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

Starting point: Patents

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

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

1. Biologics & biosimilars

2. Diagnostics and “black box” precision medicine

3. New uses for known drugs

4. Orphan drugs (rare & neglected deseases)

5. Manufacturing of small molecule drugs

6. Manufacturing of Biologics & Biosimilars

7. Antibiotics

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?

Effects of proposed solutions?

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

What do you think?