Mark I. Fitchmun — President and Senior Advisor
Biologics Assay 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. His core strengths are in bioprocess development and analytical methodologies where he has published manuscripts and holds several patents. Prior to founding Somatek, Mr. Fitchmun served as Vice President of Accelagen, Manager of Process Development at GenStar, and Group Leader at Desmos.
Brad Grimm – Senior Consultant
Biologics Process Development, and Outsource Management
Mr. Grimm has over 25 years of experience developing and implementing cGMPs for biotherapeutics. Prior to joining Somatek in 2015, Mr. Grimm was a Principal Scientist at SAFC’s virus and gene therapy site in Carlsbad CA, where he was instrumental in bringing over 15 experimental virus and gene therapy products into clinical trials. Earlier, Mr. Grimm held positions of increasing responsibility at Chiron, GenStar, and Telos.
Kathlene L. Powell — Senior Consultant
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.
Ralph Smalling — Associate and 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.
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.
Barbara M. Mueller, Ph.D. – CONSULTANT
Dr. Mueller has an extensive background writing grants in the area of cancer research and other biomedical research to NIH, NCI and other funding agencies. Working for CSRA, a service provider to the Federal Government, she has adminstered scientific peer review and post award management for clients including the DoD’s CDMRP, CPRIT, the Department of Education’s Institute for Education Research, The Susan G. Komen Foundation and others.