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Veristat Staff Content

John P. Balser, PhD

President

John Balser is the President of Veristat, Inc. and has grown the company to its current size of over 80 professionals in the areas of project management, biostatistics and programming, medical writing, and data management. In his capacity as company President, Dr. Balser works directly with the heads of each department to implement process efficiencies and service improvements. In addition to providing the global direction for the company, Dr. Balser continues to be involved with clinical projects as one of Veristat's principal statistical consultants. In this role, he assists clients with clinical study design and program development based on his many years of experience in the statistical aspects of clinical research. He is often called upon to assist clients on a variety of statistical issues at meetings with regulatory agencies. Dr. Balser received his MS and PhD in Biometrics from Cornell University, and has been actively engaged in clinical biostatistics for over 25 years. He has held positions of increasing responsibility in the biostatistics departments of E.R. Squibb, Biogen, and Miles pharmaceutical companies. Prior to founding Veristat in 1994, Dr. Balser served as Vice President, Biostatistics and Data Management at Medical & Technical Research Associates, Inc.

Barbara Balser, VMD

Executive Vice President and Chief Scientific Officer

Barbara Balser, co-founder of Veristat, Inc., is Senior Vice President and Chief Scientific Officer, and is primarily responsible for strategic planning and consulting, data quality, medical oversight, and production of regulatory submission documents. Dr. Balser has more than 25 years of clinical research experience that encompasses both the pharmaceutical and contract research organization industries. Her experience includes Phase I to IV trials across multiple therapeutic areas with a specific focus in oncology and anti-infectives. Dr. Balser has participated in the writing, oversight, and submission of multiple marketing applications to US, Canadian, and European Union regulatory authorities. Prior to co-founding Veristat, Dr. Balser served as Associate Director of Clinical Research at Medical & Technical Research Associates, Inc. where she was responsible for strategic planning, design, and management of clinical development programs in Phases I through IV; preparation and submission of regulatory applications; and scientific communications. Dr. Balser began her career in the pharmaceutical industry at Miles, Inc. (currently Bayer Corporation). In her capacity as Assistant Director of Clinical Research at Miles, Dr. Balser assisted with strategic planning for the clinical development of anti-infective compounds from Phases II to IV and with the planning, writing, and compilation of 2 successful NDAs for anti-infective products. Prior to joining the industry, Dr. Balser practiced veterinary medicine at a private veterinary hospital. Dr. Balser holds a BS in Chemical Engineering from the University of Pennsylvania, School of Engineering and Applied Science, and a VMD from the University of Pennsylvania, School of Veterinary Medicine.

Michelle Currie

Vice President, Clinical Operations

Michelle Currie is Vice President of Clinical Operations at Veristat, Inc. After holding positions of increasing responsibility in the contract research organization and biotech settings, Ms. Currie joined the company as Director of Medical Writing Services in 2000. Over the subsequent years, Ms. Currie’s role within the company has expanded as the business has grown. While at Veristat, Ms. Currie has participated in several successful NDA/BLA filings, developed key company functions and policies, and contributed toward the expansion of Veristat’s client base. As the head of Clinical Operations, Ms. Currie is responsible for cross-functional project planning, budget development and oversight, resource management within and across projects, staff mentoring, vendor management, and project operational support. Working with Business Development and Clinical Operations personnel, Ms. Currie works to build and maintain strong, effective relationships with clients, vendors, and other clinical research partners.

Prior to joining Veristat, Ms. Currie served as Manager of Medical Writing at Idenix Pharmaceuticals, Inc. (formerly Novirio Pharmaceuticals, Inc.), a biopharmaceutical company. At Idenix, Ms. Currie started the medical writing function, including development of standard procedures and templates for clinical study documents, and prepared and assisted with the filing of pre-INDs and INDs for antiviral agents. Ms. Currie began her career in the pharmaceutical industry in 1992 at PAREXEL International Corporation. At PAREXEL, Ms. Currie held positions of increasing responsibility in the Medical Writing Services group. Ms. Currie assisted with the writing, review, and compilation of 2 successful NDAs. In addition, she prepared numerous clinical documents in a variety of indications, primarily human immunodeficiency virus (HIV).

Prior to joining the industry, Ms. Currie worked in human services. Ms. Currie holds a BA in Psychology from William Smith College.

Kathy Sachse

Senior Director, Clinical Operations

Kathy Sachse is the Senior Director of Clinical Operations at Veristat, Inc. and has primary responsibility for project management functions. This includes oversight of project management personnel and resource allocation planning, maintenance of optimal department processes and the development and implementation of strategies to increase project productivity and quality, while decreasing cycle times and costs. Ms. Sachse has over 23 years of experience in clinical research with extensive experience in the management of Phase I through III trials utilizing electronic data capture (EDC). Ms. Sachse has a broad scope of experience in various therapeutic areas, including executing trials involving HIV/AIDS, Anti-Infectives, Vaccines, and Renal, Cardiovascular, and Neurological disease. Prior to joining Veristat in 2005, Ms. Sachse held the position of Data Project Manager within the Cardiovascular Division at Boston Scientific, Inc., with responsibility for oversight of clinical data management functions and EDC vendor management. Previously, Ms. Sachse served as Manager, Clinical Data Analysts in charge of safety data review and coding at MTRA, Inc. and AAI Pharma Inc., Senior Clinical Data Manager at PAREXEL International Corporation, and as Project Coordinator at the Cancer Control Research Unit and the Perinatal Epidemiology Research Unit at Yale University School of Public Health. Ms. Sachse holds an MS in Counseling and Guidance from Indiana University and a Sixth Year Certificate in School Psychology from Southern Connecticut State University.

Cindy Henderson

Senior Director, Data Technologies

Cindy Henderson is the Senior Director of Data Technologies at Veristat, Inc. with primary responsibility for all data management and information technology services. For data management, this includes oversight of the clinical data management personnel, who perform such activities as case report form development, database development in Clintrial™ and InForm™, preparation of data validation specifications, edit check programming, data review and discrepancy management, adverse event and medication coding using industry standard dictionaries such as MedDRA and WHODRL, handling of external data, database quality control and final database lock. Ms. Henderson is also responsible for the information technology group ensuring appropriate technologies are in place and are validated according to 21 CFR Part 11 requirements. Ms. Henderson has over 20 years of experience in various contract research organizations. Prior to joining Veristat in 2007, Ms. Henderson served as Senior Manager of Training, Innovations and Processes at Averion International Corporation, leading various initiatives to create and improve standard operating procedures and implement new technologies for data management as well as the overall corporation. Ms Henderson has a wide variety of data management experience from PAREXEL International Corporation, from serving as the Lead Clinical Data Manager on several international trials to the Associate Director of Data Management. Ms. Henderson is a member of the Drug Information Association (DIA).

Jeanne Corriveau

Director of Statistical Programming

Jeanne Corriveau is the Director, Statistical Programming at Veristat, Inc. and is primarily responsible for the SAS programming aspects of clinical trial projects through management of internal staff. This includes resource allocation, maintenance of department processes and procedures, assistance with the development of business proposals, and participation in client meetings/audits. Ms. Corriveau has over 26 years of clinical research experience. Prior to joining Veristat in 2007, Ms. Corriveau was Associate Director of the Waltham Biostatistics & Programming department at PAREXEL International, LLC. Ms. Corriveau holds a BA from the University of Massachusetts.

Kim Givens

Director, Business Development & Client Relations

Kim Givens is the Director of Business Development and Client Relations for Veristat, Inc.. After more than 12 years in the industry, Ms. Givens joined the Project Management group at Veristat in 2006 where she performed various roles to broaden her understanding of contract research services and Veristat’s client and project needs. In her capacity as Director of Business Development and Client Relations, Ms. Givens is primarily responsible for developing new relationships with clients and maintaining cooperative working relationships and expanding business opportunities with existing clients. Ms. Givens provides leadership to Business Development and Client Relations personnel with regard to overall business planning, development and maintenance of business partnerships, strategies for proposal development and study conduct, and identification and management of key business issues. Ms. Givens also is responsible for identifying areas for improvement within the company that will serve to enhance both company performance and client satisfaction and retention. Prior to joining Veristat, Ms. Givens held positions of increasing responsibility at Ethicon Endo-Surgery, Inc., a Johnson & Johnson company. Most recently, she was a Field Marketing Manager responsible for marketing advanced medical devices for minimally invasive surgical procedures. During her 8-year tenure at Ethicon Endo-Surgery, Ms. Givens held a variety of positions in management, sales, and professional education. In these roles, Ms. Givens gained valuable experience in the areas of business development, advertising, sales, and public relations. Ms. Givens began her career in industry at Boston Scientific Corporation as a Corporate Accounts Manager and Team Leader. Ms. Givens holds a BS from Northeastern University, College of Criminal Justice.

Christopher Schoonmaker, MPH

Associate Director of Biostatistics

Chris has held positions of Biostatistician, Senior Biostatistician, Manager of Biostatistics and Programming, and currently Associate Director of Biostatistics. While coordinating the activities of the Biostatistics department, he is also the lead statistician on several ongoing clinical trials (specializing in oncology and vaccines), has served as an active member on Data Safety Monitoring Boards (DSMBs), and provides statistical consultation on a range of topics and indications. Chris received his Master’s of Public Health in Epidemiology and Biostatics from Boston University and thereafter received PhD level training in Biostatistics. He has more than ten years of statistical evaluation experience and has held several positions in the health care industry. Prior to positions in the pharmaceutical industry, Chris was a data analyst for an evaluation firm analyzing data related to adolescent health, early childhood development, and AIDS treatment adherence. While at Boston University, Chris provided data management and statistical support at the Framingham Heart Study and also taught an introductory SAS/statistical computing class. He has provided statistical consultation for a variety of medical and health care studies related to cardiovascular disease, adolescent nutrition, and infant mortality among others, and has extensive experience in data management and advanced statistical analyses.

Doug Beckerman, MBA

Director of Finance

Doug Beckerman is the Director of Finance at Veristat,Inc. and is responsible for the business and financial strategy of the Company by planning, monitoring, and managing the financial operations. Mr. Beckerman has a varied background in both the software and biopharma service industries including financial applications and analysis, business and resource forecasting, client and corporate contracting, strategic alliances, and corporate planning. Most recently Mr. Beckerman was the Group Leader of Finance, Legal and Human Resources for BBK Worldwide, a leading global clinical trial patient recruitment marketing consultancy. At BBK, Mr. Beckerman was instrumental in the establishment of the company’s international subsidiaries, providing the financial support for a spin-off the company’s technology offering into a separate company and enhancing the client contracting process. Prior to BBK, Mr. Beckerman was the Director of Finance and Administration at Auspice Corporation, a start-up operations automation software provider. At Auspice, Mr. Beckerman built the financial and human resource infrastructure from the ground up and also provided financial support for successful rounds of angel financing. Previous to Auspice, Mr. Beckerman was the Controller at Tasking Inc., a leading embedded software developer, where he drove the acquisition efforts of the company by analyzing and integrating an acquired company from the financial and human resource perspectives. Previous experiences included varied Analyst roles at Easel Corporation and Computervision Corporation, leading client server and CAD/CAM software providers, focusing on global financial and business planning and analysis. Mr. Beckerman holds an MBA from the Thunderbird School of Global Management and a BA degree in Economics from St. Lawrence University. Mr. Beckerman is an active member of the Institute of Management Accountants and also a Massachusetts Notary.