San Michele, Maj 2013

Transcription

1 San Michele, Maj 2013 "Eftersom alla är upptagna jämt och har mycket att göra, är det av synnerlig vikt att en man reser bort från det hela För att på avstånd begrunda vårt faktiska läge i nuet och tyda de hemliga lagar som härskar över vårt liv" Hjalmar Gullberg

2 Utveckling av nya läkemedel för psykossjukdom Myterna om Schizofreni som en progressiv hjärnsjukdom som inte går att påverka, och dess konsekvenser Jonas Eberhard

3 Robert Sommer Award meeting 2013 Personalised treatments in psychiatry aspirations for the future CNS Drug development the sobering reality vs some urban myths

4 Push and Pull PUSH Incentive structure Medical innovation H T A Regulatory framework Basic Research PULL More efficient treatment Better value for money Willingness to pay

5 The Balance needed for innovation drive Risk Investmen t Time Profit PUS H The push pull must be in balance PUL L

6 Global disease burden Mental health and cardiovascular diseases are top drivers of lost output breakdown of NCD cost by disease type Mental health conditions and cardiovascular diseases cost the most. Together, mental health and cardiovascular diseases account for almost 70% of lost output, followed by cancer, chronic respiratory diseases and diabetes World Economic Forum: The Global Economic Burden of Non-communicable Diseases

7 Global disease burden WHO72008; The Global Burden of Disease 2004 update

8 CNS development takes time & leaves very short time to recoup expenditure Discovery Pre-clinical Phase research ClinicalTrials Regulatory Price and Approval Reimbursement Marketing Authorization Drug on the market 2-3 bio USD Years IP Compound Patent

9 Why is industry pulling out? Profit Risk Investment Time

10 The CNS innovation gap Depression Depression & & Schizophrenia Schizophrenia Lack Lack of of innovation innovation in in CNS CNS drug drug development? development? 16 Number of mechanistically distinct drugs Lack of novel drug targets reflects lack of disease biology understanding Translational medicine and biomarkers to help identify subgroup-specific objective endpoints and novel treatment targets s Depression Present Schizophrenia Heart disease Insel. Mol Psychiatry 2006

11 A new contract on new terms Society Basic science! Industry

12 Indirect costs are overseen WHO has estimated that psychiatric disorders are the most costly diseases for society Sick leave counts for almost 1/3 of all costs in relation to depression Reduced productivity at work is estimated to be the greatest part of all costs in depression Figure 1: Sainsbury 2008 Figure 2: Sobocki et al. 2007, European Psychiatry Gustavsson et al. 2011, EBC 2011, Eur Psychopharm Total direct cost

13 A holistic perspective is needed There is a need to look at healthcare cost in a holistic perspective including both direct and indirect cost. By doing this, we can ensure society focus and invest in research where the burden is largest, but also were the potential gain for society is - both in relation to reducing health care cost, but also increased productivity.

14 Hjärnforskningens realiteter Att utveckla läkemedel för hjärnsjukdomar är ekonomiskt riskabelt Att utveckla nya läkemedel för hjärnsjukdomar kräver mycket stora investeringar (genomsnittlig kostnad 1.8 miljarder dollar) Prövningarna kräver stora patientgrupper Diskrepans mellan vad som krävs för godkännande och vad som krävs för läkemedelsförmån Mycket långa tidsperspektiv (10-15år)

15 Decreasing risk, investment and time through patient segmentation Individualized diagnosis

16 Kliniska prövningar visar medelvärden inte individuella data Mean YMRS total score Observation day YMRS=Young Mania Rating Scale

17 Kliniska prövningar visar medelvärden inte individuella data Mean YMRS total score Observation day YMRS=Young Mania Rating Scale 1Reproduced by kind permission of E Vieta 2011

18 Kliniska prövningar visar medelvärden inte individuella data genomsnittets tyranni Mean YMRS total score Observation day YMRS=Young Mania Rating Scale

19 DSM IV criteria for MDD - 5 or more, (1 or 2 must be present) for 2 weeks Depressed mood diminished interest or pleasure weight loss weight gain Insomnia or hypersomnia agitation or retardation Fatigue worthlessness think or concentrate thoughts of death

20 Skärpt diagnostik As diseases have been defined based on symptoms not on biology we have a disconnect between drug discovery and diagnostics Consequently, rarely more than % of a patient population respond to a given treatment New treatment options emerging: Molecular diagnosis based on biological knowledge

21 A new contract on new terms Society Basic science! Industry

22 Vi måste anta nya roller Society be clear what you need = want request personalized medicine = push for patient segmentation and reshape the regulatory process and incentive structures accordingly. Get health care priorities right = WHO priority medicine Science facilitate transformation of inventions into innovation by implementing biological knowledge in clinical settings (translational medicine) Industry improved dialogue and collaboration addressing medical needs (new drugs) requires transparency and open dialogue with society = patients, research communities etc. as e.g. seen in public private partnerships

23 Incentive structure Patient population size Income over 5-10 years Income over years

24 Konklusion Vetenskapen har berett vägen för individanpassade behandlingar, men det finns en mängd hinder på vägen. Behov Industry! Society Basic science

25 We are looking for an even playing field