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Ricerca medica indipendente Nicoletta Dentico Health Innovation in Practice (HIP) La Sapienza, Roma, 4 aprile 2014 Accesso ai Farmaci Essenziali.

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Presentazione sul tema: "Ricerca medica indipendente Nicoletta Dentico Health Innovation in Practice (HIP) La Sapienza, Roma, 4 aprile 2014 Accesso ai Farmaci Essenziali."— Transcript della presentazione:

1 Ricerca medica indipendente Nicoletta Dentico Health Innovation in Practice (HIP) La Sapienza, Roma, 4 aprile 2014 Accesso ai Farmaci Essenziali

2 OMS, 1977: il TRS 615 TRS (Technical Report Series) 615, destinato a fare storia come best seller dell’OMS, ben presto diventa uno degli snodi esemplari del rapporto tra salute e sanità, pubblico e privato, economia e diritto: IL PROGRAMMA DEI FARMACI ESSENZIALI Il significato della parola ESSENZIALE, che rimanda, senza specificare, a radici, progetti, obiettivi da raggiungere

3 la rivoluzione pacifica dell’OMS Sono essenziali quei farmaci che sono di più grande importanza, di base, indispensabili, necessari pe ri bisogni di salute della maggioranza delle popolazioni dei diversi Paesi, a costi, e con condizioni di approvvigionamento, che siano compatibili con un’accessibilità corrispondente a quella auspicabile- necessaria per identificare, definire e farsi carico dei problemi-bisogni per I quali I farmaci hanno un’indicazione adeguatamente documentata  La Lista dei Farmaci Essenziali (1978)

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6 Il 10/90 GAP The 1990 Commission on Health Research for Development made the first estimates of worldwide spending on health research and development (US$30.0 billion) and in analysing the flows of resources described what became known as the “10/90 gap” – capturing the inequality revealed in their estimate that: less than 10 per cent of the global budget for health R&D was being spent on 90 per cent of the world’s health problems

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8 Non solo malattie infettive Le morti nel mondo per cancro

9 Decenni di enormi progressi nel campo della scienza e della tecnologia >50 y of parasitology: targets, inhibitors, cytotoxic compounds Migliaia di pubblicazioni, ma solo pochi farmaci contro le malattie tropicali

10 Quali farmaci per le malattie tropicali dimenticate? Non efficaci (resistenze) Tossici Costosi Di dolorosa somministrazione Difficili da monitorare Non adatti ai sistemi sanitari dei paesi poveri Non registrati nelle regioni endemiche Restrizioni dovute alla protezione brevettuale

11 Launch & utilization CHALLENGE 3 CHALLENGE 4 Specific Activities Organizations TDR Unspecified GSK WRAIR La ricerca per le malattie dimenticate nel 2000: il deserto Screening Lead identification Lead optimization In vivo efficacy Regulatory toxicity & safety Phase 1 Phase 2 Phase 3 Registration Cutaneous Leishmaniasis CHALLENGE 1 CHALLENGE 2 Visceral Leishmaniasis HAT Chagas CHALLENGE 3 Launch & utilization CHALLENGE 4

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13 2007 Drug R&D Landscape for NTDs Screening Lead identification Lead optimization In vivo efficacy Regulatory toxicity & safety Phase 1 Phase 2 Phase 3 Registration Launch & utilization HATChagasVisceral Leishmaniasis Cutaneous Leishmaniasis DengueMalaria TB CHALLENGE 1 Sandler Center IOWH MMV GSK CDND TB Alliance DNDi Specific Activities Organizations TDR NITD – PC dengue, TB CHALLENGE 2 CHALLENGE 3 CHALLENGE 4 Unspecified Buruli Ulcer Intestinal helminth WRAIR

14 BONO MSF 250 PPPH WEF PHA World Bank

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16 Ensure Sustainability Critical Challenges for Product Development Partnerships Generate Leads Optimise Leads Clinical Trial Capacity to Test New Drugs or Regimens Pragmatic ID and selection of candidates from existing compounds Delivering products to neglected populations Challenge 1 Clinical AVAILABLE to patients Screening Lead selection Discovery Pre-Clinical Lead optimisation Challenge 3 Challenge 4 Challenge 2 Challenge 5

17 The benefit of using global networks: creative harnessing of fragmented knowledge DND i

18 Sharing of experiences between South-South LEAP scientits

19 CIPIH Report int/intellectualproperty/en/ Diagnosi e raccomandazioni dell’OMS per garantire la ricerca medica essenziale “ Innovation is pointless in the absence of favourable conditions for poor people in developing countries to access existing, as well as new, products ” “ The market is not a determinant of value “

20 Il valore aggiunto delle Product Development Partnerships (PDPs) PDPs possono fungere da motore, in termini di leadership scientifica; PDPS hanno un ruolo determinante nella identificazione delle piste di R&D da seguire, e per natura possono più facilmente superare eventuali strozzature nel processo di favorire l’accesso ai farmaci ai pazienti che ne hanno bisogno PDPs reppresentano una nuova opportunità affinché big pharma re-focalizzi la sua ricerca verso i bisogni dei paesi in via di sviluppo” PPPs sono una nuova ed efficace strategia per portare avanti la ricerca che serve ai paesi impoveriti, sfruttando la diversità degi attori che riescono ad agggregare.

21 Il valore aggiunto delle PDPs PDPs can provide the drive and the scientific leadership + have a crucial role in identifying R&D pathways and overcome bottlenecks to get products to those in need PPPs represent a new opportunity for big pharma to re-focus their research for developing countries PPPs a new, effective and important means to pursue R&D relevant to developing countries, making use of a diversity of new players

22 After 15 years (and close to 1 billion US$): Combined PDP pipeline including 122 candidates – “Ripple effect”: R&D Capacity building, Developing country markets less opaque, Incentive for local industry, Regulatory networks

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24 Challenges to build innovation and research capacities in Africa Public leadership to define R&D priorities Significant investment with sustainable funding Ensure better access to knowledge and promote innovative IP management policies Enable more adapted regulatory environment Transfer technology and strengthen research capacities in developing countries

25 Challenge to conduct clinical trials in very difficult settings JSDr. Jannin, WHO GP TB Access to Sites Status of Infrastructure Staff Limitations Dr. Jannin, WHO

26 Key question: How much is funding source determining R&D agenda / priority setting? Role of endemic countries?

27 How much are developing countries in the driving seat? Notion that PDPs are global organizations with equal representation from all regions is FALSE in most cases Mision & Vision of PDPs is set in north with marginal input from south “Nature of work, scope and budget decided by head offices not African researchers: executive decision-making remains outside Africa” “....the current PPPO paradigm is fundamentally neocolonial in structure and operation and this needs to be revisited and addressed”

28 Big Pharma Pro duct Development Partnerships (PDPs) FDA, EMA, Swissmedic, etc Public R&D institutions and academia At the end of the 90s a new “North Focused” architecture for R&D for health products for Neglected Diseases disproportionately affecting developing countries begins to be shaped Regulatory approval and standard setting Translational research and developoment Knowledge generation: Funding Philanthropic and International development organizations Corporate & Private

29 “London Declaration on Neglected Tropical Diseases: Ending the Neglect & Reaching 2020 goals” (30 Jan.2012) Promoters: Abbot, AstraZeneca, Bayer, Becton Dickinson, Bill & Melinda Foundation, Bristol-Myers Squibb, DNDi, Esai, Gilead, GlaxoSmithKline, Johnson & Johnson, Merck KGaA, MSD, Mundo Sano, Novartis, Pfizer, Sanofi, UKaid, USAID, World Bank

30 E l’OMS? Accelerating work to overcome the global impact of neglected tropical diseases. A roadmap for implementation, Geneva, WHO, March 2012 Sustaining the Drive to Overcome the Global Impact of Neglected Tropical Diseases: Second WHO Report on Neglected Tropical Diseases, Geneva, January 2013, ort/en/ ort/en/

31 Quale impatto? Overall, the number of drugs shipped to endemic countries has increased nearly thirty-six percent over 2011 (995 million) with the amazing donation of nearly 1.35 billion in 2013; In the past two years, 74 countries — roughly two- thirds of all NTD-endemic countries — have developed integrated, comprehensive national NTD plans.

32 Fondo AIFA per la ricerca indipendente Quale la situazione degli studi clinici non-commerciali in Italia? I dati dell’ultimo Rapporto dell’AIFA segnalano che la percentuale di ricerca no-profit sul totale della ricerca sui farmaci in Italia, è passata dal 41,4% del 2008 al 35,7% nel 2010, fino a raggiungere un 32,3% nel E così dai 364 studi registrati nel 2008 si è arrivati a 225 nel Circa il 38% in meno.

33 Open Source Drug Discovery (OSDD), India: democratising research against Tuberculosis OSDD(www.osdd.net ) : a global initiative driven by the Indian Council of Scientific and Industrial Research (CSIR) to provide affordable healthcare to the developing world.www.osdd.net Set up in September 2008 as a platform for collaborative research, with the idea to offer a scientific venue where the best minds – scientists, doctors, research professionals, research organizations, software professionals, pharmaceutical enterprises and others with diverse expertise - can collectively endeavour to solve the complex problems associated with discovering novel therapies bacterial pathologies like TB

34 Open Source Drug Discovery (OSDD), India: democratising research against Tuberculosis (2) the financial commitment of $ 38 million granted by the Indian government, OSDD is one of the few public-funded open source initiatives dedicated to finding new affordable treatments for tuberculosis. The underlying vision of the OSDD platform was steered by the urgent need to replicate and test in the field of healthcare and medical science the success of open source models used in information technology and biotechnology, by initiating a similar open source model for drug discovery as a potentially competitive alternative to traditional closed propriety approach. See in this regard open-source/ open-source/

35 Big Pharma PDPs NTD Product access & use in the context of Endemic Country Health Systems Reshaping of NTD Product R&D and delivery architecture Product R&D based on ENDEMIC COUNTRY Frameworks for: Priority setting, Knowledge generation and access, Research collaboration, Medicines Regulation & Financing agreements

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