transgenic groundnut for drought tolerance

1
Freedom to Operate (FTO) Timelines and Cost R&D Event Selecon BRL 1 BRL 2 Introgression In-House PTTC & Partners Current Stage Event Approval 500,000 438,667 410,000 206,000 205,556 2013/14 2014/15 2011/12 Translaonal Research FTO analysis conducted for Indian and US jurisdictions on various technology components indicated non-infringement of any patent rights Product Development Cycle A A B Homology to Known allergens, toxins, anti-nutrients Blast Searches Heat Stability Acute Oral Toxicity in Rats/Mice (14 Days) Pepsin Digestibility Inheritance Over Multiple Generations RT-PCR, Southern, qPCR data available as above Western & ELISA to be performed with Ab (A) produced from the protein Pedigree Map Documentation from the data recorded from T 1 to T 5 Sequence data of inserted genetic material & of the flanking regions Identification of ORFs Genome Walking Organisation of inserted genetic material PCR & Sequencing Net House Evaluation Field trials Season 1 Field trials Season 2 Exp. Level of Protein ELISA Reproductive & Survival Biology Phenotyping Site 1 Site 2 Site 3 Site 1 Site 2 Site 3 Composition al Analysis Impact on Non-Target Org.– Tier 1 Impact on Non-Target Org – Tier 2 Livestock Feeding Studies Number of Insertion Sites qPCR data available as above Antibody Production Protein Equivalence Study Functional, Structural and Biochemical Equivalence Plant Protein purification Purification & scale up of protein from Bacterial / other systems PCR, Southern, qPCR, RT-PCR PCR, Southern, qPCR, RT-PCR PCR, Southern, qPCR, RT-PCR PCR, Southern, qPCR, RT-PCR PCR, Southern, qPCR, RT-PCR Transformation T 0 T 1 T 2 T 3 T 5 T 4 B Construct preparation R&D Event Selection BRL-I BRL- II Sub-Chronic Feeding Study in Rodents (90 Days) Molecular Studies Field Studies Protein Studies Field trials Gene Flow Aggressiveness & Weediness LOD 0.01% A A B Homology to Known allergens, toxins, anti-nutrients Blast Searches Heat Stability Acute Oral Toxicity in Rats/Mice (14 Days) Pepsin Digestibility Inheritance Over Multiple Generations RT-PCR, Southern, qPCR data available as above Western & ELISA to be performed with Ab (A) produced from the protein Pedigree Map Documentation from the data recorded from T 1 to T 5 Sequence data of inserted genetic material & of the flanking regions Identification of ORFs Genome Walking Organisation of inserted genetic material PCR & Sequencing Net House Evaluation Field trials Season 1 Field trials Season 2 Exp. Level of Protein ELISA Reproductive & Survival Biology Phenotyping Site 1 Site 2 Site 3 Site 1 Site 2 Site 3 Site 1 Site 2 Site 3 Site 1 Site 2 Site 3 Composition al Analysis Impact on Non-Target Org.– Tier 1 Impact on Non-Target Org – Tier 2 Livestock Feeding Studies Number of Insertion Sites qPCR data available as above Antibody Production Protein Equivalence Study Functional, Structural and Biochemical Equivalence Plant Protein purification Purification & scale up of protein from Bacterial / other systems PCR, Southern, qPCR, RT-PCR PCR, Southern, qPCR, RT-PCR PCR, Southern, qPCR, RT-PCR PCR, Southern, qPCR, RT-PCR PCR, Southern, qPCR, RT-PCR Transformation T 0 T 1 T 2 T 3 T 5 T 4 B Construct preparation R&D Event Selection BRL-I BRL- II Sub-Chronic Feeding Study in Rodents (90 Days) Molecular Studies Field Studies Protein Studies Field trials Gene Flow Aggressiveness & Weediness LOD 0.01% Transgenic Groundnut for Drought Tolerance Roadmap for Product Development A model depicting product development and dissemination following the regulatory approval for the selected event(s) PTTC PTTC PTTC ICRISAT NARS / SAUs KVKs / ARS State Seed Corporation Farmers Non-Market Market Technology Provider Product Development & regulatory approvals Varietal Development & Seed Production Product Dissemination Preliminary Biosafety Data Bioinformatics studies for potential allergenicity indicated absence of any homology of recombinant protein with known toxin / allergen Overview Drought Signal Transducon Transcripon / Translaon Promoter A Promoter A Promoter B Promoter B Promoter C Promoter C Promoter D Promoter D Signal Percepon Signal Percepon Gene A Gene A Gene B Gene B Gene C Gene C Gene D Gene D DRE Plant Cell Gene Expression Stress response & tolerance Regulatory Protein (Transcriponal Acvator) DREB1A DREB1A rd29A-P rd29A-P Drought Signal Transducon Transcripon / Translaon Promoter A Promoter A Promoter B Promoter B Promoter C Promoter C Promoter D Promoter D Signal Percepon Signal Percepon Promoter A Promoter A Promoter B Promoter B Promoter C Promoter C Promoter D Promoter D Signal Percepon Signal Percepon Gene A Gene A Gene B Gene B Gene C Gene C Gene D Gene D Gene A Gene A Gene B Gene B Gene C Gene C Gene D Gene D DRE Plant Cell Gene Expression Stress response & tolerance Regulatory Protein (Transcriponal Acvator) DREB1A DREB1A rd29A-P rd29A-P Improved drought tolerance Improved seed and pod yield (upto 26%) Higher root dry weight and root length density at deeper soil (40-90cm) Improved drought tolerance indices (higher relative harvest index (RHI) and yield reduction under drought stress) Sep 2011

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Freedom to Operate (FTO)

A FTO study was conducted for Indian & US jurisdictions on various components including DREB1A, NOS Promoter, npt II Marker, rd29A Promoter, NOS Terminator.

It was observed from the preliminary FTO study that there is no granted Indian patent on these components exists till date and hence the research activity is not infringing any patent rights in India.

IMOD Inclusive Market Oriented Development Innovate • Grow • Prosper •

Timelines and Cost

R&D Event Selection BRL 1 BRL 2 Introgression

In-House PTTC & PartnersCurrent Stage

Event Approval

500,000438,667 410,000 206,000205,556

2013/14 2014/152011/12

Translational Research

FTO analysis conducted for Indian and US jurisdictions on various technology components indicated non-infringement of any patent rights

Product Development Cycle

A

A

B

Homology to Known allergens, toxins,

anti-nutrients Blast Searches

Heat Stability

Acute Oral Toxicity in Rats/Mice

(14 Days)

Pepsin Digestibility

Inheritance Over Multiple Generations

RT-PCR, Southern, qPCR data available as above

Western & ELISA to be performed with Ab (A)

produced from the protein

Pedigree Map

Documentation from the data recorded

from T1 to T5

Sequence data of inserted genetic material & of the flanking regions

Identification of ORFs

Genome Walking

Organisation of inserted genetic

material

PCR & Sequencing

Net House Evaluation

Field trials

Season 1

Field trials

Season 2

Exp. Level of Protein

ELISA

Reproductive & Survival Biology

Phenotyping

Site 1

Site 2

Site 3

Site 1

Site 2

Site 3

Compositional Analysis

Impact on Non-Target

Org.– Tier 1

Impact on Non-Target

Org – Tier 2

Livestock Feeding Studies

Number of Insertion Sites

qPCR data available as

above

Antibody Production

Protein Equivalence Study

Functional, Structural and Biochemical Equivalence

Plant Protein purification

Purification & scale up of protein from Bacterial / other

systems

PCR, Southern, qPCR, RT-PCR

PCR, Southern, qPCR, RT-PCR

PCR, Southern, qPCR, RT-PCR

PCR, Southern, qPCR, RT-PCR

PCR, Southern, qPCR, RT-PCR

Transformation T0 T1 T2 T3 T5T4 BConstruct

preparation

R&

DE

ven

t S

ele

ctio

nB

RL-I

BR

L-

II

Sub-Chronic Feeding Study in Rodents

(90 Days)

Molecular Studies Field Studies

Protein StudiesField trials

Gene Flow

Aggressiveness & Weediness

LOD 0.01%

Strictly Confidential

A

A

B

Homology to Known allergens, toxins,

anti-nutrients Blast Searches

Heat Stability

Acute Oral Toxicity in Rats/Mice

(14 Days)

Pepsin Digestibility

Inheritance Over Multiple Generations

RT-PCR, Southern, qPCR data available as above

Western & ELISA to be performed with Ab (A)

produced from the protein

Pedigree Map

Documentation from the data recorded

from T1 to T5

Sequence data of inserted genetic material & of the flanking regions

Identification of ORFs

Genome Walking

Organisation of inserted genetic

material

PCR & Sequencing

Net House Evaluation

Field trials

Season 1

Field trials

Season 2

Exp. Level of Protein

ELISA

Reproductive & Survival Biology

Phenotyping

Site 1

Site 2

Site 3

Site 1

Site 2

Site 3

Site 1

Site 2

Site 3

Site 1

Site 2

Site 3

Compositional Analysis

Impact on Non-Target

Org.– Tier 1

Impact on Non-Target

Org – Tier 2

Livestock Feeding Studies

Number of Insertion Sites

qPCR data available as

above

Antibody Production

Protein Equivalence Study

Functional, Structural and Biochemical Equivalence

Plant Protein purification

Purification & scale up of protein from Bacterial / other

systems

PCR, Southern, qPCR, RT-PCR

PCR, Southern, qPCR, RT-PCR

PCR, Southern, qPCR, RT-PCR

PCR, Southern, qPCR, RT-PCR

PCR, Southern, qPCR, RT-PCR

Transformation T0 T1 T2 T3 T5T4 BConstruct

preparation

R&

DE

ven

t S

ele

ctio

nB

RL-I

BR

L-

II

Sub-Chronic Feeding Study in Rodents

(90 Days)

Molecular Studies Field Studies

Protein StudiesField trials

Gene Flow

Aggressiveness & Weediness

LOD 0.01%

Strictly Confidential

Transgenic Groundnut for Drought ToleranceRoadmap for Product Development

A model depicting product development and dissemination following the regulatory approval for the selected event(s)

PTTC

ICRISAT

NARS / SAUs

KVKs / ARS

State Seed Corporation

Farmers

Non-Market Market

Technology Provider

Product Development & regulatory approvals

Varietal Development & Seed Production

Product Dissemination

PTTC

ICRISAT

NARS / SAUs

KVKs / ARS

State Seed Corporation

Farmers

Non-Market Market

PTTC

ICRISAT

NARS / SAUs

KVKs / ARS

State Seed Corporation

Farmers

Non-Market Market

Technology Provider

Product Development & regulatory approvals

Varietal Development & Seed Production

Product Dissemination

Preliminary Biosafety Data

Bioinformatics studies for potential allergenicity indicated absence of any homology of recombinant protein with known toxin / allergen

Overview

Drought

Signal Transduction

Transcription / Translation

Promoter APromoter A

Promoter BPromoter B

Promoter CPromoter C

Promoter DPromoter D

Signal PerceptionSignal Perception

Gene AGene A

Gene B Gene B

Gene CGene C

Gene DGene D

DRE

Plant Cell

Gene Expression

Stress response & tolerance

Regulatory Protein(Transcriptional Activator)

DREB1ADREB1Ard29A-Prd29A-P

Drought

Signal Transduction

Transcription / Translation

Promoter APromoter A

Promoter BPromoter B

Promoter CPromoter C

Promoter DPromoter D

Signal PerceptionSignal Perception

Promoter APromoter A

Promoter BPromoter B

Promoter CPromoter C

Promoter DPromoter D

Signal PerceptionSignal Perception

Gene AGene A

Gene B Gene B

Gene CGene C

Gene DGene D

Gene AGene A

Gene B Gene B

Gene CGene C

Gene DGene D

DRE

Plant Cell

Gene Expression

Stress response & tolerance

Regulatory Protein(Transcriptional Activator)

DREB1ADREB1Ard29A-Prd29A-PImproved drought

tolerance

• Improved seed and pod yield (upto 26%)

• Higher root dry weight and root length density at deeper soil (40-90cm)

• Improved drought tolerance indices (higher relative harvest index (RHI) and yield reduction under drought stress)

Sep 2011