Octagon's Management Team
 The Accidental Entrepeneurs:
New York Times Article
JAMES C. WALKER – CEO & CHAIRMAN
 Mr. Walker has been working in the pharmaceutical industry for 17 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.
KIRK GALLION– PRESIDENT
 Mr. Gallion is co-founder and President of Octagon Research Solutions, Inc. He has worked in industry for over 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 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.
DAVID A. EVANS– CHIEF INFORMATION OFFICER
 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.
ROBERT LACLAIR – CHIEF FINANCIAL OFFICER
 Mr. LaClair has worked in various financial and accounting roles over the last 14 years. Prior to joining Octagon, Mr. LaClair worked for SL Waber, a multi-national manufacturing company, for over 6 years. At Waber, he initially served as company Controller and Operational Flow Manager, where he managed a financial plan of over $55 million in annual sales and spearheaded the implementation of a new multifaceted client-server system. He was then promoted to General Manager and Controller, managing an office of 65 personnel from various departments, including finance, sales, purchasing, and engineering.
Earlier in his career, Mr. LaClair worked as an auditor and business process consultant at Coopers and Lybrand (Price Waterhouse/Coopers). Mr. LaClair is a Certified Public Accountant and holds a Bachelor of Science degree in Accounting with a minor in Computer Science from Villanova University.
NANCY SMERKANICH – VICE PRESIDENT, REGULATORY AFFAIRS
 Prior to joining Octagon, Ms. Smerkanich held 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.
JOHN LAWRIE– VICE PRESIDENT, PROCESS SOLUTIONS
 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.
MATT STROSCHEIN – VICE PRESIDENT, OPERATIONS
 Mr. Stroschein joined Octagon in 2000 and was Octagon’s 4th employee. He currently serves as Vice President, Operations and has demonstrated success in reorganizing operations to improve customer service while creating internal efficiencies.
In his role as Vice President, Operations, Mr. Stroschein oversees Octagon’s Regulatory and Clinical Operations and is responsible for the development and implementation of distinctive cross-functional strategies. He has been instrumental in identifying integration points between clinical, regulatory and publishing functions and currently serves as the executive sponsor responsible for technology integration within Octagon’s submission processes.
During his tenure at Octagon, Mr. Stroschein managed the Regulatory Operations team, and electronic regulatory publishing projects while being directly responsible for project budgeting and set-up, proposal generation, process development, staffing of teams, facilitation of client relationships, and direction of project teams’ long-term and daily activities.
Mr. Stroschein’s teams have been instrumental in the development of Octagon’s enterprise submission management tool, ViewPoint®, as well as Octagon’s eCTD Viewer and eCTD Validator that assist in the optimization of complex cross-functional submission processes as well as the creation and management of electronic submissions in eCTD format.
Mr. Stroschein holds a Bachelor of Science in Management Science and Information Systems from Pennsylvania State University.
MONIQUE GARRETT– VICE PRESIDENT, MARKETING
 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.
DOUG FULLING – VICE PRESIDENT, BUSINESS DEVELOPMENT
 Mr. Fulling joined Octagon Research in 2006 as Vice President, Business Development and is directly responsible for Octagon’s worldwide revenue generation efforts as well as the day-to-day operations of the company’s business development organization. Under Mr. Fulling’s leadership, Octagon’s business development team has succeeded in significantly increasing Octagon’s client base and revenue.
Mr. Fulling has over 10 years of business development experience, holding key positions at various contract research and consulting organizations including MDS Pharma Services. While at MDS Pharma, Mr. Fulling lead the North American Business Development team, secured multiple preferred provider relationships and significantly increased sales. Prior to MDS, Mr. Fulling held positions in business development at Health Hero Network, Health Process Management and The Advisory Board Company.
Mr. Fulling holds a Master of Health Administration from Tulane University and a BS Degree in Health Care Management from Southern Illinois University.
LUKE BRENNAN – VICE PRESIDENT, ELECTRONIC DATA CAPTURE
 Mr. Brennan serves as vice president, Electronic Data Capture (EDC) and is responsible for developing the strategic and technical vision for Octagon’s EDC technology solution as well as leading Octagon’s West Coast Operations. He brings over 20 years of experience in the design, development and delivery of clinical information systems for healthcare and clinical trial technologies for the pharmaceutical and biotechnology industries with a particular focus on EDC technologies.
Prior to joining Octagon, Mr. Brennan served as vice president, Operations at Ninaza where he was responsible for managing the day-to-day business operations for Ninaza’s EDC product. Prior to Ninaza, Mr. Brennan served as vice president, Implementation Services for Medidata Solutions where he managed professional and implementation services for the company’s EDC customer implementations.
Mr. Brennan is a member of the Drug Information Association (DIA), Society for Clinical Data Management (SCDM) and the Institute of Electrical and Electronics Engineers (IEEE). He holds a BS in Computer/Electrical Engineering and an MS in Biomedical Engineering from the University of Virginia.
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