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PharmaReady - Recent News - eCTD and eDMS solution

TAKE Solutions’ Life Sciences Division Announces Global Expansion of its Submissions Assurance™ Program (more)

TAKE Solutions’ Team Announces Conatus Pharmaceuticals the Winner in PharmaReady Best Case Study Contest (more)

New eCTD Submission Created Using PharmaReady 4.0 Passes FDA Validation (more)

Leadership Team

Robert MacDougall, Executive Vice President, Sales and Marketing
Robert MacDougall serves as Executive Vice President, Sales and Marketing for PharmaReady. Robert’s organization is responsible for business development, sales, and marketing of its Life Sciences product and consulting services portfolio. These regulatory-compliant offerings are marketed under the PharmaReady™ brand. Robert's team consists of sales, technical presales, marketing, and recruiting personnel serving its global markets. A key area of competency is its use of Microsoft technology to develop custom applications to extend legacy systems to the web. Robert's group is responsible for its premier alliance with Microsoft Corporation with achieving Gold Certified Partner status for the past 11 years along with charter membership in Microsoft’s Digital Pharma and Bio IT Alliance programs.

Mr. MacDougall has 25 years experience in the Information Technology industry. Throughout his career, Robert has held leadership positions in enterprise solutions sales, contract staffing, technology consulting, and alliance program management. During 15 years with AT&T, he held senior sales and management positions within Technology Consulting and Communication Systems & Services business units. Rob has extensive sales and management experience in both commercial and government markets. Under his leadership, major sales program successes include Quintiles Transnational, GlaxoSmithKline, Fluor Corporation, Jefferson Pilot Financial, BellSouth, U.S. Postal Service, United Airlines, Chase Bank, U.S. Department of Defense, and Johns Hopkins Medical Institutions.

Mr. MacDougall holds a Bachelor of Science in Marketing from The University of Maryland

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Phillip Mosely, Executive Vice President, Operations
Phillip Mosely currently serves as Executive Vice President, Operations for PharmaReady. From 1995-2006, Phillip served as President and CEO of OnSphere Corporation. OnSphere, now a division of TAKE Solutions, Inc. specializes in the development and delivery of Microsoft project-based business solutions and consulting services. During Phillip's tenure as President of OnSphere, he profitably grew the business into a multi-million dollar company.

In 1999, Mr. Mosely's organization developed a software product and successfully created a separate company, Report2Web. Report2Web was ultimately sold to Redwood Software, headquartered in the Netherlands. While simultaneously fulfilling his duties to OnSphere, Phillip managed the due diligence process for this merger. Under Phillip's leadership, in 1995 OnSphere received local and national recognition for employee development and revenue growth - including twice being selected for the Inc. 500 award.

After joining OnSphere in 1992 as Vice President of Operations, Mr. Mosely was responsible for the solutions business and complete operational management of the company. Phillip designed and implemented OnSphere's solutions delivery model and the organization to support it - leading the company to win and successfully deliver project-based solutions while growing 50% to 100% annually. Phillip attributes OnSphere's success "to the capabilities and character of our people and to our consistent ability to deliver high quality, real world solutions in partnership with our customers."

Prior to joining OnSphere, Phillip founded the computer consulting firm, Excel Systems. Phillip began his career in 1985 as a software developer writing engineering and surveying software. Mr. Mosely’s undergraduate studies in Electrical Engineering are from North Carolina State University.

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Jonathan Seltzer, MD, MBA, MA, FACC, Chief Medical Officer
Dr. Jonathan Seltzer is a board-certified cardiologist and co-founder of Applied Clinical Intelligence LLC. His operational experience includes management and safety oversight for numerous cardiovascular trials, serving on the executive committee of a publicly traded research organization and co-chairing two nationwide cardiac care benchmarking efforts. In the regulatory arena, he has chaired Data Monitoring Committees, authored clinical section reports for new drug applications, and represented clients at the FDA. Additionally, he is skilled at regulatory interpretation of electrocardiographic data and QT interval regulatory issues. He has been an innovator in the use of large clinical databases, conducting clinical outcomes studies as well as designing clinical protocols. He has over twenty years' experience in the medical and regulatory arenas.

Dr. Seltzer serves as Director of Clinical Research at the Main Line Heart Center, is a Clinical Assistant Professor at Jefferson Medical College and was selected as a Health Science Subject Matter Specialist/Physician for the FDA systems integration (SISTIR) initiative. Dr. Seltzer received his undergraduate degree in History from Haverford College. His post-graduate degrees include an MBA and MA in Applied Economics from the University of Michigan, and an MD from the University of Pennsylvania.

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Kalyan Gopalakrishnan, Executive Vice President, Strategic Planning
Kalyan Gopalakrishnan currently serves as Executive Vice President, Strategic Planning for PharmaReady Life Sciences. Over the past decade, Kalyan has successfully performed in leadership positions with several major Clinical and Drug Safety system integration programs. His unique ability to intersect his domain insight with leading applied technologies is well-documented. Kalyan has architected comprehensive solutions resulting in delivering cross functional insights within drug research, clinical, and pre/post marketing phases - all while adhering to global regulatory requirements and industry standards. Kalyan's consistent ability to lead and direct high-performance teams to address and support client's critical challenges, business strategies, and goals is well-proven.

In Kalyan's present role at PharmaReady, he establishes and directs next generation technologies including semantic integration, service oriented architecture, and emerging data and document standards such as CDISC, HL7, and ICH. Kalyan's expertise in architecting solutions that dramatically reduce the cost and complexity of information systems that support clinical research and healthcare activities is a core strength of PharmaReady. During Kalyan professional consulting career, he has lead technology architecture roles at Accenture, Pfizer, Amgen and Novartis.

Mr. Gopalakrishnan has earned an Engineering degree with distinction in Electronics and Communication Engineering, after which, he participated in a multi-year research program in Network Systems at Indian Institute of Technology, Chennai.

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