The future of healthcareand the pharmaceuticalindustry: a CEO viewFranz B. Humer, Chairman and CEO Roche

In the century or so since the birth of the research-based pharmaceutical industry, there has never been a more demanding time. The

most pressing issue facing virtually all big pharmaceutical companies today is research and development productivity. Despite huge

investments in research and development, the number of new medicines cleared for market has declined. On the other hand, there

has never been a more exciting time to do healthcare research. New sciences and technologies are opening up radically new

perspectives and opportunities for the future. Medical practice is undergoing a historic shift towards more personalized medicine.

Over the next 10 years we can expect significant progress in the treatment of major diseases. � 2004 WPMH GmbH. Published by Elsevier

Ireland Ltd.

A historical success story

The last 100 years have seen a dramatic

change in the ability to treat and manage

disease. At the start of the 20th century

average life expectancy in the Unite States

was only 47 years, it is now 76 years.

Advances in sanitation, education and food

production have all played a part in

increasing life expectancy by tackling the

causes of disease. At the same time the

pharmaceutical industry has delivered new

weapons to battle disease itself. The phar-

maceutical industry has turned scientific

understanding into the most potent weapon

that mankind has been able to deploy

against ill health. Scientific advances have

dramatically improved the ability of physi-

cians to treat and manage disease, and have

enabled people to live longer, healthier

lives. The last 50 years in particular have

been an extraordinary period of scientific

exploration. High-profile milestones include

the identification of DNA as the hereditary

material in 1943, the subsequent elucida-

tion of its structure, and the more recent

mapping of the human genome. These

advances will not trigger a sudden revolu-

tion in treatment, but will lead to an extra-

ordinary evolution in healthcare.

Challenges remain

Despite these advances there remains a

significant level of unmet medical need

in the world. The steady increase in life

expectancy in developed countries, with

greater numbers reaching old age, brings

with it a growing need for medicines

against chronic conditions like rheuma-

tism, heart failure, Alzheimer’s disease

and cancer. Worldwide every year more

than ten million people are diagnosed with

cancer, and more than six million die from

it. In the next 20 years these numbers are

predicted to increase by 50%. In addition

new diseases such as SARS and more

resistant forms of disease will continue to

emerge. New challenges for treatment are

presented by HIV/AIDS, which has

emerged to become a global pandemic,

and drug-resistant forms of malaria and

anti-biotic resistant bacteria require

ongoing development of new medicines.

Let us also not forget the enormous chal-

lenges that have still to be addressed in

the developing world.

The mission of pharmaceuticals has

remained the same from its simple,

ancient origins to today’s complex, global

industry: to find better ways to alleviate

suffering and prolong human life.

Unravelling the molecular basisof disease

In the past, drug discovery relied heavily

on trial and error. Treatments to date

have been based on patients’ symptoms.

The medicines of the future will instead

result from careful study of the underlying

biology of disease. Applying genetic

knowledge to both diagnostics and thera-

peutics, Roche aims to pioneer a new

paradigm in medicine that promises more

precise diagnosis: better, safer and more

effective treatments; improved response

rates; better compliance; and significant

reductions in wasted healthcare spending.

Medical practice is undergoing a historic

shift, as traditional clinical diagnostic

methods are supplanted by molecular defi-

nitions of disease and molecular diagnoses.

I believe that someday a cancer diagnosis

will no longer focus on the body part

afflicted (breast, lung, or prostate) but will

give way to talk of the specific genetic

material that triggers cancerous cells to

grow out of control. As the promise of

genetic study or genomics unfolds, compa-

nies will be able to define more precisely

what their drugs do and whom they could

really help. We launched Herceptin, the

first highly targeted therapy for the treat-

ment of breast cancer 6 years ago. It is

prescribed just to the 25% or so of

patients whose tumours harbour a particu-

lar genetic quirk.

More personalizedhealthcare

The field of personalized medicine is also

progressing in other directions. Roche

took on the challenge of building a market

for DNA chips in clinical diagnostics from

scratch. Last year, we saw the launch in

Franz B. Humer

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� 2004 WPMH GmbH. Published by Elsevier Ireland Ltd. Vol. 1, No. 1, pp. 107–109, May 2004 107

the United States, for research use, of the

so called AmpliChip CYP450, the world’s

first pharmacogenomic microarray. The

test provides information on how indivi-

dual metabolic variations influence the

action of certain widely used drugs in dif-

ferent patients. It helps avoid adverse drug

effects caused by incorrect dosage and

thus represents a pioneering achievement

on the road to individualised therapeutics,

which is set to replace the present ‘one

drug fits all’ approach. We intend to com-

mercialise DNA chip-based tests for a

range of diseases, especially in oncology.

Our DNA chip-based tests could even-

tually replace such common medical pro-

cedures as mammograms to reveal breast

cancer.

Doctors will be better able to treat dis-

ease, individual people will be more able

to understand their propensity to develop

different diseases, and take informed deci-

sions on the risks and benefits of different

interventions.

New paradigm offers hugeopportunities

In 10 years time the industry will be able

to identify predispositions for major dis-

eases, such as cancer, heart disease and

stroke, based upon a combination of

genetic and environmental risk factors.

Within 10 years companies will be able to

offer diagnostics and medicines for a

growing number of diseases and will have

vastly improved the treatment of Alzhei-

mer’s disease, diabetes, and rheumatoid

arthritis. Physicians will be starting to

monitor those people with higher risk

levels to enable early treatment and offer

them more efficacious treatments, whilst

managing other risk factors, such as life-

style and diet. This evolution will place

patients at the centre of healthcare, with

more tailoring of interventions, and health

management based upon their specific

needs. In addition patients will have to

take a larger role in decision-making, as

the options for prevention, management

and treatment broaden.

A promising future for theindustry

The scientific advances will enable the

pharmaceutical industry to develop medi-

cines that continue to reduce the burden

of disease and improve quality of life. To

do this companies will have to continue to

invest for a number of years before the

hoped for advances lead to significant

numbers of new products coming to mar-

ket. The regulatory and business environ-

ment will need to encourage investment in

innovative and speculative science, and

companies will need to continue to drive

productivity, to ensure revenues are gen-

erated to fund future investments.

The pharmaceutical industry will be

altered by the opportunities, economics

and challenges of new approaches to pre-

vention and treatment, enabled by scienti-

fic advances. More companies will need to

bundle diagnostic research and develop-

ment activities with product-focused

research and development, either through

partnerships or through mergers and

acquisitions. It is this combination that

will enable the more holistic approach to

risk identification, treatment and preven-

tion that will deliver the most substantial

benefit to patients. This change may

also require companies to become a

more significant partner in healthcare

delivery, working closely with healthcare

providers and physicians to identify the

most appropriate treatments for patients.

Only a question of time

The science of targeting is still very

much a work in progress. But I firmly

believe that in the foreseeable future,

there will be no treatment without DNA-

based diagnosis. We are on the threshold

of a new era in the industry. The key

question is how long it will be before the

current rapid scientific progress has an

effect on therapeutic practice and out-

comes. The knowledge gained in such

projects will lead to development of tar-

geted diagnostic tests and medicines that

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108 Vol. 1, No. 1, pp. 107–109, May 2004

offer significant clinical benefits and

improve patients’ quality of life. In addi-

tion, they will help healthcare payers to

make optimum use of available funds.

This new way of medicine will include

risk. Innovation involves risks, and we

will certainly fail in some projects, but

not to try is to be certain of total failure.

I genuinely believe that the changes we

have seen in recent years are small com-

pared with those the next decade has in

store for us. More personalized healthcare

offers tremendous advantages for the

pharmaceutical industry, patients, provi-

ders and payers.

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Vol. 1, No. 1, pp. 107–109, May 2004 109