The Process of Drug Development: Time to Market



Pharma IQ
11/10/2010

The term Drug Development covers a wide range of activities, from clinical trials to the creation of new compounds, all of which help drive a particular product to market.

In its entirety, the process can take more than a decade, and cost pharmaceutical companies millions of dollars, with the vast majority of compounds proving unsuccessful.

Biopharma company UCB claims that it is likely that out of ten thousand of compounds tested during the drug development process, only one of two of these are likely to make it to market for use by patients.

Increasingly, time to market is becoming a bigger factor within drug development, making any systems or technology which can increase the speed of the process highly valuable.

As a report on cancer drugs, created by Deloitte, identified recently: "Scientific innovation has brought measurable rewards such as reduced development times, higher success rates for cancer drugs, and increased investment and activity across the biopharmaceutical industry."

The drug development process

Firstly, scientists will identify targets associated with the disease being treated, and the compounds they believe will influence these. The target will then be prioritised and validated based on the ability of the compound to affect the cells.

A lead compound – one which is thought to have the potential to treat the disease – is then identified, which can be compared with existing drugs to establish if they are likely to be successful. Lead optimisation the takes place, where scientists then identify the compound which will be most effective.

Once these stages, which often include testing on some living organisms, have been completed, the compounds will then move on to the Clinical Trial phase, which may first include testing on animal subjects.

Phase I is the first stage where the products are tested on human subjects – generally a small number of healthy volunteers. Phase II trials involve testing on several hundred subjects with the condition to test the safety of the drug, while Phase III tests the drug on patients to compare it with others already on the market.

From here the drug must gain approval from the required regulatory authority.

The European Union has been making efforts to improve the efficiency of the early stages of drug development, launching a consultation "to improve clarity and alignment among the stakeholders regarding what constitutes a medicine’s value and the evidence required to demonstrate that value most effectively".

Companies participating in the project developing either breast cancer or type 2 diabetes treatments, will receive consultations within the next four months, although all recommendations will be non-binding.

Opportunities for CNS and Oncological drug development

Alzheimer's and Dementia are emerging as two diseases which are likely to be the focus for drug development in the coming years, particularly in the United States.

The Pharmaceutical Research and Manufacturers of America (PhRMA) identified that as the baby boomer generation begins to age, demand for such medication will increase. 

In the United States, the numbers of those aged 65 or over is likely to double by 2050, which PhRMA predicts will mean the number of Alzheimer's patients has the potential to more than double.

If advancements are not made in the treatment of the disease, the costs of Alzheimer's patients to the economy will reach $1.08 trillion (£663 billion) in 40 years time.

However, biopharmaceutical companies were already said to be working on 98 medications for dementia at varying stages of the drug development process, including those in the clinical trial phase and drugs waiting for approval from the FDA.



John Castellani, president and chief executive officer of PhRMA, said that costs are likely to become "unsustainable" if new treatments are not discovered.

Cancer is another major focus for drug development. Figures from the Association of Clinical Research Organisations show that in 2008, 18 percent of the clinical trials its members conducted were in the field of oncology, which involved 67 unique cancer drugs.

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