Lecture 21 - Role of government in Biotechnology Flashcards
What is the overview of the Therapeutics R&D Value Chain
Discovery > development > market
What is the flow for Discovery in Therapeutics R&D Value Chain
Gene»_space;(deciding where to look(academia)» Protein (target) > Screen»_space;(Select commercial opportunity(academia, MNC, SME))» lead»_space;(Create case for investment (MNC, SME and sometimes acedemia)» Candidate
What is the flow for Development in Therapeutics R&D Value Chain
Phase I (FTIH)»_space;(early development (SME MNC))» Phase II (POC) > Phase III( Late development (MNC)
What is the flow for market in Therapeutics R&D Value Chain
File»_space;(commercialisation)» Launch
Health Products from a buyer’s perspective
- 2 key MARKET ACCESS BARRIERS - regulatory and pricing
- Products are often NON DISCRETIONARY
- Products sell into highly COMPLEX markets with many STAKEHOLDERS
- The product is IP claim and label claim
- Leads to UNCONVENTIONAL business models
Examples of Government support for Biotech
- Education and training
- Supporting PFROs (Publicly Funded Research Organisations)
- Buying health products and services
- Translation Funding (MRFF)
- Accelerators/ incubators
- Tax incentives
- Advisory programmes - capability, networks, effectiveness - often offer matched funded grants
- Regulatory policy
- Sector Capability
- Enhance collaboration with PFRO
What are the examples of Supporting PFROs (Publicly Funded Research Organisations)
o Universities
o CSIRO
o MRIs
What are the examples of Research Infrastructure support
Expensive Kit: Synchrotron/ ANSTO
-Expensive to run
Capability (crystallography, tissue banks, GMP etc)
What are the examples for Buying health products and services
o PBS o MBS o PL o NDIA/ ADHA o Other health funds
What are the examples for Translation Funding (MRFF)
o AC
o Medical Research Future Fund: BTF, Biotech Bridge, Horizons,
o Challenge based programs Biotech Horizons
What are the examples for Tax incentives
o R&D Tax incentive for business (esp. refundable part)
o Tax incentives for Early Stage Investors
o (Philanthropy)
What are the examples for Advisory programmes - capability, networks, effectiveness - often offer matched funded grants
o AusIndustry - Business Management (also IC and AC)
o Austrade
o TGA Assist
o IP Australia patent hub
o Special purpose initiatives (eg. Biotech bridge)
What are the examples for Regulatory policy
o Comp Meds and GMP
o CTN/ CTX
o Patent system
What are the examples for Sector Capability
o Clinical Trial Initiatives
o Growth Centers
What are the examples for Enhance collaboration with PFRO
o Innovation Connections
o Cooperative Research Centres and CRC-Ps
o ARC Linkage