innovation gaps on life science frontiers? - faculty of law · innovation gaps on life science...
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Innovation Gaps on Life Science Frontiers?
- from Ebola, Zika and bad bugs to new uses, big data and the black box
Prof. Dr. Timo Minssen, University of Copenhagen
OIPRC Invited Speaker Series
University of Oxford (UK)
This presentation is based on an ongoing paper collaboration with
Dr.Nicholson Price, University of Michigan and
Dr. Kathy Liddell, University of Cambridge
A. Patent mechanics
1. Prosecution/Acquisition 2. Litigation/Enforcement
B. Problems translating social welfare
1. Differential ability to pay 2. Payment distortions 3. Scientific phenomenon (ex: AB/AM resistance)
Multiple reasons for patent “limits”/gaps
2. Diagnostics and “black box” precision medicine
4. Orphan drugs (rare & neglected deseases)
A. Patent changes
B. Regulatory exclusivities
C. Money - Prizes
- Grants
- Tax Incentives
- Reimbursement
D. Individually tailored solutions - Priority Review Vouchers
- GAIN & corresponding European initiatives
- Integrated solutions
Interventions
Insuffient policy coordination ?(FDA/EMA, CMS, CAFC, PTO/EPO, EU/US Congress)
Little academic coordination
Coordination from industry?
Insufficient dialogue between decision makers academia, patients and industry?
Misinformed debates
Coordination, collaboration and exchange of information?
CatalogingLinking InformingReaching out for input!Call for action?Synthesis?
Why are we writing this paper?
CIIR’s Copenhagen Biotech and Pharma Forum (CBPF)
Copenhagen Summer School in Pharma Law and Policy
Courses in EU Life Science & Health Law
Major cross-faculty projects in Biobanks, Sys/SynBio, etc.
Copenhagen Center for Regulatory Sciences (CORS)
Collaboration with open innovation projects at Leo Pharma, Novozymes etc.
Application for Center of Excellence for Biomedical Innovation Law (CeBIL)
UCPH activities regarding legal challenges to biomedical innovation