Strategy, Product Development, Regulatory Submissions
Greg C. Flynn, Ph.D.
Quality By Design, Product Characterization, Analytical Development, Regulatory Submissions
Protein Engineering, Mammalian & E. coli expression, Formulation, Refolding, Downstream Development, Analytical Development , Strategy
Jay Stout, Ph.D.
Cell Therapy & Biologics, Process Development, Validation, Commercial Manufacture, Regulatory Submissions
Edward N. Pedersen
Facility Design, cGMP Programming, Feasibility Layouts, Equipment Space Testing, Containment Design, Facility Gap Analysis
GMP Audits, Data Integrity, PAI & GMP Inspection Prep, GMP Gap Assessment & Remediation, GMP-Intelligence
Steve D. Hughes, Ph.D.
Cell Therapy, Product Development, Risk Assessment, Regulatory Submissions, Project Management
Quality Assurance, Quality Agreements, Validation, SOPs, Change Control, Deviations, Data Review
Richard Blackmore, Ph.D.
Biologics, Biologics Process Design, Statistical Data Analysis, Statistical Design Of Experiments
Gaya Ratnaswamy, Ph.D.
Biologics, Formulation, DP Development, Lyophilization, Analytical Development, Comparability, Characterization
Subir K. Basak, Ph.D., MBA
Biologics, Due Diligence for M&A, Downstream Development, Program Management
Thomas W. Arroll, Ph.D.
Bioassay & Potency Assay Development, Transfer & Qualification, QC Implementation, Biological Characterization & Comparability, Biosimilarity
Quality Assurance, Supplier Quality Management, Validation, Change Control, CAPA, Project Management