Turning Bio Products into BioSolutions

Moving beyond the Laboratory and into the Field

Jim Petta

Agenda

• Current Marketplace globally

• Problem with bio’s

• Short/Long term Model develop sustainable bio solutions for future food production

Situation

Consumers and government agencies are moving rapidly to abandon agrichemical products, regardless of science

Regulators have little incentive to advance improved biological controls (or conventional)

Food retail companies are utilizing fears in a market driven segment to advance product positioning

Growers have limited technical knowledge or time to adjust pest management schemes

University and other agencies are researching management schemes with often gaps in potential use on farm.

Export/import growers and crops now global

Biological Control Products

BioPesticides

Biochemicals

Semio-chem

Plant

ExtractsMinerals PGRs

Organic

Acids

Microbials

Bacteria Fungi Protozoa VirusYeasts

Others

Macroorganisms

Insects MitesNema-todes

Microbials

• Bacteria; Fungi; Virus; Protozoan; Yeasts

• Bacteria, followed by Fungi make up the largest groups commercially (>90%)

• Microbials are the largest market of biopesticides at US$1.3 Bn.

• Biggest challenges for microbials are formulation related: 1) Shelf-life; 2) Stability; 3) Performance enhancement

Biochemicals

• Plant Extracts; Minerals & Others; PGRs; Semiochemicals; Organic Acids

• Plant Extracts make up the largest segment in this group

• Semiochemicals (pheromones) has the largest actual number of products

• Largest challenge for Plant Extracts is manufacturing and consistent quality in the active ingredient(s)

Macroorganisms

• Insects; Mites; Nematodes

• Insects followed by mites makeup the largest groups

• Unique in that the live organism in the form of eggs, larvae, pupae or adult is used.

• Most important challenge for Macros is logistics—shipping live organisms that have to have special care to survive

• Normally not classified as a Biopesticide—only as Biological Control Products

Biological Products

Biofertilizers

• Microbials used to enhance plant nutrient uptake from soil

• Nitrogen fixing bacteria make up largest group

• Others include mobilizers of specific nutrients (zinc, sulfur) and mycorrhizal fungi

• Biofertilizers regulated under country/state fertilizer regulations

Biostimulants

• Seaweed Extracts make up the largest segment in this group

• Microbials, primarily bacteria, often used as seed or soil treatment to aid in nutrient assimilation

• Organic acids are humic and fulvic acids used as soil amendments, formed by the microbial degradation of plant matter.

• Definition and regulation of biostimulants is still under development in most parts of the world

Bio Stimulants

Microbials

Amino Acids

K Mobilizers Others

MicrobialsPlant

Extracts

Organic Acids

Biofertilizers

Abiotic Stress Mgmt

Seaweed

Extracts

BioPesticides

• Biopesticides are derived from natural materials, such as plants, bacteria and certain minerals. Biopesticides target specific pests and are inherently less toxic than synthetic pesticides.

N Fixing

P2O5 Solubiliz

ing

Source: Dunham Trimmer LLC

Biological Products – Plant Health and Pest Control

Challenges to Adoption of Bio Products

• Impractical • Use volumes

• Formulations

• Stability

• Mixing requirements

• Waiting periods

• Efficacy

• Cost

• Knowledge of integration vs replacement

• Government/retail chain mandates• Growers they must comply

• MRL designation and limitation

Challenges to Sustainable Goals and Targets

• Sustainable? What does it mean to the growers/consumers?

• Like Brexit? • 50% for

• 50% against

• 75% do not understand the issue

• Need to agree general guidelines

Conventional/Sustainable Hectare and CropOrganic is a secondary consideration

Val

ue

and

Nu

mb

erin

Sg

eme

nt

Organic

Sustainable

Organic to conventional

New Business Model – EcoFlora

• Utilize biological field experts in integration

• Dedicated to biological products

• Global regulatory management with local requirements aligned

• Supporting with field and laboratory relevant data

➢ Dedicated Team of researchers/agronomists

➢ Dedicated Field and Lab Testing

➢ Dedicated Objective: Build a biorational solution which provides efficacy at an acceptable cost with safer, greener, and less toxic solutions to optimize conventional portfolio where necessary, not replace

Why we believe in integration of the biological space:➢ Maximize performance of control ai’s with “bio blending”

➢ Regulatory and policy limiting grower choice

➢ Integrated pest management strategies requiring new MOA’s

➢ Value chain limiting grower tools through independent MRL’s

➢ Export requirements having global effects

➢ Greater consumer sensitivity to traditional conventional ag-chemicals in

their food

Biological Development Focus to Integrate

Manages “White Spaces” which may not be adequately

addressed

Example of Global/Regional Needs with Biological Solutions

Resistance, lack of solutions, organic farming NEEDS for:- Brown Marmorated SB- Spotted Wing Drosophila- Rosey Apple Aphid- Onion Thrip- Downy Mildew- Bacterial diseases- Botrytis- Mites- Fusarium oxy.

Regulatory and value chain MRL restrictions for:- Soft bodied insecticide- Systemic Herbicides - Slugs- Mediterranean fruit fly- Botrytis

Resistance, Export Markets, Lack of solutions, & Organic Certifications for:- Black Sigatoka- Panama disease- Botrytis- Thrips, mites

Semi Organic Growers needs for:- Soil Diseases- Bacterial diseases

Resistance and lack of solutions for:- Fusarium Wheat- Canola Flea Beetle- Aphanomyces- Potato (blight & bug)

Gowan Confidential – Do not distribute

Botrytis cinerea/Apple & strawberry, Pectobacterium carotovorum/Cabbage, Fusarium/Lettuce, Aphids, Mites, and more….

Bioassays:

Downy midew/Lettuce, Spinach, Powdery mildew/Cucurbits, Bacterial speck/Tomato, Whitefly, Aphids, Mites, Thrips, and more.

Greenhouse:

Over 25 pathogens:Botrytis cinereaFusarium oxysporumRhizoctonia solaniMycosphaerella fijiensisErwinia amylovoraAphanomyces euteichesCercospora beticolaEtc

InVitro:

➢ Validates unproven products for further field evaluations

➢ Adds reference point for products with known biological activity

➢ Identifies if product candidates have efficacy beyond indicated spectrum, and on key unmet needs

➢ Looks for product synergy

Global Lab and Greenhouse Resources

Regulatory Support Is Provided In These Key Areas:

➢ Determine if Active Ingredient meets criteria for Biopesticide Classification or Low Risk Substance, globally

➢ Global MRL and residue management

➢ Determine if organic certification is possible, as proxy for global classifications

➢ Develop a registration strategy with corresponding timelines and costs, to support “Go” / “No Go” decision

➢ Lead and execute registration process as needed

Formulation Resources in the USA and LATAM

Formulation optimization

Accelerated storage

Stability

Application Viability

Gowan Confidential – Do not distribute

➢ Tests to determine degradation pathways and establish shelf lives and storage conditions of the products

➢ Provide support data for product stability information

➢ Assist in validation of analytical methods for the stability program

➢ Evaluate the product characteristics for different field requirement specifications (example: clogging of nozzles)

➢ Optimize formulations characteristics in order to reduce COGS, optimize efficacy, improve handling, or formulate mixtures

Example of Product Advancement Process: Getting the Bio from the Lab to the Field

PRE PIPELINE PHASE II PHASE III PHASE IV PHASE V

• Strategic gap /portfolio opp.

• A.I. registrable as biorational

• Commercially viable• Sourcing availability• Etc…

• Validate biological efficacy on key targets

• Explore unproven biological activity on key gaps

• Bioassay or Greenhouse studies

• Regional Field Trials• Confirm cost viability• Confirm mkt need by

region

• In Country Trials• Hand off to in-country

dev. if advanced

Country and stakeholder Buy-in

Validate position in field conditions

Validate if product is “integratable”

Validate biological efficacy

Pipeline Considerations

➢ Flexible advancement process, with the aim to manage the costs of advancing a product, available resources, and the probability of success

➢ Products with reliable data or proven commercialization in other regions can skip, or meet Phase criteria more quickly

Advancement Philosophy

Capabilities to Utilize EcoFlora Service to Growers and Agronomist Experts

Projects

Production

Market IntelligenceBranding

Market Access

Technical Knowledge

and Support

✓ Laboratories of Biology and Microbiology

✓ Chemistry support✓ Bank of Extracts✓ Field researchers✓ Colombia geography

• Diversity of crops and pest

Projects

Production

Market IntelligenceBranding

Market Access

Technical Knowledge

and Support

✓ Team with experience and focus bio products and integration

✓ Support for growers and food companies

✓ Data of products✓ Quik testing✓ Regulatory support and

bio-certification✓ Ecoflora University

Capabilities to Utilize EcoFlora Service to Growers and Agronomist Experts

Projects

Production

Market IntelligenceBranding

Market Access

Technical Knowledge

and Support

✓ We have Gowan sales and marketing

✓ Committed distribution channel via Gowan

✓ Knowledge of market✓ Brand recognition✓ Product/solution

expertise

Capabilities to Utilize EcoFlora Service to Growers and Agronomist Experts

Projects

Production

Market IntelligenceBranding

Market Access

Technical Knowledge

and Support

✓ Strategic surveillance✓ Understanding needs

and integration

Capabilities to Utilize EcoFlora Service to Growers and Agronomist Experts

Projects

Production

Market IntelligenceBranding

Market Access

Technical Knowledge

and Support

✓ EcoFlora plant extracts plus new bios✓ Ecoflora is recognized as leader in Bio

segment✓ EcoFlora is the bio solution focused

development team

Capabilities to Utilize EcoFlora Service to Growers and Agronomist Experts

Capabilities to leverage our business as Unit of Service

Projects

Production

Market IntelligenceBranding

Market Access

Technical Knowledge

and Support✓ We produce our new plant extracts

with our facility in Medellin✓ We will enlarge our production

capabilities✓ Quality management across global

regions such as EU

Summary

• Key to Biological product growth and expansion both integration and replacement technology

• Field understanding is critical to adoption

• Researchers must connect the laboratory with real world use and experience

• Dedicated, focused approach to biopesticide segment and utilization to support the growing food and fiber while reducing potential residues and consumer concerns

Thank You