Life Sciences company Millennium Pharmaceuticals and its joint venture partner, DNAture Group, announced today that up to five years can be cut off new drug delivery by short circuiting clinical trials.

Recent ground-breaking developments in pharmaceutical genomics now enable individuals to access unique treatments based on their own genetic blueprints. The increasingly effective design of diagnostic products and the delivery of specific patient treatments, mean that shorter times are needed for clinical trials.

The breakthrough in unlocking the human genome made it clear that ‘personalized medicine’ targeted to the individual, was a way to a new future. There was a shift in thinking: if you had a cure for one particular person, based on their specific genetic blueprint, why should you have to prove through years of clinical trials, that this cure works safely on the entire population?

The benefits of designer medicine, as opposed to the mass delivery of branded drugs, is potentially vast. DNAture Group (a Deloitte company) is also supporting Millennium with the development of its extensive network of booths, where your DNA blueprint is captured and analyzed digitally while you wait.

Using a cellphone individuals can transmit their genetic blueprint to Millennium and receive an online diagnosis within the hour.

ANALYSIS >> SYNTHESIS: How this scenario came to be

Background

‘Pharmacogenomics’ – the use of genomics to prescribe medication will mean drugs can be genetically targeted to ‘fit’ individual patients. Pharmaceutical companies around the world will be able to recoup billions of dollars’ worth of drug research – which is why many pharmaceutical companies are becoming ‘life sciences’ companies.

The pharmacogenomics revolution promises to:-

– Optimize the efficacy of therapeutic compounds, using the molecular understanding of disease to more effectively design treatments and diagnostic products
– Minimize adverse drug reactions and associated long-term costs
– Manage clinical trials with greater productivity and enhance their cost effectiveness
– Facilitate drug discovery, development, and approval – deliver novel products that significantly improve patient outcomes

Timeline

1993: Millennium Pharmaceuticals founded>

Millennium Pharmaceuticals is founded with a vision ‘to transcend the limits of medicine’. In its early years the company is focused on building top-notch science and business teams to help achieve its vision.

1994 onwards: Alliances formed

Millennium creates scores of strategic alliances with leading pharmaceutical and biotechnology companies, providing access to committed funding in R&D.

2000: New drugs takes up to 15 years

The new drug delivery pipeline averages 12-15 years.

2002: Human genome unlocked

With the breakthrough in unlocking the human genome, it becomes clear that ‘personalized medicines’ targeted to individuals, are a way to a new future. There is a shift in thinking: if you have a cure for one particular individual (based on their specific genetic blueprint,) why should you have to prove through years of clinical trials, that this cure works safely on the entire population?

Millennium chief executive, Mark Levine, explains, “Our goal is to use our understanding of mechanisms and pathways of disease together with the unique characteristics of the individual, to accelerate the prevention, detection and cure of illness. Millennium’s goal in personalized medicine is to redefine diseases on the molecular level, so that diagnostics and therapeutics can be targeted to specific patient populations, thus providing the right treatment to the right patient.”

“Our approach to personalized medicine relies on our knowledge of the human genome and disease biology, to focus on developing diagnostic and therapeutic products that target the underlying elements of disease and the molecular profiles of specific patient populations,” says Levine. “Personalized medicine represents a significant advance from most current diagnostic methods and therapies, which were developed to detect and treat the symptoms and the apparent causes of disease, broadly, across all patients.”

The notion of designer medicine has now been in use for a few years in the United States, in the field of customised vitamins – essentially a prescription for designer vitamins that are formulated on the specific patient’s deficiencies and lifestyle.

September 2003: Sept 2003National molecular library

The US National Institute of Health rolls out a national molecular library in an effort to accelerate the development of new drugs and nano scale agents for an ‘era of personalized medicine’. “We are headed toward an era of personalized medicine,” says Roderic Pettigrew, director of the National Insitute of Biomedical Imaging and Bioengineering. The library will act as a repository “for some of the hundreds of thousands of molecules the pharmaceutical industry screens for their use in identifying target agrents that could be uused to track or treat diseases,” adds Pettigrew.

Despite the infancy of personalized medicines, genotype-specific medication is no longer a fiction of the future, but a reality of the present.

October 2003: Oct 2003Genome on a chip

The genome on a chip has arrived. With pieces of all 30,000 or so known human genes, the new integrated gene chips, or microarrays, will allow scientists to scan all genes in a human tissue sample at once to determine which genes are active (turned on) in an organ compared with those active in a healthy organ. Pharmaceutical companies will use them to predict drug effects.

This previously required two or more chips. The new whole-genome chips will lower the cost and increase the speed of testing to achieve the genomics equivalent of Moore’s law.

2006: Delivery pipeline 5-7 years

Supported by DNAture Group, Millennium trials the short circuiting of clinical testing, with the aim of cutting up to five years off the delivery time for individual-specific treatments, based on genetic blueprints. The new drug delivery pipeline now averages 5-7 years.

2009: Delivery pipeline 2 years

Millennium cuts five years off the drug development pipeline. The benefits of genomics and brand new biotech platforms have become apparent and made faster delivery commercially viable. The new drug delivery pipeline takes a matter of months.