Food Nutraceutical Packaging Chemistry Presentation

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NeracResearch & Advisory Services

For the Food and Nutraceuticals Industries


Agenda

Introduction to Nerac, Inc.

Nerac Service Offerings

The Nerac Difference

Engaging Nerac


Who Is Nerac?

Global research and advisory firm

for companies developing innovative

products and technologies

COMPANY TYPE: PRIVATELY HELD ESOP

Founded 1966

Employees 95 / National & International

Analysts 48 Ph.D.s, Masters, MBAs, Attorneys

Clients ~1500 Worldwide


How We Serve Our Clients

Unique provider

of rapid-response research

for smaller, mission- critical

engagements that require

highly experienced

expert advisors.


What We Do Expert Research & Advisory Services

Research and Product Development Process

— Perform opportunity vetting to accelerate critical go/no-go decisions

— Expedite regulatory filings and vigilance requirements

Business Development Process

— Identify portfolio and alliance opportunities

Technical Products & Services Marketing Process

— Understand the size and financial potential of market opportunities

Intellectual Property Management Process

— Protect and leverage IP assets through portfolio management


What We Do Food and Nutraceutical Chemistry

Research and Product Development Process

—Analyze agrichemical fate, transport, efficacy

and toxicology research

—Determine the safety, efficacy and bioactivity of new ingredients

—Obtain background and overview information on new fields or

innovative technologies via peer reviews and research studies,

explore new technology areas

—Supply the research required for solutions and alternatives

for day-to-day technology challenges


What We Do Food and Nutraceutical Chemistry

Regulatory Process

—Support US, Canadian and European regulatory submissions

with safety and efficacy determinations

—Prepare Food Additive Petitions, GRAS determinations,

assessments of health effects, validation of structure function

claims, nutritional labeling claims and food safety assertions


Food & Nutraceutical ChemistryExamples of Recently Completed Projects

Developed health and structure-function claims for nutritional beverage

— Nerac reviewed the formulation of the client’s nutritional beverage, identified

ingredients for which FDA approved Health Claims were applicable, and drafted

FDA compliant structure-function claims for other ingredients, enabling a marketing

campaign leveraging those claims.

Identified functional ingredients supporting new pasta product development

— Nerac identified candidate functional ingredients suitable for pasta formulations that

supported satiety, digestive health and cardiovascular health claims that saved

client’s R&D staff valuable time on a time-critical project.

Intellectual property overview of ruminant feed additives delivering Iodine

— Nerac provided the client with a complete map of the intellectual property around

feed additives intended to supplement ruminant’s diet with iodine in support of client

patent counsel’s claim drafting efforts for patent protection of their new product line.


Issue: The SVP at an international beverage company is tasked with

developing line extensions leveraging the addition of functional ingredients

to existing products. Marketing to diverse cultures with vastly different

preferences for taste and appearance of beverage products makes this a

complex challenge.

Analyst Approach: Based on Nerac’s analysis of available functional

ingredients, their safety and efficacy data, solubility and bioavailability,

availability and cost per serving, regulatory status and IP encumbrances,

Nerac identified and ranked suitable alternatives for the spectrum culturally

driven new products from among the thousands of available alternatives.

Client Benefit: Nerac’s comprehensive assessment was data driven and

ingredient focused. The client was spared considerable development time

and expense, and was able to quickly bring new line extensions to market.

Food & Nutraceutical ChemistryClient Impact Case Study


What We Do Food Packaging

Research & Product Development Process

— Familiarize clients with the fundamentals of food and pharmaceutical

packaging regulation, and monitor regulatory developments

— Provide early stage vetting of technology, products and companies and

provide support to make go/no-go decisions

— Identify barriers to market entry early in the development process, and

match new markets for existing technology

— Supply the necessary research and due-diligence required to provide

solutions and alternative approaches for day-to-day technology

challenges

— Obtain background and overview information on new fields or innovative

technologies via peer reviews and research studies, explore new

technology areas


What We Do Food Packaging

Regulatory Process

— Determine the compliance status of existing products

— Advise clients regarding regulatory implications of changes in

composition, formulation or structure of existing products

— Develop and manage comprehensive programs to bring regulated

products to market, vetting product formulation alternatives for their

regulatory impact at the earliest possible stages of the development

process

— Prepare and submit Food Additive Petitions, Food Contact Notifications,

Type III Drug Master Files and EFSA Dossiers to obtain regulatory

approval, or demonstrate exemption from regulation


Food PackagingExamples of Recently Completed Projects

Regulatory analysis of thermolabile colorants

— Nerac reviewed the formulation of a polymer masterbatch containing thermolabile

colorants, particularly colorant synthetic byproducts and residual solvents,

determining compliance with applicable FDA food contact regulations, and allowing

client to market thermolabile children’s drinking straws that change color as cold

liquid beverages are drawn through them.

Identified suppliers for critical elements of client’s new product

— Nerac identified FDA and EU food contact compliant injection moldable

thermoplastic rubber chemistries suitable for over-molding with polyolefins, saving

the client’s engineering staff valuable time on a time-critical project.

Regulatory overview of antimicrobial plastics additives intended for food contact

use in EU member states

— Nerac provided the client with a complete map of the various EU level and member

state regulations governing antimicrobial plastics additives to facilitate European

market entry for an existing FDA approved product.


Issue: A corporate R&D Manager at a US polymer manufacturer is interested

in introducing their eco-friendly rigid polymer foam to the food contact

market for use in insulation of food-holding refrigeration units.

Analyst Approach: Based on Nerac’s analysis of the product formulation and

its intended use, all but one of the formulation components was determined

to be compliant with existing laws and regulations. The one non-compliant

formulation component was determined to be GRAS, and thus exempt from

regulation by FDA. Nerac Analyst staff prepared appropriate documentation

of the GRAS status for that formulation component.

Client Benefit: Nerac’s comprehensive assessment allowed direct

introduction of an existing product into an entirely new market with no

reformulation and no additional development cost.

Food PackagingClient Impact Case Study


Case Study Example Functional Beverage Product Development

An SVP at an international beverage company is tasked

with developing product line extensions leveraging the addition

of functional ingredients to existing products. Marketing to diverse

cultures with vastly different preferences for taste and appearance of

beverage products makes this a complex challenge. Nerac was engaged

to evaluate the various key drivers for ingredient selection including:

a. Safety and efficacy

b. Allowable health claims

c. Regulatory status

d. IP encumbrances

e. Taste, palatability, consumer appeal

f. Ingredient availability and cost per serving

http://upload.wikimedia.org/wikipedia/commons/5/5d/Belize3.jpg


Case Study Example (continued)

Functional Beverage Product Development

Approach: Nerac’s analysis of available data elucidating

the key drivers for all available ingredients allowed the palate of options

to be reduced from thousands of ingredients to just 19 that were safe,

functional, cost effective, unencumbered by IP and appealing to consumers

from diverse cultural and national backgrounds.

Result:― Based on Nerac’s data driven and ingredient focused

approach, viable options were quickly identified from

among thousands of alternatives.

― Nerac provided a scoring and ranking system to visualize

the data and facilitate decision making.

― The client was spared considerable development time

and expense, and was able to quickly bring new line

extensions to market.


Case Study ExampleFunctional Beverage Product Development

Brenda Van GoethemB.S., Bacteriology,

University of Wisconsin-Madison

Andrea BoccacinoM.A. Nutrition & Food, New York

University, New York City

Jeff EberhardPh.D., Environmental Health,

University of Cincinnati College of Medicine

Shahana JahangirM.S., Food Science, Virginia Polytechnic

Institute and State University

Shanon TruemanM.S., Microbiology,

University of Massachusetts

Nerac Analyst Bios


Case Study Example GRAS Exemption of Food Contact Polymer

A corporate R&D Manager at a US polymer manufacturer

is interested in introducing their eco-friendly rigid polymer foam to the food

contact market for use in insulation of food-holding refrigeration units.

Nerac Analysts assessed the key factors driving the regulatory status of the

client’s product:

a. Formulation components and use levels

b. Intended use scenario

c. Regulatory status of components and

impurities, byproducts, residual solvents

d. Toxicology of formulation components

that lack appropriate status

e. Potential for exposure to formulation

components that lack appropriate status


Case Study Example (continued)

GRAS Exemption of Food Contact Polymer

Approach: Based on Nerac’s analysis of the product formulation

and its intended use, all but one of the formulation components was

determined to be compliant with existing laws and regulations. The one

non-compliant formulation component was determined to be GRAS, and

thus exempt from regulation by FDA. Nerac Analyst staff prepared

appropriate documentation of the GRAS status for that formulation

component.

Result: Nerac’s comprehensive assessment allowed direct introduction of

an existing product into an entirely new market. ― No reformulation

― No development cost (other than Nerac engagement)

― No involvement of FDA’s Center for Food Safety and

Applied Nutrition

― Product marketed on the basis of Nerac’s GRAS

determination, and resulting exemption from regulation


Case Study ExampleGRAS Exemption of Food Contact Polymer

Irene ZajacM.S., Biochemistry, University of North Carolina

at Chapel Hill

Jeff EberhardPh.D., Environmental Health,

University of Cincinnati College of

Medicine

Richard HendriksPh.D., Neuroscience, University

of Melbourne, Australia

Mark PolaskyPh.D., Chemical Engineering, University of

Akron

Richard LeavittPh.D., Biochemistry, University of Pittsburgh

School of Medicine

Nerac Analyst Bios


The Nerac Experience

In Just Days

Nerac can move from

scoping client need to

project execution

A Turn-Key Research Operation

Confidential Collaboration

with highly skilled research

staff as an extension

of your team

High Impact Results

tailored to client scope,

timing and budget

Seamless

Partnership.

Rapid

Progress.


The Nerac DifferenceRapid Response, Highly-Skilled Expert Advisors

• Seamless teaming with client staff to form a trusted partnership

• Flexible engagements which offer rapid, impactful results

• Custom research services tailored to client scope, timing and budget

• Unique blend of Nerac Analysts’ keen insights and industry experience

• Unwavering integrity and relentless protection of client information

• Nerac researchers, analysts and IP advisors bring four decades experience

serving thousands of food & nutraceutical companies


Engaging Nerac Simple & Flexible Agreements

EXPERT RESEARCH

REQUEST SERVICES

Source and synthesize relevant information

from many sources

Administer and manage alerts

Research key resources, including

scientific, technical, medical and patent

sources

Contact industry, commercial, academic, or

government facilities

Discuss research or business challenges

and needs

Designed for individuals who prefer

to conduct their own synthesis and

analysis

RESEARCH & ADVISORY

SERVICES

Expert analysis of business and

technical information to produce

actionable insights

Data-driven evaluation of technical,

business and intellectual property

trends

Designed for individuals who

want expert analysis and opinion

in addition to sourcing and

synthesis

SPECIAL PROJECT SERVICES

Scope of work to be defined under a

specific agreement

Designed for large engagements

executed for a fixed price


Next Steps

Define Need

Assign and Introduce Analyst or Team of Analysts

Schedule Scoping Meeting

Distribute Agreement for Review and Sign-off

Project Launch Meeting/Discussion

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Food Nutraceutical Packaging Chemistry Presentation

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