Mark I. Fitchmun — President and Senior Advisor
Manufacturing Process Development and Outsource Management
Since founding Somatek in 2003, Mr. Fitchmun has consulted on over 40 biopharmaceutical and analytical projects including therapeutic antibodies, antibody-drug conjugates, fusion proteins, viruses, and clinical diagnostics. Mr. Fitchmun has also served as Vice President of Accelagen, a provider of enzymes for molecular biology research; Manager of Process Development at GenStar, a gene therapy company; and Group Leader at Desmos, developing new antibodies, and assays, and research methods for the study of extra cellular matrix proteins.
Mark C. Manning, Ph.D. — Associate and Senior Advisor
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. — Associate and Senior Advisor
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.
Ralph Smalling — Senior Advisor
Regulatory Affairs and Strategic Planning
Since 2005, Mr. Smalling has been a regulatory consultant specializing in biotechnology-derived products including antibody drug conjugates, stem cell and gene therapies. Before this, he served as Vice President of Regulatory Affairs and International Clinical Safety at Amgen where he oversaw the development and subsequent market approval of numerous therapeutics based on recombinant DNA technology. Mr. Smalling helped draft the FDAMA legislation passed by Congress in 1997, and was a member of the industry team that negotiated PDUFA II.