Accelerating Drugs to Market Despite Challenges, Adaptive Clinical Trials Reduce Drug Development Costs and Time to Market, presents various tools and strategies which can accelerate a drug to the market. In this report, GBI Research has studied various hurdles at different stages of drug development that can halt a drugs development. The report provides detailed information about the need for accelerated drug development. Declining R&D productivity is highlighted as one of the major needs to be addressed. The report outlines misconceptions regarding accelerated drug development; one such major misconception is the cost of development. The cost of an accelerated development program can be effectively managed by implementing a structured and complete program. The report highlights major strategies adopted by pharmaceutical companies to accelerate drug development. The adoption of the latest technologies in lead generation, preclinical stages, and the use of adaptive designs in late phase studies are regarded as tools to accelerate drugs through these stages of development.
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The process of drug development starts from the initial discovery and ends with a final medication. This is an expensive, lengthy and incremental process. The main objective of the process is to identify a molecule with the potential for producing the desired effect in the human body, and to establish the quality, safety and efficacy of the molecule for treating patients. In the present scenario drug development takes about 12 years, for a molecule to progress from the laboratory and enter the pharmaceutical market. It is estimated that out of 5,000 compounds which enter the preclinical stage of development, only five compounds will be successful enough to be tested on humans, and only one among them will be approved. The slow pace of drug development greatly affects the pharmaceutical industry and patients who are in need of new therapeutics to treat their illness.
The current process of drug development begins with the synthesis of molecules, which targets specific proteins in living cells. It is followed by in vitro tests to identify any specific toxicity associated with the synthesized molecules. The compounds which make it through this stage will go further and will be tested for in vivo toxicology studies. The information gathered from these studies is utilized for planning and conducting clinical trials in human subjects.
It is important for biopharmaceutical companies to launch their products more quickly in the market, as this will lead to early revenue generation from the product. As a large number of drugs fail at the later stages of drug development, pharmaceutical companies try to maintain their revenues by launching new drugs at the earliest possible time. The decline in the total number of new drug approvals by the regulatory bodies and the patent expirations for major blockbuster drugs are forcing pharmaceutical companies to consider ways in which the time and cost of clinical trials can be reduced without affecting their quality.
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The report presents various tools and strategies which can help to accelerate a drug to market.
The report provides detailed information about the need for accelerated drug development.
The report outlines misconceptions regarding accelerated drug development.
The report provides information on trends in drug transition and strategies and models adopted to accelerate drug transition through the various stages of development.
Description of the methods for optimum patient recruitment and retention in a clinical trial.
Analysis of efficient clinical trial site management so that completion of a trial is done on time.
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Develop strategies to implement the use of various technologies for advancing drug discovery and development in an efficient manner.
Understand the use of biomarkers and surrogate endpoints, improvised clinical trial designs and better recruitment and retention of subjects in clinical trials, in order to avoid drug lags in various phases of development.
Prioritize design elements of study protocols and balance the overall protocol.
Ensure efficient clinical trial outcomes by implementing CDISC standards.
Understand the utility of operationally seamless Phase II/III design for instantaneous transition of the drug from Phase II to Phase III.