Flux in the Pharmaceutical Industry. What insights can doctors bring?

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1 Flux in the Pharmaceutical Industry What insights can doctors bring?

2 Historical role of the Pharma Industry Implicit contract with society to develop medicines (in partnership with various stakeholders) Could the Public Sector (ie tax payer) taken on this role? Why not?

3 The Drug Development Process Long, complex and heavily regulated 10 years Expensive $1B per NCE High risk and attrition rates 1 : 100 conversion rate 1 : 20 of drugs recoup its development costs

4 Historical role of the Pharma Industry Implicit contract with society to develop medicines (in partnership with various stakeholders) Could the Public Sector (ie tax payer) taken on this role? Why not? The answer is to make the process work better to the benefit of all stakeholders One aspect of the contract has been delivered

5 Therapeutic breakthroughs with significant impact on the practice of medicine Beta blockers Ace inhibitors H2 receptor antagonists HMG CoA reductase inhibitors Cytotoxics Immunosuppressants Anti retrovirals Inhaled steroids Dopamine agonists & selegiline Beta agonists

6 Nobel Laureates in Pharmaceutical Medicine 1982: for... discoveries concerning prostaglandins & related biologically active substances Sir John Vane 1988: for their discoveries of important principles for drug treatment Sir James Black Gertrude Elion George Hitchings

7 Historical role of the Pharma Industry Implicit contract with society to develop medicines (in partnership with various stakeholders) Could the Public Sector (ie tax payer) taken on this role? Why not? One aspect of the contract has been delivered However, the business and R&D model is strained

8 Business/R&D Model under strain R&D Productivity in decline Issues in assessing Benefit-Risk of Medicines Issues related to the globalisation of medicine Poor image of Industry and need to deliver on its Social Contract

9 Does the model need to change? HOW CAN DOCTORS/SCIENTISTS CONTRIBUTE TO THE PHARMA INDUSTRY -- from without -- from within

10 INTERACTIONS OF DOCTORS AND PHARM INDUSTRY AS PHYSICIANS IN THE INDUSTRY

11 CAREERS IN PHARMA INDUSTRY In Local subsidiary: -- somewhat limited opportunities but stepping stone for global move In Global R&D organisation: -- Discovery scientist -- Translational Medicine -- Clinical Research -- Pharmacovigilance -- Regulatory affairs -- Medical Markeitng Management Positions: Medical Directors, VPs.

12 INTERACTIONS OF DOCTORS AND PHARM INDUSTRY AS PHYSICIANS IN THE INDUSTRY AS COLLABORATORS IN RESEARCH: -- Advisers & Investigators in Clinical Dev -- Discovery research (outsourced) AS PRESCRIBERS -- Ethical interactions in the marketing of medicines via Codes of Practices

13

14 Paradigm Shifts in the Development of New Medicines

15 EVOLUTION vs REVOLUTION

16 Forward Leaps Technological Advances lead to major breakthroughs.20 years on!!!

17 Cancer/immune therapeutics (early 21 st century) Result of advances in signalling and transduction mechanisms and immunology (late 80s)

18 Novel Bio-Pharmaceuticals Advances in the understanding of Large Molecules

19 Forward Leaps Catastrophic Events lead to faster changes.within a decade or less

20 The Thalidomide Tragedy

21 Research & Development Declining R&D Productivity

22 Indexed R&D expenditure (1991 = 100) Indexed R&D expenditure (1991 = 100) Declining R&D productivity Global NME output Global sales Global ethical R&D expenditure Development time (3-year rolling average) p 2008 Source: CMR Institute for Regulatory Science, 2002 Year

23 $M (in year 2000 dollars) 900 Rapid escalation of the costs of R&D Average R&D costs per drug launched Source: Tufts Center for the Study of Drug Development Year 2008

24 Increase in Phase III Failures and Product Withdrawals 50% of Phase III Failures are due to lack of Efficacy More product withdrawals in the last 7 years than in the previous 30 years

25 Scientific Advances to shift paradigm CLINICAL SCIENTISTS AS DRIVERS With high quality TRANSLATIONAL MEDICINE

26 What are the solutions to the decline in R&D productivity

27 The Drug Development Process gene protein targets screen and identify lead optimisation chemical diversity test safety & efficacy in animals and humans combinatorial chemistry

28 Will it lead to enhanced productivity and value based medicines?

29 Go/No Go Decisions In Exploratory Clinical Development PROOF OF CONCEPT (prospectively defined)

30 INNOVATIVE CLINICAL DEVELOPMENT Moving from mass production (BLOCKBUSTER PHILOSOPHY) To bespoke development (SOPHISTICATED PHILOSOPHY)

31 Drug Development in the 21st Century GENOMICS REVOLUTION Plethora of new targets Enhancing the Benefit-Risk of medicines PHARMACOGENETICS

32 Drug Development in the 21st Century GENOMICS REVOLUTION Plethora of new targets Enhancing the Benefit-Risk of new medicines Disease redefinition

33 Proportion of each genotype unaffected APOE Genotypes in Alzheimer s disease Age at onset

34 CHF Clinical definition Pathophysiological Sub-sets of CHF

35 Alternatives to DB Controlled CTs Search for Alternative real time and real life studies during the Development Phase: Advent of Adaptive Trial Designs & Bayesian Statistics. Technological support: eg IVRS (randomisation), electronic data capture, flexible clinical trial supplies

36 Regulatory challenges in Clinical Development Patient centred end points Conditional and earlier release of Medicines and Further Development in the Market place??linked to Tiered Pricing models

37 ISSUES WITH BENEFIT-RISK ASSESSMENTS

38 Benefit Risk of medicines Deeper understanding of Benefit & Risk

39 RISK-BENEFIT OF MEDICINES ARE NOT CAST IN STONE Thalidomide (hypnotic) RISK Aspirin (analgesic) Thalidomide (lepromatous leprosy) Aspirin (antithrombotic) BENEFIT

40 Benefit Risk of medicines Deeper understanding of Benefit & Risk Quantification of risk Pharmaco-epidemiology: Data bases

41 Integrated Safety Outputs

42 Future Drivers Large Molecules and Monoclonal Antibodies Emergence of Biopharmaceuticals

43 The Northwick Park Tragedy: What are the implications? Experience with small molecules is not directly transferable to large molecules

44 Early interventions: Parkinson s Disease 100% Neuronal load in Substantia Nigra 30% 0 Symptoms Normal Disease Age in Years

45 Future Drivers Medicine 2000 drug databases applications Medicine 2020 smart cards diagnostics genetic profiling Information drug

46 GLOBALISATION OF CLINICAL DEVELOPMENT

47 Drivers for Paradigm Shift towards developing nations in 21 st Century Push Factors from developed economies Declining R&D Productivity Socio political pressures towards DDW Pull Factors from developing nations Expansion of the pharmaceutical market Availability of patient populations for clinical trials Motivated Medical & Scientific talent Lower costs (with high quality data)

48 Correlation of Data Quality with Clinical Grants Clinical Grant USD/pt No of queries / 100 CRF pages Source: PRA FastTrack Systems Global Cost Databases, 2006

49 Ethical considerations in scheduling global trials in Emerging Markets Ethics Committee approvals Informed Consent Compliance and follow up of trial subjects Post trial study medication Building capability Access to experimental drug on completion of programme: is there an intention by the sponsor to launch?

50 DRIVERS FOR CHANGE TECHNOLOGICAL & SCIENTIFIC ORGANISATIONAL SOCIO-POLITICAL. concept of Pharmacopolitics

51 Pharmaco-politics Emergence of the concept of the SOCIAL CONTRACT

52 THE SOCIAL CONTRACT AVAILABILITY of medicines for Diseases of the Developing World and for Neglected Diseases AFFORDABILITY of Medicines; Differential pricing across the globe. ACCESS of Medicines is a governmental & societal responsibility

53 The perfect cure? Completely effective Completely safe Free

54 Drugs for Neglected Diseases - Public-Private Partnerships Medicines for Malaria venture - The search for a malaria vaccine GSK Gates Foundation European Governments

55 Can Big Pharma be specialists in all aspects of the process chain DISCOVERY of Medicines DEVELOPMENT of Medicines MANUFACTURE of Medicines MARKETING of Medicines

56 Medical Governance - A Core Competency and Capability

57 MEDICAL GOVERNANCE Medical Governance encompasses the recognised principles of High quality medical science Ethical aspects of patient welfare Compliance with legal & regulatory standards as applied to the development of marketing of medicines

58 MOLECULE + INFORMATION = MEDICINE

59 PARTNERSHIPS INDUSTRY ACADEMIA GOVERNMENTS REGULATORS NGOs

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