Setting the Scene - Industry. Regulatory Science. Merete Schmiegelow Senior Director, Regulatory Policy

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1 CORS-Industry Regulatory Science Setting the Scene - Industry Merete Schmiegelow Senior Director, Regulatory Policy Honorary Industrial Ambassador in Regulatory Science at the University of Copenhagen Regulatory Science - Present and Future 24 Nov, 2016

2 CORS-Industry Agenda 1 Industry R&D productivity 2 Industry Regulatory Affairs 3 Industry needs for CORS 4 CORS RS definition and focus

3 CORS-Industry Development of new therapies to patients are lengthy, expensive and with high risks for investors Drug Discovery Nonclinical testing Clinical Ph 1-3a Submission & Approval HTA & Reimbursement negot. Launch & LCM 3-6 years 6-7 years 2-5 years Total 15 years 1 in compounds Total cost to develop and launch: USD 2-4 Billions Source: Tufts - drug development 2014

4 CORS-Industry R&D productivity reduced over the years Development of new therapies to patients are lengthy, expensive and with high risks for investors Regulatory requirements Industry Response: Development Costs Focus e.g. on how to increase R&D efficiency Number of new drugs approved Increasing Increasing Stagnating

5 CORS-Industry Agenda 1 Industry R&D productivity 2 Industry Regulatory Affairs 3 Industry needs for CORS 4 CORS RS definition and focus

6 CORS-Industry Regulatory Affairs in the pharma industry Ensures licence to operate (Q-S-E-P) Apply regulatory science to ensure a strong, reliable, quality-based story line Enables best possible labelling Impacts regulatory framework Pre-requisites Understanding and building the bridge to: regulator s mindset Q-E-S data (context & content driven) HTA/payer mind-sets on regulatory parameters

7 CORS-Industry Agenda 1 Industry R&D productivity 2 Industry Regulatory Affairs 3 Industry needs for CORS 4 CORS RS definition and focus

8 CORS-Industry Optimal regulatory impact assume broad competences The industry has identified the regulatory Regulatory Affairs: and regulatory science competences from The internal experts on regulators mindset Danish universities as currently insufficient CMC Manufact. Formulation Control Quality Safety Animals Quality Efficacy Clinical Human safety Benefit/Risk Quality Regulatory Pathways Scientific advice Approval Labelling RS in Decisions Tools Standards Research Performance Predictability Research Development Approvals LCM

9 CORS-Industry Why Copenhagen Centre Of Regulatory Science A need from the pharmaceutical industry (and regulators): Improved university competences in the regulatory disciplines Increased PhDs/Postdocs within Regulatory Science supporting more evidence based regulatory practice in decision making

10 CORS-Industry CORS 2014: Unique Public Private - Partnership Academia Industry Regulators Patients with an unmet medical need Mind the gap it s time to jump on the train! Mutual trust is needed to work smarter for the benefit of patients and society

11 CORS-Industry CORS Scientific Advisory Board (SAB) Multidisciplinary UCph Faculties Health & Med. Science Humanities Law Social Science Patients Rare Diseases Association (in Denmark) Ferring Pharmaceuticals H. Lundbeck A/S LEO Pharma Authorities Danish Health and Medicines Authority Companies Novo Nordisk A/S

12 CORS-Industry Worldwide RS A ctivities Increase Significantly Lack of efficient evidence based focus and transparency Current frontrunners EU: NL & DK (& PT) US: > 30 RS educations & ~ 9 RS research units Asia: Japan, China, Singapore CORS unique governance Four multidisciplinary parties

13 CORS-Industry Agenda 1 Industry R&D productivity 2 Industry Regulatory Affairs 3 Industry needs for CORS 4 CORS RS definition and focus

14 CORS-Industry Copenhagen Center for Regulatory Science (CORS) Medical Product Innovation. Research & Education Definition of Regulatory Science (RS) 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.

15 CORS-Industry CORS Multidisciplinary Research Focus Categories Producing tools and standards Science that facilitates regulatory decision making Science that assists regulatory decision making Producing evidence Testing performance Science that evaluates regulatory decision making

16 Postponed to panel discussions CORS-Industry