Avoid Patent Eclipse – Accelerate Your Study Start Up and Tracking

The faster you start and execute a clinical trial, the faster a new product is released to market and the longer that drug is commercially-available under patent. Patent eclipse begins on day one and the clock is ticking.

Working in partnership with Appian and Princeton Blue, Clinical Sciences and Operations (CSO) at Sanofi created a modern technology solution to accelerate study start-up and progress tracking. The Required Essential Document System (READY) application has been designed to allow Sanofi to reach the key milestones of Investigational Medicinal Product greenlight and Site Initiation Visit in less time, with fewer errors, while still meeting compliance for industry regulations such as Statement of Investigator Form 1572 and CV submissions. This application is the primary driver that signals to downstream functions that drug shipment and Site Initiation Visits can proceed.

Attend this webinar to learn:

• How a modern application platform can deliver automation, control, data accuracy and on-demand operational transparency in critical initial trial phases
• How to achieve easy navigation of information across various operational levels and solve the time-consuming document and reporting challenges
• How to keep up with the pace of change through a more flexible approach to IT

Speakers

Michael Calluori, Sr. Business Analyst BPM, Sanofi

Michael Calluori is a Sr. Business Analyst of BPM at Sanofi in Bridgewater, NJ. He has over 20 years of Business Analysis and Project Management experience in drug research and development with a focus on Clinical, Regulatory Submissions and Drug Safety. His focus since 2012 has been working on Appian applications for Safety Signal Tracking, SRD1572, Clinical Study Startup, and several other applications as part of the Clinical BPM portfolio.

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Pramod Sachdeva, Managing Director and Founder, Princeton Blue

Pramod Sachdeva is the Founder and Managing Director at Princeton Blue and has been an evangelist for business transformation thru BPM and Business Rules since the late 90’s. Princeton Blue focuses on enhancing the user experience and improving operational efficiency through innovative technologies like BPM, Rules and Mobile. Princeton Blue has delivered many such projects for Pharmaceutical clients in the area of clinical, safety and regulatory compliance.

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Evi Cohen, Global Practice Leader, Life Sciences, Appian

As Global Practice Leader, Life Sciences at Appian, Evi has extensive experience developing global business portfolios with emphasis on new products, technologies, and intellectual property. Formerly, VP of Global Innovation & Portfolio Management at Catalent Pharma Solutions with prior roles in Legal Affairs, R&D, Quality Assurance, Regulatory Affairs and Project Management at Teva. Evi holds an M.B.A. in Pharmaceutical Management, and an M.S. in Biotech, Biochemistry and Food Science from Drexel University, and a B.S. in Chemistry from the Hebrew University of Jerusalem.

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