SlideShare a Scribd company logo
1 of 70
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
• Basic overview of agriculture and aquaculture
• The state of the art
• Regulatory nuances
• Future trends
• Case studies and examples
4
Session 3 Overview
Agriculture and aquaculture
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
Agriculture and aquaculture
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
Agriculture and aquaculture
6
Basic overview of agriculture and aquaculture
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
Agriculture and aquaculture
7
Basic overview of agriculture and aquaculture
• 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
Agriculture and aquaculture
8
Basic overview of agriculture and aquaculture
• Basic overview of agriculture and aquaculture
• The state of the art
• Regulatory nuances
• Future trends
• Case studies and examples
9
Session 3 Overview
Agriculture and aquaculture
• 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
Agriculture and aquaculture
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
Agriculture and aquaculture
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
Agriculture and aquaculture
12
State of the art
Transgenic plants
Selection
Natural Selection
Ecological Selection Sexual Selection
Artificial Selection
Agriculture and aquaculture
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
Agriculture and aquaculture
14
State of the art
Transgenic Plants- artificial selection
Agriculture and aquaculture
15
State of the art
GMOs - anti-freeze resistant crops
Flounder
Flounder Cell
Flounder DNA
Anti-Freeze gene
Isolated Anti-Freeze gene
Agriculture and aquaculture
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
Agriculture and aquaculture
17
State of the art
Gene Silencing
Agriculture and aquaculture
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
Agriculture and aquaculture
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
Agriculture and aquaculture
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%
Agriculture and aquaculture
21
State of the art
Aquaculture
Agriculture and 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
Agriculture and aquaculture
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
• Basic overview of agriculture and aquaculture
• The state of the art
• Regulatory nuances
• Future trends
• Case studies and examples
24
Session 3 Overview
Agriculture and aquaculture
Agriculture and aquaculture
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
Agriculture and aquaculture
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
Agriculture and aquaculture
27
Regulatory bodies - APVMA
Agricultural and Veterinary Chemicals Administration Act
• 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
Agriculture and aquaculture
28
Regulatory nuances
Agricultural and Veterinary Chemicals Administration Act
Food Standards Australia New Zealand (FSANZ) is
responsible for setting the standards for the safety, content
and labelling of food
Agriculture and aquaculture
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
Agriculture and aquaculture
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”
Agriculture and aquaculture
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
Agriculture and aquaculture
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
Agriculture and aquaculture
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
Agriculture and aquaculture
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
Agriculture and aquaculture
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
Agriculture and aquaculture
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
Agriculture and aquaculture
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
Agriculture and aquaculture
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
Agriculture and aquaculture
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
Agriculture and aquaculture
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
Agriculture and aquaculture
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
Agriculture and aquaculture
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
Agriculture and aquaculture
43
GTR licensing process
Regulatory nuances- License and risk assessment
process
Agriculture and aquaculture
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
Agriculture and aquaculture
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
Agriculture and aquaculture
46
Regulatory framework and formal guidance – S.A.
Gene Technology Act 2001
Genetically Modified Crops Management Act 2004
• Moratorium on commercial cultivation and transport of
GM food crops and/or seed
• Whole of state designated GM free area
• Exemptions granted for field trials under specific
conditions
Agriculture and aquaculture
47
Regulatory framework and formal guidance – W.A.
Gene Technology Act 2006
Genetically Modified Crop Free Areas Act 2003
• Moratorium on commercial cultivation of all GM crops
• Whole of state designated GM free area
• Exemptions for commercial production of approved GM
cotton since 2008 and GM canola since 2010
Agriculture and aquaculture
48
Regulatory framework and formal guidance – N.T.
Gene Technology Act 2004
• No GM crop moratorium
• No commercial cultivation of GM crops
Agriculture and aquaculture
49
Regulatory framework and formal guidance – Qld
Gene Technology Act 2001
• No GM crop moratorium
• Large-scale commercial cultivation of GM cotton
Agriculture and aquaculture
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
Agriculture and aquaculture
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
Agriculture and aquaculture
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)
Agriculture and aquaculture
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
Agriculture and aquaculture
54
Regulatory nuances
Quarantine Act
• Basic overview of agriculture and aquaculture
• The state of the art
• Regulatory nuances
• Future trends
• Case studies and examples
55
Session 3 Overview
Agriculture and aquaculture
• 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
Agriculture and aquaculture
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
Agriculture and aquaculture
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
Agriculture and aquaculture
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
Agriculture and aquaculture
59
Future trends − aquaculture
• Basic overview of agriculture and aquaculture
• The state of the art
• Regulatory nuances
• Future trends
• Case studies and examples
60
Session 3 Overview
Agriculture and aquaculture
Agriculture and aquaculture
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
Agriculture and aquaculture
62
Case Studies and Examples
R&D Tax Incentive Biotechnology Guidance example in context
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
Agriculture and aquaculture
63
Case Studies and Examples
R&D Tax Incentive Biotechnology Guidance example in context
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%
http://www.dupont.com/products-and-services/crop-protection/corn-protection/press-releases.html
Agriculture and aquaculture
64
Case Studies and Examples
R&D Tax Incentive Biotechnology Guidance example in context
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
http://www.dupont.com/products-and-services/crop-protection/corn-protection/press-releases.html
Agriculture and aquaculture
65
Case Studies and Examples
R&D Tax Incentive Biotechnology Guidance example in context
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
Agriculture and aquaculture
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
Agriculture and aquaculture
67
Case studies and examples
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm268781.htm
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
Agriculture and aquaculture
68
Case studies and examples
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm268781.htm
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
Agriculture and aquaculture
69
Case studies and examples
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
Agriculture and aquaculture
70
Case studies and examples
www.sciencedaily.com/releases/2014/02/140207083727.htm

More Related Content

What's hot

Transgenic crops for food quality.
Transgenic crops for food quality.Transgenic crops for food quality.
Transgenic crops for food quality.Sheetal Mehla
 
Fish for all: role of biotechnology in improving nutrition
Fish for all: role of biotechnology in improving nutritionFish for all: role of biotechnology in improving nutrition
Fish for all: role of biotechnology in improving nutritionExternalEvents
 
breeding for vegetable quality
breeding for vegetable qualitybreeding for vegetable quality
breeding for vegetable qualitySukhdev Singh
 
Use of provende of mangoes poultry feed
Use of provende of mangoes poultry feedUse of provende of mangoes poultry feed
Use of provende of mangoes poultry feedFrancois Stepman
 
Status of GMOs crops in pakistan
Status of  GMOs crops in  pakistanStatus of  GMOs crops in  pakistan
Status of GMOs crops in pakistanMohsinMukhtar6
 
Using next generation sequencing to describe epiphytic microbiota associated ...
Using next generation sequencing to describe epiphytic microbiota associated ...Using next generation sequencing to describe epiphytic microbiota associated ...
Using next generation sequencing to describe epiphytic microbiota associated ...Agriculture Journal IJOEAR
 
Genetically Modified Organisms (GMO)
Genetically Modified Organisms (GMO)Genetically Modified Organisms (GMO)
Genetically Modified Organisms (GMO)Tanvi Vasani
 
Genetic enhancement of groundnut for resistance to aflatoxin contamination
Genetic enhancement of groundnut for resistance to aflatoxin contaminationGenetic enhancement of groundnut for resistance to aflatoxin contamination
Genetic enhancement of groundnut for resistance to aflatoxin contaminationILRI
 
Production of transgenics in oilseeds by Kanak Saxena
Production of transgenics in oilseeds by Kanak SaxenaProduction of transgenics in oilseeds by Kanak Saxena
Production of transgenics in oilseeds by Kanak SaxenaDr. Kanak Saxena
 
Bacterial wilt in irish potato
Bacterial wilt in irish potatoBacterial wilt in irish potato
Bacterial wilt in irish potatoMohamedManjale
 
Genetically modified organism tested in the philippines
Genetically modified organism tested in the philippinesGenetically modified organism tested in the philippines
Genetically modified organism tested in the philippinescbsua
 
Breeding techniques for organic agriculture.
Breeding techniques for organic agriculture.Breeding techniques for organic agriculture.
Breeding techniques for organic agriculture.sreevathsasagar
 

What's hot (20)

Transgenic crops for food quality.
Transgenic crops for food quality.Transgenic crops for food quality.
Transgenic crops for food quality.
 
Fish for all: role of biotechnology in improving nutrition
Fish for all: role of biotechnology in improving nutritionFish for all: role of biotechnology in improving nutrition
Fish for all: role of biotechnology in improving nutrition
 
Genetically Modified Potato
Genetically Modified PotatoGenetically Modified Potato
Genetically Modified Potato
 
Geac
GeacGeac
Geac
 
breeding for vegetable quality
breeding for vegetable qualitybreeding for vegetable quality
breeding for vegetable quality
 
Seminar
SeminarSeminar
Seminar
 
Use of provende of mangoes poultry feed
Use of provende of mangoes poultry feedUse of provende of mangoes poultry feed
Use of provende of mangoes poultry feed
 
Status of GMOs crops in pakistan
Status of  GMOs crops in  pakistanStatus of  GMOs crops in  pakistan
Status of GMOs crops in pakistan
 
Using next generation sequencing to describe epiphytic microbiota associated ...
Using next generation sequencing to describe epiphytic microbiota associated ...Using next generation sequencing to describe epiphytic microbiota associated ...
Using next generation sequencing to describe epiphytic microbiota associated ...
 
Genetically Modified Organisms (GMO)
Genetically Modified Organisms (GMO)Genetically Modified Organisms (GMO)
Genetically Modified Organisms (GMO)
 
GMOs in Agriculture
GMOs in AgricultureGMOs in Agriculture
GMOs in Agriculture
 
Bea ganda2
Bea ganda2Bea ganda2
Bea ganda2
 
Genetic enhancement of groundnut for resistance to aflatoxin contamination
Genetic enhancement of groundnut for resistance to aflatoxin contaminationGenetic enhancement of groundnut for resistance to aflatoxin contamination
Genetic enhancement of groundnut for resistance to aflatoxin contamination
 
Production of transgenics in oilseeds by Kanak Saxena
Production of transgenics in oilseeds by Kanak SaxenaProduction of transgenics in oilseeds by Kanak Saxena
Production of transgenics in oilseeds by Kanak Saxena
 
EXPERT TOPIC 1401- SHRIMP
EXPERT TOPIC 1401- SHRIMPEXPERT TOPIC 1401- SHRIMP
EXPERT TOPIC 1401- SHRIMP
 
Bacterial wilt in irish potato
Bacterial wilt in irish potatoBacterial wilt in irish potato
Bacterial wilt in irish potato
 
Genetically modified organism tested in the philippines
Genetically modified organism tested in the philippinesGenetically modified organism tested in the philippines
Genetically modified organism tested in the philippines
 
Transgenic Crops
Transgenic CropsTransgenic Crops
Transgenic Crops
 
Organic foods
Organic foodsOrganic foods
Organic foods
 
Breeding techniques for organic agriculture.
Breeding techniques for organic agriculture.Breeding techniques for organic agriculture.
Breeding techniques for organic agriculture.
 

Similar to Nw biotech fundamentals day 2 session 3 agriculture and aquaculture

Conservation and availability of plant genetic diversity
Conservation and availability of plant genetic diversity Conservation and availability of plant genetic diversity
Conservation and availability of plant genetic diversity Bioversity International
 
56.Biodiversity conservation A Presentation By Mr. Allah Dad Khan Visiting Pr...
56.Biodiversity conservation A Presentation By Mr. Allah Dad Khan Visiting Pr...56.Biodiversity conservation A Presentation By Mr. Allah Dad Khan Visiting Pr...
56.Biodiversity conservation A Presentation By Mr. Allah Dad Khan Visiting Pr...Mr.Allah Dad Khan
 
Aquatic biotechnology
Aquatic biotechnologyAquatic biotechnology
Aquatic biotechnologyshani49315
 
Types of Biotechnology (1).pptx
Types of Biotechnology (1).pptxTypes of Biotechnology (1).pptx
Types of Biotechnology (1).pptxAsadShah695612
 
Strategies for enhancement of organic farming in india copy
Strategies for enhancement of organic farming in india   copyStrategies for enhancement of organic farming in india   copy
Strategies for enhancement of organic farming in india copyreshma murgun
 
MMH 1st seminar PPT 13.05.19 (1).ppt
MMH 1st seminar PPT 13.05.19 (1).pptMMH 1st seminar PPT 13.05.19 (1).ppt
MMH 1st seminar PPT 13.05.19 (1).pptMahfuzurRahman849488
 
Aquaponics for safe food production and.ppt
Aquaponics for safe food production and.pptAquaponics for safe food production and.ppt
Aquaponics for safe food production and.pptMahfuzurRahman849488
 
Nanotechnology in agriculture ,animal husbandry and food
Nanotechnology in agriculture ,animal husbandry and foodNanotechnology in agriculture ,animal husbandry and food
Nanotechnology in agriculture ,animal husbandry and foodAditya Amrut Pawar
 
Protecting Water Quality on Organic Farms
Protecting Water Quality on Organic FarmsProtecting Water Quality on Organic Farms
Protecting Water Quality on Organic FarmsElisaMendelsohn
 
Protecting Water Quality on Organic Farms
Protecting Water Quality on Organic FarmsProtecting Water Quality on Organic Farms
Protecting Water Quality on Organic FarmsElisaMendelsohn
 
marine biotechnology.pptx
marine biotechnology.pptxmarine biotechnology.pptx
marine biotechnology.pptxSanduniRoland1
 
Intro. to Food_Sci_1.pptbbbbbiochemistry
Intro. to Food_Sci_1.pptbbbbbiochemistryIntro. to Food_Sci_1.pptbbbbbiochemistry
Intro. to Food_Sci_1.pptbbbbbiochemistryAnnie Annie
 
Update of the tasmanian pacific oyster health surveillance program kevin ...
Update of the tasmanian pacific oyster health surveillance program     kevin ...Update of the tasmanian pacific oyster health surveillance program     kevin ...
Update of the tasmanian pacific oyster health surveillance program kevin ...adamsaddler
 
Nuclear Techniques in Food and Agriculture
Nuclear Techniques in Food and AgricultureNuclear Techniques in Food and Agriculture
Nuclear Techniques in Food and AgricultureJeju National University
 

Similar to Nw biotech fundamentals day 2 session 3 agriculture and aquaculture (20)

Conservation and availability of plant genetic diversity
Conservation and availability of plant genetic diversity Conservation and availability of plant genetic diversity
Conservation and availability of plant genetic diversity
 
Blue biotechnology
Blue biotechnologyBlue biotechnology
Blue biotechnology
 
Nuclear tech
Nuclear techNuclear tech
Nuclear tech
 
Organic farming
Organic farmingOrganic farming
Organic farming
 
56.Biodiversity conservation A Presentation By Mr. Allah Dad Khan Visiting Pr...
56.Biodiversity conservation A Presentation By Mr. Allah Dad Khan Visiting Pr...56.Biodiversity conservation A Presentation By Mr. Allah Dad Khan Visiting Pr...
56.Biodiversity conservation A Presentation By Mr. Allah Dad Khan Visiting Pr...
 
Aquaculture
AquacultureAquaculture
Aquaculture
 
Aquatic biotechnology
Aquatic biotechnologyAquatic biotechnology
Aquatic biotechnology
 
Types of Biotechnology (1).pptx
Types of Biotechnology (1).pptxTypes of Biotechnology (1).pptx
Types of Biotechnology (1).pptx
 
Strategies for enhancement of organic farming in india copy
Strategies for enhancement of organic farming in india   copyStrategies for enhancement of organic farming in india   copy
Strategies for enhancement of organic farming in india copy
 
MMH 1st seminar PPT 13.05.19 (1).ppt
MMH 1st seminar PPT 13.05.19 (1).pptMMH 1st seminar PPT 13.05.19 (1).ppt
MMH 1st seminar PPT 13.05.19 (1).ppt
 
Aquaponics for safe food production and.ppt
Aquaponics for safe food production and.pptAquaponics for safe food production and.ppt
Aquaponics for safe food production and.ppt
 
Bioprospecting
Bioprospecting Bioprospecting
Bioprospecting
 
Nanotechnology in agriculture ,animal husbandry and food
Nanotechnology in agriculture ,animal husbandry and foodNanotechnology in agriculture ,animal husbandry and food
Nanotechnology in agriculture ,animal husbandry and food
 
Protecting Water Quality on Organic Farms
Protecting Water Quality on Organic FarmsProtecting Water Quality on Organic Farms
Protecting Water Quality on Organic Farms
 
Protecting Water Quality on Organic Farms
Protecting Water Quality on Organic FarmsProtecting Water Quality on Organic Farms
Protecting Water Quality on Organic Farms
 
marine biotechnology.pptx
marine biotechnology.pptxmarine biotechnology.pptx
marine biotechnology.pptx
 
Transgenic plants
Transgenic plantsTransgenic plants
Transgenic plants
 
Intro. to Food_Sci_1.pptbbbbbiochemistry
Intro. to Food_Sci_1.pptbbbbbiochemistryIntro. to Food_Sci_1.pptbbbbbiochemistry
Intro. to Food_Sci_1.pptbbbbbiochemistry
 
Update of the tasmanian pacific oyster health surveillance program kevin ...
Update of the tasmanian pacific oyster health surveillance program     kevin ...Update of the tasmanian pacific oyster health surveillance program     kevin ...
Update of the tasmanian pacific oyster health surveillance program kevin ...
 
Nuclear Techniques in Food and Agriculture
Nuclear Techniques in Food and AgricultureNuclear Techniques in Food and Agriculture
Nuclear Techniques in Food and Agriculture
 

More from Nicholas Weston Lawyers

IP for Accountants Companion launch presentation
IP for Accountants   Companion launch presentationIP for Accountants   Companion launch presentation
IP for Accountants Companion launch presentationNicholas Weston Lawyers
 
Nw biotech fundamentals day 2 session 5 summary and wrap up
Nw biotech fundamentals day 2 session 5   summary and wrap upNw biotech fundamentals day 2 session 5   summary and wrap up
Nw biotech fundamentals day 2 session 5 summary and wrap upNicholas Weston Lawyers
 
Nw biotech fundamentals day 2 session 4 medical devices and diagnostics
Nw biotech fundamentals day 2 session 4   medical devices and diagnosticsNw biotech fundamentals day 2 session 4   medical devices and diagnostics
Nw biotech fundamentals day 2 session 4 medical devices and diagnosticsNicholas Weston Lawyers
 
Nw biotech fundamentals day 2 session 2 industrial applications and cleantech
Nw biotech fundamentals day 2 session 2   industrial applications and cleantechNw biotech fundamentals day 2 session 2   industrial applications and cleantech
Nw biotech fundamentals day 2 session 2 industrial applications and cleantechNicholas Weston Lawyers
 
Nw biotech fundamentals day 2 session 1 introduction
Nw biotech fundamentals day 2 session 1   introductionNw biotech fundamentals day 2 session 1   introduction
Nw biotech fundamentals day 2 session 1 introductionNicholas Weston Lawyers
 
Nw biotech fundamentals day 1 session 5 life sciences
Nw biotech fundamentals day 1 session 5   life sciencesNw biotech fundamentals day 1 session 5   life sciences
Nw biotech fundamentals day 1 session 5 life sciencesNicholas Weston Lawyers
 
Nw biotech fundamentals day 1 session 4 trends and techniques
Nw biotech fundamentals day 1 session 4   trends and techniquesNw biotech fundamentals day 1 session 4   trends and techniques
Nw biotech fundamentals day 1 session 4 trends and techniquesNicholas Weston Lawyers
 
Nw biotech fundamentals day 1 session 3 regulatory
Nw biotech fundamentals day 1 session 3   regulatoryNw biotech fundamentals day 1 session 3   regulatory
Nw biotech fundamentals day 1 session 3 regulatoryNicholas Weston Lawyers
 
Nw biotech fundamentals day 1 session 2 the business lifecycle of a biotech
Nw biotech fundamentals day 1 session 2   the business lifecycle of a biotechNw biotech fundamentals day 1 session 2   the business lifecycle of a biotech
Nw biotech fundamentals day 1 session 2 the business lifecycle of a biotechNicholas Weston Lawyers
 
Nw biotech fundamentals day 1 session 1 20140612
Nw biotech fundamentals day 1 session 1 20140612Nw biotech fundamentals day 1 session 1 20140612
Nw biotech fundamentals day 1 session 1 20140612Nicholas Weston Lawyers
 

More from Nicholas Weston Lawyers (10)

IP for Accountants Companion launch presentation
IP for Accountants   Companion launch presentationIP for Accountants   Companion launch presentation
IP for Accountants Companion launch presentation
 
Nw biotech fundamentals day 2 session 5 summary and wrap up
Nw biotech fundamentals day 2 session 5   summary and wrap upNw biotech fundamentals day 2 session 5   summary and wrap up
Nw biotech fundamentals day 2 session 5 summary and wrap up
 
Nw biotech fundamentals day 2 session 4 medical devices and diagnostics
Nw biotech fundamentals day 2 session 4   medical devices and diagnosticsNw biotech fundamentals day 2 session 4   medical devices and diagnostics
Nw biotech fundamentals day 2 session 4 medical devices and diagnostics
 
Nw biotech fundamentals day 2 session 2 industrial applications and cleantech
Nw biotech fundamentals day 2 session 2   industrial applications and cleantechNw biotech fundamentals day 2 session 2   industrial applications and cleantech
Nw biotech fundamentals day 2 session 2 industrial applications and cleantech
 
Nw biotech fundamentals day 2 session 1 introduction
Nw biotech fundamentals day 2 session 1   introductionNw biotech fundamentals day 2 session 1   introduction
Nw biotech fundamentals day 2 session 1 introduction
 
Nw biotech fundamentals day 1 session 5 life sciences
Nw biotech fundamentals day 1 session 5   life sciencesNw biotech fundamentals day 1 session 5   life sciences
Nw biotech fundamentals day 1 session 5 life sciences
 
Nw biotech fundamentals day 1 session 4 trends and techniques
Nw biotech fundamentals day 1 session 4   trends and techniquesNw biotech fundamentals day 1 session 4   trends and techniques
Nw biotech fundamentals day 1 session 4 trends and techniques
 
Nw biotech fundamentals day 1 session 3 regulatory
Nw biotech fundamentals day 1 session 3   regulatoryNw biotech fundamentals day 1 session 3   regulatory
Nw biotech fundamentals day 1 session 3 regulatory
 
Nw biotech fundamentals day 1 session 2 the business lifecycle of a biotech
Nw biotech fundamentals day 1 session 2   the business lifecycle of a biotechNw biotech fundamentals day 1 session 2   the business lifecycle of a biotech
Nw biotech fundamentals day 1 session 2 the business lifecycle of a biotech
 
Nw biotech fundamentals day 1 session 1 20140612
Nw biotech fundamentals day 1 session 1 20140612Nw biotech fundamentals day 1 session 1 20140612
Nw biotech fundamentals day 1 session 1 20140612
 

Recently uploaded

Advances in AI-driven Image Recognition for Early Detection of Cancer
Advances in AI-driven Image Recognition for Early Detection of CancerAdvances in AI-driven Image Recognition for Early Detection of Cancer
Advances in AI-driven Image Recognition for Early Detection of CancerLuis Miguel Chong Chong
 
Loudspeaker- direct radiating type and horn type.pptx
Loudspeaker- direct radiating type and horn type.pptxLoudspeaker- direct radiating type and horn type.pptx
Loudspeaker- direct radiating type and horn type.pptxpriyankatabhane
 
CHROMATOGRAPHY PALLAVI RAWAT.pptx
CHROMATOGRAPHY  PALLAVI RAWAT.pptxCHROMATOGRAPHY  PALLAVI RAWAT.pptx
CHROMATOGRAPHY PALLAVI RAWAT.pptxpallavirawat456
 
KDIGO-2023-CKD-Guideline-Public-Review-Draft_5-July-2023.pdf
KDIGO-2023-CKD-Guideline-Public-Review-Draft_5-July-2023.pdfKDIGO-2023-CKD-Guideline-Public-Review-Draft_5-July-2023.pdf
KDIGO-2023-CKD-Guideline-Public-Review-Draft_5-July-2023.pdfGABYFIORELAMALPARTID1
 
Science (Communication) and Wikipedia - Potentials and Pitfalls
Science (Communication) and Wikipedia - Potentials and PitfallsScience (Communication) and Wikipedia - Potentials and Pitfalls
Science (Communication) and Wikipedia - Potentials and PitfallsDobusch Leonhard
 
ESSENTIAL FEATURES REQUIRED FOR ESTABLISHING FOUR TYPES OF BIOSAFETY LABORATO...
ESSENTIAL FEATURES REQUIRED FOR ESTABLISHING FOUR TYPES OF BIOSAFETY LABORATO...ESSENTIAL FEATURES REQUIRED FOR ESTABLISHING FOUR TYPES OF BIOSAFETY LABORATO...
ESSENTIAL FEATURES REQUIRED FOR ESTABLISHING FOUR TYPES OF BIOSAFETY LABORATO...Chayanika Das
 
Environmental acoustics- noise criteria.pptx
Environmental acoustics- noise criteria.pptxEnvironmental acoustics- noise criteria.pptx
Environmental acoustics- noise criteria.pptxpriyankatabhane
 
Introduction of Human Body & Structure of cell.pptx
Introduction of Human Body & Structure of cell.pptxIntroduction of Human Body & Structure of cell.pptx
Introduction of Human Body & Structure of cell.pptxMedical College
 
BACTERIAL SECRETION SYSTEM by Dr. Chayanika Das
BACTERIAL SECRETION SYSTEM by Dr. Chayanika DasBACTERIAL SECRETION SYSTEM by Dr. Chayanika Das
BACTERIAL SECRETION SYSTEM by Dr. Chayanika DasChayanika Das
 
DNA isolation molecular biology practical.pptx
DNA isolation molecular biology practical.pptxDNA isolation molecular biology practical.pptx
DNA isolation molecular biology practical.pptxGiDMOh
 
Total Legal: A “Joint” Journey into the Chemistry of Cannabinoids
Total Legal: A “Joint” Journey into the Chemistry of CannabinoidsTotal Legal: A “Joint” Journey into the Chemistry of Cannabinoids
Total Legal: A “Joint” Journey into the Chemistry of CannabinoidsMarkus Roggen
 
whole genome sequencing new and its types including shortgun and clone by clone
whole genome sequencing new  and its types including shortgun and clone by clonewhole genome sequencing new  and its types including shortgun and clone by clone
whole genome sequencing new and its types including shortgun and clone by clonechaudhary charan shingh university
 
Charateristics of the Angara-A5 spacecraft launched from the Vostochny Cosmod...
Charateristics of the Angara-A5 spacecraft launched from the Vostochny Cosmod...Charateristics of the Angara-A5 spacecraft launched from the Vostochny Cosmod...
Charateristics of the Angara-A5 spacecraft launched from the Vostochny Cosmod...Christina Parmionova
 
6.1 Pests of Groundnut_Binomics_Identification_Dr.UPR
6.1 Pests of Groundnut_Binomics_Identification_Dr.UPR6.1 Pests of Groundnut_Binomics_Identification_Dr.UPR
6.1 Pests of Groundnut_Binomics_Identification_Dr.UPRPirithiRaju
 
GLYCOSIDES Classification Of GLYCOSIDES Chemical Tests Glycosides
GLYCOSIDES Classification Of GLYCOSIDES  Chemical Tests GlycosidesGLYCOSIDES Classification Of GLYCOSIDES  Chemical Tests Glycosides
GLYCOSIDES Classification Of GLYCOSIDES Chemical Tests GlycosidesNandakishor Bhaurao Deshmukh
 
final waves properties grade 7 - third quarter
final waves properties grade 7 - third quarterfinal waves properties grade 7 - third quarter
final waves properties grade 7 - third quarterHanHyoKim
 
EGYPTIAN IMPRINT IN SPAIN Lecture by Dr Abeer Zahana
EGYPTIAN IMPRINT IN SPAIN Lecture by Dr Abeer ZahanaEGYPTIAN IMPRINT IN SPAIN Lecture by Dr Abeer Zahana
EGYPTIAN IMPRINT IN SPAIN Lecture by Dr Abeer ZahanaDr.Mahmoud Abbas
 
BACTERIAL DEFENSE SYSTEM by Dr. Chayanika Das
BACTERIAL DEFENSE SYSTEM by Dr. Chayanika DasBACTERIAL DEFENSE SYSTEM by Dr. Chayanika Das
BACTERIAL DEFENSE SYSTEM by Dr. Chayanika DasChayanika Das
 

Recently uploaded (20)

Advances in AI-driven Image Recognition for Early Detection of Cancer
Advances in AI-driven Image Recognition for Early Detection of CancerAdvances in AI-driven Image Recognition for Early Detection of Cancer
Advances in AI-driven Image Recognition for Early Detection of Cancer
 
Loudspeaker- direct radiating type and horn type.pptx
Loudspeaker- direct radiating type and horn type.pptxLoudspeaker- direct radiating type and horn type.pptx
Loudspeaker- direct radiating type and horn type.pptx
 
CHROMATOGRAPHY PALLAVI RAWAT.pptx
CHROMATOGRAPHY  PALLAVI RAWAT.pptxCHROMATOGRAPHY  PALLAVI RAWAT.pptx
CHROMATOGRAPHY PALLAVI RAWAT.pptx
 
KDIGO-2023-CKD-Guideline-Public-Review-Draft_5-July-2023.pdf
KDIGO-2023-CKD-Guideline-Public-Review-Draft_5-July-2023.pdfKDIGO-2023-CKD-Guideline-Public-Review-Draft_5-July-2023.pdf
KDIGO-2023-CKD-Guideline-Public-Review-Draft_5-July-2023.pdf
 
Science (Communication) and Wikipedia - Potentials and Pitfalls
Science (Communication) and Wikipedia - Potentials and PitfallsScience (Communication) and Wikipedia - Potentials and Pitfalls
Science (Communication) and Wikipedia - Potentials and Pitfalls
 
ESSENTIAL FEATURES REQUIRED FOR ESTABLISHING FOUR TYPES OF BIOSAFETY LABORATO...
ESSENTIAL FEATURES REQUIRED FOR ESTABLISHING FOUR TYPES OF BIOSAFETY LABORATO...ESSENTIAL FEATURES REQUIRED FOR ESTABLISHING FOUR TYPES OF BIOSAFETY LABORATO...
ESSENTIAL FEATURES REQUIRED FOR ESTABLISHING FOUR TYPES OF BIOSAFETY LABORATO...
 
Environmental acoustics- noise criteria.pptx
Environmental acoustics- noise criteria.pptxEnvironmental acoustics- noise criteria.pptx
Environmental acoustics- noise criteria.pptx
 
Introduction of Human Body & Structure of cell.pptx
Introduction of Human Body & Structure of cell.pptxIntroduction of Human Body & Structure of cell.pptx
Introduction of Human Body & Structure of cell.pptx
 
BACTERIAL SECRETION SYSTEM by Dr. Chayanika Das
BACTERIAL SECRETION SYSTEM by Dr. Chayanika DasBACTERIAL SECRETION SYSTEM by Dr. Chayanika Das
BACTERIAL SECRETION SYSTEM by Dr. Chayanika Das
 
DNA isolation molecular biology practical.pptx
DNA isolation molecular biology practical.pptxDNA isolation molecular biology practical.pptx
DNA isolation molecular biology practical.pptx
 
Total Legal: A “Joint” Journey into the Chemistry of Cannabinoids
Total Legal: A “Joint” Journey into the Chemistry of CannabinoidsTotal Legal: A “Joint” Journey into the Chemistry of Cannabinoids
Total Legal: A “Joint” Journey into the Chemistry of Cannabinoids
 
whole genome sequencing new and its types including shortgun and clone by clone
whole genome sequencing new  and its types including shortgun and clone by clonewhole genome sequencing new  and its types including shortgun and clone by clone
whole genome sequencing new and its types including shortgun and clone by clone
 
Charateristics of the Angara-A5 spacecraft launched from the Vostochny Cosmod...
Charateristics of the Angara-A5 spacecraft launched from the Vostochny Cosmod...Charateristics of the Angara-A5 spacecraft launched from the Vostochny Cosmod...
Charateristics of the Angara-A5 spacecraft launched from the Vostochny Cosmod...
 
6.1 Pests of Groundnut_Binomics_Identification_Dr.UPR
6.1 Pests of Groundnut_Binomics_Identification_Dr.UPR6.1 Pests of Groundnut_Binomics_Identification_Dr.UPR
6.1 Pests of Groundnut_Binomics_Identification_Dr.UPR
 
Interferons.pptx.
Interferons.pptx.Interferons.pptx.
Interferons.pptx.
 
GLYCOSIDES Classification Of GLYCOSIDES Chemical Tests Glycosides
GLYCOSIDES Classification Of GLYCOSIDES  Chemical Tests GlycosidesGLYCOSIDES Classification Of GLYCOSIDES  Chemical Tests Glycosides
GLYCOSIDES Classification Of GLYCOSIDES Chemical Tests Glycosides
 
PLASMODIUM. PPTX
PLASMODIUM. PPTXPLASMODIUM. PPTX
PLASMODIUM. PPTX
 
final waves properties grade 7 - third quarter
final waves properties grade 7 - third quarterfinal waves properties grade 7 - third quarter
final waves properties grade 7 - third quarter
 
EGYPTIAN IMPRINT IN SPAIN Lecture by Dr Abeer Zahana
EGYPTIAN IMPRINT IN SPAIN Lecture by Dr Abeer ZahanaEGYPTIAN IMPRINT IN SPAIN Lecture by Dr Abeer Zahana
EGYPTIAN IMPRINT IN SPAIN Lecture by Dr Abeer Zahana
 
BACTERIAL DEFENSE SYSTEM by Dr. Chayanika Das
BACTERIAL DEFENSE SYSTEM by Dr. Chayanika DasBACTERIAL DEFENSE SYSTEM by Dr. Chayanika Das
BACTERIAL DEFENSE SYSTEM by Dr. Chayanika Das
 

Nw biotech fundamentals day 2 session 3 agriculture and aquaculture

  • 1. Biotech Boot Camp Session 3 – Agriculture and aquaculture Presenter: Viktoriia Hristova Melbourne, Brisbane, Sydney 28 May – 18 June, 2014
  • 2. 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
  • 3. • 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
  • 4. • Basic overview of agriculture and aquaculture • The state of the art • Regulatory nuances • Future trends • Case studies and examples 4 Session 3 Overview Agriculture and aquaculture
  • 5. 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 Agriculture and aquaculture 5 Basic overview of agriculture and aquaculture
  • 6. • 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 Agriculture and aquaculture 6 Basic overview of agriculture and aquaculture
  • 7. 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 Agriculture and aquaculture 7 Basic overview of agriculture and aquaculture
  • 8. • 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 Agriculture and aquaculture 8 Basic overview of agriculture and aquaculture
  • 9. • Basic overview of agriculture and aquaculture • The state of the art • Regulatory nuances • Future trends • Case studies and examples 9 Session 3 Overview Agriculture and aquaculture
  • 10. • 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 Agriculture and aquaculture 10 State of the art Understanding the language
  • 11. • Both crops and livestock are referred to as • genetically modified organisms (GMOs) • genetically enhanced organisms (GEOs) or genetically engineered organisms • transgenic organisms Agriculture and aquaculture 11 State of the art Understanding the language
  • 12. • 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 Agriculture and aquaculture 12 State of the art Transgenic plants Selection Natural Selection Ecological Selection Sexual Selection Artificial Selection
  • 13. Agriculture and aquaculture 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
  • 14. • 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 Agriculture and aquaculture 14 State of the art Transgenic Plants- artificial selection
  • 15. Agriculture and aquaculture 15 State of the art GMOs - anti-freeze resistant crops Flounder Flounder Cell Flounder DNA Anti-Freeze gene Isolated Anti-Freeze gene
  • 16. Agriculture and aquaculture 16 Addison Wesley Longman Inc. 2014 State of the art GMOs- anti-freeze resistant crops DNA containing anti- freeze gene
  • 17. 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 Agriculture and aquaculture 17 State of the art Gene Silencing
  • 18. Agriculture and aquaculture 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
  • 19. • 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 Agriculture and aquaculture 19 State of the art GMOs
  • 20. • 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 Agriculture and aquaculture 20 State of the art GM Cotton
  • 21. • 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% Agriculture and aquaculture 21 State of the art Aquaculture
  • 22. Agriculture and 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. Agriculture and aquaculture 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
  • 24. • Basic overview of agriculture and aquaculture • The state of the art • Regulatory nuances • Future trends • Case studies and examples 24 Session 3 Overview Agriculture and aquaculture
  • 25. Agriculture and aquaculture 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. Agriculture and aquaculture 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
  • 27. 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 Agriculture and aquaculture 27 Regulatory bodies - APVMA Agricultural and Veterinary Chemicals Administration Act
  • 28. • 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 Agriculture and aquaculture 28 Regulatory nuances Agricultural and Veterinary Chemicals Administration Act
  • 29. Food Standards Australia New Zealand (FSANZ) is responsible for setting the standards for the safety, content and labelling of food Agriculture and aquaculture 29 Regulatory bodies - FSANZ Australia and New Zealand Food Standards Code
  • 30. • 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 Agriculture and aquaculture 30 Regulatory nuances Australia and New Zealand Food Standards Code
  • 31. 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” Agriculture and aquaculture 31 Regulatory nuances
  • 32. 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 Agriculture and aquaculture 32 Regulatory nuances
  • 33. • 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 Agriculture and aquaculture 33 Regulatory nuances
  • 34. 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 Agriculture and aquaculture 34 Regulatory nuances
  • 35. • 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 Agriculture and aquaculture 35 Regulatory nuances
  • 36. 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 Agriculture and aquaculture 36 Regulatory nuances
  • 37. 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 Agriculture and aquaculture 37 Regulatory nuances
  • 38. 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 Agriculture and aquaculture 38 Regulatory nuances
  • 39. 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 Agriculture and aquaculture 39 Regulatory nuances
  • 40. 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 Agriculture and aquaculture 40 Regulatory nuances
  • 41. 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 Agriculture and aquaculture 41 Regulatory nuances
  • 42. • 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 Agriculture and aquaculture 42 Regulatory nuances
  • 43. • 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 Agriculture and aquaculture 43 GTR licensing process Regulatory nuances- License and risk assessment process
  • 44. Agriculture and aquaculture 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. Agriculture and aquaculture 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. Agriculture and aquaculture 46 Regulatory framework and formal guidance – S.A. Gene Technology Act 2001 Genetically Modified Crops Management Act 2004 • Moratorium on commercial cultivation and transport of GM food crops and/or seed • Whole of state designated GM free area • Exemptions granted for field trials under specific conditions
  • 47. Agriculture and aquaculture 47 Regulatory framework and formal guidance – W.A. Gene Technology Act 2006 Genetically Modified Crop Free Areas Act 2003 • Moratorium on commercial cultivation of all GM crops • Whole of state designated GM free area • Exemptions for commercial production of approved GM cotton since 2008 and GM canola since 2010
  • 48. Agriculture and aquaculture 48 Regulatory framework and formal guidance – N.T. Gene Technology Act 2004 • No GM crop moratorium • No commercial cultivation of GM crops
  • 49. Agriculture and aquaculture 49 Regulatory framework and formal guidance – Qld Gene Technology Act 2001 • No GM crop moratorium • Large-scale commercial cultivation of GM cotton
  • 50. Agriculture and aquaculture 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
  • 51. • 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 Agriculture and aquaculture 51 Regulatory nuances Use of transgenic plants as feedstocks
  • 52. • 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 Agriculture and aquaculture 52 Regulatory nuances Animal Biotechnology
  • 53. 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) Agriculture and aquaculture 53 Regulatory bodies - AQIS Quarantine Act
  • 54. • 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 Agriculture and aquaculture 54 Regulatory nuances Quarantine Act
  • 55. • Basic overview of agriculture and aquaculture • The state of the art • Regulatory nuances • Future trends • Case studies and examples 55 Session 3 Overview Agriculture and aquaculture
  • 56. • 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 Agriculture and aquaculture 56 Future trends − agriculture
  • 57. 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 Agriculture and aquaculture 57 Future trends − polymers
  • 58. 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 Agriculture and aquaculture 58 Future trends − polymers
  • 59. • 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 Agriculture and aquaculture 59 Future trends − aquaculture
  • 60. • Basic overview of agriculture and aquaculture • The state of the art • Regulatory nuances • Future trends • Case studies and examples 60 Session 3 Overview Agriculture and aquaculture
  • 61. Agriculture and aquaculture 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. Agriculture and aquaculture 62 Case Studies and Examples R&D Tax Incentive Biotechnology Guidance example in context 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. Agriculture and aquaculture 63 Case Studies and Examples R&D Tax Incentive Biotechnology Guidance example in context 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% http://www.dupont.com/products-and-services/crop-protection/corn-protection/press-releases.html
  • 64. Agriculture and aquaculture 64 Case Studies and Examples R&D Tax Incentive Biotechnology Guidance example in context 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 http://www.dupont.com/products-and-services/crop-protection/corn-protection/press-releases.html
  • 65. Agriculture and aquaculture 65 Case Studies and Examples R&D Tax Incentive Biotechnology Guidance example in context 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. Agriculture and aquaculture 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. Agriculture and aquaculture 67 Case studies and examples http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm268781.htm 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. Agriculture and aquaculture 68 Case studies and examples http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm268781.htm 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
  • 69. 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 Agriculture and aquaculture 69 Case studies and examples www.sciencedaily.com/releases/2014/02/140207083727.htm
  • 70. 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 Agriculture and aquaculture 70 Case studies and examples www.sciencedaily.com/releases/2014/02/140207083727.htm