The Molecular Revolution
Subtitle: A Future With Immense Opportunity. From medicines for "evry body" to medicines for "my body".  (Personalized medicine).
Publisher: Raider Publishing International
Published: 2008
Place of publication: New York, London, Johannesburg
Language: eng
Format: Paperback
Number of pages: 460
Description: “The Molecular Revolution” is the title of a new book by Gilbert Mertens, Healthcare Policy Adviser, International Institutions. It is an in-depth, wide-ranging, fact rich and thought provoking analysis of the issues and dynamics driving Healthcare stakeholders towards a future of unseen therapeutic, preventive and predictive opportunities in healthcare. It masterly synthesizes future scenarios in a promising, fast changing health & wellness-care environment, and the credibility aspect of targeted medicines‘ claim of efficacy,  created by advances in medical care.

Gilbert Mertens has extensive experience of working within the healthcare industry,  including an extended period as a general manager with both a major global pharmaceutical company in Germany, and a leading international communications agency in Paris, France. Based on his profound knowledge of the European and US healthcare sector and his personal relationship  with many renowned scientists, national healthcare authorities and  his excellent access to business  leaders, Gilbert Mertens offers strategic healthcare management reflections to key decision makers under constant challenge to redefine  a multi-faceted, competitive  and constantly changing  healthcare environment. His series of Healthcare Management reports, published by the Financial Times and by Reuters Business Insight,  have been received within the  sector as benchmark reports. 

In this book, Gilbert Mertens writes that science will definitely contribute to turn medicines for “everybody” into medicines for “my body”. In an interview published on the Internet, Mr. Mertens gave us a glimpse of what he is explaining in his newest work:

Mr. Mertens, you state that  preparing for a future of unseen opportunity in healthcare requires a profound shift in thinking from all the stakeholders and that a new era of personalized medicine, ushered in by advances in biotechnology and genetic engineering (among other technologies), will  radically transform the nature of the healthcare systems world-wide. Can our Social Welfare State cope with this?

Advances in technology and better understanding of disease management is ensuring that  the aging population will consume 5% or more of GDP per year.  This can be forecast to grow from7-8% to an average of 12.14% of GDP. Most countries‘ current systems only fund half this amount. It could therefore be argued that we have barely started to address the impact of healthcare costs. In systems where healthcare is effectively free at the point of delivery, it is no surprise that the consumer of that service feels no pressure to control costs. Governments in industrialized countries  have tried a variety of discriminatory processes to introduce some element of control –largely without success- but with the consequence of effectively rationing healthcare, usually unfairly.  

The dangers of focusing a disproportionate amount of resources on high technology, curative care to the near total exclusion of primary health care; the increasing administrative burden on the system; drifting intergenerational relations; the unstoppable “social” healthcare systems financial deficits, amplified by Government’s appetite for all sort of taxes on medicines and medical services; the accelerating rhythm in genetic discoveries promising new dimensions in treatment of health disorders…the perception and possibilities of maintaining the welfare state, leading to reform after reform of the Western nation’s Health Care  systems in an aging world and a globally linked economy is one of today’s core social and economic issues, and will  remain at the center of the western post-industrialized countries’  political agenda for years to come.

The challenge is to eliminate wastage and abuse, to penalize socially driven cost escalation (tobacco, alcohol, drugs, etc.) and to encourage life cycle financial planning, to ensure better preparations are made by all individuals to manage their own care as they age, and...to think beyond cost containment measures.

The golden future of healthcare is ahead of us, not behind. Genomics open the horizons for discovery of treatments for unconquered diseases.   The future of gene-based drug therapy will allow patients to be classified into genetically defined subsets based on disease susceptibility and drug responsiveness, with the ultimate goal of optimizing drug therapy by improving efficacy and decreasing toxicity.
Does this mean that the Medical Community is now at a crossroads?
Ethics and human suffering run headlong into direct conflict with a healthcare system in need of general overhaul. The driving force behind the development of health economics is the increase in healthcare costs worldwide, no matter which health care system is concerned. 

Not too long ago, the cost of medicines did not matter that much, and only the efficacy, safety and quality of the pharmaceuticals involved were the parameters any decision was based on.  But particularly for pharmaceuticals, costs have become a key issue (although prescription drugs take only a 10% share of the total healthcare spending, they receive a 90% share in the attention of health authorities).  And, consequently, pressure on prices for the pharmaceutical industry’s products has increased dramatically. From their side, doctors face unprecedented cuts in their already modest  (when compared to other professions and to their responsibility) revenues; the pharmaceutical industry is being blamed for its “excessive “ promotion and prices.

Turning  scientific progress in therapies to prevent or cure disease is what the medical community expects from the pharmaceutical industry. In view of the many unresolved health problems, Society expects the industry to continue playing an important role in the discovery process of new medicines. At an accelerated pace. 

Is the industry ready? What about the vision of those who have the experience of making drugs?  Is the pharmaceutical industry ready to tune in to a changed new healthcare world? What changes will the medical community itself undergo?

Calculations are easily made of how one can create and develop blockbuster drugs, but the reality is that barely 1% of all drugs reach a turnover of US 1bn. The rapid decrease of the patent period makes it less likely in the future that billion dollar drugs will dominate top-line growth. It is more likely that ever more money will need to be invested in marketing in order to grow each of the products to its maximum sales.  The salvation of the large companies will be their effective product development, leaving the discovery itself to external entrepreneurs. In the search for higher efficiency and profit, the larger companies find themselves progressively more dependent on outside expertise, alliances, cooperation, mergers.

The drug industry has not much time left to decide how it will metamorphose itself. Instead of recognizing and responding to the fundamental changes facing their sector of activity, many companies will stick to their tired ideas. Expect and prepare for exciting times in a health care industry with new dimensions.
Your description of turning medicines for EVERYBODY into medicines for MY BODY is fascinating. The pharmaceutical industry focused its strategy on  Medicines for the Masses. It brought them substantial profits. Why should they change their philosophy?
The pharmaceutical industry creates brands, invests in brands, and sees the investment disappear in smoke in a relatively short period of time, due to its own success of constantly creating new, better medicines. No other industry is destroying  its success, and the huge efforts to get there, at such a rapid pace. 
Thanks to many great  scientists and intelligent industry leaders, Society became used to a constant flow of new, better medicines.
The healthier Western society became, the more it regarded maximum access to medicine as a right and duty, the more medicine it craved and the more it required from that super-medicine. Everyone wanted the best medicine…provided someone else pays the bill. High expectations from society and investors alike, pushed industry leaders to focus their efforts on few, high selling primary care drugs (by preference for the chronically ill). 

The „one size fits all“ primary care blockbuster medicines model is primary an American one if we consider the healthcare system, the US market and the number of patents that will expire in the very near future. The consequences of „blockbuster“ patent loss for pharmaceutical companies are a key consideration. This system presupposes a launch of 2 to 3 new chemical entities (NCE) per year to maintain double-digit growth of the „blockbuster-based“ company. Mission impossible. From the medicines supply side, society will experience two major categories of drugs: generic compounds for the masses (generics will assume a more central role as patients bear a greater percentage of their healthcare costs and payers seek to restrict the growth of healthcare expenditures), and more targeted therapies for „niche“ patient groups.

You know that Europeans are considered to be the better niche-players, compared to the global thinking and aspirations of the Americans. What does this all mean for Europe? 
For science to advance, researchers need to have a vision of what the future may hold. Many scientists have built their careers on being able to foresee the critical trends in medical science, in fields ranging from stem cells to genetics to health-care policy. Europe's regulatory overreach, resulting from its view that society can be rationally planned and directed, thereby making the union of 27 selfish nations  (with 27 national health authorities defending their specific interests) the tax and spend champions of the world, forced the medical community (researchers, physicians, pharmaceutical companies, biotech entrepreneurs)  to leave for more supportive regions. It resulted in a reversal of the European dominance of drug discovery that had held sway since the Industrial Revolution. It  allowed America's medical-industrial sector to rise to dominance.

Shortsighted European, particularly German healthcare politics resulted in a climate that one can describe as  most unfriendly to medical innovation. It is amazing that there are still scientists having the courage to stay.

In the meantime, everyone has become aware of the fact that the India-China region will come more on its own in the twenty-first century and their enthusiastically developing pharmaceutical industry, aware of the huge challenges and opportunities it faces, will respond with increased investment in R&D and new technologies in order to participate in tomorrows smaller but in number rapidly proliferating, high return-on-investment generating, and more individually tailored custom business. The industry has already moved far from its origins as the producer of copycat drugs, has extended its scientific network by e.g. cross-border alliances, and is evolving quickly towards becoming a highly specialized sector, resulting in a number of companies that will be among the global leading experts in well-defined areas of a more sophisticated drug discovery and development process.

Coming back to your description of medicines for every body turning into medicines for my body,  how do you see a healthcare industry reinventing itself?
In order to meet the demands of tomorrow’s healthcare, as well as those of the financial community, the monolithic pharmaceutical industry, unable to respond to the demand of a multitude of specialty has to fundamentally rethink its value proposition. 

The medical product development process is no longer able to keep pace with the tremendous basic scientific innovation. Only a concerted effort to apply the new biomedical science to medical product development will succeed in modernizing the critical path.  The new science is not being used to guide the technology discovery process in the same way that it is accelerating the technology discovery process. For medical technology, performance is measured in terms of product safety and effectiveness.  Not enough applied scientific work has been done in creating new tools to get fundamentally better answers about how the safety and effectiveness of new products can be demonstrated, in faster time frames, with more certainty, and at lower costs. As a result, the vast majority of investigational products that enter the clinical trials fail. 

In the 1960s, scientists discovered three different classes of clinical drug, each of which recognized DNA in a different way. Subsequent drugs have used only these three ways to recognize the DNA. 
New research, announced early 2006,  has isolated a fourth, which is completely different and opens up entirely new possibilities for drug design. This discovery will revolutionize the way that drug developers think about how to design molecules to interact with DNA. It will send chemical drug research off on a new tangent. By targeting specific structures in the DNA scientists may finally start to achieve control over the way our genetic information is processed and apply that to fight disease. 

Will this contribute to make the development of new medicines even more costly than it is already?
By 2015, and largely due to the billion dollar cost of basic drug research, only five to seven of today’s major Western pharmaceutical companies, joined by a few newly arrived industry giants from India and China,  are expected to be responsible for 80% of global innovative drug  research. Society will have to decide if this is in the world community’s  interest? Will the world leave the choice of therapeutic research areas to a handful of company CEO’s? 
This fact did not yet receive much attention, but is going to be of crucial importance.

To the advantage of patients worldwide, progress in the battle against disease will come from those basic research driven drug developers that, by capitalizing on their knowledge and expertise in targeted medicines, and encouraged by patient advocacy groups and academics recognize the signs on the wall and will come to discover the real value of ‚neglected diseases‘; of less prevalent diseases. The focus of their drug discovery will move away from a small number of mostly chronic diseases that have been traditionally targeted by the medical research community and towards other, numerous areas of less prevalent diseases- This will, in turn, create a targeted medicines sector and, in time, lead to the development of personalized health  maintenance programs.  

From the economies of healthcare to biotechnology, and the ethics of genetic testing to ethnicity and individualized medicine, your book explores the new relationships that are being forged across the social, political, medical-industrial  sectors of the healthcare environment. What exactly will be the role of biotechnology?
Biotechnology is often called the “Third Industrial Revolution”. This is probably an understatement. The first two revolutions affected merely products and processes, material aspects of the quality of modern life. 
By many measures, medicines have played a major role in the improved health of the world during the 20th century. This becomes obvious when one simply looks at the 1930´s and the role medicines played in eradicating diseases during that period. The first real effective medicine, a sulfonamide called Protonsil red,  was launched in 1936. Let’s not forget that this was the start of modern medicine. And let’s not forget that this is just seventy years ago. Only seventy years ago.  In the 1960s again, medicines played a very substantial role in medical progress. They helped reduce mortality and improve quality of life. The biotechnology revolution addresses the individual himself as well as his individual aspects and perceptions. Biotechnology has already begun to change our society and culture persistently, with so far unseen speed and dynamics.

A scientific revolution is taking place. We are reaching new heights in our understanding of life and disease. In the past, the goal was to develop new drugs –proteins or small molecules—that helped correct the chemical imbalances within a body suffering from disease. Now, with the availability of genetic information, that paradigm has changed completely and forever. The drug providers of the future  do not simply produce medicines  anymore but advance and apply the use of scientific knowledge itself. This fact  transforms not only the research driven new drug developer’s  world  but the practice of medicine as well.

Can you be more precise?
Scientific research and new drug development  is to provide huge benefits over the next 20 years: 
 Therapeutic  advances will prevent  4.400.000 deaths from heart attacks and strokes;
 Lung cancer deaths will be cut by 400.000 as a result of new drug discoveries;
 New medicines will reduce leukemia deaths by 80.000 or more;
 Prescription drugs will decrease the severity of rheumatoid arthritis cases by as much as 50%;
 For many diseases, such as Alzheimer’s, and arthritis, new drug research and development will likely generate nearly all of the future medical progress;
 Breakthroughs in biotechnology will advance the fight against cancer and viral diseases.

Modern biology right now is in metamorphosis, much like physics at the beginning of the last century.  A transition takes place from a rather descriptive subject into a discipline that is coming to understand its molecular foundations.  Preconditions to this were technological developments in the 1970s and 1980s that made it possible to register the molecular base for relevant categories of molecules (DNA, RNA, proteins, metabolites) qualitatively and quantitatively. Most fundamental modern technological developments (such as recombinant DNA, sequencing, computer technologies) were developed in the US and are being commercialized over there faster and more consequently than anywhere else. Biotechnology has been responsible for a disproportionate number of the new drugs introduced to the market in recent years, accounting for nearly 60 percent of new molecular entities (NMEs) during 2006. Biotechnology’s greatest potential for curing chronic and currently “incurable” diseases lies in gene therapy.

Don’t you forget the role of the physician?
I am not going to predict that the doctor as we know him today will be replaced by a kind of intelligent robot. Human suffering  will increasingly need emotional care, not less. This said, the medical doctor will no longer be the main repository of medical expertise for a sophisticated patient. The accelerating rate of change in medicine makes the “half-life” of knowledge too short. We are not far from the time when the most up-to-date information will be obtained from a database run by a computer expert or dedicated server and where the last missing link to semi-automated medical care is long-distance accurate diagnosis, something that has already been proven to be feasible.
The medical world pays much attention to new drug delivery systems, to alliances between all stakeholders that are needed to turn high expectations in new medicines into reality. Do you see differentiating strategies in drug delivery systems?
In this new book, I also  highlight the protein-centric nature of drug development: almost all drugs on the market, as well as almost all drug candidates in clinical trials, target proteins, with the next largest category, nucleic acids, comprising only 2% of drug targets.

Researchers are a step closer to being able to deliver life-saving drugs through tiny molecules that would travel through the bloodstream and destroy only disease-ridden cells

Tomorrow’s therapy model will be based on drugs that target higher severity conditions. Certain of them will be based on large molecules. Although their degree of therapeutic clinical advantage will replace the current focus on size, these new targeted therapeutics will be big in their respective niches. A variety of new generations of drug delivery systems will contribute to optimal therapy outcome.

 Although drug delivery is still young, today 10% of medicines sold world wide incorporate one form of patented drug delivery technologies. Proprietary Drug Delivery technologies are adding real value to drug products by making them more convenient, efficacious and safe. In the future, an increasing number of medicines will incorporate drug delivery technologies. This boom will be driven by NCEs incorporating melt tablets, water insoluble, injectable depot, PEGylation, inhalation, and targeted delivery technologies, as well as the life cycle management medicines from large pharmaceutical companies and super generics from the drug delivery companies/specialty pharma.

That is going in the direction of targeted medicines, isn’t it?
Indeed, it is. Stomach retentive technologies of the future  will allow scientists to develop best modified release drug products  in terms of the timing and the speed of drug release.  In the oral delivery field we should expect to see more products using melt tablets as well as water insoluble drug technologies.  Because of its importance, investment and efforts in  the development of effective delivery technologies for the oral delivery of macromolecules will continue. Injectable depot formulations will keep adding real value to injected macromolecular drugs and provide both convenience and improved efficacy and safety to patience. Novel delivery systems to transport drugs from circulating blood into the central nervous system (current drug delivery is restricted by the blood barrier and the blood-cerebrospinal fluid barrier) will emerge. Researchers work on micropsheres, liposomes, polymeric micelles, vector-mediated delivery, niosomes, nanoparticles, solid lipid nanoparticles, noninvasive gene therapy, and nasal administration to try to circumvent the blood - brain barrier. Targeted drug delivery has the chance to revolutionize drug treatment by providing safer and more efficacious delivery for cancer and immune diseases. Delivery of large molecular drugs from the skin by poration technologies may be a reality within the next 5-10 years.
In their  ongoing search for better medicines, scientists and new medicine developers put much faith in genomics. Will the application of pharmacogenomics and pharmacogenetics be the key to more sophisticated new medicine based therapies?
The medicines currently marketed reach only about 10% to 20% of the body’s possible drug targets, or 400 to 500 protein receptors and enzymes out of an estimated 5.000. In the next twenty years, all 5.000 targets will be accessible.

Genomics is expected to lead to the identification of thousands of new targets for development. Whether these will be amenable to small molecule intervention or require protein and nucleic acid based therapies remains to be seen. To overcome the difficulty of biological and chemical diversity, the message is „creativity is everything“. 
The application of pharmacogenomics and pharmacogenetics in drug development holds great promise to shed scientific light on the often risky and costly process of drug development, and to provide greater confidence about the risks and benefits of drugs in specific populations. Pharmacogenomics’ promise lies in its potential ability to individualize therapy by predicting which  individuals have a greater chance of benefit or risk, thus helping to maximize drugs’ effectiveness and safety. 
Using genomic testing to guide drug therapy will constitute a significant shift from the current practice of population-based treatment towards  ‘fine-tuning’ individual therapy.
It is hoped that pharmacogenomic testing will help identify diseases that have a high probability of responding to a particular medication or regimen and that it may also be used to help track down the cause of certain rare, serious drug side  effects.

The formation of the genome database and the identification of the significance of genes are leading the discovery process away from the old ‚symptom-indication‘-based R&D approach to one where a protein and a gene may have significance in disease states that have nothing to do with the ‚specialized‘ expertise of a pharmaceutical company. The growing ability to more accurately define the target population through DNA screening will help to make medicines more efficient and largely eliminate the side-effects seen when a drug is used in a less suitable patient. It also means that older, previously rejected or strongly restrained drugs can be reconsidered for the right patient group –identified on the basis of their genome.

Researchers  think there are over two million mutations directly causing disease in the human genome. Some 100,000 mutations have been discovered. But there is no systematic global system for collecting and sharing complete and accurate information on these mutations with clinicians around the world. And 95 percent of human mutations are yet to be discovered. Fast, reliable access  for researchers to information on mutations, and the damage they cause, would transform genetic medicine by: 1) enabling doctors to rapidly diagnose and inform patients with rare diseases; 2) allowing new diagnostics; 3) helping researchers develop new treatments for hundreds of genetic diseases including cystic fibrosis and thalassemia; 4) assisting in uncovering the causes of common diseases such as breast cancer and asthma. 

Let me add that, in my book, I give a sampling of  scientific developments and fascinating trends to watch in  the coming years. E.g.: Engineering RNA for medical purposes; A role for dueling RNAs; The promise of RNAi in gene therapy;  The tumor-targeting capability of nanoparticles, and many, many more.

All the information point in the same direction: the end of the small-molecule, oral-formulation drug era and the emergence of therapies based on New Biology, including gene replacement and protein-based therapeutics in combination with various drug delivery systems. Challenging times with big rewards are awaiting the medical world  beyond 2015.
Coming up with medicines  not imagined even a decade ago? How realistic is this? How justified is your great optimism?
Medicines that will make their own way through the body and attack precisely the diseased cells on reaching their destination – such has been the dream of physicians and pharmacists since time immemorial. Each day,  researchers  come a little closer to reaching this goal.

Disease, as diagnosed by symptoms is said to be replaced by genomics, which identifies people who will definitely respond to a specific medicine. The future is said to offer prevention, protection and treatment of disease on a personalized base. High-speed computers and DNA filters called microarrays, which made it possible to quickly identify varieties in genes, allow for more forays into personalized medicine. A new “one-size-fits-one” approach instead of “one-size-fits-all”-approach will develop with more drugs like Herceptin and Iressa to treat disease.

The understanding of the genetic basis of gene activity will help medical research to provide individuals with information about their personal predisposition to disease.

Sorry to interrupt you, Mr. Mertens, but do you refer to what is said to become true predictive disease?
I am saying that the promise of stem cells and regenerative medicine discoveries and their potential to transform the treatment of disease, continues to drive biological research and technology development in the life sciences. Analysts predict that a market based on stem cell therapies could grow anywhere from $10-30 billion by 2012

Predictive disease may well be the future of health care.  And so is regenerative medicine: Its goal is to refurbish diseased or damaged tissue using the body's own healthy cells. It's a term that is often used synonymously with tissue engineering, though those involved in regenerative medicine place more emphasis on the use of stem cells to produce tissues.
Advanced therapies herald new forms of medical treatment. Tissue engineering, through its focus on the regeneration of human tissues, is expected to have a major impact on future medical practice. One of the longer term perspectives is to be able to regenerate full organs and hence to tackle the issue of donor shortages.

By 2012, it is likely that predictive genetic tests will be available for as many as a dozen common conditions, enabling individuals to take preventive steps to reduce their risks of developing such disorders. Doctors will also begin tailoring prescribing practices to each patient's unique genetic profile, choosing medications that are most likely to produce a positive response.

“Molecular" techniques have become firmly entrenched in the diagnostic armamentarium of pathologists and clinicians, and are a bridge to the future of medical diagnostics and therapeutics.
Molecular  testing for the complex  genetic diseases can be expected by 2015. The testing researchers are doing in 2008  is for single gene defects that are not very common diseases. For other diseases, like diabetes or atherosclerosis, which also have a genetic component,  they  just don't know all the genes yet. ..but are confident that within the near future, they  will at least know a majority of them. And probably through some kind of microarray technology, they’ll be able to do some kind of predictive testing for coronary artery
disease, hypertension, diabetes, etc..

Personalized medicine?
By 2020, the impact of personalized  medicine is likely to be far more important  than any of us can envision today. New gene-based  drugs will be developed for diabetes, heart disease, Alzheimer's disease, schizophrenia, and many other conditions.

Nanotechnological advances will allow the effective introduction of “personalized therapy”, such as administration of a small dose of a drug to obtain maximum effect; the reduction of secondary effects by means of drugs that act only on the therapeutic target; or the development of new more effective administration routes.
A whole, and long chapter of your book focuses on cancer as an example of targeted therapies. You write that oncogenics can provide one of the key routes to the development of successful targeted therapies. Can you elaborate on this?
It does this by: accelerating the stream of novel targets for small molecule drugs; reducing the timeline between discovery of new gene targets and new drugs from 10-15 years to 5 years; and enabling high throughput screening, combinatorial chemistry and microarrays that should speed up drug development. 

Molecularly targeted therapies based on recent progress in genomics and proteomics hold out the promise of being far more selective, thereby drastically reducing the incidence of side effects in patients undergoing treatment.

Improved diagnostics are central to the ongoing development and success of targeted therapies. Trastuzumab is one recent example of an innovative drug for which the development of an appropriate diagnostic test has proven essential to strong uptake within the breast cancer therapy segment and allowed the drug to be appropriately targeted and demonstrate cost-effectiveness for certain patients.

There has been a clear move away from cytotoxics in favor of cytostatic drugs, which has been integral to the development of targeted cancer therapies. While traditional chemotherapy agents kill cancer cells by being cytotoxic, many new agents work mostly by interrupting their growth i.e. are cytostatic. 

For breast cancer, new treatments will be driven by: improved screening techniques; research in into the multiple tissue-specific interactions of the ER (estrogen receptor) and its response to antiestrogen therapy will be studied extensively; the development of pure antiestrogen agents which completely block estrogenic activity; increasing use of cytostatic therapy, combination therapy (of antiestrogens and aromatase inhibitors).
The challenges present an opportunity for targeted cancer drugs that may reduce the side effect profile and outperform the efficacy of existing drugs.

And for other cancers, for example for colorectal cancer?
Drug treatments for colorectal cancer exhibit similar limitations to those for other cancers in terms of excessive side effects and insufficient survival benefit. In the absence of curative treatment, there is also a need for agents that improve the quality of life for patients with unresectable tumors. Existing treatments tend to follow protracted delivery schedules and are expensive.

Lung cancer?
The major unmet need with lung cancer is extension of patient survival. The  current five-year survival rate is less than 15%, dramatically less than the rate for other major cancers. There is also a need for improved second-line treatments for patients who fail to respond to first-line treatments, or suffer a relapse after receiving first-line therapy.

Prostate cancer?
While cure rates for early-stage disease are high, there remains a critical unmet need for a curative treatment for advanced metastatic prostate cancer or hormone-refractory prostate cancer. There is also a need for new treatments with fewer side effects than current cytotoxics and hormonals.

Currently, treatment for cancer therapies depends on the type of cancer; the size, location, the stage of disease and the person’s general health. Advances in research  mean the treatment will less depend on cancer type (organ, location,, histology) and be more driven by molecular features.

What exactly do you mean?
Innovatives are the most promising area for all cancers and may create the answer to reduced side effects associated with cancer treatment and have the vast potential of dramatically increasing disease free survival and overall survival rates. The promise behind innovatives and reduced side effects arises from the potential of specifically targeting cancer cells, avoiding killing normal healthy cells, a common problem associated with cytotoxics and anti-metabolites.

For decades, scientists have looked for new therapies that target cancer. Researchers now know that cancer cells have several unique characteristics -- they require new blood vessels to deliver oxygen and nutrients (angiogenesis), they grow uncontrollably (proliferation), they travel throughout the body (metastasis), and they escape programmed cell death, a natural process by which the body rids itself of damaged or unwanted cells (apoptosis). The medical research community is dedicated to finding the next generation of small molecule and biologic therapies that will have an impact on this horrible disease.

In the book I also describe the role of specific drugs in cancer therapy, e.g.: sorafenib, sinutinib, rapamycin, bevacizumab, temsirolimus, vatalanib, cilengitide, cetuximab, gefitinib, erlotinib, panitumumab, lapatinib, tipifarnib, lonafarnib, bortezomib, bexaroten,  perifosine, oblimersen, aprinocarsen, exisulind, seliciclib, dasatinib, indisulam,UCN-01, ibritumomab, and innovative early stage drug development projects.

From the Greeks  to the First World War, medicine’s tasks were simple : to grapple with lethal diseases and gross disabilities, to ensure live births and manage pain. It performed these as best it could but with meager success.  You write that a new (second) dimension in healthcare emerged in the 1930`s, with the sulfonamides as the first medicines to cure disease, that progress in biomedicine provided doctors with the tools to ease  suffering rather than watch patients die.  You also say that a tremendous shift in ideas about medicine occurred,  that it is to the credit of conventional medicine that, when science revealed progress, it has abandoned products of a former generation of medicines for better ones. Are you adding a new, a third dimension in healthcare?

The postwar healthcare thinking resulted in generous socialized Statutory Healthcare Systems. Universal healthcare was a fantastic social ideology based on the willingness of bringing relief to the suffering, whenever illness strikes. At the same time, the manipulation of power by parties involved in health provision  increased. The focus  started to shift away from universal healthcare for the suffering patient to the care of an ailing healthcare system, which  itself suffered from budget overruns. 
Currently, the economics of care, the cost-benefit analysis, leading to  a rational drug therapy philosophy, dominates the debate.

Genomics introduces many more objectives for the future therapy providers, so makes the links in the “value chain” far more complex. The new linked areas are: 
 Gene sequencing. How do the proteins made by the identified gene sequences cause the effects of the disease and how can this be altered by individualized drug therapy?;
 Population genotyping. Will genotyping -the prediction of future morbidity-  ever become routine for individuals and populations with no history of disease? Will the health outcomes of these patients be improved? Does knowledge and fear of a future disease improve or diminish a person’s present quality of life? Do individuals have a right to genetic information about family members, if this data affects their own health and future?;
 Health economic modeling. Models which demonstrate that the probable increased cost of the new innovative therapies and diagnostic tools leads to a decreased overall cost of healthcare spend per patient by reducing inpatient stays, reducing the onset and severity of disease, and providing therapy that should provide effective treatment as it has been designed to  target the identified genetic causative factor of the disease; 
 Drug discovery and development. Further basic research into how the gene mutation alters the proteins produced and the effect proteins have on causing the disease state, resulting in innovative drug therapies, adjunct therapies, nutrigenomics; 
 Diagnostics and diagnosis. Development and validation of genetic test kits, both for the identification of future morbidity, and of the specific identification of the exact genetic cause of a disease state; 
 Information management. Management of an individual’s genetic data on a scale and of a complexity which today is almost unimaginable; 
 Disease management. Development of total health/wellness and disease management packages –with he potential of healthcare services, including education of the individual, the measurement of health outcomes, as will the personalized drug therapies supplied.

Let me repeat my question on personalized medicine. Are you saying that we will inevitably come to a kind of tailored treatment?
With further research into the information provided by the human genome project, scientists will be able to compare individual variations against a general blueprint for the human race. The result will be tailored treatments and the ability to pinpoint the mechanisms that can result in problems later in a person’s life. Scientists believe that one day in the not so far future, they will be able of predicting whether a person will develop diabetes, mental disorders, cancer, heart disease and a range of other conditions.

We are entering an exciting new era of predictive health where an individuals personal genetic code will provide guidance on healthcare decisions. Maps of insertions and deletions will be used together with SNP maps to create one big unified map of variation that can identify specific patterns of genetic variation to help us predict the future health of an individual.  The next phase is to figure out which changes correspond to changes in human health and develop personalized health treatments. This could include specific drugs tailored to each individual, given their specific genetic code. 
Ultimately, each person's genome could be re-sequenced in a doctor's office and his or her genetic code analyzed to make predictions about their future health. 

And the regulatory aspects?
The traditional government approval processes will prove inadequate to service the demand for an ever increasing number of specialized drugs.

On the way to becoming ‚virtual‘, basic research driven drug developers are expected to develop so-called Integrated Therapeutic Providers that combine the genomic, pharmaceutical, biotechnological and diagnostic know-how‘ to take advantage of the significant unmet medical need and the rapid pace of scientific advances in the treatment of health problems.

On the way to predictive medicine, a less isolated or restricted view of the „value chain of health“ will have to take a place at the center of all activities. 

In the new healthcare environment, the leftovers of today’s drug research companies become system providers. Their  salvation (at least of a few of them) will be their effective marketing creativity and clout, leaving the discovery itself to more nimble entrepreneurs and the development to government funded international institutions, e.g. the National Institutes of Health, the National Cancer Institute, and others.

You were right with you former question: Visionary stakeholders prepare for a healthcare system of the third dimension.
Table of contents: title: “The Molecular Revolution” is the title of a new book by Gilbert Mertens, Healthcare Policy Adviser, International Institutions. It is an in-depth, wide-ranging, fact rich and thought provoking analysis of the issues and dynamics driving Healthcare stakeholders towards a future of unseen therapeutic, preventive and predictive opportunities in healthcare. It masterly synthesizes future scenarios in a promising, fast changing health & wellness-care environment, and the credibility aspect of targeted medicines‘ claim of efficacy,  created by advances in medical care.; title: Gilbert Mertens has extensive experience of working within the healthcare industry,  including an extended period as a general manager with both a major global pharmaceutical company in Germany, and a leading international communications agency in Paris, France. Based on his profound knowledge of the European and US healthcare sector and his personal relationship  with many renowned scientists, national healthcare authorities and  his excellent access to business  leaders, Gilbert Mertens offers strategic healthcare management reflections to key decision makers under constant challenge to redefine  a multi-faceted, competitive  and constantly changing  healthcare environment. His series of Healthcare Management reports, published by the Financial Times and by Reuters Business Insight,  have been received within the  sector as benchmark reports.; title: In this book, Gilbert Mertens writes that science will definitely contribute to turn medicines for “everybody” into medicines for “my body”. In an interview published on the Internet, Mr. Mertens gave us a glimpse of what he is explaining in his newest work:; title: Mr. Mertens, you state that  preparing for a future of unseen opportunity in healthcare requires a profound shift in thinking from all the stakeholders and that a new era of personalized medicine, ushered in by advances in biotechnology and genetic engineering (among other technologies), will  radically transform the nature of the healthcare systems world-wide. Can our Social Welfare State cope with this?; title: Advances in technology and better understanding of disease management is ensuring that  the aging population will consume 5% or more of GDP per year.  This can be forecast to grow from7-8% to an average of 12.14% of GDP. Most countries‘ current systems only fund half this amount. It could therefore be argued that we have barely started to address the impact of healthcare costs. In systems where healthcare is effectively free at the point of delivery, it is no surprise that the consumer of that service feels no pressure to control costs. Governments in industrialized countries  have tried a variety of discriminatory processes to introduce some element of control –largely without success- but with the consequence of effectively rationing healthcare, usually unfairly.; title: The dangers of focusing a disproportionate amount of resources on high technology, curative care to the near total exclusion of primary health care; the increasing administrative burden on the system; drifting intergenerational relations; the unstoppable “social” healthcare systems financial deficits, amplified by Government’s appetite for all sort of taxes on medicines and medical services; the accelerating rhythm in genetic discoveries promising new dimensions in treatment of health disorders…the perception and possibilities of maintaining the welfare state, leading to reform after reform of the Western nation’s Health Care  systems in an aging world and a globally linked economy is one of today’s core social and economic issues, and will  remain at the center of the western post-industrialized countries’  political agenda for years to come.; title: The challenge is to eliminate wastage and abuse, to penalize socially driven cost escalation (tobacco, alcohol, drugs, etc.) and to encourage life cycle financial planning, to ensure better preparations are made by all individuals to manage their own care as they age, and...to think beyond cost containment measures.; title: The golden future of healthcare is ahead of us, not behind. Genomics open the horizons for discovery of treatments for unconquered diseases.   The future of gene-based drug therapy will allow patients to be classified into genetically defined subsets based on disease susceptibility and drug responsiveness, with the ultimate goal of optimizing drug therapy by improving efficacy and decreasing toxicity.; title: Does this mean that the Medical Community is now at a crossroads?; title: Ethics and human suffering run headlong into direct conflict with a healthcare system in need of general overhaul. The driving force behind the development of health economics is the increase in healthcare costs worldwide, no matter which health care system is concerned.; title: Not too long ago, the cost of medicines did not matter that much, and only the efficacy, safety and quality of the pharmaceuticals involved were the parameters any decision was based on.  But particularly for pharmaceuticals, costs have become a key issue (although prescription drugs take only a 10% share of the total healthcare spending, they receive a 90% share in the attention of health authorities).  And, consequently, pressure on prices for the pharmaceutical industry’s products has increased dramatically. From their side, doctors face unprecedented cuts in their already modest  (when compared to other professions and to their responsibility) revenues; the pharmaceutical industry is being blamed for its “excessive “ promotion and prices.; title: Turning  scientific progress in therapies to prevent or cure disease is what the medical community expects from the pharmaceutical industry. In view of the many unresolved health problems, Society expects the industry to continue playing an important role in the discovery process of new medicines. At an accelerated pace.; title: Is the industry ready? What about the vision of those who have the experience of making drugs?  Is the pharmaceutical industry ready to tune in to a changed new healthcare world? What changes will the medical community itself undergo?; title: Calculations are easily made of how one can create and develop blockbuster drugs, but the reality is that barely 1% of all drugs reach a turnover of US 1bn. The rapid decrease of the patent period makes it less likely in the future that billion dollar drugs will dominate top-line growth. It is more likely that ever more money will need to be invested in marketing in order to grow each of the products to its maximum sales.  The salvation of the large companies will be their effective product development, leaving the discovery itself to external entrepreneurs. In the search for higher efficiency and profit, the larger companies find themselves progressively more dependent on outside expertise, alliances, cooperation, mergers.; title: The drug industry has not much time left to decide how it will metamorphose itself. Instead of recognizing and responding to the fundamental changes facing their sector of activity, many companies will stick to their tired ideas. Expect and prepare for exciting times in a health care industry with new dimensions.; title: Your description of turning medicines for EVERYBODY into medicines for MY BODY is fascinating. The pharmaceutical industry focused its strategy on  Medicines for the Masses. It brought them substantial profits. Why should they change their philosophy?; title: The pharmaceutical industry creates brands, invests in brands, and sees the investment disappear in smoke in a relatively short period of time, due to its own success of constantly creating new, better medicines. No other industry is destroying  its success, and the huge efforts to get there, at such a rapid pace.; title: Thanks to many great  scientists and intelligent industry leaders, Society became used to a constant flow of new, better medicines.; title: The healthier Western society became, the more it regarded maximum access to medicine as a right and duty, the more medicine it craved and the more it required from that super-medicine. Everyone wanted the best medicine…provided someone else pays the bill. High expectations from society and investors alike, pushed industry leaders to focus their efforts on few, high selling primary care drugs (by preference for the chronically ill).; title: The „one size fits all“ primary care blockbuster medicines model is primary an American one if we consider the healthcare system, the US market and the number of patents that will expire in the very near future. The consequences of „blockbuster“ patent loss for pharmaceutical companies are a key consideration. This system presupposes a launch of 2 to 3 new chemical entities (NCE) per year to maintain double-digit growth of the „blockbuster-based“ company. Mission impossible. From the medicines supply side, society will experience two major categories of drugs: generic compounds for the masses (generics will assume a more central role as patients bear a greater percentage of their healthcare costs and payers seek to restrict the growth of healthcare expenditures), and more targeted therapies for „niche“ patient groups.; title: You know that Europeans are considered to be the better niche-players, compared to the global thinking and aspirations of the Americans. What does this all mean for Europe?; title: For science to advance, researchers need to have a vision of what the future may hold. Many scientists have built their careers on being able to foresee the critical trends in medical science, in fields ranging from stem cells to genetics to health-care policy. Europe's regulatory overreach, resulting from its view that society can be rationally planned and directed, thereby making the union of 27 selfish nations  (with 27 national health authorities defending their specific interests) the tax and spend champions of the world, forced the medical community (researchers, physicians, pharmaceutical companies, biotech entrepreneurs)  to leave for more supportive regions. It resulted in a reversal of the European dominance of drug discovery that had held sway since the Industrial Revolution. It  allowed America's medical-industrial sector to rise to dominance.; title: Shortsighted European, particularly German healthcare politics resulted in a climate that one can describe as  most unfriendly to medical innovation. It is amazing that there are still scientists having the courage to stay.; title: In the meantime, everyone has become aware of the fact that the India-China region will come more on its own in the twenty-first century and their enthusiastically developing pharmaceutical industry, aware of the huge challenges and opportunities it faces, will respond with increased investment in R&D and new technologies in order to participate in tomorrows smaller but in number rapidly proliferating, high return-on-investment generating, and more individually tailored custom business. The industry has already moved far from its origins as the producer of copycat drugs, has extended its scientific network by e.g. cross-border alliances, and is evolving quickly towards becoming a highly specialized sector, resulting in a number of companies that will be among the global leading experts in well-defined areas of a more sophisticated drug discovery and development process.; title: Coming back to your description of medicines for every body turning into medicines for my body,  how do you see a healthcare industry reinventing itself?; title: In order to meet the demands of tomorrow’s healthcare, as well as those of the financial community, the monolithic pharmaceutical industry, unable to respond to the demand of a multitude of specialty has to fundamentally rethink its value proposition.; title: The medical product development process is no longer able to keep pace with the tremendous basic scientific innovation. Only a concerted effort to apply the new biomedical science to medical product development will succeed in modernizing the critical path.  The new science is not being used to guide the technology discovery process in the same way that it is accelerating the technology discovery process. For medical technology, performance is measured in terms of product safety and effectiveness.  Not enough applied scientific work has been done in creating new tools to get fundamentally better answers about how the safety and effectiveness of new products can be demonstrated, in faster time frames, with more certainty, and at lower costs. As a result, the vast majority of investigational products that enter the clinical trials fail.; title: In the 1960s, scientists discovered three different classes of clinical drug, each of which recognized DNA in a different way. Subsequent drugs have used only these three ways to recognize the DNA.; title: New research, announced early 2006,  has isolated a fourth, which is completely different and opens up entirely new possibilities for drug design. This discovery will revolutionize the way that drug developers think about how to design molecules to interact with DNA. It will send chemical drug research off on a new tangent. By targeting specific structures in the DNA scientists may finally start to achieve control over the way our genetic information is processed and apply that to fight disease.; title: Will this contribute to make the development of new medicines even more costly than it is already?; title: By 2015, and largely due to the billion dollar cost of basic drug research, only five to seven of today’s major Western pharmaceutical companies, joined by a few newly arrived industry giants from India and China,  are expected to be responsible for 80% of global innovative drug  research. Society will have to decide if this is in the world community’s  interest? Will the world leave the choice of therapeutic research areas to a handful of company CEO’s?; title: This fact did not yet receive much attention, but is going to be of crucial importance.; title: To the advantage of patients worldwide, progress in the battle against disease will come from those basic research driven drug developers that, by capitalizing on their knowledge and expertise in targeted medicines, and encouraged by patient advocacy groups and academics recognize the signs on the wall and will come to discover the real value of ‚neglected diseases‘; of less prevalent diseases. The focus of their drug discovery will move away from a small number of mostly chronic diseases that have been traditionally targeted by the medical research community and towards other, numerous areas of less prevalent diseases- This will, in turn, create a targeted medicines sector and, in time, lead to the development of personalized health  maintenance programs.; title: From the economies of healthcare to biotechnology, and the ethics of genetic testing to ethnicity and individualized medicine, your book explores the new relationships that are being forged across the social, political, medical-industrial  sectors of the healthcare environment. What exactly will be the role of biotechnology?; title: Biotechnology is often called the “Third Industrial Revolution”. This is probably an understatement. The first two revolutions affected merely products and processes, material aspects of the quality of modern life.; title: By many measures, medicines have played a major role in the improved health of the world during the 20th century. This becomes obvious when one simply looks at the 1930´s and the role medicines played in eradicating diseases during that period. The first real effective medicine, a sulfonamide called Protonsil red,  was launched in 1936. Let’s not forget that this was the start of modern medicine. And let’s not forget that this is just seventy years ago. Only seventy years ago.  In the 1960s again, medicines played a very substantial role in medical progress. They helped reduce mortality and improve quality of life. The biotechnology revolution addresses the individual himself as well as his individual aspects and perceptions. Biotechnology has already begun to change our society and culture persistently, with so far unseen speed and dynamics.; title: A scientific revolution is taking place. We are reaching new heights in our understanding of life and disease. In the past, the goal was to develop new drugs –proteins or small molecules—that helped correct the chemical imbalances within a body suffering from disease. Now, with the availability of genetic information, that paradigm has changed completely and forever. The drug providers of the future  do not simply produce medicines  anymore but advance and apply the use of scientific knowledge itself. This fact  transforms not only the research driven new drug developer’s  world  but the practice of medicine as well.; title: Can you be more precise?; title: Scientific research and new drug development  is to provide huge benefits over the next 20 years:; title:  Therapeutic  advances will prevent  4.400.000 deaths from heart attacks and strokes;; title:  Lung cancer deaths will be cut by 400.000 as a result of new drug discoveries;; title:  New medicines will reduce leukemia deaths by 80.000 or more;; title:  Prescription drugs will decrease the severity of rheumatoid arthritis cases by as much as 50%;; title:  For many diseases, such as Alzheimer’s, and arthritis, new drug research and development will likely generate nearly all of the future medical progress;; title:  Breakthroughs in biotechnology will advance the fight against cancer and viral diseases.; title: Modern biology right now is in metamorphosis, much like physics at the beginning of the last century.  A transition takes place from a rather descriptive subject into a discipline that is coming to understand its molecular foundations.  Preconditions to this were technological developments in the 1970s and 1980s that made it possible to register the molecular base for relevant categories of molecules (DNA, RNA, proteins, metabolites) qualitatively and quantitatively. Most fundamental modern technological developments (such as recombinant DNA, sequencing, computer technologies) were developed in the US and are being commercialized over there faster and more consequently than anywhere else. Biotechnology has been responsible for a disproportionate number of the new drugs introduced to the market in recent years, accounting for nearly 60 percent of new molecular entities (NMEs) during 2006. Biotechnology’s greatest potential for curing chronic and currently “incurable” diseases lies in gene therapy.; title: Don’t you forget the role of the physician?; title: I am not going to predict that the doctor as we know him today will be replaced by a kind of intelligent robot. Human suffering  will increasingly need emotional care, not less. This said, the medical doctor will no longer be the main repository of medical expertise for a sophisticated patient. The accelerating rate of change in medicine makes the “half-life” of knowledge too short. We are not far from the time when the most up-to-date information will be obtained from a database run by a computer expert or dedicated server and where the last missing link to semi-automated medical care is long-distance accurate diagnosis, something that has already been proven to be feasible.; title: The medical world pays much attention to new drug delivery systems, to alliances between all stakeholders that are needed to turn high expectations in new medicines into reality. Do you see differentiating strategies in drug delivery systems?; title: In this new book, I also  highlight the protein-centric nature of drug development: almost all drugs on the market, as well as almost all drug candidates in clinical trials, target proteins, with the next largest category, nucleic acids, comprising only 2% of drug targets.; title: Researchers are a step closer to being able to deliver life-saving drugs through tiny molecules that would travel through the bloodstream and destroy only disease-ridden cells; title: Tomorrow’s therapy model will be based on drugs that target higher severity conditions. Certain of them will be based on large molecules. Although their degree of therapeutic clinical advantage will replace the current focus on size, these new targeted therapeutics will be big in their respective niches. A variety of new generations of drug delivery systems will contribute to optimal therapy outcome.; title: Although drug delivery is still young, today 10% of medicines sold world wide incorporate one form of patented drug delivery technologies. Proprietary Drug Delivery technologies are adding real value to drug products by making them more convenient, efficacious and safe. In the future, an increasing number of medicines will incorporate drug delivery technologies. This boom will be driven by NCEs incorporating melt tablets, water insoluble, injectable depot, PEGylation, inhalation, and targeted delivery technologies, as well as the life cycle management medicines from large pharmaceutical companies and super generics from the drug delivery companies/specialty pharma.; title: That is going in the direction of targeted medicines, isn’t it?; title: Indeed, it is. Stomach retentive technologies of the future  will allow scientists to develop best modified release drug products  in terms of the timing and the speed of drug release.  In the oral delivery field we should expect to see more products using melt tablets as well as water insoluble drug technologies.  Because of its importance, investment and efforts in  the development of effective delivery technologies for the oral delivery of macromolecules will continue. Injectable depot formulations will keep adding real value to injected macromolecular drugs and provide both convenience and improved efficacy and safety to patience. Novel delivery systems to transport drugs from circulating blood into the central nervous system (current drug delivery is restricted by the blood barrier and the blood-cerebrospinal fluid barrier) will emerge. Researchers work on micropsheres, liposomes, polymeric micelles, vector-mediated delivery, niosomes, nanoparticles, solid lipid nanoparticles, noninvasive gene therapy, and nasal administration to try to circumvent the blood - brain barrier. Targeted drug delivery has the chance to revolutionize drug treatment by providing safer and more efficacious delivery for cancer and immune diseases. Delivery of large molecular drugs from the skin by poration technologies may be a reality within the next 5-10 years.; title: In their  ongoing search for better medicines, scientists and new medicine developers put much faith in genomics. Will the application of pharmacogenomics and pharmacogenetics be the key to more sophisticated new medicine based therapies?; title: The medicines currently marketed reach only about 10% to 20% of the body’s possible drug targets, or 400 to 500 protein receptors and enzymes out of an estimated 5.000. In the next twenty years, all 5.000 targets will be accessible.; title: Genomics is expected to lead to the identification of thousands of new targets for development. Whether these will be amenable to small molecule intervention or require protein and nucleic acid based therapies remains to be seen. To overcome the difficulty of biological and chemical diversity, the message is „creativity is everything“.; title: The application of pharmacogenomics and pharmacogenetics in drug development holds great promise to shed scientific light on the often risky and costly process of drug development, and to provide greater confidence about the risks and benefits of drugs in specific populations. Pharmacogenomics’ promise lies in its potential ability to individualize therapy by predicting which  individuals have a greater chance of benefit or risk, thus helping to maximize drugs’ effectiveness and safety.; title: Using genomic testing to guide drug therapy will constitute a significant shift from the current practice of population-based treatment towards  ‘fine-tuning’ individual therapy.; title: It is hoped that pharmacogenomic testing will help identify diseases that have a high probability of responding to a particular medication or regimen and that it may also be used to help track down the cause of certain rare, serious drug side  effects.; title: The formation of the genome database and the identification of the significance of genes are leading the discovery process away from the old ‚symptom-indication‘-based R&D approach to one where a protein and a gene may have significance in disease states that have nothing to do with the ‚specialized‘ expertise of a pharmaceutical company. The growing ability to more accurately define the target population through DNA screening will help to make medicines more efficient and largely eliminate the side-effects seen when a drug is used in a less suitable patient. It also means that older, previously rejected or strongly restrained drugs can be reconsidered for the right patient group –identified on the basis of their genome.; title: Researchers  think there are over two million mutations directly causing disease in the human genome. Some 100,000 mutations have been discovered. But there is no systematic global system for collecting and sharing complete and accurate information on these mutations with clinicians around the world. And 95 percent of human mutations are yet to be discovered. Fast, reliable access  for researchers to information on mutations, and the damage they cause, would transform genetic medicine by: 1) enabling doctors to rapidly diagnose and inform patients with rare diseases; 2) allowing new diagnostics; 3) helping researchers develop new treatments for hundreds of genetic diseases including cystic fibrosis and thalassemia; 4) assisting in uncovering the causes of common diseases such as breast cancer and asthma.; title: Let me add that, in my book, I give a sampling of  scientific developments and fascinating trends to watch in  the coming years. E.g.: Engineering RNA for medical purposes; A role for dueling RNAs; The promise of RNAi in gene therapy;  The tumor-targeting capability of nanoparticles, and many, many more.; title: All the information point in the same direction: the end of the small-molecule, oral-formulation drug era and the emergence of therapies based on New Biology, including gene replacement and protein-based therapeutics in combination with various drug delivery systems. Challenging times with big rewards are awaiting the medical world  beyond 2015.; title: Coming up with medicines  not imagined even a decade ago? How realistic is this? How justified is your great optimism?; title: Medicines that will make their own way through the body and attack precisely the diseased cells on reaching their destination – such has been the dream of physicians and pharmacists since time immemorial. Each day,  researchers  come a little closer to reaching this goal.; title: Disease, as diagnosed by symptoms is said to be replaced by genomics, which identifies people who will definitely respond to a specific medicine. The future is said to offer prevention, protection and treatment of disease on a personalized base. High-speed computers and DNA filters called microarrays, which made it possible to quickly identify varieties in genes, allow for more forays into personalized medicine. A new “one-size-fits-one” approach instead of “one-size-fits-all”-approach will develop with more drugs like Herceptin and Iressa to treat disease.; title: The understanding of the genetic basis of gene activity will help medical research to provide individuals with information about their personal predisposition to disease.; title: Sorry to interrupt you, Mr. Mertens, but do you refer to what is said to become true predictive disease?; title: I am saying that the promise of stem cells and regenerative medicine discoveries and their potential to transform the treatment of disease, continues to drive biological research and technology development in the life sciences. Analysts predict that a market based on stem cell therapies could grow anywhere from $10-30 billion by 2012; title: Predictive disease may well be the future of health care.  And so is regenerative medicine: Its goal is to refurbish diseased or damaged tissue using the body's own healthy cells. It's a term that is often used synonymously with tissue engineering, though those involved in regenerative medicine place more emphasis on the use of stem cells to produce tissues.; title: Advanced therapies herald new forms of medical treatment. Tissue engineering, through its focus on the regeneration of human tissues, is expected to have a major impact on future medical practice. One of the longer term perspectives is to be able to regenerate full organs and hence to tackle the issue of donor shortages.; title: By 2012, it is likely that predictive genetic tests will be available for as many as a dozen common conditions, enabling individuals to take preventive steps to reduce their risks of developing such disorders. Doctors will also begin tailoring prescribing practices to each patient's unique genetic profile, choosing medications that are most likely to produce a positive response.; title: “Molecular" techniques have become firmly entrenched in the diagnostic armamentarium of pathologists and clinicians, and are a bridge to the future of medical diagnostics and therapeutics.; title: Molecular  testing for the complex  genetic diseases can be expected by 2015. The testing researchers are doing in 2008  is for single gene defects that are not very common diseases. For other diseases, like diabetes or atherosclerosis, which also have a genetic component,  they  just don't know all the genes yet. ..but are confident that within the near future, they  will at least know a majority of them. And probably through some kind of microarray technology, they’ll be able to do some kind of predictive testing for coronary artery; title: disease, hypertension, diabetes, etc..; title: Personalized medicine?; title: By 2020, the impact of personalized  medicine is likely to be far more important  than any of us can envision today. New gene-based  drugs will be developed for diabetes, heart disease, Alzheimer's disease, schizophrenia, and many other conditions.; title: Nanotechnological advances will allow the effective introduction of “personalized therapy”, such as administration of a small dose of a drug to obtain maximum effect; the reduction of secondary effects by means of drugs that act only on the therapeutic target; or the development of new more effective administration routes.; title: A whole, and long chapter of your book focuses on cancer as an example of targeted therapies. You write that oncogenics can provide one of the key routes to the development of successful targeted therapies. Can you elaborate on this?; title: It does this by: accelerating the stream of novel targets for small molecule drugs; reducing the timeline between discovery of new gene targets and new drugs from 10-15 years to 5 years; and enabling high throughput screening, combinatorial chemistry and microarrays that should speed up drug development.; title: Molecularly targeted therapies based on recent progress in genomics and proteomics hold out the promise of being far more selective, thereby drastically reducing the incidence of side effects in patients undergoing treatment.; title: Improved diagnostics are central to the ongoing development and success of targeted therapies. Trastuzumab is one recent example of an innovative drug for which the development of an appropriate diagnostic test has proven essential to strong uptake within the breast cancer therapy segment and allowed the drug to be appropriately targeted and demonstrate cost-effectiveness for certain patients.; title: There has been a clear move away from cytotoxics in favor of cytostatic drugs, which has been integral to the development of targeted cancer therapies. While traditional chemotherapy agents kill cancer cells by being cytotoxic, many new agents work mostly by interrupting their growth i.e. are cytostatic.; title: For breast cancer, new treatments will be driven by: improved screening techniques; research in into the multiple tissue-specific interactions of the ER (estrogen receptor) and its response to antiestrogen therapy will be studied extensively; the development of pure antiestrogen agents which completely block estrogenic activity; increasing use of cytostatic therapy, combination therapy (of antiestrogens and aromatase inhibitors).; title: The challenges present an opportunity for targeted cancer drugs that may reduce the side effect profile and outperform the efficacy of existing drugs.; title: And for other cancers, for example for colorectal cancer?; title: Drug treatments for colorectal cancer exhibit similar limitations to those for other cancers in terms of excessive side effects and insufficient survival benefit. In the absence of curative treatment, there is also a need for agents that improve the quality of life for patients with unresectable tumors. Existing treatments tend to follow protracted delivery schedules and are expensive.; title: Lung cancer?; title: The major unmet need with lung cancer is extension of patient survival. The  current five-year survival rate is less than 15%, dramatically less than the rate for other major cancers. There is also a need for improved second-line treatments for patients who fail to respond to first-line treatments, or suffer a relapse after receiving first-line therapy.; title: Prostate cancer?; title: While cure rates for early-stage disease are high, there remains a critical unmet need for a curative treatment for advanced metastatic prostate cancer or hormone-refractory prostate cancer. There is also a need for new treatments with fewer side effects than current cytotoxics and hormonals.; title: Currently, treatment for cancer therapies depends on the type of cancer; the size, location, the stage of disease and the person’s general health. Advances in research  mean the treatment will less depend on cancer type (organ, location,, histology) and be more driven by molecular features.; title: What exactly do you mean?; title: Innovatives are the most promising area for all cancers and may create the answer to reduced side effects associated with cancer treatment and have the vast potential of dramatically increasing disease free survival and overall survival rates. The promise behind innovatives and reduced side effects arises from the potential of specifically targeting cancer cells, avoiding killing normal healthy cells, a common problem associated with cytotoxics and anti-metabolites.; title: For decades, scientists have looked for new therapies that target cancer. Researchers now know that cancer cells have several unique characteristics -- they require new blood vessels to deliver oxygen and nutrients (angiogenesis), they grow uncontrollably (proliferation), they travel throughout the body (metastasis), and they escape programmed cell death, a natural process by which the body rids itself of damaged or unwanted cells (apoptosis). The medical research community is dedicated to finding the next generation of small molecule and biologic therapies that will have an impact on this horrible disease.; title: In the book I also describe the role of specific drugs in cancer therapy, e.g.: sorafenib, sinutinib, rapamycin, bevacizumab, temsirolimus, vatalanib, cilengitide, cetuximab, gefitinib, erlotinib, panitumumab, lapatinib, tipifarnib, lonafarnib, bortezomib, bexaroten,  perifosine, oblimersen, aprinocarsen, exisulind, seliciclib, dasatinib, indisulam,UCN-01, ibritumomab, and innovative early stage drug development projects.; title: From the Greeks  to the First World War, medicine’s tasks were simple : to grapple with lethal diseases and gross disabilities, to ensure live births and manage pain. It performed these as best it could but with meager success.  You write that a new (second) dimension in healthcare emerged in the 1930`s, with the sulfonamides as the first medicines to cure disease, that progress in biomedicine provided doctors with the tools to ease  suffering rather than watch patients die.  You also say that a tremendous shift in ideas about medicine occurred,  that it is to the credit of conventional medicine that, when science revealed progress, it has abandoned products of a former generation of medicines for better ones. Are you adding a new, a third dimension in healthcare?; title: The postwar healthcare thinking resulted in generous socialized Statutory Healthcare Systems. Universal healthcare was a fantastic social ideology based on the willingness of bringing relief to the suffering, whenever illness strikes. At the same time, the manipulation of power by parties involved in health provision  increased. The focus  started to shift away from universal healthcare for the suffering patient to the care of an ailing healthcare system, which  itself suffered from budget overruns.; title: Currently, the economics of care, the cost-benefit analysis, leading to  a rational drug therapy philosophy, dominates the debate.; title: Genomics introduces many more objectives for the future therapy providers, so makes the links in the “value chain” far more complex. The new linked areas are:; title:  Gene sequencing. How do the proteins made by the identified gene sequences cause the effects of the disease and how can this be altered by individualized drug therapy?;; title:  Population genotyping. Will genotyping -the prediction of future morbidity-  ever become routine for individuals and populations with no history of disease? Will the health outcomes of these patients be improved? Does knowledge and fear of a future disease improve or diminish a person’s present quality of life? Do individuals have a right to genetic information about family members, if this data affects their own health and future?;; title:  Health economic modeling. Models which demonstrate that the probable increased cost of the new innovative therapies and diagnostic tools leads to a decreased overall cost of healthcare spend per patient by reducing inpatient stays, reducing the onset and severity of disease, and providing therapy that should provide effective treatment as it has been designed to  target the identified genetic causative factor of the disease;; title:  Drug discovery and development. Further basic research into how the gene mutation alters the proteins produced and the effect proteins have on causing the disease state, resulting in innovative drug therapies, adjunct therapies, nutrigenomics;; title:  Diagnostics and diagnosis. Development and validation of genetic test kits, both for the identification of future morbidity, and of the specific identification of the exact genetic cause of a disease state;; title:  Information management. Management of an individual’s genetic data on a scale and of a complexity which today is almost unimaginable;; title:  Disease management. Development of total health/wellness and disease management packages –with he potential of healthcare services, including education of the individual, the measurement of health outcomes, as will the personalized drug therapies supplied.; title: Let me repeat my question on personalized medicine. Are you saying that we will inevitably come to a kind of tailored treatment?; title: With further research into the information provided by the human genome project, scientists will be able to compare individual variations against a general blueprint for the human race. The result will be tailored treatments and the ability to pinpoint the mechanisms that can result in problems later in a person’s life. Scientists believe that one day in the not so far future, they will be able of predicting whether a person will develop diabetes, mental disorders, cancer, heart disease and a range of other conditions.; title: We are entering an exciting new era of predictive health where an individuals personal genetic code will provide guidance on healthcare decisions. Maps of insertions and deletions will be used together with SNP maps to create one big unified map of variation that can identify specific patterns of genetic variation to help us predict the future health of an individual.  The next phase is to figure out which changes correspond to changes in human health and develop personalized health treatments. This could include specific drugs tailored to each individual, given their specific genetic code.; title: Ultimately, each person's genome could be re-sequenced in a doctor's office and his or her genetic code analyzed to make predictions about their future health.; title: And the regulatory aspects?; title: The traditional government approval processes will prove inadequate to service the demand for an ever increasing number of specialized drugs.; title: On the way to becoming ‚virtual‘, basic research driven drug developers are expected to develop so-called Integrated Therapeutic Providers that combine the genomic, pharmaceutical, biotechnological and diagnostic know-how‘ to take advantage of the significant unmet medical need and the rapid pace of scientific advances in the treatment of health problems.; title: On the way to predictive medicine, a less isolated or restricted view of the „value chain of health“ will have to take a place at the center of all activities.; title: In the new healthcare environment, the leftovers of today’s drug research companies become system providers. Their  salvation (at least of a few of them) will be their effective marketing creativity and clout, leaving the discovery itself to more nimble entrepreneurs and the development to government funded international institutions, e.g. the National Institutes of Health, the National Cancer Institute, and others.; title: You were right with you former question: Visionary stakeholders prepare for a healthcare system of the third dimension.