The importance of regulatory science in a societal and industrial perspective Annual Conference CORS 24 November 2016
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1 The importance of regulatory science in a societal and industrial perspective Annual Conference CORS 24 November 2016 Marianne Kock, Head of Global Regulatory Affairs & Managing Director, Ferring Pharmaceuticals A/S
2 In my office..at Ferring 1
3 Copenhagen Center for Regulatory Science (CORS) Regulatory Science: The science of developing new tools standards approaches to evaluate the efficacy, safety, quality and performance of medical products in order to assess benefit/risk and facilitate a sound and transparent regulatory decision making. 1985: A literature search would not find regulatory science 2014: A search for regulatory science resulted in 200,000 hits 2
4 Regulatory Science vs Regulatory Affairs Regulatory Science focuses on the scientific underpinnings and concerns. Regulatory science is an emerging area of interest within pharmaceutical medicine as the shaping and implementation of legislation and guidelines Regulatory affairs and regulatory law refer to the administrative and legal aspects including implementation, compliance, or enforcement of existing legislations/laws 3
5 Regulatory Science: ideas for the future Regulatory Science must keep pace with biomedical research to develop safe and effective medicines/treatments to serve the needs of the patients and the society and which are available at reasonable cost to patients New and innovative regulatory pathway is needed for drug approvals, otherwise the pharmaceutical industry investment will dry out New and more clinically meaningful endpoint with patient involvement needs to be continuously developed Understanding the biology of diseases will help to better define patient population resulting in increased responder rate; improving benefit/risk Patients may have different perceptions of risk than regulators Improve the science of benefit/risk assessment by engaging the patients 4
6 Industry perspective: example Acceptable Non-acceptable Quality Pharmacology Non-clinical Clinical Phase 1 Clinical Phase 2 Clinical Phase 3 Risk Management Plan Patients reported Outcomes (PROs) 5 Full risk / benefit evaluation by Agency: Might be approval Final label Experience or Science?
7 Industry perspective: example Quality Pharmacology Non-clinical Clinical Phase 1 V 6 Clinical Phase 2 Clinical Phase 3 Risk Management Plan Price dossier Reimbursement Label NICE / insurance comp. etc. Launch and a new product for patient Not enough! Regulatory Science
8 Drug development in the future The process of drug development must be more efficient and serve a medical need Must be beneficial for patients, doctors and society Biomarkers may become one of the key tools in improving the drug development. International consensus on the qualification of biomarkers must be agreed upon (Regulatory science) Similarly, companion diagnostics allow to better target treatments for patients 7
9 Regulatory dossiers should be global R&D is global in nature Significant differences in the approval process for clinical trials and products in different countries/regions In spite of harmonisation, there are significant regional/national differences in regulatory requirements Significant differences between approved labels in the different regions Identical regulatory dossier may lead to approval or rejection by the FDA and the EU 8
10 Transparency of data and its use Rolling evaluation of new products Transparency of data will help regulatory science (companies / universities) by identifying assumptions, judgements, and related processes during the regulatory evaluation process Those involved in development of regulations & legislations 9
11 Paradigme shifts have started and will impact the evaluation of new medicinal products From Programmatic to Cognitive/AI ( Augmented IBM Watson Intelligence ) Health 1 - Broad collaboration with pharmaceutical companies, Data Driven Solutions hospitals and research institutions - Analytical access to +200 data sources 2 - Centricity Oncology: and 95% Solutions of accuracy in diagnosis, 3 treatment recommendations - Analysis of 10 years research documentation: 6 new From Product to Platforms molecules in 10 weeks 4 Kaiser Permanente Innovation - Integrated 5 patient records, including behavioural data - Seamless management of customers, personalized Patients Physicians management and treatments Insurance companies Hospitals Universities Biotech / VC From Product Centricity to Customer From Closed to Open and Networked From Selective Data Analysis to Big 10
12 From new products to accessing new technologies and the review of these. In today s Pharma, internal research is partly replaced by access to external innovation from universities, biotechs and different other companies New opportunities Other indications New products for patients 11 New way of capture data to give added value: APPs, instruments etc. Henry W. Chesbrough, Why Companies Should Have Open Business Models, MIT Sloan Management Review, Winter 2007, Volume 48, Np. 2, p.27.
13 Where can regulatory science act in a societal and industrial perspective Be part of making regulations/ guidance's based on regulatory science on how and what to be included in future applications/dossiers Find way to embrace global development and find ways to make R&D global Speed up evaluations of new medicinal products. Agencies direct access to data as they are made ( rolling submissions) Be part of evaluate biomarkers which can be used Combination products: products with, pen, apps, instruments, databases.. CORS Regulatory Science : "The science of developing new tools, standards and approaches to evaluate the efficacy, safety, quality and performance of medical products in order to assess benefit-risk and facilitate a sound and transparent regulatory decision-making 12
14 Vision, future, collaboration Thank you for your Pharma companies Universities attention. Agencies Customers/ patients Looking forward to the collaboration.. 13
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