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Biotech Boot Camp
A biotechnology fundamentals course
Presenters: Nick Weston + Viktoriia Hristova
June 2014
• Introduction
• The business lifecycle of a Biotech Company
• Regulatory
• Discussion of Trends and Techniques
• Life Sciences
2
Presentation Overview
Day One
• Introduction
• Industrial applications and clean-tech
• Aquaculture and agriculture
• Medical devices and diagnostics
• Summary and wrap-up
Presentation Overview
Day Two
3
• Introduction
• The business lifecycle of a Biotech Company
• Regulatory
• Discussion of Trends and Techniques
• Life Sciences
Presentation Overview
Day One
4
Nick Weston,
B. Ec., LL.B
• Commercial IP lawyer
• WIPO Arbitrator and Domain Name Panelist
• Chairman of Agenix Limited (ASX: AGX) since 2008, Chairman
+ CEO since 2010 - Raised multiple rounds of capital
• Experience in drug and diagnostic development projects based
in Australia, the USA and China
• Country Ambassador, Aptuit, LLC.
Presenters
5
Viktoriia Hristova,
B. Sc. (Biomedical
Science), LL.B.
• Commercial intellectual property lawyer
• Experience in commercialising research, management of
intellectual property portfolios, licensing,
• Previously at Francis Abourikz Lightowlers (FAL), a
commercialisation law firm that acts for numerous CRCs
and research institutes such as the Baker Institute, WEHI
and CSIRO
• Contributing writer, Bioshares Magazine
• Stints in VC and plant genomics research
Presenters
6
The term "biotechnology" is used to connote a group of
diverse industries with the common link that they
apply scientific knowledge to living organisms or the
products from living organisms to benefit life on Earth term
The term "biologics" is used more restrictively for products
that are produced by means of biological processes
involving DNA technology
Biotechnology
7
Definition
For millennia, human beings have sought to use living
organisms or their products for commercial purposes.
Crops and animals were domesticated by selective
breeding. New strains and processes for brewing beer,
making cheese or baking bread were developed to improve
their quality and diversity
These activities made civilisation possible
Biotechnology
8
History
Biotechnology harnesses cellular and bio-molecular
processes to develop technologies and products that
combat debilitating and rare diseases, reduce our
environmental footprint, feed the hungry, use less and
cleaner energy, and have safer, cleaner and more efficient
industrial manufacturing processes
Definition of biotech
9
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)
Definition of biotech
10
1953 – Structure of DNA defined
1957 – Lord Todd wins Nobel Prize “for his work on
nucleotides and nucleotide co-enzymes”
1962 – Watson and Crick win Nobel Prize
1974 – Boyer and Cohen demonstrate the expression of a
foreign gene in bacteria
1976 – Genentech, first biologics company is formed
1978 – First successful laboratory production of recombinant
human insulin
History of biotech
11
1980 – Genentech goes public
1980 – First human test of recombinant insulin
1980 – Biogen produces Interferon
1982 – Human insulin approved by FDA and marketed by Eli
Lilly under license from Genentech
1982 – Agen spins out of QUT to develop d-dimer monoclonal
antibody test (MaB) for coagulation
1982 – first recombinant DNA vaccine for livestock developed
1983 – First MaB approved for testing for Chlamydia
Trachomatis
History of biotech
12
1984 – Genetic fingerprinting discovered
1985 – Polymerase Chain Reaction (PCR) technology
developed
1985 – Genentech receives FDA approval for human growth
hormone – first drug to be marketed by biotechnology
company
1986 – First GM plants grown outside in USA (tobacco)
1986 – Chiron receives FDA license for Hepatitis B vaccine –
first recombinant vaccine
History of biotech
13
1986 – Muromonab-CD3 receives FDA approval for reversal
of acute kidney transplant rejection – first monoclonal
antibody approved for therapy
1987 – Agen goes public on ASX
1988 – Only five proteins from genetically engineered cells
approved as drugs by FDA: synthetic insulin, human growth
hormone, hepatitis B vaccine, alpha-interferon, and tissue
plasminogen activator (TPa) for lysis of blood clots
History of biotech
14
1989 – Discovery of defective gene for cystic fibrosis quickly
followed by link specific genes to autism, Huntington’s and
Right Ventricular Cardiomyopathy builds body of knowledge
1990 – First gene therapy for adenosine deaminase (ADA)
immuno-deficiency
1990 – Jurassic Park book published
1991 – UCSF and Stanford earn $40 million from patents –
changes way universities look at biotechnology
History of biotech
15
1991 – First enzyme replacement therapy - Alglucerase FDA
approved to treat Gaucher’s disease
1993 – Jurassic Park film released
1997 – First cloned sheep - Dolly
1997 – Rituximab receives FDA approval – first antibody
based treatment for cancer (non-Hodgkin’s Lymphoma)
1997 – UN adopts Universal declaration on the Human
Genome and Human Rights
History of biotech
16
1998 – The roundworm C elegans becomes the first
multicellular organism to have its genome completely
sequenced
1999 – Swiss and Germans scientists develop golden rice,
fortified with betacarotene which stimulates production of
vitamin A, thus preventing forms of blindness
2000 – Human Genome mapped
2003 – SARS genome sequenced
2005 – Billionth biotech acre planted by one of 8.5M farmers
in one of 21 countries
History of biotech
17
2007 – Australian vaccine Gardasil® for human
papillomavirus (HPV), a cause of cervical cancer, approved
for use by women and girls in more than 80 countries
2010 – J. Craig Venter Institute creates first fully synthetic,
self-replicating bacterial cell
2014 – Obama endorses of the importance of agricultural
research and biotechnology to feed the 9 billion people
expected to live on this planet by 2050
History of biotech
18
History of biotech
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
Source: CMS, Lehman Brothers research
Typical life sciences development process
20 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
21
Time 4 days* – 9 months
Test
population
Computational studies, discovery analytical sciences, assays
development and in vitro profiling, pre-clinical in vivo
pharmacology, microbiology, pharmacokinetics
Purpose Testing whether it is specific, whether there a concentration
range where it is effective and safe (therapeutic window)
Success
rate
Thousands of hits evaluated
Hit to lead, lead to candidate
*Affinity Bio www.affinitybio.com.au
Typical life sciences development process
22 Graphic: Aptuit 2014
Typical life sciences development process
2
3
File IND at TGA/EMA/FDA/CFDA
Typical life sciences development process
2
4
*Source: Calvert Research Institute
Years 1 - 5 years
Test
population
Laboratory and animal studies
Purpose Assess safety and biological activity, bioanalysis, toxicity,
pathology, safety pharmacology, CMC development and
manufacture
Success
rate
5,000 compounds evaluated*
Pre-clinical development and testing
Typical life sciences development process
2
5
*Source: Calvert Research Institute
Years 1
Test
population
20 – 80 healthy volunteers
Purpose Determine safety and dosage, typically using single ascending
dosage (SAD) or multiple ascending dosage (MAD) statistical
designs to establish the maximum tolerated dose (MTD)
Success
rate
5 enter trials*
Phase 1
Typical life sciences development process
26 *Source: Calvert Research Institute
Years 2
Test
population
100 – 300 patient volunteers
Purpose Evaluate effectiveness, look for side-effects
Success
rate
5 enter trials*
Phase 2
Typical life sciences development process
27 *Source: Calvert Research Institute
Years 3
Test
population
1,000 – 3,000 patient volunteers
Purpose Verify effectiveness, monitor adverse reactions from long-term
use
Success
rate
5 enter trials*
Phase 3
Typical life sciences development process
28
File NDA at TGA/EMA/FDA/CFDA
Typical life sciences development process
29 *Source: Calvert Research Institute
Years 2.5
Test
population
Purpose Review process / Approval
Success
rate
1 approved*
EMA/FDA/EMA/CFDA
Typical life sciences development process
30
Typically, 9 - 12 years
Typical life sciences development process
31
Phase IV - Pharmacovigilance
Helps us to meet our basic needs
• food
• clothing
• shelter
• health
• safety
• energy
• environment
Relevance of biotech
32
A high value economic driver
• high quality jobs
• serves broad markets
• innovation and entrepreneurial strength
• R&D intensity
DNA evidence in Court cases
You may be asked to create biotech related law and policy
R&D Tax Incentive assessments and rulings
Relevance of biotech
33
Eg: the Human Genome Project in the U.S.
• this $10.4 billion investment in basic sciences during the
1993 to 2010 period drove $796 billion in economic
impact
• created 3.8 million job-years of employment over this
period
• launched the genomic revolution that has revolutionised
agriculture and veterinary medicine; environmental
remediation; biofuels; and other industrial applications
Relevance of biotech
34
• More nutritious crops with longer shelf-lives
• Higher yields per acre (pest resistance, herbicides and
environmental conditions such as drought or salinity)
• Better vaccines and drugs, especially for cancer
• Transgenic animals and plants which produce human
hormones, antibodies or enzymes
• Bio-remediation to clean up pollutants by altering
microbes or plants
• Therapeutic cloning, eg: grow skin cells for burn victims
Relevance of biotech
35
Some applications
• Investment in major biotech development initiatives
• Development of the agricultural biotech, bio-energy and
bio-products industrial sub-sectors
• Building research and development capacity and
advancing commercialisation of research discoveries
• Continuing to address biotech companies’ needs for
early-stage capital
• Biotech supportive tax policies
Relevance of biotech
36
Key drivers of growth
• regulatory environment
• access to capital
Relevance of biotech
37
Key challenges
Real products = real profits
Waves
• immune-modulatory oncology targets
• Nonalcoholic steatohepatitis (NASH) candidates for fatty
liver disease
• structural genomics and chemigenomics
• nanotech/microfluidics
• regenerative medicine
• RNA therapies
• protein microarrays
• post genomics and the consumer
State of play
38
More than 250 biotechnology health care products and
vaccines available to patients, many for previously
untreatable diseases
Over 17 million farmers utilising biotechnology globally, at
least 15 million of whom are small, resource-poor farmers
in developing countries
In excess of 50 bio-refineries are being built across North
America to test and refine technologies to produce biofuels
and chemicals from renewable biomass
State of play
39
55 Australian companies tracked by BBI by the end of
Q4 2013 a total market capitalisation of $38.5 billion
With a market cap of $33.4 billion @ Q4 2013, CSL
represents 86.8 per cent of the total market capitalisation of
companies tracked by BBI
State of play
40
State of play
41
The blue line is without CSL
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
Foundation built for substantial growth
Challenges remain
State of play
42

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Nw biotech fundamentals day 1 session 1 20140612

  • 1. Biotech Boot Camp A biotechnology fundamentals course Presenters: Nick Weston + Viktoriia Hristova June 2014
  • 2. • Introduction • The business lifecycle of a Biotech Company • Regulatory • Discussion of Trends and Techniques • Life Sciences 2 Presentation Overview Day One
  • 3. • Introduction • Industrial applications and clean-tech • Aquaculture and agriculture • Medical devices and diagnostics • Summary and wrap-up Presentation Overview Day Two 3
  • 4. • Introduction • The business lifecycle of a Biotech Company • Regulatory • Discussion of Trends and Techniques • Life Sciences Presentation Overview Day One 4
  • 5. Nick Weston, B. Ec., LL.B • Commercial IP lawyer • WIPO Arbitrator and Domain Name Panelist • Chairman of Agenix Limited (ASX: AGX) since 2008, Chairman + CEO since 2010 - Raised multiple rounds of capital • Experience in drug and diagnostic development projects based in Australia, the USA and China • Country Ambassador, Aptuit, LLC. Presenters 5
  • 6. Viktoriia Hristova, B. Sc. (Biomedical Science), LL.B. • Commercial intellectual property lawyer • Experience in commercialising research, management of intellectual property portfolios, licensing, • Previously at Francis Abourikz Lightowlers (FAL), a commercialisation law firm that acts for numerous CRCs and research institutes such as the Baker Institute, WEHI and CSIRO • Contributing writer, Bioshares Magazine • Stints in VC and plant genomics research Presenters 6
  • 7. The term "biotechnology" is used to connote a group of diverse industries with the common link that they apply scientific knowledge to living organisms or the products from living organisms to benefit life on Earth term The term "biologics" is used more restrictively for products that are produced by means of biological processes involving DNA technology Biotechnology 7 Definition
  • 8. For millennia, human beings have sought to use living organisms or their products for commercial purposes. Crops and animals were domesticated by selective breeding. New strains and processes for brewing beer, making cheese or baking bread were developed to improve their quality and diversity These activities made civilisation possible Biotechnology 8 History
  • 9. Biotechnology harnesses cellular and bio-molecular processes to develop technologies and products that combat debilitating and rare diseases, reduce our environmental footprint, feed the hungry, use less and cleaner energy, and have safer, cleaner and more efficient industrial manufacturing processes Definition of biotech 9
  • 10. 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) Definition of biotech 10
  • 11. 1953 – Structure of DNA defined 1957 – Lord Todd wins Nobel Prize “for his work on nucleotides and nucleotide co-enzymes” 1962 – Watson and Crick win Nobel Prize 1974 – Boyer and Cohen demonstrate the expression of a foreign gene in bacteria 1976 – Genentech, first biologics company is formed 1978 – First successful laboratory production of recombinant human insulin History of biotech 11
  • 12. 1980 – Genentech goes public 1980 – First human test of recombinant insulin 1980 – Biogen produces Interferon 1982 – Human insulin approved by FDA and marketed by Eli Lilly under license from Genentech 1982 – Agen spins out of QUT to develop d-dimer monoclonal antibody test (MaB) for coagulation 1982 – first recombinant DNA vaccine for livestock developed 1983 – First MaB approved for testing for Chlamydia Trachomatis History of biotech 12
  • 13. 1984 – Genetic fingerprinting discovered 1985 – Polymerase Chain Reaction (PCR) technology developed 1985 – Genentech receives FDA approval for human growth hormone – first drug to be marketed by biotechnology company 1986 – First GM plants grown outside in USA (tobacco) 1986 – Chiron receives FDA license for Hepatitis B vaccine – first recombinant vaccine History of biotech 13
  • 14. 1986 – Muromonab-CD3 receives FDA approval for reversal of acute kidney transplant rejection – first monoclonal antibody approved for therapy 1987 – Agen goes public on ASX 1988 – Only five proteins from genetically engineered cells approved as drugs by FDA: synthetic insulin, human growth hormone, hepatitis B vaccine, alpha-interferon, and tissue plasminogen activator (TPa) for lysis of blood clots History of biotech 14
  • 15. 1989 – Discovery of defective gene for cystic fibrosis quickly followed by link specific genes to autism, Huntington’s and Right Ventricular Cardiomyopathy builds body of knowledge 1990 – First gene therapy for adenosine deaminase (ADA) immuno-deficiency 1990 – Jurassic Park book published 1991 – UCSF and Stanford earn $40 million from patents – changes way universities look at biotechnology History of biotech 15
  • 16. 1991 – First enzyme replacement therapy - Alglucerase FDA approved to treat Gaucher’s disease 1993 – Jurassic Park film released 1997 – First cloned sheep - Dolly 1997 – Rituximab receives FDA approval – first antibody based treatment for cancer (non-Hodgkin’s Lymphoma) 1997 – UN adopts Universal declaration on the Human Genome and Human Rights History of biotech 16
  • 17. 1998 – The roundworm C elegans becomes the first multicellular organism to have its genome completely sequenced 1999 – Swiss and Germans scientists develop golden rice, fortified with betacarotene which stimulates production of vitamin A, thus preventing forms of blindness 2000 – Human Genome mapped 2003 – SARS genome sequenced 2005 – Billionth biotech acre planted by one of 8.5M farmers in one of 21 countries History of biotech 17
  • 18. 2007 – Australian vaccine Gardasil® for human papillomavirus (HPV), a cause of cervical cancer, approved for use by women and girls in more than 80 countries 2010 – J. Craig Venter Institute creates first fully synthetic, self-replicating bacterial cell 2014 – Obama endorses of the importance of agricultural research and biotechnology to feed the 9 billion people expected to live on this planet by 2050 History of biotech 18
  • 19. History of biotech 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 Source: CMS, Lehman Brothers research
  • 20. Typical life sciences development process 20 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).
  • 21. Typical life sciences development process 21 Time 4 days* – 9 months Test population Computational studies, discovery analytical sciences, assays development and in vitro profiling, pre-clinical in vivo pharmacology, microbiology, pharmacokinetics Purpose Testing whether it is specific, whether there a concentration range where it is effective and safe (therapeutic window) Success rate Thousands of hits evaluated Hit to lead, lead to candidate *Affinity Bio www.affinitybio.com.au
  • 22. Typical life sciences development process 22 Graphic: Aptuit 2014
  • 23. Typical life sciences development process 2 3 File IND at TGA/EMA/FDA/CFDA
  • 24. Typical life sciences development process 2 4 *Source: Calvert Research Institute Years 1 - 5 years Test population Laboratory and animal studies Purpose Assess safety and biological activity, bioanalysis, toxicity, pathology, safety pharmacology, CMC development and manufacture Success rate 5,000 compounds evaluated* Pre-clinical development and testing
  • 25. Typical life sciences development process 2 5 *Source: Calvert Research Institute Years 1 Test population 20 – 80 healthy volunteers Purpose Determine safety and dosage, typically using single ascending dosage (SAD) or multiple ascending dosage (MAD) statistical designs to establish the maximum tolerated dose (MTD) Success rate 5 enter trials* Phase 1
  • 26. Typical life sciences development process 26 *Source: Calvert Research Institute Years 2 Test population 100 – 300 patient volunteers Purpose Evaluate effectiveness, look for side-effects Success rate 5 enter trials* Phase 2
  • 27. Typical life sciences development process 27 *Source: Calvert Research Institute Years 3 Test population 1,000 – 3,000 patient volunteers Purpose Verify effectiveness, monitor adverse reactions from long-term use Success rate 5 enter trials* Phase 3
  • 28. Typical life sciences development process 28 File NDA at TGA/EMA/FDA/CFDA
  • 29. Typical life sciences development process 29 *Source: Calvert Research Institute Years 2.5 Test population Purpose Review process / Approval Success rate 1 approved* EMA/FDA/EMA/CFDA
  • 30. Typical life sciences development process 30 Typically, 9 - 12 years
  • 31. Typical life sciences development process 31 Phase IV - Pharmacovigilance
  • 32. Helps us to meet our basic needs • food • clothing • shelter • health • safety • energy • environment Relevance of biotech 32
  • 33. A high value economic driver • high quality jobs • serves broad markets • innovation and entrepreneurial strength • R&D intensity DNA evidence in Court cases You may be asked to create biotech related law and policy R&D Tax Incentive assessments and rulings Relevance of biotech 33
  • 34. Eg: the Human Genome Project in the U.S. • this $10.4 billion investment in basic sciences during the 1993 to 2010 period drove $796 billion in economic impact • created 3.8 million job-years of employment over this period • launched the genomic revolution that has revolutionised agriculture and veterinary medicine; environmental remediation; biofuels; and other industrial applications Relevance of biotech 34
  • 35. • More nutritious crops with longer shelf-lives • Higher yields per acre (pest resistance, herbicides and environmental conditions such as drought or salinity) • Better vaccines and drugs, especially for cancer • Transgenic animals and plants which produce human hormones, antibodies or enzymes • Bio-remediation to clean up pollutants by altering microbes or plants • Therapeutic cloning, eg: grow skin cells for burn victims Relevance of biotech 35 Some applications
  • 36. • Investment in major biotech development initiatives • Development of the agricultural biotech, bio-energy and bio-products industrial sub-sectors • Building research and development capacity and advancing commercialisation of research discoveries • Continuing to address biotech companies’ needs for early-stage capital • Biotech supportive tax policies Relevance of biotech 36 Key drivers of growth
  • 37. • regulatory environment • access to capital Relevance of biotech 37 Key challenges
  • 38. Real products = real profits Waves • immune-modulatory oncology targets • Nonalcoholic steatohepatitis (NASH) candidates for fatty liver disease • structural genomics and chemigenomics • nanotech/microfluidics • regenerative medicine • RNA therapies • protein microarrays • post genomics and the consumer State of play 38
  • 39. More than 250 biotechnology health care products and vaccines available to patients, many for previously untreatable diseases Over 17 million farmers utilising biotechnology globally, at least 15 million of whom are small, resource-poor farmers in developing countries In excess of 50 bio-refineries are being built across North America to test and refine technologies to produce biofuels and chemicals from renewable biomass State of play 39
  • 40. 55 Australian companies tracked by BBI by the end of Q4 2013 a total market capitalisation of $38.5 billion With a market cap of $33.4 billion @ Q4 2013, CSL represents 86.8 per cent of the total market capitalisation of companies tracked by BBI State of play 40
  • 41. State of play 41 The blue line is without CSL
  • 42. 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 Foundation built for substantial growth Challenges remain State of play 42