Innovation: Sind wirtschaftliche Erfolge und wissenschaftliche Exzellenz Gegensätze? Prof. Dr. Dr. h. c. Günter Stock„Gerechtigkeit und Forschungsfinanzierung „Gerechtigkeit und Forschungsfinanzierung –– Was macht Deutschland?“Was macht Deutschland?“
Prof. Dr. Dr. h. c. Günter StockProf. Dr. Dr. h. c. Günter Stock Präsident Präsident
der Berlinder Berlin--BrandenburgischenBrandenburgischen Akademie der WissenschaftenAkademie der Wissenschaften
6. IGES-Kongress zum Fortschritt im Gesundheitswesen von morgen
Berlin, 23. Oktober 2008
R&D R&D expenditureexpenditure in in comparisoncomparison (2001)(2001)
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315 USA
315 USA
175 EU
52 Deutsch-
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R&D R&D expenditureexpenditure in in thethe US US accordingaccording to to selectedselected disciplinesdisciplines
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Forschungsfinanzierung Forschungsfinanzierung a)a) in den USA nach thematischer Ausrichtung 1970in den USA nach thematischer Ausrichtung 1970––20022002 (Summe Wissenschaft und Wirtschaft, in Mrd. US(Summe Wissenschaft und Wirtschaft, in Mrd. US--$ zu Preisen von 2000)$ zu Preisen von 2000)
6. IGES-Kongress Berlin, 23. Oktober 2008 4
Finanzierungsanteil des Staates an Finanzierungsanteil des Staates an ForschungsForschungs-- u. Entwicklungsaufwendungen der Wirtschaft (in Prozent)u. Entwicklungsaufwendungen der Wirtschaft (in Prozent)
Quelle: Fraunhofer-Gesellschaft (Büro der Forschungsunion Wirtschaft-Wissenschaft) – eigene Berechnungen auf Basis von BMBF 2008
6. IGES-Kongress Berlin, 23. Oktober 2008 5
Wege zu günstigen ArzneimittelnWege zu günstigen Arzneimitteln
Quelle: Verband forschender Arzneimittelhersteller VfA (www.vfa.de/de/politik/artikelpo/medikamente-in- entwicklungslaendern-3.html)
6. IGES-Kongress Berlin, 23. Oktober 2008 6
Erfolgsraten in der pharmazeutischen F&EErfolgsraten in der pharmazeutischen F&E
Gründe für einen Ausfall (1991-2000)
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SuccessSuccess Rates in Rates in PharmaceuticalPharmaceutical R&DR&D
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The data are from the ten biggest drug companies during 1991-2000 (The companies are AstraZeneca, Bristol- Myers Squibb, Eli Lilly, F. Hoffmann La-Roche, GlaxoWellcome, Johnson & Johnson, Novartis, Pfizer, Pharmacia, Schering Plough and SmithKline Beecham; data were obtained by Datamonitor in the Pharmaceutical Benchmarking Study.)
6. IGES-Kongress Berlin, 23. Oktober 2008 8
Projekte forschender Pharmafirmen für neue Arzneimittel gegen KrProjekte forschender Pharmafirmen für neue Arzneimittel gegen Krankheiten der Entwicklungsländerankheiten der Entwicklungsländer
Krankheit Projekte f. Medikamente zur Behandlung
(davon in klinischer Erprobung/ Zulassung)
Projekte für Impfstoffe (davon in klinischer Erprobung/ Zulassung)
Malaria 22 (10) 4 (3)
Tuberkulose 20 (7) 2 (2)
Dengue-Fieber 3 (0) 2 (2)
Schlafkrankheit 6 (1) -
Chagas-Krankheit 3 (0) -
Bilharziose 1 (0) -
Flussblindheit 1 (1) -
Rotaviren - 2 (2)
Patents Patents areare notnot a a BarrierBarrier to to MedicineMedicine AccessAccess
In many markets where patent laws have been introduced relatively recently, access to medicines has improved. More likely than patents, other causes including poverty, medical regulatory regimes in the various countries, tariffs and sales taxes, and a lack of international aid to fund AIDS treatments impede access to antiretroviral treatments in Africa.1)
In 65 low- and middle-income countries (4 billion people ≅ 2/3 of world population), patenting for essential medicines is rare (overall patent incidence of 1.4 %).2)
Thus, there is no patent barrier for generics in 98.6% of the essential medicines.
Other causes such as poverty and poor infrastructure are limiting the access to medicines.
1) A. Attaran and L. Gillespie-White, Journal of the American Medical Association, 2001, Vol. 286 2) A. Attaran, Health Affairs, Vol. 23, 155-166 A. Attaran is a fellow in the Royal Institute of International Affairs in London
6. IGES-Kongress Berlin, 23. Oktober 2008 10
BirthBirth of an Industry (I)of an Industry (I)
19531953 DNA structure proposed by James Watson and Francis Crick
19601960 Arthur Kornberg synthesizes DNA in vitro
19701970 Hamilton Smith and Kent Wilcox isolate the first restriction enzyme
19711971 The first biological engineering company, Cetus, founded
19721972 Paul Berg uses a restriction enzyme to form a hybrid circular molecule
19731973 Stanley Cohen and Herbert Boyer develop DNA cloning and recombinant DNA
19761976 Robert Swanson and Herbert Boyer found Genentech
19771977 Genentech clones the hormone somatostatin in bacteria, the first cloning of a protein using a synthetic recombinant gene
19781978 Biogen founded, now the oldest independent biotech company Genentech and City of Hope National Medical Center announce the successful production of human insulin
19801980 Amgen founded Leroy Hood and Mike Hunkapiller develop protein sequencer Fred Sanger and colleagues develop the shotgun method for sequencing genomes
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BirthBirth of an Industry (II)of an Industry (II)
19831983 Kary Mullis invents the polymerase chain reaction
19861986 US Environmental Protection Agency approves release of genetically altered tobacco, the first genetically engineered crop
19871987 Susan Horvath, Mike Hunkapiller and Leroy Hood develop DNA synthesizer
19881988 Philip Leder and Timothy Stewart are awarded patent for mouse breast-cancer model, the first patent given for a genetically altered animal
19941994 US Food and Drug Administration deems the Flavr Savr, a genetically modified tomato, safe, thus bringing to market the first transgenic food product
19971997 Roslin Institute scientists clone Dolly the sheep, the first mammal to be cloned successfully from an adult cell
19981998 Independent teams led by James Thomson and John Gearhart are the first to grow embryonic stem cells successfully
20012001 Public and private teams publish draft versions of the human genome sequence
20022002 Over 200,000 jobs exist across 4,000 biotech companies worldwide (Ernst & Young)
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2006: 2006: MoreMore thanthan 50 50 yearsyears agoago Watson & Crick Watson & Crick decodeddecoded thethe DNA DNA structurestructure
Watson and Crick with their DNA model in the Cavendish Labor in Cambridge, 2121stst May 1953May 1953 (Photo from Anthony Barrington Brown)
25.04.2008 | 13"Medizinische Biotechnologie in Deutschland 2008" | Boston Consulting Group/VFA Bio
Biopharmazeutika bestimmen wesentliche Therapiebereiche Insbesondere bei Stoffwechsel-, Infektions-, Krebs- und immunologischen Erkrankungen
25.04.2008 | 13"Medizinische Biotechnologie in Deutschland 2008" | Boston Consulting Group/VFA Bio
Gesamt- pharmamarkt € 26,8 Mrd.3
1. Exklusive hämatologische Onkologie 2. u. a. Gastroenterologie, Dermatologie, Urologie etc. 3. Umsatz in Krankenhaus und Apotheke zu Herstellerabgabepreisen 4. CAGR = Compound Annual Growth Rate Quelle: IMS; VFA-Mitgliedsunternehmen; EvaluatePharma; BCG-Analyse
51%51%
11% 24%
Stoff-wechsel
32% 25%
Onko-logie
Hämato-logie1
2004 – 2007
2%
Anteil an neu zugelassenen Wirkstoffen weiterhin hoch Biopharmazeutika mit Anteil von 20-30 Prozent an Neuzulassungen in Deutschland
2000 2001 2002 2003 2004 2005 2006 2007
Anteil Biopharma- zeutika
Anteil Biopharma- zeutika 29%29% 33%33% 20%20% 18%18% 23%23%24%24% 31%31% 25%25%
Zahl der neu zugelassenen Wirkstoffe in DeutschlandZahl der neu zugelassenen Wirkstoffe in Deutschland
Quelle: EMEA; Europäische Kommission; VFA; BCG-Analyse
Biopharma- zeutika
Medizinische Biotechnologie schafft Arbeitsplätze Zahl der Mitarbeiter um 14 Prozent gestiegen
25.04.2008 | 15"Medizinische Biotechnologie in Deutschland 2008" | Boston Consulting Group/VFA Bio
Unternehmen mit Technologieplattform3
1. Umsatz mit Biopharmazeutika (Krankenhäuser und Apotheken) 2. Umsatz mit Lizenzen, Meilensteinzahlungen, Serviceleistungen etc. von aufstrebenden Unternehmen (Umsatz < 30 Mio. €, Quelle: Geschäftsberichte); BCG-Schätzung 3. Aber ohne eigene Wirkstoffentwicklung Quelle: Bureau van Dijk; VFA-Mitgliedsunternehmen; Ernst & Young 2007; BCG-Analyse
Anzahl der Unternehmen in Deutschland 2007
Anzahl der Unternehmen in Deutschland 2007
274
371
+1%+1%
Umsatz der Unternehmen in Deutschland 2007 (in Mio. €) Umsatz der Unternehmen in Deutschland 2007 (in Mio. €)
622
4.978
+26%
+14%
4.0111
+ 3452
6.464
27.483
33.947
+15%
+6%
16
InnovationInnovation
First approved MS Therapy Betaferon approval as 1993 orphan drug
Introduction of MRI as an MRI results critical in FDA innovative technology to approval besides clinical assess treatment outcomes endpoints 1993/95
Definition of MS includes MRI criteria integral part of MS MRI criteria diagnosis and therapy monitoring
Definition of MS (McDonald criteria) based on MRI criteria 2000
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17
Improved diagnostic techniques (McDonald-criteria)Improved diagnostic techniques (McDonald-criteria)
Pathology more completely understoodPathology more completely understood
Effective treatmentEffective treatment
Greater emphasis on early diagnosis and managementGreater emphasis on early diagnosis and management
A more positive future for MS-patients and their management
A more positive future for MS-patients and their management
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Instructions from EgyptianInstructions from Egyptian papyri (1850 B.C.E.)papyri (1850 B.C.E.)
- Vaginal application of crocodile dung as pessary or paste .....
- Cotton tampons or sponges filled with honey, sodium bicarbonate, fluid from pomegranate
4000 4000 YearsYears of of FemaleFemale ContraceptionContraception
384 384 -- 322 B.C.E.322 B.C.E. The Greek philosopher AristotleAristotle is thought to be the first person to propose using natural chemicals such as cedar oil, lead ointment or frankincense oilfrankincense oil as spermicides. Source: www.pbs.org
The First Pill in Europe:The First Pill in Europe: AnovlarAnovlar (1961)(1961)
6. IGES-Kongress Berlin, 23. Oktober 2008 1919
The First Oral Contraceptive in Europe:The First Oral Contraceptive in Europe: AnovlarAnovlar (1961*)(1961*)
* first Anovlar launch: Australia; January 01, 1961
6. IGES-Kongress Berlin, 23. Oktober 2008 2020
TransitionTransition of of ConceptsConcepts
ContraceptivesContraceptives forfor Fertility Control
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OC’sOC’s: there is more than Contraception: there is more than Contraception
Unwanted pregnancies ↓
Morbidity/Mortality in pregnancy ↓
„Cycle“ control ~50% Dysmenorrhea ~60% Anemia ~25% Acne, Seborrhea ~80% PCO ~50% Premenstrual Syndrome ~25% Pelvic inflammatory disease~50% benign ovarian tumors ~80% benign breast tumors ~50% Endometriosis ~50% Ovarian-Ca. ~50% Endometrium-Ca. ~50%
Contraceptive Benefits Additional Benefits+
Yasmin® has Proven the Value of Contraceptives with Added BenefitsYasminYasmin®® has has ProvenProven thethe ValueValue of of ContraceptivesContraceptives withwith AddedAdded BenefitsBenefits
1960 2004
2010
2000
2005
Contraceptives with new progestins that have added benefits e.g. DRSP
New application forms e.g. patch
Contraceptives with estradiol instead of ethinyl estradiol
Contraceptives with unique added benefits e.g. dysfunctional uterine bleeding
Our FC pipeline is „best in the business“
The Future:The Future: Challenges and TasksChallenges and Tasks
2010
2000
2005
Contraceptives with new progestins that have added benefits e.g. DRSP
New application forms e.g. patch
Contraceptives with estradiol instead of ethinyl estradiol
Contraceptives with unique added benefits e.g. dysfunctional uterine bleeding
Our FC pipeline is „best in the business“
moremore choiceschoices (various and new compounds, dosages, regimens and application forms)
conceptconcept of of addedadded benefitbenefit
fertilityfertility controlcontrol on on demanddemand
nonnon--hormonal hormonal methodsmethods
R&D expenditure in comparison (2001)
R&D expenditure in the US according to selected disciplines
Finanzierungsanteil des Staates an Forschungs- u. Entwicklungsaufwendungen der Wirtschaft (in Prozent)
Wege zu günstigen Arzneimitteln
Projekte forschender Pharmafirmen für neue Arzneimittel gegen Krankheiten der Entwicklungsländer
Patents are not a Barrier to Medicine Access
Birth of an Industry (I)
Birth of an Industry (II)
2006: More than 50 years ago Watson & Crick decoded the DNA structure
Biopharmazeutika bestimmen wesentliche TherapiebereicheInsbesondere bei Stoffwechsel-, Infektions-, Krebs- und immunologische
Anteil an neu zugelassenen Wirkstoffen weiterhin hochBiopharmazeutika mit Anteil von 20-30 Prozent an Neuzulassungen in Deuts
Medizinische Biotechnologie schafft ArbeitsplätzeZahl der Mitarbeiter um 14 Prozent gestiegen
Innovation
The First Oral Contraceptive in Europe: Anovlar (1961*)
Transition of Concepts
The Future:Challenges and Tasks