Costs associated with drug development have risen from around $138m in 1975 to over $1 billion in 2005, with clinical trials representing a key factor in this increasing expenditure.
Clinical trials have grown longer and more complex, while volunteer enrolment and retention rates have fallen. More than 30% of experimental drugs that reach Phase III fail at this point. Late stage failures are costly to the industry - Pfizer's torcetrapib, which failed its Phase III trial in 2006, led to the value of Pfizer dropping by $21 billion over night, and 10,000 job losses being announced the following year.
Recent analyses show that this problem has grown in recent years. Overall, clinical approval success rates have fallen to approximately 16%, though this figure varies widely by therapeutic area. Pivotal trial and regulatory failures were recorded for 31 drugs in 2011, with Eli Lilly, Bristol-Myers Squibb, AstraZeneca, Merck, Sanofi, Novartis and GlaxoSmithKline all suffering at least one setback.
The most common reason for drug failure during Phase II development is a lack of efficacy as determined by primary endpoints. Phase III failures tend to be in therapeutic areas that may provide a higher chance of approval and reimbursement, such as cancer or neuroscience. Whilst it is tempting to speculate that drug development is more difficult for drugs with novel mechanisms of action in these areas of unmet need, this data implies that the pressure on companies to keep development pipelines full may also have led to compounds advancing into Phase III on the basis of inadequate or marginal proof-of-concept.
Others have argued that the majority of failures in clinical trials are due to the inadequacy of animal models to predict success in humans, implying a fundamental flaw in drug development processes which use animal testing methods.
It is essential that R&D productivity is improved, and the 'quick win, fast fail' model is being touted as a possible way to achieve this. This model argues that investments made early in the process increase the information available on which to base key decisions, enabling the earlier termination of projects prior to huge investments being made for the Phase III program.
This research report examines the reasons why the pharmaceutical industry is looking for improvements in efficiency whilst acknowledging that pharmaceutical R&D remains a long and risky process. It looks in detail at precompetitive research and evaluates how the industry is pulling together to research solutions to problems that are common to all companies. The report investigates innovation in the clinical drug development arena, documenting modeling and simulation based approaches to improving efficiency, as well as novel clinical trial designs. Lastly, the report examines innovation in business models within the industry that aim to help the industry to achieve its mantra of "doing more with less", which will be critical for its future success.
The report is built using information from primary and secondary research including interviews with experts in the field.
Our analysis shows that collaboration and open innovation will play increasingly important roles in the future by enabling research that would not be possible for companies to undertake individually. Many examples exist, driven in large part by the FDA's Critical Path Initiative and the European Innovative Medicines Initiative, and experiences gained by early consortia will help facilitate the logistical challenges of setting up new collaborations.
Within companies, innovations including the increased use of modeling and simulation throughout the drug development process, adaptive clinical trials and exploratory clinical trials have all been studied for some years, suggesting that innovation is hard, but important. Innovation is also occurring in the business models applied within individual companies to enable them to achieve "more with less". Through adoption of new scientific approaches and business models, companies are hoping not only to refuel their pipelines but to regain the confidence of investors and the public in their ability to deliver meaningful treatments for patients at the same time as generating profits in the coming years.
- Detailed analysis of the reasons for the industry to be looking closely at improving efficiency
- Definition of precompetitive collaboration, analysis of areas in which precompetitive collaboration is occurring, and discussion of the expansion of this space in the future
- Explorations of the key challenges facing consortia and the factors that make them successful
- Case studies of key innovations in drug development including model-based drug development, adaptive clinical trials and exploratory clinical trials
- Detailed insights into innovation in business models, including virtual networks, open innovation and extensive academic collaborations
Reasons to buy
- Identify key projects in the precompetitive space
- Learn the most important factors for successful precompetitive collaborations
- Develop strategies and priorities for participating in precompetitive collaborations
- Understand current thinking on innovative areas of drug development, including model-based drug development, adaptive clinical trials and exploratory clinical trials, from the viewpoints of companies and regulators
- Explore the business models and partnerships of the largest pharmaceutical companies to support new drug development strategies
Click for Report details:Pathways to Efficient Drug Development - Advances in Modeling and Simulation Outcomes to Fuel Pipeline Productivity