Somatek’s team includes subject matter experts in biologics process development and assay development, outsource management, quality/regulatory, formulation development, and product stability.
Mark I. Fitchmun — President and CEO
Biologics Assay Development and Outsource Management
Since founding Somatek in 2003, Mr. Fitchmun has contributed to the development of over 45 biopharmaceuticals including therapeutic antibodies, antibody-drug conjugates, fusion proteins, viruses, and clinical diagnostics. He has expertise in risk-based strategies for product development in the biologics space. His core strengths are in bioprocess development and analytical method development where he has published manuscripts and holds several patents. Mr. Fitchmun has served as Vice President at Accelagen, Vice President, CMC at Cold Genesys, Vice President, Manufacturing at AlphaEleven, and Manager of Process Development at GenStar.
Barbara M. Mueller, Ph.D. – Vice President
Project Management and Technical Writing
Dr. Mueller has an extensive background in translational cancer research. She has held faculty positions at The Scripps Research Institute, Sidney Kimmel Cancer Center and San Diego Biomedical Research Institute. At Scripps, she contributed to the development of an anti-GD2 antibody, ch14.18, now FDA/EMA approved for treatment of neuroblastoma. She has experience with grant applications including SBIRs to NIH/NCI. Working for General Dynamics Information Systems, a service provider to the Federal Government, she has administered scientific peer review and post award management for clients including the DoD’s CDMRP, CPRIT, The Susan G. Komen Foundation and others.
Gina Cruz-Aranda — Head of Operations
Biologics Process Development and Project Leadership
Ms. Cruz-Aranda has significant expertise in process development, scale up, and the manufacture of proteins (including monoclonal antibodies) at 5L to 500L production scales under GMP. She has led multi-functional teams and coordinated in house experts and CROs/CDMOs to support non-clinical and clinical development for numerous clients. Prior to joining Somatek, Ms. Aranda-Cruz served as Director of Process Development at Abzena, Associate Director of Process Development and Analytical Method Development at PacificGMP, and Staff Scientist at MediVas.
Kathy L. Powell — Senior Consultant
Quality Assurance and Regulatory
Since 2005, Ms. Powell has consulted for both established and startup companies on quality assurance and CMC. She has expertise with small molecules as well as biotechnology-derived medical products. Prior to her affiliation with Somatek, Ms. Powell served as Manager of Validation at Genentech, Vice President of Quality and Regulatory at Diosynth-RTP, and Chief Quality Officer at Raptor Pharmaceutical Corp.
Mark C. Manning, Ph.D. — Consultant
Formulation Development and Product Stability
Dr. Manning has been on the faculty at the University of Kansas, and later, at the University of Colorado, where he helped found the Center for Pharmaceutical Biotechnology, widely considered the country’s leading educational program for training formulation scientists to handle biotechnology-based products. Dr. Manning has directed numerous formulation projects for clients, first as CTO at HTD BioSystems and then as CSO for Legacy BioDesign.
Dr. Manning has published over 100 scientific articles, holds five US patents, and has edited three books on protein formulation.
John J. Chicca II, Ph.D. — Consultant
Models and Assays
Dr. Chicca received his doctorate from Pennsylvania State University and conducted his postdoctoral studies at The Scripps Research Institute in La Jolla California. His expertise includes in vitro assay development, qualification and validation, as well as preclinical in vivo studies including drug efficacy screening and testing, immunogenicity testing, toxicology assessment, and drug pharmacokinetics and metabolism.
Dr. Chicca is president of Molecular Diagnostic Services, a San Diego based GLP contract research laboratory.