How Drugs Are Developed: 3rd Edition

Informa Healthcare
September 1, 2007
236 Pages - SKU: IFHC1693929
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Overview
The principles of R&D have not changed markedly in the intervening years, but like any industry, Pharma has been forced to take stock of the manner in which it operates. Analysis of financial profits and losses consistently shows that increasingly greater investment is required for reduced number of marketed products.

Despite the introduction of new technologies aimed at faster and more innovative drug discovery, the numbers of new introductions with novel mechanisms of action has remained constant. And threats to public safety, whilst rare, demand ever more stringent regulatory procedures.

Description
The industry continues to consolidate through merger and acquisition. Although these activities in themselves rarely provide long-term growth, they provide an opportunity to divest activities no longer considered essential for in-house ownership. From this has sprung the need for contract organisations. Specialist companies with expertise upon particular phases of pharmaceutical R&D which range from supply of drug targets and chemical building blocks, through non-clinical development and on to clinical evaluation and regulatory affairs.

Innovation in the industry is not at a standstill, it has changed direction. Where once, small molecule research provided the mainstay, biological drugs are now making their presence felt. While the range of genomic sciences waits to make its impact, biologicals are providing the current focus for novel discovery. This move doesn't come without a price. Biologicals do not behave like small molecules; they have large molecular weights and are most usually species specific. The rules for their development are different and often little understood; witness the tragedy which occurred at Northwick Park following the administration of an immune activator to healthy volunteers in March 2006.

The 2007 update to How Drugs are Developed responds to these changes. Sections which were previously focussed upon small molecules have been expanded where necessary. There are two new chapters outlined below:
  • project management
  • the fundamentals of managing multidisciplinary teams and the ways in which the role is changing to encompass external as well as internal interfaces.
  • expansion of translational research
  • ways in which laboratory concepts can be converted into medical advances
The updated report will provides you with:
  • An introduction to the drug discovery and development process
  • Definitions of all the key terms
  • Detailed explanations of all technologies involved
  • An overview of the legislation and regulation governing drug discovery and development
  • Clarification of the roles of individuals, departments and business functions within R&D


 

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