Drug development successful management

The end result for drug development is to successfully supply cost-effective drugs that provide better patient treatment, offering cures from new therapies and improvements in disease management including the development... 

The different ways in which research is organized as between firms in the Henderson-Cockburn sample have striking effects on the probability of success. The authors note the presence of enduring idiosyncratic differences among firms in the organization and management of the drug development... 

An impressive variety of LC/MS-based solutions, incorporating quantitative and qualitative process approaches, are now routinely applied to accelerate drug development. The results are significant and led to the successful development of innovative therapies and numerous novel drugs. The use of LC/MS with other technologies for sample preparation, analysis, and data management is now an inextricably linked element of drug development. 

Analysts study companies pipelines and calculate the probabilities of successful clinical trials in preparing advice on their own investments. Investors tend to have a much shorter-term view than industiy managers and scientists can afford to have. The influence of investors on drug development decisions should not be underestimated, and the influence is not always positive. 

The potential for clinical translatabUity of preclinical findings of pancreatic toxicity needs to be determined on a case-by-case basis. Since pancreatic toxicity is a known risk factor for many approved drugs, it is clear that, if first identified early on in a drug development program, the risk does not necessarily preclude the further development of the drug candidate. However, such risk would need to be fuUy understood mechanistically, so that its potential for extrapolation to humans could be determined, successfully monitored and managed in the chnic, and balanced relative to the desired benefit of the proposed drug candidate for the patient population. 

The prospect for cancer treatment in, say, twenty years, is very likely to be a mix of the newer successful targeted therapies and improved existing ones. New cytotoxic agents will continue to play an important role in die clinical management of cancer and innovative platinum agents are therefore still of clinical interest. Iliis chapter reviews experiences in platinum drug development from an academic perspective. 

An example is a view given to us by a discovery manager that if a drug candidate could not reach a successful market launch, the next best thing for a discovery team would be to have their compound progress to late stages of development before failure, because this implies that any problem was hard to predict, for example, a rare event. Yet this is exactly the most expensive kind of failure. 

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