Management Team
Anton-Lewis Usala, MD / President and CEO 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 devised Quality Systems, using the principles of cGMP review and Corrective and Preventative Action (CAPA) Systems, for use at clinical investigative sites with the goal of effectively and reproducibly assuring site performance. Since April 2004, Dr. Usala has led the only clinical trial management group to effectively implement, design and utilize design-reviewed GMP-like processes, under layered Quality Systems 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 91% of sites reaching or exceeding contracted patient numbers (compared to only 25% site success nationally). Dr. Usala is author of 17 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.
Rich Klann, PhD / Chief Operations Officer received his undergraduate degree from the University of Michigan and his PhD from Oak Ridge National Laboratory’s Graduate School of Biomedical Sciences. After post-doctoral studies in respiratory and skin carcinogenesis he became a Research Assistant Professor in Pediatrics at East Carolina University School of Medicine. He developed molecular biology screens to assess the success of chemotherapy in pediatric oncology patients and characterized familial mutations critical for development of metabolic disorders. His industry experience includes 12 years in a start-up Tissue Engineering company where as Director of Research and Development he managed the cell and molecular research, analytical testing and quality control functions to support development of an orthopedic and wound care product from initial inception to market launch as a medical device. Dr. Klann brings his previous experience in SOP, CAPA, and Design Review implementation to CTMG’s Quality-based Systems. He joined CTMG in 2009 as Chief Operations Officer and manages the overall function of the company’s day-to-day operations and preparations for future growth and development nationwide.
Mary H. Usala, BSN, MSN, CCRC / Executive Director Clinical Operations 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.
Janell Lopez, RN, CCRC / Director of Clinical Services After earning her Nursing degree in 1992, Janell Lopez managed the clinical staff for a private multi-physician office for eleven years while also serving as the site’s clinical research coordinator. As the site’s research coordinator, Ms. Lopez was involved with multiple clinical trials and experienced the operational difficulties that private practice physicians encountered attempting to balance clinical service with clinical research. In 2004 Ms. Lopez accepted a clinical consultant position at PPD, Inc. in Research Triangle Park where she quickly rose to Operations Manager. There she coordinated multiple pharmaceutical research projects from the traditional Sponsor-CRO perspective. It became apparent that poor investigator site enrollment was the largest determinant of study delay for both the Sponsor and their CRO. Understanding that CTMG’s protocol-specific Quality-based approach to site management provided a viable solution, Ms. Lopez joined CTMG in 2007. She is currently Director of Clinical Services and manages all clinical research coordinator activities within CTMG’s physician network.
Laura A. Thompson, MAIS / Business Development and Trial Acquisition Manager received her BA from the University of North Carolina at Greensboro and her Masters of International Studies with specialization in Public Health from East Carolina University. She joined CTMG in 2007 as Executive Assistant for Quality Assurance Operations and was promoted to Business Development and Trial Acquisition Manager in 2009 where she is responsible for transitioning studies from first Sponsor contact through Site Initiation Visit. In this capacity she interfaces with management from all Sponsors (Pharmaceutical, Biotechnology, and medical device) and their CROs as well as CTMG Business Associate Physicians, in coordinating contract and study startup procedures. Ms. Thompson is also the point of contact in discussing expansion of CTMG services with potential partners, LThompson@CTMGInc.com.
Jonathan Thompson, M.S. / Quality Systems Manager Jonathan Thompson received his Undergraduate degree in Biochemistry and Masters degree in Chemistry from the University of North Carolina at Greensboro. Jonathan spent three years in the pharmaceutical industry performing Quality Control testing on finished product and stability samples and managed Quality Control investigations of atypical analytical test results. He also taught General Chemistry part-time as an Adjunct Professor. Jonathan joined CTMG in 2009. He brought his experience and expertise in current Good Manufacturing Practices (cGMP) from the pharmaceutical industry and applied them to developing quality system-based Good Clinical Practices at CTMG. Jonathan oversees policy and procedure creation that ensures consistency and reproducibility of CTMG operations and manages Quality Assurance review of clinical study data.