President & CEO, Colleen Hittle, RAC, coordinates and directs Anson’s FDA practice, overseeing a staff of more than 80 staff and contract consultants and specialists. Under her direction, Anson’s capabilities have expanded to include corporate compliance assessment, compliance risk management, and other innovative services. Ms. Hittle has been an active participant in industry group dialogues with the FDA on such issues as combination product approval procedures and drug/device cross-labeling. A Purdue Engineering graduate, Ms. Hittle spent 8 years in industry quality system and regulatory technical and management roles before joining The Anson Group in 1997.

Advisor, Gerald A. Richardson is responsible for general management and business planning and development, and manages Anson’s Medical Technology Commercialization consulting practice. Mr. Richardson draws upon 4 decades of engineering, entrepreneurial, strategic planning, and management consulting experience in the U.S. and international medical device industries. Mr. Richardson developed The Anson Group philosophy of “Enhancing the Value of Medical Technologies,” which reflects our focus on providing quality expert services that are directed to further clients’ business objectives.

Senior Regulatory Consultant John Worzalla, M.S., RAC, assists clients in FDA interactions and submissions. He has 11 years experience in regulatory affairs, including 9 years in the U.S. Regulatory Affairs Group at Eli Lilly and Company, where he supported the oncology drug portfolio. His regulatory experience in oncology and other therapeutic areas includes hands-on experience with various regulatory processes including IND and NDA submissions, accelerated approval, orphan drug designation, fast track designation and FDA advisory committee meetings. With more than 25 years of experience in cancer laboratory research, Mr. Worzalla has authored numerous publications and abstracts. In addition, he serves as a visiting lecturer with the Purdue University M.S. degree program in Regulatory and Quality Compliance.

Senior Consultant Russell T. Gray provides quality system and regulatory consulting services for medical device, diagnostic and combination product companies. His expertise includes product design control and risk management systems compliance with FDA QSR, ISO13485, and ISO14971 requirements, including integration of these requirements with phase gate product commercialization processes, as well as regulatory submission consulting for software-intensive products. During his 35 years of industry experience, Mr. Gray has directed global product development and quality departments for Beckman-Coulter and Roche Diagnostics, served as an executive leader for a medical device contract development and manufacturing company, and led 25 scientists and engineers in the development of medical devices for his own product development company. In addition, he holds three patents and graduated with distinction in Interdisciplinary Engineering at Purdue University.

Executive Director of the Connected Healthcare Practice Dane Stout The Connected Health Practice at Anson is focused on assisting clients successfully commercialize wireless, mobile, and networked technologies under existing regulatory policies and rules of the Food & Drug Administration. In addition, the Connected Health Practice works to track and lead the development of new policies that will enable clearer pathways to market for innovation that spans the rapidly converging worlds of telecommunications, information technology, consumer electronics, life science, and healthcare information technology. Mr. Stout has over 25 years of technology industry experience that includes commercial and technical computing systems in life science and healthcare, as well as both business and clinical systems used in the healthcare delivery industry. Prior to joining Anson he served as the Global Market Segment Manager for the Healthcare and Life Sciences Industries at Sun Microsystems, Inc.