Nw biotech fundamentals day 2 session 3 agriculture and aquaculture

Biotech Boot Camp
Session 3 – Agriculture and aquaculture
Presenter: Viktoriia Hristova
Melbourne, Brisbane, Sydney
28 May – 18 June, 2014

This session provides an overview of the biotechnology in
agriculture and aquaculture
Analysis includes key biotech techniques and processes in
genetically modified organisms and use of transgenic plants
The session also provides specific insights on how these
applications are regulated and looks at the adoption of
these techniques in agriculture and aquaculture
2
Session 4 Overview
Agenda

• Basic overview of agriculture and aquaculture
• The state of the art
• Regulatory nuances
• Future trends
• Case studies and examples
3
Session 3 Overview
Agriculture and aquaculture

• Future trends
4
Session 3 Overview

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
Aquaculture is the cultivation of freshwater and marine
resources, both plant and animal, for human consumption
or use
5
Basic overview of agriculture and aquaculture

• Biotech in agriculture means food biotechnology and
involves genetics to enhance the traits of plants, animals,
and micro-organisms for food production
• Food biotechnology is a safe, more efficient way to
improve crops
• Selecting specific genes to add or extract is a more
precise method of plant breeding, offering farmers more
ways to improve crops
• Estimated biotechnology crops planted since 2002 > 145
million acres worldwide
6

What is aquaculture?
• Aquaculture is wet agriculture = farming in water
• Requires active cultivation (maintenance or
production) of marine and freshwater aquatic
organisms (plants and animals) under controlled
conditions
• The application of the new biotechnology techniques
of proteomics to discover new proteins and bio-
markers for fish quality
7

• Marine organisms have evolved a wide variety of toxins and
novel chemical adaptations that help them compete
successfully in demanding environments, such as in a
crowded coral reef, deep ocean sediments, thermal vents, and
Antarctic/Arctic waters
• Corals, molluscs, sponges, echinoderms, and bryozoans,
have evolved chemical weapons to help them compete for
limited resources, avoid predation, or deter overgrowth by
competitors
• Research in the field hopes to identify compounds that will
provide useful drugs, anticancer agents, agricultural products,
and industrial enzymes
8

• Future trends
9
Session 3 Overview

• Farmers have been using genetic modification to produce
desirable characteristics in plants and animals for
thousands of years, through cross breeding
• Cross-breeding involves the random transfer of
characteristics within the same species
• Modern Biotechnology enables farmers to specifically
transfer one or more genes from one organism to another
10
State of the art
Understanding the language

• Both crops and livestock are referred to as
• genetically modified organisms (GMOs)
• genetically enhanced organisms (GEOs) or genetically
engineered organisms
• transgenic organisms
11
State of the art
Understanding the language

• Naturally occurring in nature
• Natural selection
• Nature and the environment selects the strongest
plant, or animal to survive
• Desired traits are passed on through breeding
12
State of the art
Transgenic plants
Selection
Natural Selection
Ecological Selection Sexual Selection
Artificial Selection

13
State of the art
Transgenic plants
• Early work of Mendel
demonstrated the
beginning of
agriculture
• Farmers have used
natural selection and
breeding to their
advantage for many
years

• An organism containing a transgene introduced by
technological (not breeding) methods is called transgenic
• Transgenes are the genetically engineered genes added
to a species
• Transfer of DNA via a vector is the most common method
of introducing foreign genes into a plant or organism
• Another method of genetically modifying an organism is
by gene silencing
14
State of the art
Transgenic Plants- artificial selection

15
State of the art
GMOs - anti-freeze resistant crops
Flounder
Flounder Cell
Flounder DNA
Anti-Freeze gene
Isolated Anti-Freeze gene

16 Addison Wesley Longman Inc. 2014
State of the art
GMOs- anti-freeze resistant crops
DNA containing anti-
freeze gene

RNA interference (RNAi) is a gene silencing technique that
was discovered in the 1990’s to occur naturally in petunia
plants
• mRNA in cells is normally single stranded
• Cells have evolved enzymes that recognise and destroy
double stranded mRNA
In order to prevent a gene from being expressed scientists
would insert short pieces of RNA to hybridize to the
complementary sequence of mRNA forming double
stranded RNA which is then destroyed by enzymes
17
State of the art
Gene Silencing

18
State of the art
GMOs
• Transgenic tomato with
delayed ripening:
• lower level of ethylene
production
• Reduced activity of the cell
wall degrading enzymes,
gene name:
polygalacturonases
• Advantages are prolonged
storage time

• The use of GMOs in agricultural systems offer a range of
opportunities
− including increased plant and animal production,
greater efficiency of plant and animal production
− the potential to better manage environmental
challenges such as drought and salinity
• GM technology can also confer novel attributes in food
which can assist in dealing with nutrition and other health
challenges
19
State of the art
GMOs

• GM cotton has been grown commercially in Australia
since the approval and introduction of the first GM variety
in 1996
• Currently, around 95% of the Australian cotton crop is
made up of GM varieties
• There are a number of new GM cotton varieties currently
being developed
20
State of the art
GM Cotton

• Novaq - world’s first fish-free prawn food
• CSIRO developed product based on microscopic
marine organisms
• Increased prawn growth rate by 40% and
• Increased prawn growth by 40%
21
State of the art
Aquaculture

22
State of the art − harvesting aquatic traits
Clinical
Status
Compound
Name
Trademark Marine
Organism
Chemical
Class
Molecular
Target
Clinical
Trials*
Disease
Area
Company/
Institutionc
FDA
Approved
Cytarabine
(Ara-C)
Cytosar-U® Sponge Nucleoside DNA
polmerase
814 Cancer Bedford
Laboratories
Ziconotide Prialt® Cone snail Peptide N-Type Ca
chanel
5 Pain Azurpharma
Eribulin
Mesylate
(E7389)
Halaven® Sponge Macrolide Microtubules 62 Cancer Eisai Inc
Omega-3-
acid ethyl
esters
Lovaza® Fish Omega-3
fatty acids
Trygliceride-
synthesizing
enzymes
124 Hypertriglyce
ridemia
GlaxoSmithKl
ine
Trabectedin
(ET-743)
(EU
Registered
only)
Yondelis® Tunicate Alkaloid Minor groove
of DNA
42 Cancer Pharmamar
Brentuximab
vedotin
(SGN-35)
Adcetris® Mollusk/
cyanobacteri
um
Antibody
drug
conjugate
(MM
auristatin E)
CD30 &
microtubules
35 Cancer Seattle
Genetics
* Ongoing clinical/total trials as reported at http://www.clinicaltrials.gov/ in February 2014

23
State of the art − harvesting aquatic traits
** Ongoing clinical/total trials as reported at http://www.clinicaltrials.gov/ in February 2014
Clinical
Status
Compound
Name
Trademark Marine
Organisma
Chemical
Class
Molecular
Target
Clinical
Trials**
Disease
Area
Company/
Institutionc
Phase III
Plitidepsin Aplidin® Tunicate Depsipeptid
e
Rac1 & JNK
activation
7 Cancer Pharmamar
Tetrodotoxi
n
Tectin® Pufferfish Guanidiniu
m alkaloid
Soduim
Channel
2 Pain Wex
Pharma-
ceuticals Inc
Phase II
DMXBA
(GTS-21)
NA Worm Alkaloid α7 nicotinic
acetylcholin
e receptor
4 Schizophren
ia
UCHSC
PM00104 Zalypsis® Mollusk Alkaloid DNA-
binding
3 Cancer Pharmamar
PM01183 NA Tunicate Alkaloid Minor
groove of
DNA
4 Cancer Pharmamar
CDX-011 NA Mollusk/
cyanobacter
ium
Antibody
drug
conjugate
(MM
auristatin E)
Glycoprotei
n NMB &
microtubule
s
3 Cancer Celldex
Therapeutic,
Inc

• Future trends
24
Session 3 Overview

25
The elements of agriculture and aquaculture regulation
• Risk assessment and management strategies
commensurate to the level of risk
• Development consent processes
• Licensing - authorising the activity and conditions of
operation (eg: GM authorisations)
• Compliance
• Environmental Management Systems and eco-efficiency
Regulatory nuances

26
Agricultural and Veterinary Chemicals Administration Act
1992 (Cth)
Agricultural and Veterinary Chemicals Code Act 1994 (Cth)
Australia New Zealand Food Standards Code
Control of Genetically Modified Crops Act 2004 (Vic)
Export Control Act 1982 (Cth)
Gene Technology Act 2000 (Cth)
Imported Food Control Act 1992 (Cth)
Quarantine Act 1908 (Cth)
Regulatory framework and formal guidance - Cth

The Australian Pesticides and Veterinary Medicines Authority
(APVMA) is responsible for the registration, quality
assurance and compliance of all pesticides and veterinary
medicines up to the point of sale
This includes regulation of pesticides created by, or used on,
GM crops
27
Regulatory bodies - APVMA

• Food containing new genetic material or protein as a
result of the genetic modification or have altered
characteristics must be labeled as GM (1.5.2)
• Packaged foods must contain the words 'genetically
modified' in conjunction with the name of the food, or in
association with the specific ingredient within the
ingredient list
• Unpackaged foods (fruit and vegetables) the words
'genetically modified' must be displayed in association
with the food
28
Regulatory nuances

Food Standards Australia New Zealand (FSANZ) is
responsible for setting the standards for the safety, content
and labelling of food
29
Regulatory bodies - FSANZ
Australia and New Zealand Food Standards Code

• Food containing new genetic material or protein as a
result of the genetic modification or have altered
characteristics must be labeled as GM (1.5.2)
• Packaged foods must contain the words 'genetically
modified' in conjunction with the name of the food, or in
association with the specific ingredient within the
ingredient list
• Unpackaged foods (fruit and vegetables) the words
'genetically modified' must be displayed in association
with the food
30
Regulatory nuances
Australia and New Zealand Food Standards Code

Gene Technology Act (GTA) - object- Section 3
“The object of this Act is to protect the health and safety of
people, and to protect the environment, by identifying risks
posed by or as a result of gene technology, and by
managing those risks through regulating certain dealings
with GMOs”
31
Regulatory nuances

Regulatory Framework - GTA - Section 4
The object of this Act is to be achieved through a regulatory framework
which
(aa) Provides that where there are threats of serious or irreversible
environmental damage, a lack of full scientific certainty should not
be used as a reason for postponing cost effective measures to
prevent environmental degradation and
(a) Provides an efficient and effective system for the application of
gene technologies; and
(b) Operates in conjunction with other Commonwealth and State
regulatory schemes relevant to GMOs and GM products
32
Regulatory nuances

• Office of the Gene Technology Regulator (OGTR),
• Food Standards of Australia and New Zealand (FSANZ)
and
• Australian Pesticides and Veterinary Medicines Authority
(APVMA) are the three main bodies responsible for
assessment, licencing and approvals of GMOs in
Australia
33
Regulatory nuances

GMO register
Dealings with GMOs may be entered on the GMO Register
once they have been licensed for a certain period of time.
Dealings will not be entered onto the Register until the
Regulator is satisfied that the dealings are safe enough that
they can be undertaken by anyone, and that safety does not
depend on oversight by a licence holder
34
Regulatory nuances

• What are dealings?
• ‘Deal with’, in relation to a GMO, means the following
• conduct experiments with the GMO
• make, develop, produce or manufacture the GMO
• breed the GMO
• propagate the GMO
• use the GMO in the course of manufacture of a thing that is not the
GMO
• grow, raise or culture the GMO
• import the GMO
• transport the GMO
• dispose of the GMO
• and includes the possession, supply or use of the GMO for the
purposes of, or in the course of, a dealing mentioned in any of those
listed above
35
Regulatory nuances

Exempt dealings
Certain types of dealings with GMOs involve a very low risk
(i.e. contained research involving very well understood
organisms and processes for creating and studying GMOs).
Other than listing in the Regulations, the only legislative
requirement for exempt dealings is that they must not involve
an intentional release of a GMO into the environment
36
Regulatory nuances

Notifiable Low Risk Dealings- NLRD
The Regulations also set out categories of dealings with
GMOs which are low risk and may proceed if certain
conditions are observed, such as specified dealings only
being undertaken in certified contained facilities, overseen
by Institutional Biosafety Committees and notified annually to
the Regulator
An NLRD must not involve the intentional release of a GMO
into the environment
37
Regulatory nuances

Dealings Not involving Intentional Release- DNIR
DNIR of GMOs into the environment are dealings with
GMOs in contained facilities which do not meet the criteria
for classification as Exempt Dealings or NLRDs
These dealings must be licensed by the GTR
In general, DNIRs often involve work with pathogenic
organisms
38
Regulatory nuances

Dealing Involving Release- DIR
Dealings involving an Intentional Release (DIR) of GMOs
into the Australian environment are dealings with GMOs
which take place outside of containment facilities
The release of GM animals would also require a DIR licence
39
Regulatory nuances

Emergency Dealing Determination
The Minister may make an EDD authorising dealings with
GMOs for a limited time in an emergency
The Minister must be satisfied that
(a) there is an actual or imminent threat to people or the
environment
(b) that the EDD would adequately address the threat and
(c) that the risks posed are able to be managed to protect
people and the environment
The Minister must receive advice from the Regulator about
managing these risks
40
Regulatory nuances

Licences
All dealings with GMOs (that are not exempt, Notifiable Low Risk
Dealings (NLRD) or already on the GMO Register) need to be licensed
by the Regulator
The licensing system is based on rigorous scientific risk assessment
and extensive consultation with expert advisory committees and
government agencies—and for intentional releases of GMOs into the
environment, the public
The GTR has 90 working days in which to make a decision to either
issue, or refuse to issue, a licence for the dealings proposed in a DNIR
application
41
Regulatory nuances

• The OGTR carries out risk analysis to identify and
manage any risks posed by new GM crops before
allowing field trials and before seeds can be
commercially produced and sold to farmers
• If a new GM crop poses risks that the Regulator
determines cannot be adequately managed, then a
licence will not be granted
• Before a licence is granted, the Regulator prepares a risk
assessment and risk management plan
42
Regulatory nuances

• Applications lodged
• Reviewed by Institutional Biosafety Committee (IBC)
• Submitted to Gene Technology Register (GTR)
• GTR prepares Risk And Risk Management Plan
(RARMP)
• Public consultation on RARMP
• Decision on licence
• Post-approval procedures
43
GTR licensing process
Regulatory nuances- License and risk assessment
process

44
Regulatory framework and formal guidance - Vic
Control of Genetically Modified Crops Act 2004
Gene Technology Act 2001
• No GM crop moratorium
• Commercial cultivation of GM canola since 2008

45
Regulatory framework and formal guidance - Tas
Gene Technology (Tasmania) Act 2012
Genetically Modified Organisms Control Act 2004
• Moratorium on commercial cultivation of all GM crops
• Whole of state designated GM free area

46
Regulatory framework and formal guidance – S.A.
Genetically Modified Crops Management Act 2004
• Moratorium on commercial cultivation and transport of
GM food crops and/or seed
• Exemptions granted for field trials under specific
conditions

47
Regulatory framework and formal guidance – W.A.
Genetically Modified Crop Free Areas Act 2003
• Moratorium on commercial cultivation of all GM crops
• Exemptions for commercial production of approved GM
cotton since 2008 and GM canola since 2010

48
Regulatory framework and formal guidance – N.T.
• No commercial cultivation of GM crops

49
Regulatory framework and formal guidance – Qld
• Large-scale commercial cultivation of GM cotton

50
Regulatory framework and formal guidance – N.S.W
Gene Technology (GM Crop Moratorium) Act 2003
Gene Technology (New South Wales) Act 2003
• Moratorium on commercial cultivation of GM food crops
• GM cotton exempt from moratorium and commercially
cultivated
• Exemption for commercial cultivation

• Same regulatory nuances as per GMOs- Algae and
microorganisms for controlled release (GTA licenses
apply)
• Extra regulatory assessment from FSANZ
• Highly refined foods from GM crops that do not contain
DNA or protein in the final product do not require
labeling as they cannot be distinguished from the non-
GM source
• Refined oil from GM cottonseed, does not require a
label as the oil contains no genetic material and the
cottonseed oil is identical to conventional cottonseed
oil
51
Regulatory nuances
Use of transgenic plants as feedstocks

• There is a small amount of work currently being
conducted in Australia on genetically engineered
agriculturally-relevant animals
• chicken & sheep
• The work is being carried out by public and private
research institutions and universities
• No GE/GM or cloned animals are currently in commercial
production in Australia
• GE/GM animals are considered ‘Notifiable Low Risk
Dealings’ (NLRDs) by the GTA
52
Regulatory nuances
Animal Biotechnology

The Australian Quarantine and Inspection Service (AQIS) is part of the
Australian government Department of Agriculture, Fisheries and Forestry
(DAFF)
AQIS provides quarantine inspection for (amongst other things) plants
and plant products arriving in Australia in accordance with the Quarantine
Act 1908 (Cth)
AQIS also administers the imported food inspection scheme under the
Imported Food Control Act 1992 (Cth) and certifies exports of agrifood
products and commodities under the Export Control Act 1982 (Cth)
53
Regulatory bodies - AQIS
Quarantine Act

• Approval via import permit to import declared GM seed
and grain
• Director of Quarantine takes into account same risk
assessment prepared and decision made, as the OGTR
54
Regulatory nuances
Quarantine Act

• Future trends
55
Session 3 Overview

• High performance cell lines for the biological manufacture of fuel
ethanol, industrial enzymes and pharmaceutical products
• Conversion of industrial waste gases into fuels
• Modified yeast strain that increases ethanol production
• Increased nutritional content of food
• Use of transgenic plant model with weakened cell wall in cancer
treatment
• Manipulate cancer cells like plant cells so anti cancer
therapeutics affect weakened cancer cells and not healthy cells
56
Future trends − agriculture

CRC for Polymers
• An improved process for producing cellular therapies based on
polymer surface technology
• a new polymer-based delivery technology for developing and
manufacturing a series of novel animal health products that will
significantly impact the competitiveness of Australian livestock
production
• End user participants for this next five year period include:
Mesoblast Ltd, Virbac (Australia) Pty Ltd, BASF Australia Ltd,
Coliban Regional Water Corporation, Integrated Packaging
Australia Pty Ltd, Greening Australia Ltd, and Rice Research
Australia Pty Ltd
57
Future trends − polymers

CRC for Polymers
• system for controlling the air-water interface and reducing
evaporation from water storages
• developing an automated polymer-based evaporation control
system for use on water surfaces prone to excessive evaporation
such as farm dams, irrigation channels and larger water storages
• The system will apply and maintain an economical,
environmentally friendly, thin surface layer of a novel monolayer-
polymer complex, which restricts the transfer of water to air
enough to mitigate evaporation whilst not adversely affecting
aquatic life or water quality
58
Future trends − polymers

• Natural products from the sea: Using seaweed to cure
cancer
• Many phase II and phase III trials looking into using
naturally occurring marine products to provide anti-
cancer therapeutics
• Food from the sea: Biotech to feed the world
• Novaq used to increase production of prawns
59
Future trends − aquaculture

• Future trends
60
Session 3 Overview

61
Case Studies and Examples
R&D Tax Incentive Biotechnology Guidance example in context
New Natural*
Development of fungicide for protection of agricultural
crops
The unmet need
• Fungal diseases such as powdery mildew cause major crop yield
losses worldwide, reduce crop quality and contaminate grain
• Chemical fungicides are not always economically or
environmentally sustainable
* Fictitious example from AusIndustry R&D TaxIncentive Biotechnology Guidance product, April 2013

62
Real life example- DuPont Crop Protection
• Aproach® (sic) fungicide
• provide more reliable plant health and disease control
performance and yield opportunities through both
preventive and curative disease control, redistribution
through the plant for more complete coverage, and
rapid movement into and within the plant
• DuPont recently received approval from the U.S.
Environmental Protection Agency for sale in 2014
http://www.dupont.com/products-and-services/crop-protection/corn-protection/press-releases.html

63
The technology
Development of fungicide for protection of agricultural crops
• In field tests ahead of registration, DuPont reports that Aproach
decreased soybean rust by 92% over an untreated control plot and
delivered a 16-bushel yield bump over competitive products
• In seed corn, Aproach maintained green leaf area more effectively
and increased yield by 11 bushels per acre versus untreated acres.
And in a winter wheat trial, Aproach reduced the severity of
powdery mildew by nearly 99%, and Septoria tritici - the cause of
Septoria leaf blotch - by nearly 85%

64
The benefits
• Within its class of fungicides, Aproach® has unprecedented
movement into and within the plant. This movement rapidly protects
poorly covered leaf surfaces, plus leaves and stems that have not
yet emerged, and delivers protection closer to the soil surface
where many plant diseases originate
• Better coverage, preventive and curative activity, and residual
control means Aproach® helps compensate for less-than-ideal
application timing, so growers are better able to defend yield
despite challenging conditions

65
New Natural*
Development of fungicide for protection of agricultural crops
• Nimbus and Monsanto
• Clinical focus in cancer, obesity and rare diseases
• Agricultural giant
• joint entity focused on developing fungicides for crops
* Fictitious example from AusIndustry R&D Tax Incentive Biotechnology Guidance product, April 2013

66
Case studies and examples
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm268781.htm
Seattle Genetics
The unmet need
• Systemic anaplastic large cell lymphoma (ALCL) is a rare
malignant tumour (non-Hodgkin lymphoma) that may appear in
several parts of the body including the lymph nodes, skin, bones,
soft tissue, lungs or liver
• The last FDA-approved treatment for HL was in 1977 and there
has been no FDA approved treatment for ALCL

67
Seattle Genetics
The technology
• ADCETRIS® (brentuximab vedotin) is an injection for intravenous
infusion
• ADCETRIS ® is an antibody-drug conjugate that combines an
antibody and drug, allowing the antibody to direct the drug to a
target on lymphoma cells known as CD30
• FDA approval in 2011 for two uses:
• the treatment of patients with Hodgkin lymphoma (HL) after
failure of autologous stem cell transplant (ASCT)
• the treatment of patients with systemic anaplastic large cell
lymphoma (ALCL) after failure of at least one prior multi-agent
chemotherapy regimen
• ADCETRIS was the first new FDA-approved treatment for HL
since 1977 and the first specifically indicated to treat ALCL

68
Seattle Genetics
The results
• The effectiveness of ADCETRIS in patients with HL was evaluated
in a single clinical trial involving 102 patients.
• Single-arm trial where patients were only treated with ADCETRIS
• The study’s primary endpoint was objective response rate, the
percentage of patients who experienced complete or partial
cancer shrinkage or disappearance after treatment
• 73% of patients achieved either a complete or partial response to
the treatment
• On average, these patients responded to the therapy for 6.7
months

Synthetic sponge chemical for anti-cancer
• RMIT and Bio21 institute
• Identified and produced 15-aza-Salicylihalamide A analogue
demonstrates potent activity against several leukaemia cell lines
• Salicylihalamide A is a natural marine product that has been
isolated from a marine sponge
• Salicylihalamide A is cytotoxic - or a toxin which is known to
destroy cells and which also provides a defence for the sea
sponge
• Early research data has found that the aza-salicylihalamide A
analogue molecules when exposed to NCI-60 leukaemia cell lines,
exhibit antiproliferating effects on the group of cells
69
www.sciencedaily.com/releases/2014/02/140207083727.htm

Synthetic sponge chemical for anti-cancer
• Other findings revealed it to be an inhibitor of vacuolar ATPase and
proton pumps, frequently found in metastatic cancer cells
• These cellular mechanisms allow cancer cells to migrate through
the bloodstream and from more advanced tumours
• RMIT expect there will be further research to investigate its
effectiveness on different cancers, potentially leading to extensive
drug development
70
www.sciencedaily.com/releases/2014/02/140207083727.htm

Nw biotech fundamentals day 2 session 3 agriculture and aquaculture

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Nw biotech fundamentals day 2 session 3 agriculture and aquaculture