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Globalization of Drug Development Operations:Evolution & Opportunities

Venture Center,Pune

Thursday, August 30, 2012 from 4:00 PM to 5:00 PM (IST)

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BioPune Seminar  # 2




“Globalization of Drug Development Operations: Evolution & Opportunities”






Chitra Lele,


PhD, Chief Scientific Officer, Sciformix Corporation






Taking a page out of the globalization and off-shoring of software development, global pharmaceutical companies started planning support of their drug development operations from offshore locations about 15 years back. India featured prominently in the plans.



 This presentation will provide an overview of the type of activities and processes that have been supported from offshore locations, how they have evolved, the domain expertise and skills required to perform these and how the required capability has been built in India. We will also look at how this trend has led to creation of an entire segment of the off-shoring industry in India, which business models have emerged, how entrepreneurs have responded to the opportunity and how the current trends are likely to shape the future of this industry. We will also briefly review the relevance of this development to the pharmaceutical industry in India.


About the speaker:



 Currently Chief Scientific Officer of Sciformix Corporation, a KPO that focuses on


Safety and Risk Management, Biostatistics, Pharmacovigilance, Scientific writing & Regulatory Affairs; member of the founding team  Prior to Sciformix, was Executive Director, Development Operations India, Pfizer Global R&D .During 9+ years at Pfizer, was responsible for establishing the first offshore Clinical Data Management centre in India, and then growing it to a size of over 400, including captive and contract resources. Prior to Pfizer, worked as a biostatistician in Medical schools in the US, and as a faculty member in US & in India.



 Other significant professional activities:



(1)    Instrumental in setting up Academy for Clinical Excellence (ACE) at the Bombay College of Pharmacy (BCP), a governing council member and a course developer and faculty member.


(2)    Founding member of the Indian Association for Statistics in Clinical Trials


(3)    Visiting faculty member at University of Pune and at IIT Bombay for several years, involved in teaching and research activities


(4)    Instrumental in creating awareness about applications of statistics in clinical trials in India and in developing M.Sc courses on this topic


(5)     As a pioneer in setting up offshore statistics and data management operations in India to support global clinical trials, was responsible for advising several global pharma cos and CROs who set up similar units in India and thus contributed significantly to the establishment and development of this profession in India


(6)    Associate member of the Society of Actuaries, USA






Have questions about Globalization of Drug Development Operations:Evolution & Opportunities? Contact Venture Center,Pune

When & Where

Training Room, Venture Center

Thursday, August 30, 2012 from 4:00 PM to 5:00 PM (IST)

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Venture Center,Pune

Welcome to Venture Center

Venture Center strives to nucleate and nurture technology and knowledge-based enterprises by leveraging the scientific and engineering competencies of the institutions in the "Pune region" in India. The Venture Center is a technology business incubator specializing in technology startups offering products and services exploiting scientific expertise in the areas of materials, chemicals and biological sciences & engineering.

The Venture Center is the trademark of Entrepreneurship Development Center, a not-for-profit company hosted by the National Chemical Laboratory, Pune, India.

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