1. THE FUTURE OF THE
PHARMACEUTICAL
INDUSTRY
Aïmane El BOUAZZAOUI
Stojana TADIC
5th year of Pharmaceutical Studies
Faculty of Pharmacy, Montpellier University
December 2014
2. Plan
• Past and Present of the Pharmaceutical Industry
• Futuristic Look of the Three Levels of the Pharmaceutical Industry
• Inner level: Pharmaceutical science/ R&D
• Middle level: Pharmaceutical and business environment
• Outer level: Healthcare and societal context
• Conclusions
2
3. Plan
• Past and Present of the Pharmaceutical Industry
• Futuristic Look of the Three Levels of the Pharmaceutical Industry
• Inner level: Pharmaceutical science/ R&D
• Middle level: Pharmaceutical and business environment
• Outer level: Healthcare and societal context
• Conclusions
3
4. History of the Pharmaceutical Industry (1)
• The roots lie back with the apothecaries and pharmacies
that offered traditional/naturally remedies
• Origins of modern industry: middle of the 19th century
• Two breakthroughs presaged the arrival of the
pharmaceutical industry as we know it today: penicillin and
insulin
4
Merck
1827
GSK
middle
XIX c.
Pfizer
1849
Eli Lilly
1876
Edward
Robinson
Squibb
1858
Bayer
1863
5. History of the Pharmaceutical Industry (2)
• Golden age 1940-1970
• The processes of internationalization begun in 1951 – Pfizer
alone opened subsidiaries in nine new countries
• In 1977, Tagamet - the first ever “blockbuster” drug, $1billion
a year and the Nobel Prize
• The “blockbuster” model
• Prozac in 1987, Eli Lilly
• The first statin in 1987, Merck
5
6. Current Pharmaceutical Industry (1)
• Comprises hundreds of companies (biotech firms,
wholesalers, “Big Pharma”…)
• http://www.currentpartnering.com/insight/company-tracker/top-50-
pharma/
• http://www.currentpartnering.com/insight/company-tracker/top-
bigbiotech/
• US$300 billion market
• one-third of all sales revenue goes on marketing - twice
what they spend on research and development
• 7740 total number of drugs
6
Do pharmacists
really know all
the drugs in
use?
7. Current Pharmaceutical Industry (2)
• Crisis in R&D productivity
• Can the industry still innovate?
• Expiring patents
7
http://www.pwc.com/gx/en/pharma-life-sciences/
8. Plan
• Past and Present of the Pharmaceutical Industry
• Futuristic Look of the Three Levels of the Pharmaceutical Industry
• Inner level: Pharmaceutical science/ R&D
• Middle level: Pharmaceutical and business environment
• Outer level: Healthcare and societal context
• Conclusions
8
10. Stem cells/Tissue engineering (1)
• stem cells:
• Totipotent --> entire
organism
• Pluripotent --> most
tissues of an organism
• Multipotent --> specific
tissue (skin, blood…)
10
11. Christopher Lyles
• Adenoid cystic carcinoma (rare form of tracheal cancer)
• 1st US patient to get stem cells trachea transplant in
November 2010
11
12. Christopher Lyles
• Cooperation between:
• University College London, UK: designing and building the
nanocomposite tracheal scaffold
• Groups in the USA and Germany producing a specific bioreactor to
seed the scaffold with the patient stem cells
• Karolinska Institute, Sweden (Pr. Paolo Macchiarini)
• Use of bone marrow stem cells
• 12 hours procedure
• Died 4 months later (March 2011)
12
13. • number of stem cells
clinical trials
(4734 worldwide)
• number of embryonic
stem cells clinical trials
(34 worldwide)
13
15. With all the elements that you have
and your personal beliefs, what do
you think about research on
embryonic stem cells?
15
16. Medical devices/Connected devices (1)
• Connected health is a model for healthcare delivery that
uses technology to provide healthcare remotely.
• 2014 the rise of connected health
• Mobile medical applications
• Medical device data systems
• Software
• Wireless technology
• Intelligent medicines
16
17. Medical devices/Connected devices (2)
• Google is aiming to diagnose cancers, impending heart
attacks or strokes and other diseases, at a much earlier
stage than is currently possible
• Pill containing a disease-detecting nanoparticles with a
wrist-worn sensor
• glucose-measuring contact lenses
17
18. Personalized medicine (1)
“The term "personalized medicine" is often described as
providing "the right patient with the right drug at the right
dose at the right time." More broadly, "personalized
medicine" may be thought of as the tailoring of medical
treatment to the individual characteristics, needs, and
preferences of a patient during all stages of care, including
prevention, diagnosis, treatment, and follow-up.”
FDA
18
19. Personalized medicine (2)
• “Today we live in an era of «one size fits all» medicine with
many drugs not working on 50% or more of the population”
• Today - oncology space
• In near future – other disease areas
• Costs and time of genome sequencing
• Genome, transcriptome, proteome and metabolome
analyses
19
20. Personalized medicine (3)
“Pharmacogenomics allows us to identify sources of an
individual’s profile of drug response and predict the best
possible treatment option for this individual. The use of
genomic information has opened new possibilities in drug
discovery and development ”
FDA
20
24. Plan
• Past and Present of the Pharmaceutical Industry
• Futuristic Look of the Three Levels of the Pharmaceutical Industry
• Inner level: Pharmaceutical science/ R&D
• Middle level: Pharmaceutical and business environment
• Outer level: Healthcare and societal context
• Conclusions
24
25. Middle circle/Pharmaceutical and
business environment
• Today’s “high risk/high gain” model is unlikely to be
sustainable
• New business models
• Cooperation between companies:
• pharmaceutical and life science companies
• internet-related
• academic partnership
• public authorities
• merge between « drug » companies and « devices »
companies
• Drug + Service
25
26. Plan
• Past and Present of the Pharmaceutical Industry
• Futuristic Look of the Three Levels of the Pharmaceutical Industry
• Inner level: Pharmaceutical science/ R&D
• Middle level: Pharmaceutical and business environment
• Outer level: Healthcare and societal context
• Conclusions
26
27. Outer circle/ Healthcare social context
• Image of pharmaceutical industry / public trust
• Ex. drug scandals, raise of traditional medicine,
• Transparency
• ‘Patient power’ : advisory committees , patients
associations (decision making)
• Informed and demanding patients
• Patients become more like consumers
• Price health insurance
27
28. Plan
• Past and Present of the Pharmaceutical Industry
• Futuristic Look of the Three Levels of the Pharmaceutical Industry
• Inner level: Pharmaceutical science/ R&D
• Middle level: Pharmaceutical and business environment
• Outer level: Healthcare and societal context
• Conclusions
28
29. Conclusions (1)
• “Health is a state of complete physical, mental and social
well-being and not merely the absence of disease or
infirmity” WHO
• Health is a basic need
• Missions and visions of pharmaceutical industry vs public
image/trust
• New business model
29
30. Conclusions (2)
Difficult to predict what we might be doing in the future!
« I couldn’t tell you I have no fears, I generally have a lot of
hopes »
Professor Dame Nancy Rothwell
President and Vice-Chancellor of the University of Manchester
Director of pharmaceuticals company AstraZeneca
30
AEB
The roots of the pharmaceutical industry lie back with the apothecaries and pharmacies that offered traditional/naturally occuring remedies: Medicinal herbs - Digitalis to stimulate heart muscle, Quinine for malaria, Pecacuanha for dysentery, Mercury to treat syphilis
Merck 1827, alkaloids
GSk : middle of 19 century
Pfizer was founded in 1849, as demand for painkillers and antiseptics rocketed³
Ellie lilly: 1876
Edward Robinson Squibb 1858
Bayer was founded in 1863 as a dye maker and synthesis of aspirin in 1895 by Bayer
Origins of modern industry: second half of the 19th century;
Two breakthroughs presaged the arrival of the pharma industry as we know it today: insuline, peniciline
ST
Golden age 1940-1970 (contraceptive pill, diazepam, monoamine oxidase inhibitor (MAOI), haloperidol, oncology medicines , ACE inhibitors, paracetamol /acetaminophen, ibuprofen )
The processes of internationalisation begun in 1951 – Pfizer alone opened subsidiaries in nine new countries
In 1977, Tagamet, an ulcer medication, became the first ever “blockbuster” drug, earning its manufacturers more than $1 billion a year and its creators the Nobel Prize.
This marked a new departure as companies competed to be the developer of the next big blockbuster, and many achieved great success.
Eli Lilly released Prozac, in 1987, once again revolutionising mental health practice.
The first statin was also approved in 1987, manufactured by Merck (MSD).
Chemical synthesis of artificial dyes proved to be therapeutically useful.
Large-scale industrial production of insulin.
Industrial-scale production of penicillin that boosted the development of biopharmaceutical industry.
ST
The global pharmaceuticals market is worth US$300 billion a year.
Companies currently spend one-third of all sales revenue on marketing their products - roughly twice what they spend on research and development.
ST
Over the past years R&D returns have steadily declined
AEB
Chemotherapy and raditherapy weren’t effective
Patient was discharged 2 weeks after surgery
Cost aproximatively 500 000 $
Paolo Macchiarini
On top: number of stem cells clinical trials (4734 worldwide)
Botom: number of embryonic clinical trials (34 worldwide)
AEB
AEB
ST
Pill with a sensor on it (puls, blood cholesterol) send a msg to your smartphone or to your physicien
Drug delivery systems (pump insulin for a year)
Connected Health refers to electronic methods of health care delivery that allow users to deliver and receive care outside of traditional health care settings. Examples include mobile medical apps, medical device data systems, software, and wireless technology.
ST
Google X, stylized as Google[x],[1] is a semi-secret facility run by Google dedicated to making major technological advancements.
Google contact lenses that monitor glucose in tears
give you the ability to explore the body at a molecular and cellular level
slight changes in the person's biochemistry
ST
Today in oncology space but more can be done across other disease areas
The rise of personalized medecine is supported by a rapid decline in the costs of genome sequencing
Comprehension of the cell as a global entity
Different genomic levels ( genome, …)
AEB
DNA:
Molecular Structure of Nucleic Acids discovered in 1953 by Watson and Crick (1962 Nobel Prize in Physiology or Medicine)
Human Genom Project (1990-2003)
So now I’m going to talk about the previous point. A few minutes ago, Stojana talked about 4 major points regarding personalized medicine. What were they?
I’m going to give an example for two of those points.
This a story of a girl name Angie. Her mother died several years ago from breast cancer at a very young age.
One day, she decided that she wanted to now if she inherited genes from her mother that would increase her risk of developing the same type of cancer.
Quick word on BRCA1/2: human tumor suppressors genes, producing tumor suppressor proteins that help repair damaged DNA.
If the BRCA1/2 mutation, then damaged DNA is not repaired properly and this increases the risk of breat cancer. (up to an 80% risk of breast cancer)
Breast cancer: 12% of women in the general population. 50% of women who inherit a harmful BRCA1/2 mutation will develop breast cancer by age 70
So Angie decides to meet her oncogenetic doctor and to have her DNA sequenced. She ended up having both mutations and choose to have a double mastectomy. End of the story…
But what if? What if she didn’t do anything? She might never has had breast cancer. Let’s say she did have breast cancer. Then, her oncologist decides to run a blood test to see if her cancer is sensitive to hormonotherapy. She is a lucky girl, her cancer is sensitive to hormonotherapy. So her oncologist decides to treat her with Tamoxifen. This same oncologist who is a realy good oncologist decides to run an other DNA test to see if Angie has mutations in the genes implicated in the metabolisation of the drug. He finds out that Angie has a mutation in the CYP 2D6 molecule. Unfortunately for Angie, who isn’t that lucky, this mutation slows the transformation of tamoxifen into Endoxifen witch is the active drug. The result being a decrease of Angie’s survival chances
ST
ST
Demographic changes
interdisciplinary education and transnational programmes
Biology and engineering will join forces
ST
AEB
ST
ST et AEB
Since the origins of modern pharmaceutical industry, drugs have played a major part in increasing life expectancy
Strong belief that they are going to continue to save lives and to make difference in the human life
Drugs have played a major part in increasing life expectancy
Though drugs have helped increasing life expectancy over the past century, there is a gap wider and wider between tha pharmaceutical industry and its image necessitating a change in the business model. Furthermore
