Anton-Lewis Usala, MD / President and CEO
Dr. Usala founded CTMG, Inc. in 2004 to address the gaps he observed in site clinical trial quality systems first as a University Medical Center researcher, and later as he directed the Biotechnology company he founded (Encelle, Inc.) into FDA monitored clinical trials. While at his biotechnology company, Dr. Usala observed all facets of investigational product development are controlled by cGxP-linked quality systems, except for the human clinical research portion conducted at Physician Investigator sites. Dr. Usala utilized design-review techniques to create processes that translate a specific protocol’s requirements into discrete measurable steps, whose completion as intended at the Physician Site is ensured in real time by linked Quality Systems. Since April 2004, Dr. Usala has led the only clinical trial management group to effectively create, implement, and utilize design-reviewed GMP-like processes, under layered Quality Systems side-by-side with the Physician Investigator, to ensure that what is intended in the investigative protocol is actually done at the investigative site. His designed systems approach has resulted in CTMG’s rapid patient enrollment and retention, resulting in 98% of sites reaching or exceeding contracted patient numbers (compared to only 25% site success nationally) since 2008. Dr. Usala is an author of 18 U.S. patents, and has testified seven times before different U.S. Senate and House subcommittees on issues related to regenerative medicine research. Dr. Usala received his undergraduate degree in Biology and Political Science from Swarthmore College, his Medical Degree from Jefferson Medical College, and his pediatric and pediatric endocrinology/pharmacology training at Case Western Reserve University.
Mary H. Usala, BSN, MSN, CCRC / Senior Executive Director Clinical Operations
Mary Usala received her RN and BSN from Gwynedd Mercy College in Philadelphia, and her MSN with specialization in diabetes clinical research from the Frances Payne Bolton School of Nursing at Case Western Reserve University. With over twenty years nursing experience in both inpatient (including cardiac, surgical ICU, medical ICU), and outpatient settings (Emergency Room and Urgent Care), Ms. Usala then served as a consultant for clinical operations to several early stage biotechnology companies. She joined CTMG, Inc. at its inception as Director of Nursing Services in April, 2004, to train CTMG’s clinical staff in the company’s GMP/Quality System approach to protocol task completion. As Executive Director of Clinical Operations, Ms. Usala currently integrates company departments (including Contract, Finance, Quality Systems, and Clinical Services) to provide comprehensive implementation of clinical protocol activities at CTMG investigative sites. In this capacity she also provides clinical operational oversight of departments involved in business development, protocol review and operational feasibility, investigational site start up, and medical supervision of the clinical coordinators involved in research studies.
Michelle Nanney, BSE, MBA, MSSM / Chief Quality Systems Engineer
Michelle Nanney’s expertise in operations, process, and strategy have been honed through multiple opportunities in a variety of industries. After completing her B.S. in Bioengineering from Texas A&M University, Michelle began her career troubleshooting cardiac electrophysiology monitoring systems at hospitals all along the east coast of the United States. She then found her love for operations and process as Manager of Production Control and Project Management at Kiosk Information Systems. With her entrepreneurial spirit, she founded and operated five niche market e-commerce businesses for seven years where she further developed her operational skills to increase efficiencies and speed of service. These experiences motivated her to complete her MBA and M.S. in Strategic Management from Indiana University and then use those skills to provide consulting services to startup companies and small businesses. As the Senior Executive Director of Business Operations at CTMG, she is working to perfect CTMG’s innovative processes by further eliminating gaps, removing obstacles, and scaling operations.