Octagon's Management Team
Mr. Walker has been working in the pharmaceutical industry for 15 years. He is founder of Octagon Research Solutions, Inc. Prior to founding Octagon, he worked as the Senior Manager of Worldwide Regulatory Affairs for the Schering-Plough Corporation ("Schering"). While at Schering, he was responsible for clinical and pre-clinical in the antihistamine, central nervous system, and critical care therapeutic areas. Prior to joining Schering, Mr. Walker worked across multiple therapeutic areas in the Regulatory Affairs/Clinical and Clinical Quality Assurance department at the R.W. Johnson Pharmaceutical Research Institute (PRI). Mr. Walker has extensive experience in and knowledge of all phases of clinical research and both FDA and European regulations. He is skilled at process improvement and providing insight across multiple disciplines within drug development.
Mr. Walker holds a B.S. in Biological Sciences from Villanova University, a Masters in Environmental Sciences from Rutgers University, and an M.B.A. from Duke University.
Mr. Gallion is co-founder and President of Octagon Research Solutions, Inc. He has worked in industry for nearly 10 years. Prior to joining Octagon he worked as a technology consultant for Andersen Consulting. While at Andersen, he was responsible for installing and customizing of an imaging system for a large pharmaceutical company (AstraZeneca), developing a system of corporate intranet websites, and developing automated tools to facilitate electronic publishing. Prior to joining Andersen, Mr. Gallion served as a captain in the United States Army. He was responsible for the production of facility that employed 160 personnel operated under a $1.2 million budget. During his tenure, he was awarded the Army Commendation Medal, and two Army Achievement medals in addition to being rated the best of 68 junior officers in the command.
Mr. Gallion holds a Bachelor of Science degree in Physics from Frostburg State University where he was a member of numerous honor societies in math and physics.
Mr. Horgan is a senior executive of both the Contract Research and Pharmaceutical Industry, with experience of leading and managing complex organizations in the United States, Europe, and Asia. Prior to joining Octagon, he was group Vice President, Late Stage Development at MDS Pharma Services. He ran the Global Phase II/III/IV clinical development businesses and the Global Central Laboratory Services with revenues in excess of $160 million and 1600 people in 23 countries. His experience in the drug development sector began at Covance, the world’s second largest CRO, - which he joined in 1997 as General Manager of their European Clinical development operations. He went onto run their Global clinical CRO services before moving to MDS in 2002.
Mr. Horgan began his career at ER Squibb & sons and has worked at Boots Pharmaceuticals Ltd., Fisons UK Ltd., and Rhone-Poulenc Rorer.
Mr Horgan holds a B.Sc (Hons) in Biochemistry from Warwick University in England.
Mr. Evans is a senior technology and clinical research executive with over twenty years experience in the clinical research, regulatory and healthcare industries. He has served in many industry leadership roles, among them as Chief Technology Officer for a leading clinical research organization, as Chief Operating Officer for a clinical software development firm and as Chief Technology Officer for First Genetic Trust, a provider of comprehensive, secure information technology infrastructure to support the development and adoption of genetic based medicine and diagnostics.
He has extraordinary experience in corporate development, clinical data management, clinical trial management, complex clinical data warehousing, regulatory data analysis, automated data capture, regulatory quality management and clinical business process engineering. Dave is recognized industry-wide as a leading technology visionary for developing and implementing complex process and system solutions. He was the architect and developer of the first electronic submission to the FDA in 1985 and has been responsible for over 70 electronic submissions and complex clinical data warehouses. He is also a frequent industry speaker and has led numerous industry committees and conferences.
Mr. Evans holds a Bachelor of Science from Ursinus College and a Multidisciplinary Masters of Biomedical Engineering from Drexel University.
Prior to joining Octagon, Ms. Smerkanich has been in various positions within Regulatory Affairs Departments and most recently consulting for nearly 20 years. She spent 10 years with Merck before becoming a consultant.
She has prepared and maintained IND applications for over 30 compounds and prepared multiple New Drug Applications, background packages, safety update reports, Summary Basis of Approval documents, efficacy and labeling supplements, annual NDA and periodic ADR reports for submission to regulatory authorities. She is trained and experienced in preparing Electronic Submissions. She has also written Standard Operating Procedures for many of the leading pharmaceutical companies. She has served as Regulatory Liaison with FDA/CBER and the Orphan Drug Product Office. She has directed preparations for FDA meetings and has provided technical expertise for numerous NDA filings. Ms. Smerkanich has also directed activities relating to Quality Assurance Audits and participated in training activities for in-house personnel and industry leaders.
Ms. Smerkanich holds a Bachelor of Science Degree in MicroBiology and a Bachelor of Arts in Russian from the University of Connecticut.
Mr. Lawrie has 10 years of business process consulting in the pharmaceutical industry. He currently heads Octagon's Process Solutions group which focuses on helping our clients build electronic submission capabilities. He has extensive experience with implementing document management and publishing systems using the latest available technologies. Mr. Lawrie has assisted with the submission of multiple electronic applications and has developed processes for producing concurrent submissions for multiple regulatory markets. He has worked with R&D functional areas to develop cross-functional standards and processes around using technology to produce electronic submission-ready contributions. Prior to joining Octagon, Mr. Lawrie worked for Computer Sciences Corporation where he led business analysis, process design, organizational change and project management activities.
Mr. Lawrie graduated with honors from Bucknell University with a BS degree in Mechanical Engineering.
Ms. Garrett is currently responsible for all marketing activities at
Octagon, bringing over 13 years of industry experience to her role. Prior to joining Octagon, Ms. Garrett was employed for four years by an
electronic publishing software vendor. In her previous role as Director of Regulatory Strategies, she was responsible for tracking industry trends and helping to identify, develop and communicate electronic publishing
solutions for the Life Sciences industry. Prior roles included managing
the US sales support group and directing multiple client software
implementations.
Ms. Garrett also spent six years in the pharmaceutical industry working in
the areas of regulatory operations, document management and electronic
publishing, developing best practices, processes and training to support
those systems. This included four years managing the regulatory
submissions, electronic publishing and official regulatory files at
AstraMerck and two years managing regulatory filings for Sterling Winthrop
(Sanofi).
Ms. Garrett earned her BS in Human Resources with honors from the
University of Delaware and a Masters in Management from Pennsylvania State
University.
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