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Pharmaceutical Manufacturing and Packing Sourcer

Supply and Demand

The R&D of a new molecular entity (NME) is a constant battle and requires tradeoffs between the budget set by the organisation, product development goals, personnel available and the public health issues of the country. The total worldwide R&D expenditure of pharmaceutical and biotechnology companies increased from $108 billion in 2006 to $141 billion in 2015. Paul et al reported that:
  • Drug discovery and preclinical development account for 33% of the total cost per NME ($281 million)
  • Clinical development (Phase 1 to submission) represents 63% ($548 million)
  • Submission to launch costs 5% of the overall expenditures per NME ($44 million)
Discovery research lasts four and a half years; preclinical testing continues for a further year; the three clinical development phases take 1.5, 2.5 and 2.5 years respectively; and the phase from submission to launch requires another 18 months. The above is a clear testimonial of the significance of the whole clinical research process that accounts for the majority of the cost and time involved in bringing an innovation to market.

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With over 19 years of clinical research experience in global project management and CTS, Partha Chatterjee is Head of Clinical Research and Clinical Trial Supplies Management at SIRO Clinpharm. A postgraduate in Microbiology from the Institute of Science, India, he was one of the earliest members of the company and his knowledge and expertise have been pivotal in managing numerous key clinical trials across therapeutic areas such as oncology, nephrology, endocrinology and infectious diseases.
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Partha Chatterjee
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