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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
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Innovation Gaps on Life Science Frontiers? - Faculty of Law · Innovation Gaps on Life Science Frontiers?-from Ebola, ... (CeBIL) UCPH activities regarding legal challenges to biomedical

May 25, 2018

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Page 1: Innovation Gaps on Life Science Frontiers? - Faculty of Law · Innovation Gaps on Life Science Frontiers?-from Ebola, ... (CeBIL) UCPH activities regarding legal challenges to biomedical

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

Page 2: Innovation Gaps on Life Science Frontiers? - Faculty of Law · Innovation Gaps on Life Science Frontiers?-from Ebola, ... (CeBIL) UCPH activities regarding legal challenges to biomedical

Starting point: Patents

Page 3: Innovation Gaps on Life Science Frontiers? - Faculty of Law · Innovation Gaps on Life Science Frontiers?-from Ebola, ... (CeBIL) UCPH activities regarding legal challenges to biomedical

A Paradigm Shift in the Pharma & Health Care Sectors ??????

Page 4: Innovation Gaps on Life Science Frontiers? - Faculty of Law · Innovation Gaps on Life Science Frontiers?-from Ebola, ... (CeBIL) UCPH activities regarding legal challenges to biomedical

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

Page 6: Innovation Gaps on Life Science Frontiers? - Faculty of Law · Innovation Gaps on Life Science Frontiers?-from Ebola, ... (CeBIL) UCPH activities regarding legal challenges to biomedical

1. Biologics & biosimilars

Page 8: Innovation Gaps on Life Science Frontiers? - Faculty of Law · Innovation Gaps on Life Science Frontiers?-from Ebola, ... (CeBIL) UCPH activities regarding legal challenges to biomedical

3. New uses for known drugs

Page 10: Innovation Gaps on Life Science Frontiers? - Faculty of Law · Innovation Gaps on Life Science Frontiers?-from Ebola, ... (CeBIL) UCPH activities regarding legal challenges to biomedical

5. Manufacturing of small molecule drugs

Page 11: Innovation Gaps on Life Science Frontiers? - Faculty of Law · Innovation Gaps on Life Science Frontiers?-from Ebola, ... (CeBIL) UCPH activities regarding legal challenges to biomedical

6. Manufacturing of Biologics & Biosimilars

Page 12: Innovation Gaps on Life Science Frontiers? - Faculty of Law · Innovation Gaps on Life Science Frontiers?-from Ebola, ... (CeBIL) UCPH activities regarding legal challenges to biomedical

7. Antibiotics

Page 13: Innovation Gaps on Life Science Frontiers? - Faculty of Law · Innovation Gaps on Life Science Frontiers?-from Ebola, ... (CeBIL) UCPH activities regarding legal challenges to biomedical

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

Page 14: Innovation Gaps on Life Science Frontiers? - Faculty of Law · Innovation Gaps on Life Science Frontiers?-from Ebola, ... (CeBIL) UCPH activities regarding legal challenges to biomedical
Page 15: Innovation Gaps on Life Science Frontiers? - Faculty of Law · Innovation Gaps on Life Science Frontiers?-from Ebola, ... (CeBIL) UCPH activities regarding legal challenges to biomedical

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?

Page 16: Innovation Gaps on Life Science Frontiers? - Faculty of Law · Innovation Gaps on Life Science Frontiers?-from Ebola, ... (CeBIL) UCPH activities regarding legal challenges to biomedical

Effects of proposed solutions?

Page 17: Innovation Gaps on Life Science Frontiers? - Faculty of Law · Innovation Gaps on Life Science Frontiers?-from Ebola, ... (CeBIL) UCPH activities regarding legal challenges to biomedical

CatalogingLinking InformingReaching out for input!Call for action?Synthesis?

Why are we writing this paper?

Page 18: Innovation Gaps on Life Science Frontiers? - Faculty of Law · Innovation Gaps on Life Science Frontiers?-from Ebola, ... (CeBIL) UCPH activities regarding legal challenges to biomedical

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

Page 19: Innovation Gaps on Life Science Frontiers? - Faculty of Law · Innovation Gaps on Life Science Frontiers?-from Ebola, ... (CeBIL) UCPH activities regarding legal challenges to biomedical

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