Inside CIS

People
Management Team
Subject Matter Experts

Features

Government Programs & Pricing Compliance

PharmaComplianceXchange (PCX)

Management team

Toni Barsh
Vice President, Account Management
Toni Barsh brings 20 years of industry experience in pharmaceutical consulting expertise to clients. As Co-Founder and Vice President, Account Management, Toni is responsible for working closely with clients and project teams to develop and execute strategic and comprehensive compliance programs. These solutions include services such as corporate compliance programs, compliance assessments, policy and procedure development, audits and training.

Prior to CIS, Toni was Founder and President of Barsh Consultancy, Inc., which focused on the implementation of clinical training and a consulting resource consortium focusing on all regulatory issues in manufacturing, clinical and lab practices. Barsh Consultancy, Inc. managed various projects and activities that support those in need of clinical training by providing creative adult learning options.
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Chris Cobourn
Senior Vice President, Commercial Business Strategy
Chris Cobourn has worked with the pharmaceutical industry in commercial and government contracting for more than a decade, from the policy and procedure development perspective, as well as in systems and audit.

As Senior Vice President of Commercial Business Strategy for CIS, Chris works closely with pharmaceutical manufacturers in areas related to the management of government programs, including policy review, methodology development, policy and procedure documentation, systems implementation, as well as Class of Trade and related commercial systems. Chris supports manufacturers as they work with the federal government in self-reports, restatements and investigative activity. He has also worked closely with compliance and audit departments to develop monitoring and audit plans and in conducting wholesaler audits, vendor audits, and internal audits related to government programs. Chris specializes in helping businesses evaluate, assess and prioritize risks, and helps them put practical and manageable compliance programs in place.

In addition to his GP policy and procedure focus, Chris has also helped bring new services to the industry to help address common challenges. Some of these new services include customer master validation and Class of Trade analysis, PHS eligibility validation, government programs pre-audit assessments, and the development of the Pharmaceutical Compliance Exchange, a web-based source for government program guidance documentation.

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Mark Sabatelli
Senior Vice President, Business Development & Marketing
Mark Sabatelli brings over twenty years of industry and sales experience to CIS. As Senior Vice President, Business Development & Marketing, Mark is responsible for leading a team of BD Directors in developing and expanding CIS’ presence and company awareness within the pharmaceutical marketplace. Mark works with the CIS Practice Leads in developing new compliance services for pharmaceutical companies from Global Clinical Research & Development through Commercial Compliance and Government Programs to further enhance CIS compliance offerings.

Mark spent 20 years in the pharmaceutical industry, 14 years working with a major pharmaceutical company in the Commercial and Government contracting operations areas and 6 years with a technology company identifying and evaluating software solutions that would provide value to the industry and streamline the contracting process.

His past experience includes developing and implementing short and long term  pricing strategies and tactics for Managed Care, GPO, LTC, Physician and Wholesaler markets, Government Rebates and Pricing, and Contract Management Activities (chargeback processing, rebates, administrative fees, membership/plan & eligibility).  Mark’s responsibilities also included system evaluations, business process re-engineering, contract strategy & analysis, Government Program Compliance and Auditing.
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Mertie Snead
Vice President, Clinical Compliance
Mertie is Vice President, Clinical Compliance leading the strategy and growth of CIS’ clinical business area. Mertie comes to CIS after an exciting 19-year career at a major pharmaceutical company and a total of 25 years industry experience. She most recently held the position of Director/Head of Global Quality & Compliance Externalization. In this role, Mertie partnered with Business Development, Legal and R&D Medicines Development to establish a quality and compliance governance framework for strategic alliances and co-development partnerships. She has also held Research and Development positions in the areas of pre-clinical toxicology, GLP quality assurance, clinical data management, corporate compliance investigations, clinical monitoring /study management and GCP quality assurance.

Mertie has domestic and international experience in Drug Development, Medical Governance, Risk Management, Corporate Compliance and GCP Regulatory Compliance. Her past experience includes establishing an internal Clinical Quality Management function within a major Europe-based vaccines company, directing global clinical quality assurance teams, leading the strategic direction for quality assurance operations (audit management, CAPA management, inspection management). Mertie has extensive experience in the management and follow-up for FDA and international regulatory inspections. Throughout her career Mertie has succeeded in building quality partnerships with CRO’s, contract quality assurance providers, IRBs, strategic alliance partners and regulatory agencies.
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David M. Greeley
Vice President, GMP Corporate Compliance
Dave brings more than 20 years of global pharmaceutical experience to CIS including sales, marketing and account management. He has been responsible for managing more than $60 million in new and repeat business in his former roles as director, vice president, and COO for some of the world's most successful pharmaceutical and contract research companies. In addition, David brings a broad background of experience in Quality, Regulatory, IT, HR and Engineering. David brings experience in key CIS business areas, including clinical, manufacturing and commercial. He graduated with a Bachelor of Science degree in biochemistry from the College of Charleston and holds advanced degrees in business and pharmaceutical marketing from the University of Colorado.
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jamie l. kendall, esquire
Senior Director, Compliance, Ethics & Legal Affairs
Jamie L. Kendall is the Senior Director of Compliance, Ethics and Legal Affairs.  Jamie identifies exposure to compliance risks and implementation, and adherence to legal and regulatory requirements in areas such as clinical and manufacturing, commercial compliance, government programs, and sales and marketing.  Jamie provides expertise and knowledge across all areas of compliance, including Policy and Standard Operating Procedure Development, Review and Harmonization, Risk Management Processes, Audits and Assessments, System Evaluation, Implementation, and Validation Training Development and Delivery. Prior to joining CIS, Jamie was an associate with Morgan, Lewis & Bockius LLP in its Philadelphia, Pennsylvania office where her practice focused on pharmaceutical compliance, government investigations and litigation involving Office of Inspector General’s (OIG) guidelines, U.S. Food and Drug Administration (FDA) regulations, state and federal price reporting laws, fraud, abuse and anti-kickback statutes, prescription drug marketing and reimbursement regulations, compliance with Corporate Integrity Agreements (CIAs), the Health Insurance Portability and Accountability Act (HIPAA), and exposure to the Foreign Corrupt Practices Act (FCPA). She received her Juris Doctorate from Rutgers University School of Law.
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William Baxter
Strategic Advisor, Government Affairs
Bill Baxter is the Strategic Advisor, Government Affairs at CIS. Previously, Bill was a Director of Medicaid Market & Rebate Management at Johnson & Johnson Health Care Systems where he was responsible for Medicaid basic and supplemental rebates and state pharmaceutical assistance rebate issues for all J&J pharmaceutical and consumer products operating companies. His extensive industry experience includes field sales management, field sales training, and Government affairs for Ortho-McNeil Pharmaceuticals, Johnson & Johnson ICOM and Johnson & Johnson Health Care Systems. Additionally, Bill served as a co-chairman for Johnson & Johnson State Health Care Policy Council, and a contributing member of the J&J Medicaid Taskforce and J&J Medicare Taskforce.
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joe cunningham
Vice President, Account Management
Joe Cunningham is Vice President of Account Management at CIS.  Joe brings more than 25 years of global pharmaceutical sales, marketing and account management experience to CIS and has been responsible for managing more than $100 million in new and repeat business in his former roles as director, vice president, and senior vice president for some of the world’s most successful sales and consulting firms.  Joe brings experience in all key CIS business areas, including clinical, manufacturing and commercial. He graduated with a Bachelor of Science degree in economics from the University of Missouri in Rolla, Missouri. 
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Karen Brown
Vice President, Marketing
Karen is a marketing professional and business development leader with over 20 years of strategy and tactical execution at small, mid and large organizations.

Prior to CIS, Karen was Senior Director, Global Marketing with the world’s largest CRO, where she established a high impact, consistent customer experience, accomplished through customer segmentation, internal communications, brand management, thought leadership and integrated programs for a wide range of clinical development services (early to late phase).  She has contributed to a publication on Strategic Research, A Practical Handbook for  Phase IIIB and Phase IV Clinical Studies and has created a global print and online magazine called Envisage, for the biopharma industry.

Karen supports the CIS’ brand evolution and all business areas from Clinical R&D to Commercial Compliance and Government Programs.
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