CIS - Compliance Implementation Services

Toni Barsh, Global Clinical R&D
VP, Account Management
Toni Barsh brings twenty years of industry experience in pharmaceutical consulting expertise to clients. As Co-Founder and VP, 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.

As Manager of Business Development and Manager of Training, Toni spent five years with Barnett International/PAREXEL leading business growth and managing various internal/external teams. Previous to Barnett, Toni was an Account Manager at several pharmaceutical marketing/consulting agencies where she worked closely with clients on Continuing Medical Education Programs, product positioning and advertising. Several years were also spent at Wyeth during the launch of Norplant.

Toni was an active member of Drug Information Association (DIA), Healthcare Business Women’s Association (HBA), the American Society for Training & Development (ASTD), and the Association of Clinical Research Professionals (ACRP) where she served as the Chairperson for ACRP’s Trainers Forum and is serving on the 2002-2003 Annual Meeting Program Chair Committee. Toni graduated in 1989 from Lycoming College with a Bachelor of Arts Degree in Communications and a Minor in Psychology.
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Chris Cobourn, US Commercial Compliance
VP, Regulatory Compliance
Chris Cobourn is the VP of Regulatory Compliance. He has worked with the industry in Commercial and Government Contracting for over a decade, from the policy and procedure development perspective, as well as systems and audit. Chris works closely with pharmaceutical manufacturers in areas related to 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 government in self-reports, restatements and investigative activity. He has also worked closely with compliance and audit departments in developing monitoring and audit plans and conducting internal audits related to Government Programs, as well as wholesaler and other vendor audits. He helps businesses evaluate, assess and prioritize its risks, and to help 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, including Customer Master validation and Class of Trade Analysis, PHS eligibility validation, Government Programs pre-audit assessments and the Pharmaceutical Compliance Exchange (PCX), a web-based source for Government Program guidance documentation.
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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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Annette Horner, Global Clinical R&D
Senior Director, Clinical Compliance
Annette Horner is Senior Director of Clinical Compliance at CIS. Annette consults with senior managers in key functional areas of Clinical R&D including Clinical Operations, Data Management, Drug Safety/Pharmacovigilance, Regulatory Affairs, Quality Assurance, Training and Medical Affairs. She works with these groups in areas related to process improvement, policy and procedure development, implementing new technologies, GCP compliance, training strategy and design, international change management, and clinical research metrics design.

Annette has directed an international consulting team to implement clinical and regulatory reengineering changes for a top five pharmaceutical manufacturer, impacting more than 2000 end users in more than 25 countries. For another large pharmaceutical manufacturer, she led a multi-site consulting team to conduct a compliance gap analysis and then remediate clinical procedural documentation for a vaccine product under review for out-licensing. She has led more than 30 company-specific process design, documentation and harmonization projects for pharmaceutical, medical device and biotech companies, in U.S., Europe, and Japan. Recently, she led design and development of the Clinical R&D Pharmaceutical Compliance Exchange (PCX), a searchable, web-based source for ICH, FDA and EU regulations and guidance.
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jamie l. ghen, esquire
Director, Compliance, Ethics & Legal Affairs
Jamie L. Ghen is the 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, US Commercial Compliance
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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Dave Rice, US Commercial Compliance
Director, FSS Contracting & Pricing
Dave Rice is the Director of Federal Contracting at CIS. He has over 25 years of diverse pharmaceutical industry experience including FSS Contracting, Business Development, FSS Compliance, Pricing and Contracting, Finance and Auditing. His expertise in these areas has contributed to the success of numerous companies participating in the Federal Government market.

Prior to his work at CIS, he worked at WSI, Pharmacia, Pharmacia & Upjohn and The Upjohn Company, where he held key positions in auditing, pricing and contacting, Federal Government Compliance and Federal Government Business Development.

Dave is a past Chairman of the AMSUS-Sustaining Members (Association of Military Surgeons of the United States). The organization brings together private healthcare industry representatives with key Department of Defense, Department of Veterans Affairs and U.S. Public Health Service decision makers.
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Mark Sabatelli
VP, Business Development & Marketing
Mark Sabatelli brings over twenty years of industry and sales experience to CIS. As VP, 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 US 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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Karen Brown
Senior Director, 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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Inside CIS

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Management team