Personalized medicine is the engine of progress
The development of personalized medicine encourages the creation of alliances between diagnostic and pharmaceutical companiesAccording to the new PricewaterhouseCoopers review "Diagnostics-2009: Moving towards personalized medicine" ("Diagnostics 2009: Moving towards personalized medicine"), the expansion of personalized medicine services aimed at improving the treatment of patients may contribute to the conclusion of more alliances between diagnostic and pharmaceutical companies.
This trend is confirmed by the recently announced deal between GlaxoSmithKline and the British diagnostic group Enigma, aimed at developing a new test that will detect specific strains of influenza, including pandemic influenza H1N1, in just one hour.
Although attempts to adapt treatment to the characteristics of a particular patient are not being made for the first time, it is necessary to achieve better results in this work, since today drug efficacy indicators can be very low – from 20% to 75%, depending on the specific drug.
Alina Lavrentieva, Partner, Head of PricewaterhouseCoopers practice in Russia for working with pharmaceutical companies, notes:
"According to our calculations, over the next two to five years, the number of alliances between diagnostic and pharmaceutical companies in the industry will increase. The main factors influencing the formation of such alliances will be the prices for diagnostics, the degree of reimbursement of drug costs by the state, as well as the burden of clinical trials that are required to bring new medicines to market.
Although from a medical point of view, the need to create tests to determine the conditions for prescribing a particular drug is obvious, economic considerations complicate such work. The cost of such tests does not always reflect the level of costs for their development and their significance for the general state of health, and this may negatively affect the economic justification for the development of a new diagnostic method.
It is very important to find a solution to this puzzle in order to make diagnostics a full-fledged means of improving the health of patients. This solution will also become an essential element in the toolkit that allows the pharmaceutical company to improve its portfolio of drugs and the process of their development."
The PwC study highlights that personalized medicine plays a prominent role in current mergers and acquisitions, as well as licensing deals in the laboratory diagnostics (in vitro) sector. In 2008, personalized medicine served as an incentive for the conclusion of three of the ten largest mergers and acquisitions and four of the ten licensing deals in the laboratory diagnostics sector.
According to PwC experts, a number of factors will contribute to the development of personalized medicine and increase the value of innovative diagnostic methods:
• Regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA), which support the field of personalized medicine by introducing official requirements for testing for certain biomarkers before prescribing certain medications.
• Legislative acts adopted in May 2008 in the United States and Europe aimed at protecting individuals from discrimination as a result of the use of genetic information may increase the number of people willing to undergo genetic testing or participate in innovative research.
• The civil petition of the pharmaceutical company Genentech, filed in December 2008, renewed the discussion around the lack of a unified approach to regulatory regulation of the process of bringing new methods of laboratory diagnostics to the market.
• Formal approval of new diagnostic technologies in standards developed by reputable clinical communities, which should accelerate the introduction of these technologies on the market. The MammaPrint method of Agendia (a DNA–based test that allows you to determine the risk of breast cancer spreading to other organs) is an example of a new diagnostic method that helps to develop an individual treatment program. Recently, this method was tested by an influential clinical organization – the Dutch Institute for Health Improvement (CBO).
Alina Lavrentieva makes the following conclusion:
"Over time, there will be fewer and fewer pharmaceutical companies that will begin the clinical development of a particular drug without a clear program for the diagnosis of relevant diseases. Companies are aware of how important the role of diagnostics is in the success of clinical trials and the introduction of new drugs to the market. In addition, when a decision is made to reimburse the costs of a medicine, the availability of the results of concomitant diagnostic tests is also taken into account, since the payers of the healthcare system are paying more and more attention to this. Together, these factors can contribute to the development of new diagnostic methods for personalized medicine. We believe that the emergence of appropriate alliances and the strengthening of cooperation between industry participants is inevitable."
The full text of the study ‘Diagnostics 2009: Moving towards personalized medicine’ can be downloaded here.
Portal "Eternal youth" http://vechnayamolodost.ru25.08.2009