the future of the pharmaceutical industry

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THE FUTURE OF THE PHARMACEUTICAL INDUSTRY Aïmane El BOUAZZAOUI Stojana TADIC 5 th year of Pharmaceutical Studies Faculty of Pharmacy, Montpellier University December 2014

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The Future of the Pharmaceutical IndustryAmane El BOUAZZAOUIStojana TADIC5th year of Pharmaceutical Studies Faculty of Pharmacy, Montpellier University December 2014

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PlanPast and Present of the Pharmaceutical IndustryFuturistic Look of the Three Levels of the Pharmaceutical IndustryInner level: Pharmaceutical science/ R&DMiddle level: Pharmaceutical and business environmentOuter level: Healthcare and societal contextConclusions

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PlanPast and Present of the Pharmaceutical IndustryFuturistic Look of the Three Levels of the Pharmaceutical IndustryInner level: Pharmaceutical science/ R&DMiddle level: Pharmaceutical and business environmentOuter level: Healthcare and societal contextConclusions

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History of the Pharmaceutical Industry (1)The roots lie back with the apothecaries and pharmacies that offered traditional/naturally remediesOrigins of modern industry: middle of the 19th century

Two breakthroughs presaged the arrival of the pharmaceutical industry as we know it today: penicillin and insulin4

AEBThe 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, alkaloidsGSk: middle of 19 centuryPfizer was founded in 1849, as demand for painkillers and antiseptics rocketedEllie lilly: 1876Edward Robinson Squibb 1858Bayer was founded in 1863 as a dye maker and synthesis of aspirin in 1895 by BayerOrigins 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

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History of the Pharmaceutical Industry (2)Golden age 1940-1970 The processes of internationalization begun in 1951 Pfizer alone opened subsidiaries in nine new countriesIn 1977, Tagamet - the first ever blockbuster drug, $1billion a year and the Nobel PrizeThe blockbuster modelProzac in 1987, Eli Lilly The first statin in 1987, Merck5

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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 countriesIn 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.

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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 development7740 total number of drugs

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Do pharmacists really know all the drugs in use?

STThe 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.

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Current Pharmaceutical Industry (2) Crisis in R&D productivityCan the industry still innovate? Expiring patents

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http://www.pwc.com/gx/en/pharma-life-sciences/

STOver the past years R&D returns have steadily declined 7

PlanPast and Present of the Pharmaceutical IndustryFuturistic Look of the Three Levels of the Pharmaceutical IndustryInner level: Pharmaceutical science/ R&DMiddle level: Pharmaceutical and business environmentOuter level: Healthcare and societal contextConclusions

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Inner Level: Pharmaceutical ScienceStem cells/Tissue engineeringMedical devices/Connected devicesPersonalized medicine: treatment, diagnostic, prevention9

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Stem cells/Tissue engineering (1)stem cells:

Totipotent --> entire organism

Pluripotent --> most tissues of an organism

Multipotent --> specific tissue (skin, blood)

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Christopher Lyles

Adenoid cystic carcinoma (rare form of tracheal cancer)

1st US patient to get stem cells trachea transplant in November 201011

Chemotherapy and raditherapy werent effective11

Christopher LylesCooperation between:University College London, UK: designing and building the nanocomposite tracheal scaffoldGroups in the USA and Germany producing a specific bioreactor to seed the scaffold with the patient stem cellsKarolinska Institute, Sweden (Pr. Paolo Macchiarini)

Use of bone marrow stem cells12 hours procedureDied 4 months later (March 2011)

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Patient was discharged 2 weeks after surgeryCost aproximatively 500 000 $Paolo Macchiarini

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number of stem cells clinical trials (4734 worldwide)

number of embryonic stem cells clinical trials (34 worldwide)

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On top: number of stem cells clinical trials (4734 worldwide)Botom: number of embryonic clinical trials (34 worldwide)13

We want to ask !14

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With all the elements that you have and your personal beliefs, what do you think about research on embryonic stem cells?

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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 healthMobile medical applicationsMedical device data systemsSoftwareWireless technologyIntelligent medicines

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STPill with a sensor on it (puls, blood cholesterol) send a msg to your smartphone or to your physicienDrug 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.16

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

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STGoogle X, stylized asGoogle[x],[1]is a semi-secret facility run byGooglededicated to making major technological advancements.Google contact lensesthat monitor glucose in tearsgive you the ability to explore the body at a molecular and cellular levelslight changes in the person's biochemistry

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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

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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 populationToday - oncology space In near future other disease areasCosts and time of genome sequencingGenome, transcriptome, proteome and metabolome analyses

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STToday in oncology space but more can be done across other disease areasThe rise of personalized medecine is supported by a rapid decline in the costs of genome sequencing Comprehension of the cell as a global entityDifferent genomic levels ( genome, )

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Personalized medicine (3) Pharmacogenomics allows us to identify sources of an individuals 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 FDA20

AEBDNA:Molecular Structure of Nucleic Acids discovered in 1953 by Watson and Crick (1962 Nobel Prize in Physiology or Medicine)Human Genom Project (1990-2003)

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Personalized medicine (4)

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The Angie Story22

prevention

treatment

So now Im going to talk about the previous point. A few minutes ago, Stojana talked about 4 major points regarding personalized medicine. What were they?Im 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 didnt do anything? She might never has had breast cancer. Lets 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 isnt that lucky, this mutation slows the transformation of tamoxifen into Endoxifen witch is the active drug. The result being a decrease of Angies survival chances22

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Would you be ready to get you DNA sequenced?

PlanPast and Present of the Pharmaceutical IndustryFuturistic Look of the Three Levels of the Pharmaceutical IndustryInner level: Pharmaceutical science/ R&DMiddle level: Pharmaceutical and business environmentOuter level: Healthcare and societal contextConclusions

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Middle circle/Pharmaceutical and business environment

Todays high risk/high gain model is unlikely to be sustainableNew business modelsCooperation between companies:pharmaceutical and life science companiesinternet-related academic partnership public authoritiesmerge between drug companies and devices companies Drug + Service

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STDemographic changesinterdisciplinary education and transnational programmesBiology and engineering will join forces

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PlanPast and Present of the Pharmaceutical IndustryFuturistic Look of the Three Levels of the Pharmaceutical IndustryInner level: Pharmaceutical science/ R&DMiddle level: Pharmaceutical and business environmentOuter level: Healthcare and societal contextConclusions

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Outer circle/ Healthcare social contextImage of pharmaceutical industry / public trustEx. drug scandals, raise of traditional medicine,

Transparency

Patient power : advisory committees , patients associations (decision making)Informed and demanding patientsPatients become more like consumersPrice health insurance27

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PlanPast and Present of the Pharmaceutical IndustryFuturistic Look of the Three Levels of the Pharmaceutical IndustryInner level: Pharmaceutical science/ R&DMiddle level: Pharmaceutical and business environmentOuter level: Healthcare and societal contextConclusions

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Conclusions (1)

Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity WHOHealth is a basic need Missions and visions of pharmaceutical industry vs public image/trust New business model

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ST et AEBSince the origins of modern pharmaceutical industry, drugs have played a major part in increasing life expectancyStrong belief that they are going to continue to save lives and to make difference in the human lifeDrugs have played a major part in increasing life expectancyThough 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

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Conclusions (2)

Difficult to predict what we might be doing in the future!

I couldnt tell you I have no fears, I generally have a lot of hopes

Professor Dame Nancy RothwellPresident and Vice-Chancellor of the University of ManchesterDirector of pharmaceuticals companyAstraZeneca

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Thank you for your attention !

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