Food Nutraceutical Packaging Chemistry Presentation

Nerac
Research & Advisory Services
For the Food and Nutraceuticals Industries

© 2010 All Rights Reserved. Nerac Inc. | 1 Technology Drive, Tolland, CT 06084

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 Chemistry
Examples 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.


Food & Nutraceutical Chemistry
Client Impact Case Study

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.


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 Packaging
Examples 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.


Food Packaging
Client Impact Case Study

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.


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


Case Study Example (continued)
 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 Example
Nerac Analyst Bios

Andrea Boccacino Shanon Trueman
M.A. Nutrition & Food, New York M.S., Microbiology,
University, New York City University of Massachusetts

Jeff Eberhard Brenda Van Goethem
Ph.D., Environmental Health, B.S., Bacteriology,
University of Cincinnati College of Medicine University of Wisconsin-Madison

Shahana Jahangir
M.S., Food Science, Virginia Polytechnic
Institute and State University


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)
 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 Example
Nerac Analyst Bios

Mark Polasky
Jeff Eberhard Ph.D., Chemical Engineering, University of
Ph.D., Environmental Health, Akron
University of Cincinnati College of
Medicine

Richard Hendriks Irene Zajac
M.S., Biochemistry, University of North Carolina
Ph.D., Neuroscience, University
at Chapel Hill
of Melbourne, Australia

Richard Leavitt
Ph.D., Biochemistry, University of Pittsburgh
School of Medicine


The Nerac Experience

A Turn-Key Research Operation

Seamless
Partnership.
Rapid
Progress.

In Just Days Confidential Collaboration High Impact Results
Nerac can move from with highly skilled research tailored to client scope,
scoping client need to staff as an extension timing and budget
project execution of your team


The Nerac Difference
Rapid 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 RESEARCH & ADVISORY SPECIAL PROJECT SERVICES
REQUEST SERVICES SERVICES
Source and synthesize relevant information Expert analysis of business and Scope of work to be defined under a
from many sources technical information to produce specific agreement
actionable insights Designed for large engagements
Administer and manage alerts
Data-driven evaluation of technical, executed for a fixed price
Research key resources, including
business and intellectual property
scientific, technical, medical and patent
trends
sources
Designed for individuals who
Contact industry, commercial, academic, or
want expert analysis and opinion
government facilities
in addition to sourcing and
Discuss research or business challenges synthesis
and needs
Designed for individuals who prefer
to conduct their own synthesis and
analysis


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


Food Nutraceutical Packaging Chemistry Presentation

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