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Emerging Clinical Trial Locations – India

A number of key issues confronting the pharmaceutical and biotechnology industry have been identified. These are generic competition, intellectual property protection, managing regulatory compliance, cost containment and government funding restrictions, obtaining and maintaining competitive advantage, recruitment and retention of a skilled workforce, improvement to research and development productivity, reducing time to market for next generation drugs and high risks and costs associated with drug development.

Issues concerning the costs associated with drug development have been identified as: escalating costs associated with clinical trials, global increase in the number of clinical trials conducted, longer R&D development times and increased attrition rates during R&D.

Introduction

Over the last decade both the pharmaceutical and biotechnology companies have entered a period where they have become confronted by a variety of complex issues affecting their operational efficiency and profitability. It has now become generally acknowledged that the current business models have now become both economically unsustainable and operationally unsuited to act quickly enough to produce the types of innovative treatments that will be demanded by global markets. The key issues and challenges (as depicted in Figure 1) that are currently being confronted by the pharmaceutical and biotechnology industry have been identified as:

Generic competition

All research based pharmaceutical and biotechnology companies are affected by and having to overcome the issues relating to the expiry of the patents protecting their major products and the emergence of generic competition. This ranges from traditional “blockbuster” products whose patents have already expired e.g. Eli Lilly’s Prozac to products that will be losing patent protection between 2010 and 2013. This includes Pfizer’s Lipitor, the world’s number one selling brand, Sanofi-Aventis/Bristol-Myers Squibb’s (BMS) Plavix, the best selling platelet aggregation inhibitor, and Novartis’s anti-hypertensive Diovan.

Intellectual property protection

The core principle of most pharmaceutical and biotechnology companies is their innovative research-driven approach to the discovery or invention of genuinely new drugs. As the biotechnology/pharmaceutical industry continues to develop it has become increasingly aware that there is a need to protect the intellectual property associated with the discoveries that have been made and will continue to be made. The principle methods by which companies and individuals are able to protect intellectual property are patent, copyright, trademark, and trade secrets such as sales revenues and proprietary market share data.

 

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