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Biotech Boot Camp
A biotechnology fundamentals course
Day 2
Presenters: Nick Weston + Viktoriia Hristova
Melbourne, Brisbane, Sydney
28 May - 18 June 2014
• Introduction
• Industrial applications and clean-tech
• Aquaculture and agriculture
• Medical devices and diagnostics
• Summary and wrap-up
Presentation Overview
Day Two
2
• Introduction
• Industrial applications and clean-tech
• Aquaculture and agriculture
• Medical devices and diagnostics
• Summary and wrap-up
Presentation Overview
Day Two
3
Biotechnology
4
Let’s recap from yesterday
A resilient sector that serves a diverse set of markets, across:
• Dx and medical devices
• agricultural products from animal health to seeds and crop
protection
• Rx (biomedical drugs)
• bio-based industrial products such as enzymes for industry
chemical processes and bio-remediation, bio-plastics and
bio-fuels (cleantech)
The term “life sciences" is used to connote sciences
concerned with the study of living organisms (as opposed
to physical sciences), including biology, botany, zoology,
microbiology, medicine, human therapeutics, veterinary
therapeutics, physiology, the ‘omics’ (eg: proteomics,
genomics), biochemistry, biotechnology, and related
subjects
Biotechnology
5
Definitions
The term “medical devices and diagnostics" is used to describe any instrument,
apparatus, appliance, material or other article, and the software to run it,
intended by the manufacturer to be used for human beings to:
• diagnose, prevent, monitor, treat or alleviate disease, injuries or handicaps
• investigate, replace or modify the anatomy or a physiological process, or control
conception
and which does not achieve its principal intended action in or on the human
body by pharmacological, immunological or metabolic means, but which may
be assisted in its function by such means
Biotechnology
6
Definitions
The term “industrial biotechnology" is the application of
molecular biology technology to modify the biological
function of an organism to generate industrial products and
processes
• biomass-based materials such as fuels and chemicals; and
• the treatment of waste water and producing energy using more
efficient measures
Biotechnology
7
Definitions
The term “cleantech" recycling, renewable energy (wind
power, solar power, biomass and hydropower, biofuels),
information technology, green transportation, electric
motors, green chemistry, lighting, and many other
appliances that are now more energy efficient. It is a means
to create electricity and fuels with a smaller environmental
footprint and minimise pollution
Biotechnology
8
Definitions
The term “agriculture" is the science, art, or practice of
cultivating the soil, producing crops, and raising livestock
and in varying degrees the preparation and marketing of
the resulting products
The term “aquaculture" is the cultivation of freshwater and
marine resources, both plant and animal, for human
consumption or use
Biotechnology
9
Definitions
The ‘Valley of Death’
1
0
The ‘Valley of Death’
1
1
Bioeconomy success
12 Source: Burrill Transforming Healthcare Report 2014, (originally in PwC Moneytree)
Strong global pipeline
Bioeconomy success
13 Source: Scientific American Worldview 2013
Australia No.7
Bioeconomy success
14 Source: PwC Bioforum Q1, 2014
Australia still strong for secondary raisings
Three criteria for a granted patent
• It must be novel
• It must be non-obvious
• It must have commercial utility
In Australia there are two types of patent applications
available
• Standard Patents
• Innovation Patents
Intellectual Property
1
5
Patents
Utility Patent Protects the way in which an invention is made, how
it is used or how it functions
- Expires 20 years from the effective filing date
Design Patent Protects new ornamental design for an article of
manufacture
- Expires 14 years from the date of grant
Plant Patent Protects distinct and new plant varieties
- Expires 20 years from the effective filing date
Intellectual Property
16
Patents
Intellectual Property
17 QUT-2004
Typical patent process and cost
$0
$50,000
$100,000
$150,000
$200,000
Provisional
Application
PCT
Application
National
Phase
Entry
Examination Renewals
Months
0 12 30
Patent granted
Cumulative cost
Defence
>$1m
Patents Trade Secrets
Protects against independent discovery
No protection against independent discovery
or reverse engineering
20 years of protection Protection lasts as long as secret
Scope for publication of development No opportunity for publication
Enforcement: infringement
Enforcement: breach of confidence, breach of
contract, breach of fiduciary duty
Protection can be broadened beyond
specific discovery/development
Protection specific to particular secret
Intellectual Property
18
Patents v. Trade Secrets
The genomics era
19
penicillins
sulphonamides
aspirin
psychotropics
NSAIDS
H2-antagonists
beta blockers
lipid lowerers
ACE-inhibitors
Biotech drugs
chronic
degenerative
disease associated
with ageing,
inflammation,
cancer
drugs against
targets identified
from disease genes
1900 20301950 1960 1970 1980 1990 2000 2010 2020 2040
NewTherapeuticCycles
1st generation 2nd generation 3rd generation
natural products
and derivatives
serendipity
receptors
enzyme
genetic engineering
cell pharmacology/
molecular biology
genomics/proteomics/metabolomics
Source: CMS, Lehman Brothers research
• Association of Molecular Pathology v Myriad Genetics
(2013)
• Naturally-occurring DNA is not patent eligible
• cDNA is patent eligible because it is not naturally-occurring
• Data protection
• 5 years Au, 6 years China, 10 years EU, 12 years US
• Hatch-Waxman Act extension (U.S.) (lesser of 5 years
from regulatory approval or 14 years of effective patent
life)
• Second medical use patents
Intellectual Property
Idiosyncrasies of protecting biologics - Patents
20
Prescription medicine regulation
21
Recap
The TGA is accountable for the quality, safety, efficacy and
timely availability of drugs and medical devices in Australia
Performance targets for TGA drug evaluation and approval
were set and are included in the Regulations
The TGA operates on a 100% cost recovery basis
Prescription medicine regulation
22
Recap
Before a drug (prescription or non-prescription), medical
device, vitamin, nutritional, ‘TCM’, ‘alternative medicine’ or
herbal product can be marketed in, imported to, or exported
from Australia it must be listed on the Australian Register of
Therapeutic Goods (ARTG) by the TGA
New chemical entities and applications which require
expert advice are referred to the Advisory Committee on
Prescription Medicines (ACPM) for its non-binding
recommendations
Prescription medicine regulation
23
Recap
Also regulatory channels for
Biologicals
Biosimilars
Medical devices
IVD
GMOs (GT Register or licensing regime)
Basic overview of the life sciences
24
Recap
2003 2014
• Biotechs that wanted to emulate
bigpharma (a build model)
• Bigpharma wants to emulate
biotech (a buy model)
• Small molecule blockbusters • Antibody drug conjugates
• Cell based therapies
• Treatments that regulate or
alter genes
• Trial and error drug projects • Therapies designed to precisely
target molecular drivers
• Treatment of symptoms • Treatment of causes
• Move to curative medicine
• Human Genome Project
completed at cost of $3billion
• Illumina can sequence genome
for <$1,000
Typical life sciences development process
25 Graphic: Aptuit 2014
A life sciences biotech project starts with high throughput
screening identification of promising drug targets in the lab
(hits) that undergo in vitro testing for safety, specificity and
efficacy (candidate), proceeds to testing in animals and then
humans and ends in regulatory approval for marketing. The
focus of regulatory approval is on the safety and efficacy of the
drug in humans. Most countries have a government agency to
regulate and oversee the path to drug approval (approval).
Typical life sciences development process
26 Graphic: Aptuit 2014
Discovery
Disciplines
Development
Disciplines
Recap
Typical life sciences development process
27 Graphic: Aptuit 2014
Drug Design & Discovery
Preclinical Biosciences
API Development &
Manufacture
Solid State Chemistry
Pharmaceutical Sciences
Computational Support
Synthetic chemistry, small scale product synthesis
NMR, Chiral separation, UPLC/MSMS…..
Recap
Typical life sciences development process
28 Graphic: Aptuit 2014
Recap
Sector is approaching middle age
Hundreds of drugs and diagnostics approved
Technologies are proving their value (eg MaBs)
Biotech has plenty of scope for further innovation
Data analytics driving medical breakthroughs
Foundation built for substantial growth
Challenges remain
State of play
29
Recap
• Introduction
• Industrial applications and clean-tech (morning tea)
• Aquaculture and agriculture
• Medical devices and diagnostics
• Summary and wrap-up (finished by lunch-time)
Presentation Overview
Today
30

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Nw biotech fundamentals day 2 session 1 introduction

  • 1. Biotech Boot Camp A biotechnology fundamentals course Day 2 Presenters: Nick Weston + Viktoriia Hristova Melbourne, Brisbane, Sydney 28 May - 18 June 2014
  • 2. • Introduction • Industrial applications and clean-tech • Aquaculture and agriculture • Medical devices and diagnostics • Summary and wrap-up Presentation Overview Day Two 2
  • 3. • Introduction • Industrial applications and clean-tech • Aquaculture and agriculture • Medical devices and diagnostics • Summary and wrap-up Presentation Overview Day Two 3
  • 4. Biotechnology 4 Let’s recap from yesterday A resilient sector that serves a diverse set of markets, across: • Dx and medical devices • agricultural products from animal health to seeds and crop protection • Rx (biomedical drugs) • bio-based industrial products such as enzymes for industry chemical processes and bio-remediation, bio-plastics and bio-fuels (cleantech)
  • 5. The term “life sciences" is used to connote sciences concerned with the study of living organisms (as opposed to physical sciences), including biology, botany, zoology, microbiology, medicine, human therapeutics, veterinary therapeutics, physiology, the ‘omics’ (eg: proteomics, genomics), biochemistry, biotechnology, and related subjects Biotechnology 5 Definitions
  • 6. The term “medical devices and diagnostics" is used to describe any instrument, apparatus, appliance, material or other article, and the software to run it, intended by the manufacturer to be used for human beings to: • diagnose, prevent, monitor, treat or alleviate disease, injuries or handicaps • investigate, replace or modify the anatomy or a physiological process, or control conception and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means Biotechnology 6 Definitions
  • 7. The term “industrial biotechnology" is the application of molecular biology technology to modify the biological function of an organism to generate industrial products and processes • biomass-based materials such as fuels and chemicals; and • the treatment of waste water and producing energy using more efficient measures Biotechnology 7 Definitions
  • 8. The term “cleantech" recycling, renewable energy (wind power, solar power, biomass and hydropower, biofuels), information technology, green transportation, electric motors, green chemistry, lighting, and many other appliances that are now more energy efficient. It is a means to create electricity and fuels with a smaller environmental footprint and minimise pollution Biotechnology 8 Definitions
  • 9. The term “agriculture" is the science, art, or practice of cultivating the soil, producing crops, and raising livestock and in varying degrees the preparation and marketing of the resulting products The term “aquaculture" is the cultivation of freshwater and marine resources, both plant and animal, for human consumption or use Biotechnology 9 Definitions
  • 10. The ‘Valley of Death’ 1 0
  • 11. The ‘Valley of Death’ 1 1
  • 12. Bioeconomy success 12 Source: Burrill Transforming Healthcare Report 2014, (originally in PwC Moneytree) Strong global pipeline
  • 13. Bioeconomy success 13 Source: Scientific American Worldview 2013 Australia No.7
  • 14. Bioeconomy success 14 Source: PwC Bioforum Q1, 2014 Australia still strong for secondary raisings
  • 15. Three criteria for a granted patent • It must be novel • It must be non-obvious • It must have commercial utility In Australia there are two types of patent applications available • Standard Patents • Innovation Patents Intellectual Property 1 5 Patents
  • 16. Utility Patent Protects the way in which an invention is made, how it is used or how it functions - Expires 20 years from the effective filing date Design Patent Protects new ornamental design for an article of manufacture - Expires 14 years from the date of grant Plant Patent Protects distinct and new plant varieties - Expires 20 years from the effective filing date Intellectual Property 16 Patents
  • 17. Intellectual Property 17 QUT-2004 Typical patent process and cost $0 $50,000 $100,000 $150,000 $200,000 Provisional Application PCT Application National Phase Entry Examination Renewals Months 0 12 30 Patent granted Cumulative cost Defence >$1m
  • 18. Patents Trade Secrets Protects against independent discovery No protection against independent discovery or reverse engineering 20 years of protection Protection lasts as long as secret Scope for publication of development No opportunity for publication Enforcement: infringement Enforcement: breach of confidence, breach of contract, breach of fiduciary duty Protection can be broadened beyond specific discovery/development Protection specific to particular secret Intellectual Property 18 Patents v. Trade Secrets
  • 19. The genomics era 19 penicillins sulphonamides aspirin psychotropics NSAIDS H2-antagonists beta blockers lipid lowerers ACE-inhibitors Biotech drugs chronic degenerative disease associated with ageing, inflammation, cancer drugs against targets identified from disease genes 1900 20301950 1960 1970 1980 1990 2000 2010 2020 2040 NewTherapeuticCycles 1st generation 2nd generation 3rd generation natural products and derivatives serendipity receptors enzyme genetic engineering cell pharmacology/ molecular biology genomics/proteomics/metabolomics Source: CMS, Lehman Brothers research
  • 20. • Association of Molecular Pathology v Myriad Genetics (2013) • Naturally-occurring DNA is not patent eligible • cDNA is patent eligible because it is not naturally-occurring • Data protection • 5 years Au, 6 years China, 10 years EU, 12 years US • Hatch-Waxman Act extension (U.S.) (lesser of 5 years from regulatory approval or 14 years of effective patent life) • Second medical use patents Intellectual Property Idiosyncrasies of protecting biologics - Patents 20
  • 21. Prescription medicine regulation 21 Recap The TGA is accountable for the quality, safety, efficacy and timely availability of drugs and medical devices in Australia Performance targets for TGA drug evaluation and approval were set and are included in the Regulations The TGA operates on a 100% cost recovery basis
  • 22. Prescription medicine regulation 22 Recap Before a drug (prescription or non-prescription), medical device, vitamin, nutritional, ‘TCM’, ‘alternative medicine’ or herbal product can be marketed in, imported to, or exported from Australia it must be listed on the Australian Register of Therapeutic Goods (ARTG) by the TGA New chemical entities and applications which require expert advice are referred to the Advisory Committee on Prescription Medicines (ACPM) for its non-binding recommendations
  • 23. Prescription medicine regulation 23 Recap Also regulatory channels for Biologicals Biosimilars Medical devices IVD GMOs (GT Register or licensing regime)
  • 24. Basic overview of the life sciences 24 Recap 2003 2014 • Biotechs that wanted to emulate bigpharma (a build model) • Bigpharma wants to emulate biotech (a buy model) • Small molecule blockbusters • Antibody drug conjugates • Cell based therapies • Treatments that regulate or alter genes • Trial and error drug projects • Therapies designed to precisely target molecular drivers • Treatment of symptoms • Treatment of causes • Move to curative medicine • Human Genome Project completed at cost of $3billion • Illumina can sequence genome for <$1,000
  • 25. Typical life sciences development process 25 Graphic: Aptuit 2014 A life sciences biotech project starts with high throughput screening identification of promising drug targets in the lab (hits) that undergo in vitro testing for safety, specificity and efficacy (candidate), proceeds to testing in animals and then humans and ends in regulatory approval for marketing. The focus of regulatory approval is on the safety and efficacy of the drug in humans. Most countries have a government agency to regulate and oversee the path to drug approval (approval).
  • 26. Typical life sciences development process 26 Graphic: Aptuit 2014 Discovery Disciplines Development Disciplines Recap
  • 27. Typical life sciences development process 27 Graphic: Aptuit 2014 Drug Design & Discovery Preclinical Biosciences API Development & Manufacture Solid State Chemistry Pharmaceutical Sciences Computational Support Synthetic chemistry, small scale product synthesis NMR, Chiral separation, UPLC/MSMS….. Recap
  • 28. Typical life sciences development process 28 Graphic: Aptuit 2014 Recap
  • 29. Sector is approaching middle age Hundreds of drugs and diagnostics approved Technologies are proving their value (eg MaBs) Biotech has plenty of scope for further innovation Data analytics driving medical breakthroughs Foundation built for substantial growth Challenges remain State of play 29 Recap
  • 30. • Introduction • Industrial applications and clean-tech (morning tea) • Aquaculture and agriculture • Medical devices and diagnostics • Summary and wrap-up (finished by lunch-time) Presentation Overview Today 30