Big Pharma's Recent Challenges

ISSN: 2213-4778 (Online)
ISSN: 2213-476X (Print)

Volume 4, 3 Issues, 2017

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Applied Clinical Research, Clinical Trials and Regulatory Affairs

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Satish Chandra
Tawam Hospital
Al Ain

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Big Pharma's Recent Challenges

Applied Clinical Research, Clinical Trials and Regulatory Affairs, 1(1): 28-36.

Author(s): Harish Dureja, Neelam Dalal and Swagat Tripathy.

Affiliation: Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak-124001, India.


The golden era of drug discovery and development began to show cracks as research productivity has started to slump for such reasons that business analyst finds difficult to trace any specific point. To sort out this problem, this paper highlights not only few areas that are really exacerbating the situation such as imminent patent expiry of drugs, shrinking pipeline of NME, challenges from Regulatory Agencies, changing disease state and ageing population, worsened risk/reward ratio for research and development outlays, narrowing Return on Investment (ROI) for the Pharmaceutical R&D Industry and the related rise of cheaper generic alternatives, but also few approaches such as mergers and acquisitions, consolidation, diversification, in licensing, and strategic alliances that Industry is following to make Pharma business environment sustainable.


Aging population, branded generics, mergers and acquisition, new molecular entity, outsourcing, patent, pay for delay, personalised medicines, product hopping, regulatory challenges, return of investment, risk-reward ratio, technology-led discovery.

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Article Details

Volume: 1
Issue Number: 1
First Page: 28
Last Page: 36
Page Count: 9
DOI: 10.2174/2213476X114016660001
Adaptive Designs in Clinical Trials

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