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Our Team

Ali R Siahpush, Ph.D.

Ali R Siahpush, Ph.D.

President

Cell Therapy & Biologics,  Technology Transfer, Validation, Technical Investigations, Regulatory Submissions, Strategy

Greg C. Flynn, Ph.D.

Greg C. Flynn, Ph.D.

Prin. Consultant

Quality By Design, Product Characterization, Analytical Development, Regulatory Submissions

Kuldip Sra, Ph.D.

Kuldip Sra, Ph.D.

Sr. Consultant

Cell Therapy, Gene Editing, Vaccines, Viral Vectors, Analytical development, Method Qualification, Method Validation

Steven L. Cockrill, Ph.D.

Steven L. Cockrill, Ph.D.

Sr. Consultant ​

Characterization/Comparability, Method Lifecycle Management, Regulatory Submissions, QC, Technical Documentation

Prathiba Sampath

Prathiba Sampath

Consultant

Project Management, Tech Transfer, Cell Therapy, CAR-T, Lentivirus, Risk Based Approach, Process modeling, technical writing, CMC, Smartsheet

Mihaela Marian

Mihaela Marian

Sr. Consultant

Quality Assurance, Quality Control, Quality Systems, Compliance Audits & regulatory Inspections, Regulatory Requirements

Rajesh G. Beri, Ph.D.

Rajesh G. Beri, Ph.D.

Prin. Consultant

Process & Analytical Development, Technology Transfer, cGMP Manufacturing, Project Management, Cell Culture, Microbial Fermentation, Monoclonal antibodies, ADC’s, mRNA and Lipid Nanoparticles.

Jeff Wedeking

Jeff Wedeking

Sr. Consultant

Quality Assurance, Quality Control, Quality system, GMP Audits & Inspections, PAI, Regulatory Requirements

Bryan A. Bernat, Ph.D.

Bryan A. Bernat, Ph.D.

Prin. Consultant

Peptides, Biologics, Biosimilars, Analytical, Formulation,
Combination Products,
Regulatory Submissions

Pranhitha Reddy, Ph.D.

Pranhitha Reddy, Ph.D.

Prin. Consultant

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

Tom Boone

Tom Boone

Prin. Consultant

Protein Engineering, Mammalian & E. coli expression, Formulation, Refolding, Downstream Development, Analytical Development, Strategy.

Klaus Beck, MD/Ph.D.

Klaus Beck, MD/Ph.D.

Prin. Consultant

Clinical Development, Pharmacovigilance, Clinical Safety, Medical Affairs, Business Development, Licensing

Richard Blackmore, Ph.D.

Richard Blackmore, Ph.D.

Sr. Consultant

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

Karen Benson

Karen Benson

Consultant

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

Bruce Kerwin, Ph.D.

Bruce Kerwin, Ph.D.

Prin. Consultant

Formulation Development, Drug Product Development, High Throughput Screening, High concentration/viscosity, Co-formulation, Viral Vectors

Reza Movafaghi, MBA

Reza Movafaghi, MBA

Sr. Consultant

Biologics cGMP Manufacturing, Cell and Gene Therapy, Technology Transfer, Investigation, Change Control, Operations
Management

Sara Cook, Ph.D.

Sara Cook, Ph.D.

Sr. Consultant

CMC Statistics and Data Analytics, Data Processing Automation, Business Intelligence, Process Characterization, Data Governance

Michael Landau

Michael Landau

Sr. Consultant

GMP Manufacturing, Technical Transfer, Remediation, External Manufacturing, Supplier Relationship, Operational Excellence

Marc Better, Ph.D.

Marc Better, Ph.D.

Prin. Consultant

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

Thomas W. Arroll, Ph.D.

Thomas W. Arroll, Ph.D.

Sr. Consultant

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

Steve D. Hughes, Ph.D.

Steve D. Hughes, Ph.D.

Sr. Consultant

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

Gaya Ratnaswamy, Ph.D.

Gaya Ratnaswamy, Ph.D.

Sr. Consultant

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

Aaron Pilling, Ph.D.

Aaron Pilling, Ph.D.

Sr. Consultant

Process Design, Process Development, CMC, Biologics, CDMO Selection & Management, Process Characterization

Edward N. Pedersen

Edward N. Pedersen

Process Architect

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

Li Malmberg, Ph.D.

Li Malmberg, Ph.D.

Prin. Consultant

Biologics manufacturing, Process Development, Fermentation, CHO cells, ADC, Fusion proteins, Monoclonal antibodies, CMC regulatory

Deisy Corredor, Ph.D., RAC

Deisy Corredor, Ph.D., RAC

Sr. Consultant

Process Development, Technology Transfer, CMC Regulatory, CDMO Management, Due Diligence, Facility Fit

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