Kate Hanham, Ph.D.
President

Kate Hanham, Ph.D. is president and founder of Mentara, Inc, formerly Hanham Consulting.  Dr. Hanham has consulted for organizations ranging from start-up biotechnology to some of the top ten pharmaceutical companies. She has provided strategic input at all stages of product development, designed and implemented clinical, regulatory and manufacturing strategies from early development through NDA.  Dr. Hanham has held lead responsibilities in critical communications with the FDA and international regulatory agencies.  She has also provided assessment of technology, product development and clinical operations for financial groups seeking to invest in biotechnology.

Dr. Hanham earned her Ph.D. in biochemistry at the University of Birmingham, England, and was awarded a Wellcome Trust fellowship at Yale University.  After receiving a faculty position at Yale, Dr. Hanham moved into private industry where her work experience included Centocor, Repligen and Aviron prior to founding her consulting company in 1996.  Dr. Hanham's research career in infectious diseases, applied immunology and vaccine development has provided experience critical to organizations developing a variety of products, including monoclonal antibodies, HIV and other viral vaccines, immune modulating agents and small molecule therapeutics. Dr. Hanham has designed and implemented pre-clinical and clinical research protocols in many therapeutic areas, and with her team at Mentara, established the logistics of data capture and specimen management for complex global clinical trials, designed analytical and test laboratories, established and validated analytical methods; provided project management support at all stages of product development and managed domestic and international manufacturing operations.

East Coast

Angela L. Mellon, M.A.
Drug Development Consultant

Angela L. Mellon, MA has worked as a Drug Development Consultant with Mentara since 1998. Ms. Mellon has supported clients ranging from start-ups to large pharmaceutical companies in a variety of roles, including project management, IND and other regulatory filings, clinical protocol development and review, clinical operations, laboratory operations, quality audits and the establishment of documentation systems and batch records.  Ms. Mellon specializes in quality auditing, laboratory compliance, clinical operations, data management and tracking operations.   After obtaining her undergraduate degree in Zoology, Ms. Mellon earned her M.A. from Harvard University, studying the application of direct gene transfer.  Ms. Mellon's research experience includes studies of neurologic disorders, autoimmunity, oncology and infectious diseases. She has worked on a wide range of products including small molecules, monoclonal antibodies, peptide vaccines, and gene and cell therapies.