DZNE & BfArM Collaboration and future challenges

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1 DZNE & BfArM Collaboration and future challenges Prof. Pierluigi Nicotera, MD PhD DZNE

2 Facts on Dementia & other Neurodegenerative Diseases Estimated total funding on dementia research in Germany: i.e. total funding DZNE, KNDD, DFG clusters, projects and SFBs: 85 Mio Euro in 2014 Costs of dementia: Costs for community and medical care a: / per patient / year * Total costs of dementia in Germany in 2008: 10 Billion ** > 1.5 Mio dementia patients (2014) 60 Euro/patient/year spent on Research in Germany vs. costs of to per patient per year. > Patient number expected to be 2 Mio in 2025 *Doblhamer et al., Demografie der Demenz, 2012 ** Leicht et al., PLOS One 2013

3 Major challenges in neurodegenerative diseases Causes are still unclear (syndromes?) Factors that link ageing to neurodegeneration Disease stratification (younger, older individuals). Paucity of disease-relevant animal models. Lack of strong predictive biomarkers. Weak design and weak outcome measure in clinical trials. Lack of models for large data integration

4 The DZNE Mission DZNE a research organisation within the Helmholtz Gemeinschaft that was created to research into the causes of neurodegenerative diseases and find new preventive and therapeutic strategies. DZNE has 900 members of staff and it is at the forefront of translational research on NDs. Alzheimer s Disease Parkinson s Disease Other Neurodegenerative diseases Ich habe mich sozusagen verloren An Essay on the Shaking Palsy" (1817).

5 DZNE Drug Development Regulatory Authorities Strategic partnership with Industry Venture Capital Academic Collaborations 5

6 Following the G8 recommendation to intensify research on dementia, the DZNE tributes to a panel of world experts, the World Dementia Council, that has developed ilestone program with measures to tackle dementia in the next decade. The WDC

7 Engaging Regulatory Agencies Program and proposals by the World Dementia Council Main strategy: Engagement with regulatory agencies: ensuring collaboration and innovation, in the context of the research gaps and development challenges, using existing laws and regulations in the most optimal way. Spearheading adaptive clinical development: focusing on the possibility of medicines regulators and developers working multilaterally to facilitate the development of safe, effective and affordable medicines. This is the only global regulatory initiative on dementia, to enable regulators and developers to work collectively to improve drug development efforts.

8 Engaging Regulatory Agencies Program and proposals by the World Dementia Council Priorities to improve engagement of regulatory agencies: Attrition analysis to assemble and analyse a relevant sample of data and examine the features of terminated development. Clinical trial efficiency to draw together transferable insights from oncology, rheumatology and antimicrobial resistance, including adoption of master protocols designs, consent forms and data mining in order to improve the efficiency of clinical trials for drug development. Composite end points to advance cognitive measures that could be in a composite end point for the early stages of AD (mild, not moderate or severe AD). Risk-benefit balance to consider strategically how best to balance possible benefits given the high level of uncertainty about the disease.

9 Recommendations Expert opinion (by Mrs Raj Long, Senior Regulatory Officer, Integrated Development, Global Health, Bill & Melinda Gates Foundation; Director Integrated Development UK Department of Health and Member of World Dementia Council) Recommendation 4: Spearhead adaptive clinical development by focusing on accelerated regulatory pathways for dementia medicines. Employ a sensitive and patient centric approach to risk-benefit ratio, learning from other diseases like HIV, oncology and rheumatoid arthritis and assessing applicability to dementia. Recommendation 5: Build on existing Multilateral Cooperation between regulators, and create a multilateral advisory platform of research experts who can, working in conjunction with regulators, to advise companies on optimal development strategies, to facilitate increased outcomes for dementia drug development.

10 Work Groups Established work groups to address specific regulatory questions and to integrate regulatory agencies in research pipeline Clinical trial efficiencies - Lead: SwissMedic (Dr Claus Bolte) Risk Benefit Balance - Lead: Danish Health and Medicines Authority (Dr Jens Heisterberg) Multilateral Cooperation - Lead: European Medicines Agency (Mr Manuel Haas) Modelling and Extrapolation - Lead: Italian Medicines Agency (Dr Valentina Mantua) Composite end points - Lead: Federal Institute of Drugs and Medical Devices (Prof Dr Karl Broich) Attrition Analysis - Lead: Imperial College and Office of Health Economics (Prof Lefkos Middleton)

11 The Need to Blend Regulatory Aspects & Research Integration of efforts to make new treatments for NDs requires cooperation with regulatory agencies. Regulatory agencies can be involved at early stages of drug development in cooperation with academia and industry Regulatory Agencies must therefore develop complementary in house research.

12 Joint research group Dr. B. Hänisch Focus and aims of the group: The study of the use and effects of drugs in populations Assessment of efficiency and safety of pharmacotherapy Detection of risk constellations in view of different treatments

13 Collaboration Group Dr. B. Hänisch Data and Methods Primary data: Longitudinal cohort studies, e.g. German Study on Aging, Cognition and Dementia in Primary Care Patients (AgeCoDe/AgeQualiDe, GP cohort, 75 years, since 2003, baseline, n=3,327) Secondary data: Longitudinal claims data from public health insurance funds, e.g. AOK, extract of 500,000 IDs, Regression models, time-dependent covariates, inclusion of available potential confounders such as age, gender, ApoE4, education, co-morbidities, poly-pharmacy >Preliminary data shows an effect of currently used drugs for other indications on risk of developing dementia

14 PPI inhibitors, Anticholinergics an the risk of dementia Examples of results from AgeCoDe analyses Proton pump inhibitors and dementia risk Anticholinergic drugs, M1 receptor affinity and dementia risk No use No use

15 Linking Pharmacoepidemiology and Neurodegenerative Diseases Results from multi-site research (Heneka/Doblhammer-Reiter) Key result: Anti-diabetic drugs influence risk of developing dementia (people diagnosed with diabetes, data from health insurance company)

16 Linking Pharmacoepidemiology and Neurodegenerative Diseases Results from multi-site research (Heneka/Doblhammer-Reiter) Sample size: Approx. 145,000 data sets for people of age 60 and above Difference between specific drugs: Data was available for Metformin, Pioglitazone, and Rosiglitazone

17 Conclusion Regulatory Authorities Strategic partnership with Industry Academic Collaborations Venture Capital Foster Research in regulatory agencies! 17

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