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Nutrasource Diagnostics Inc.
The Value of Product-Specific Data for Sales
and Marketing Return on Investment

Friday, March 7th, 2014
William Rowe, BA
President & CEO
wrowe@nutrasource.ca
www.nutrasource.ca
Outline
• About Nutrasource and our product commercialization
platform
• Product claims and product-specific data
• 3 unique case studies: food, raw material ingredient,
dietary supplement
• 4 stages of development:
–
–
–
–

Systematic scientific literature reviews
Product analytics
Human clinical trials
Health/product/marketing claims

• Return on investment
• Additional Nutrasource information
www.ifosprogram.com
www.nutrasource.ca

Booth # 176
About Nutrasource and Our Product
Commercialization Platform

www.nutrasource.ca

Booth # 176
About Nutrasource
• Nutrasource Diagnostics Inc. (NDI) is a full
service R&D department for the consumer
health products industry from ‘farm’ to
‘pharm.’
• Delivering commercialization
since 2002

www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Product Development:
2 Key Scenarios
1. Launching a new product
2. Re-launching/re-positioning an existing
product

www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Answering the 5 Key Questions
To help determine your product’s sales, marketing,
regulatory and R&D strategy, we ask the 5 key
questions:
1. Where is it made?
2. How is it made?
3. What is it?
4. What would you like to say and what can you
say about it?
5. What country would you like to sell it in?
www.ifosprogram.com
www.nutrasource.ca

Booth # 176
From Concept to Claim/Market

www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Start with the End in Mind
Reverse the concept to claim pathway with the
product claims as your starting point to ensure
all research, development, regulatory,
intellectual property and marketing are
positioned with this common thread

www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Product Claims and
Product-Specific Data

www.nutrasource.ca

Booth # 176
Product Claim: Part 1
Remember – your product claim (health claim,
nutrient content claim, structure-function claim)
drives your marketing, your collateral, and your
intellectual property

www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Product Claim: Part 2
Remember – your product claim is the intersect
point where science, legal and marketing
converge and this is
where ROI on new
product launches and
product re-positioning
occurs

www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Product Claim: Part 3
Remember – it is time to stop thinking about
these aspects of product development as
individual silos of activity but as one continuous
commercialization strategy

www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Product-Specific Data
Product-specific data is data
that provides unique and novel
marketing, sales and regulatory
information and positioning
specific to your product’s
formula, its characterization,
its attributes, and its implied
or direct health benefits
www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Why is it important?
• Strengthen company name and product brand
• Establish integrity and credibility
• Create research rights and intellectual
property
• Product claims substantiation
• Increase sales exponentially

www.ifosprogram.com
www.nutrasource.ca

Booth # 176
General Observations
• Companies are providing very similar marketing
messages within categories
• Companies do not see the ROI on clinical trials or
similar larger budget research and development
• Companies see the FDA, EFSA and Health Canada
as an adversary instead of an ally
• Companies fight the tightening of the regulatory
environment instead of using it for marketing
leverage
www.ifosprogram.com
www.nutrasource.ca

Booth # 176
3 Unique Case Studies:
> Food
> Raw material ingredient
> Dietary supplement

www.nutrasource.ca

Booth # 176
Case 1: Seafood Situation
• Company provided fresh seafood meals to the
cruise line industry
• A rogue employee set up down the street
began taking market share up to ~30%
• Regular marketing using terms
like “fresh,” “natural,” “delicious”
• Traditional marketing was not working

www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Case 1: Product-Specific Data
Difference
• Stability testing to demonstrate novel production
process gave an additional 3 days shelf life over
competitor
• Regulatory and nutritional analysis assessment to
provide insight to more aggressive claims around
EPA and DHA levels in seafood dishes
• Define reported adverse events profile from FDA
in the public record to show low frequency of
issues and strong lack of illness track record (over
1 billion meals served and only 10 reported
events to the FDA)
www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Case 1: The Result
• Rogue competitor shutdown in 3 months
• Company returned to industry leading status
in category

www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Case 2: Moving Right Along
• Company with an insoluble oat hull fibre wanting
novel fibre claim applicable across multiple food
categories for the US and Canada
• Precedent had not been
set for one submission
covering this many
applications in various
cereals, breads and pastas
www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Case 2: Product-Specific Data
Difference
• Create systematic literature review on
scientific rationale for metabolic controlled
diets
• Design a ‘free range human’ study with
assessment of 9 product arms following
subjects for 5 months
• Use Radio Opaque rings to track stool volume
and transit time
www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Case 2: The Result
• Most widely applicable novel fibre claim ever
approved in North America
• Company can transfer related claims up to the
end user on the supply chain for food and
dietary supplement applications
• IP around process technology allows company
to retain IP and tie claim back into IP

www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Case 3: Breast is Best
• Company required an implied breast cancer
prevention claim
• Breast Cancer claims in Canada are a Schedule
A disease claim typically
reserved for large scale
pharmaceutical
development
• What to do next?
www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Case 3: Product-Specific Data
Difference
• Systematic literature review to confirm
theoretical formula optimization and biomarker
identification based on published literature
• Health Claim strategy around brand name and
actual claims relating to estrogen metabolite
levels and ratios
• Clinical trial in pre and post menopausal women
specific to health claim strategy and regulatory
filing
www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Case 3: The Result
• The only Natural Health Product ever licensed
in Canada with implied breast cancer
prevention health claims
• A publication in an oncology journal
• ‘Immeasurable ROI’ according to the client

www.ifosprogram.com
www.nutrasource.ca

Booth # 176
4 Stages of Product Development:
> Systematic Scientific Literature Reviews
> Product Analytics
> Clinical Trials
> Health & Marketing Claims

www.nutrasource.ca

Booth # 176
Strategies and Tactics: Systematic
Scientific Literature Reviews
• Assessment biomarkers of interest for your
formula and claims
• Theoretical formula optimization from a
claims perspective
• Jurisdictional assessments of level of
aggressiveness around the claim
• Assessing the research gap of where you are
vs. where you need to be for claims
substantiation
www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Strategies and Tactics: Product
Analytics
•
•
•
•

Contamination assessments
Stability assessments
Active ID and Concentration
Characterization of
formula and unique
attributes

www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Strategies and Tactics: Human Clinical
Trials
•
•
•
•
•

Efficacy assessments
Safety assessments
Publication strategy
Biomarker strategy
Study design to answer
as much as possible!!!

www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Strategies and Tactics:
Health/Marketing Claims
•
•
•
•
•

Marketing collateral
IP strategy
Certification strategy
Government approval/compliance strategy
Label messaging strategy

www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Return on Investment

www.nutrasource.ca

Booth # 176
Strategies and Tactics: ROI for New
Product with Clinical Trial
Dietary Supplement - Enhanced Competitive Positioning
The Scenario

$500
$150,000

New Positioning Revenue

$350,000

Baseline Revenue Growth

5.5%

Revenue Growth Increase

0.0%

Change in Profitability

0.0%

$300

Discount Rate
Net Present Value
Internal Rate of Return
Payback

10%
$54,939
45%
3.0 years

Current
Positioning

$200
$100

$0
Year 0

$35,000
The Business Case

New
Positioning

$400

Investments in
$K

Investments

Net Profit and
Revenue $K

Baseline Revenue

Year 1

$30
$20
Phase IIa Study

$10

Phase I Study
$0

Sources: Frost & Sullivan (2005); NHP Insider (March 2012)

www.ifosprogram.com
www.nutrasource.ca

Year 2

Booth # 176

Year 3

Year 4

Year 5
Strategies and Tactics: ROI for New
Product with Clinical Trial
• Such an investment would yield a 45% return
and a 3 year payback generating a Net
Present Value (NPV) of $54,939
• The NPV is a measure of how much profit the
investment produces in today’s dollars and is
determined by adding the discounted cash
flows of the project over its lifetime

www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Strategies and Tactics: ROI for Existing
Product with Clinical Trial
Nutraceutical (OTC) Supplement - Enhanced Competitive Positioning
The Scenario

$4.0
$1,000,000

New Positioning Revenue

$3,000,000

Baseline Revenue Growth

13.8%

Revenue Growth Increase

0.0%

Change in Profitability

0.0%

$2.0
$1.0
Year 0

$400,000
The Business Case

Discount Rate
Net Present Value
Internal Rate of Return
Payback

10%
$511,387
32%
5.8 years

New
Positioning
Current
Positioning

$3.0

$0.0

Investments in
$K

Investments

Net Profit and
Revenue $M

Baseline Revenue

Year 1

$300
$200
Phase IV

$100

Phase III

$0

Sources: Frost & Sullivan (2005); NHP Insider (March 2012)

www.ifosprogram.com
www.nutrasource.ca

Booth # 176

Year 2

Year 3

Year 4

Year 5
Strategies and Tactics: ROI for Existing
Product with Clinical Trial
• Such an investment would yield a 32% return
and a 5.8 year payback generating a Net
Present Value (NPV) of $511,387
• The NPV is a measure of how much profit the
investment produces in today’s dollars and is
determined by adding the discounted cash
flows of the project over its lifetime

www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Additional Information About
Nutrasource and Our Services

www.nutrasource.ca

Booth # 176
Our Memberships & Affiliations
NDI is a proud and active member of:

www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Our Testing & Certification Programs
• Nutrasource is also the developer and
exclusive provider of testing and
certification program for:
• Fish oils – International Fish Oil
Standards Program (IFOS™)

“

IFOS played a significant role in Renew Life’s
ability to grow in the omega-3 category in 2013
despite the category’s decline of approximately
10%. – Peter Agostino, Renew Life

”

www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Our Testing & Certification Programs
• Nutrasource is also the developer and
exclusive provider of testing and
certification program for:
• Krill oils – International Krill Oil
Standards Program (IKOS™)
• Sports & fitness supplements –
International Fitness Ingredient
Testing Program (IFIT™)

www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Diteba: Analytical and Bioanalytical
Laboratory
• Testing performed in accordance with the U.S.
FDA 21CFR Part 210 & 211, Health Canada
GMP guidelines and ICH guidelines
• Licensed by Health Canada as a GMP drug
establishment (#102117-A) and registered as a
Drug Establishment with the FDA and licensed
by Health Canada to handle controlled drugs
and substances.
www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Have a product you’d like to
launch or re-launch? We can help!
Stop by the Nutrasource booth #176
for a one-on-one consultation with
myself or a member of my team to
discuss your product R&D and
marketing strategy.
www.ifosprogram.com
www.nutrasource.ca

Booth # 176
Thank you!
William Rowe, BA
President & CEO
wrowe@nutrasource.ca

Connect with Nutrasource:
www.nutrasource.ca
facebook.com/nutrasourcediagnostics
@Nutrasource_NDI
linkedin.com/company/nutrasource-diagnostics-inc.
© Nutrasource Diagnostics Inc.

www.ifosprogram.com
www.nutrasource.ca

Booth # 176

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The Value of Product-Specific Data for Marketing and Sales ROI

  • 1. Nutrasource Diagnostics Inc. The Value of Product-Specific Data for Sales and Marketing Return on Investment Friday, March 7th, 2014 William Rowe, BA President & CEO wrowe@nutrasource.ca www.nutrasource.ca
  • 2. Outline • About Nutrasource and our product commercialization platform • Product claims and product-specific data • 3 unique case studies: food, raw material ingredient, dietary supplement • 4 stages of development: – – – – Systematic scientific literature reviews Product analytics Human clinical trials Health/product/marketing claims • Return on investment • Additional Nutrasource information www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 3. About Nutrasource and Our Product Commercialization Platform www.nutrasource.ca Booth # 176
  • 4. About Nutrasource • Nutrasource Diagnostics Inc. (NDI) is a full service R&D department for the consumer health products industry from ‘farm’ to ‘pharm.’ • Delivering commercialization since 2002 www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 5. Product Development: 2 Key Scenarios 1. Launching a new product 2. Re-launching/re-positioning an existing product www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 6. Answering the 5 Key Questions To help determine your product’s sales, marketing, regulatory and R&D strategy, we ask the 5 key questions: 1. Where is it made? 2. How is it made? 3. What is it? 4. What would you like to say and what can you say about it? 5. What country would you like to sell it in? www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 7. From Concept to Claim/Market www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 8. Start with the End in Mind Reverse the concept to claim pathway with the product claims as your starting point to ensure all research, development, regulatory, intellectual property and marketing are positioned with this common thread www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 9. Product Claims and Product-Specific Data www.nutrasource.ca Booth # 176
  • 10. Product Claim: Part 1 Remember – your product claim (health claim, nutrient content claim, structure-function claim) drives your marketing, your collateral, and your intellectual property www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 11. Product Claim: Part 2 Remember – your product claim is the intersect point where science, legal and marketing converge and this is where ROI on new product launches and product re-positioning occurs www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 12. Product Claim: Part 3 Remember – it is time to stop thinking about these aspects of product development as individual silos of activity but as one continuous commercialization strategy www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 13. Product-Specific Data Product-specific data is data that provides unique and novel marketing, sales and regulatory information and positioning specific to your product’s formula, its characterization, its attributes, and its implied or direct health benefits www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 14. Why is it important? • Strengthen company name and product brand • Establish integrity and credibility • Create research rights and intellectual property • Product claims substantiation • Increase sales exponentially www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 15. General Observations • Companies are providing very similar marketing messages within categories • Companies do not see the ROI on clinical trials or similar larger budget research and development • Companies see the FDA, EFSA and Health Canada as an adversary instead of an ally • Companies fight the tightening of the regulatory environment instead of using it for marketing leverage www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 16. 3 Unique Case Studies: > Food > Raw material ingredient > Dietary supplement www.nutrasource.ca Booth # 176
  • 17. Case 1: Seafood Situation • Company provided fresh seafood meals to the cruise line industry • A rogue employee set up down the street began taking market share up to ~30% • Regular marketing using terms like “fresh,” “natural,” “delicious” • Traditional marketing was not working www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 18. Case 1: Product-Specific Data Difference • Stability testing to demonstrate novel production process gave an additional 3 days shelf life over competitor • Regulatory and nutritional analysis assessment to provide insight to more aggressive claims around EPA and DHA levels in seafood dishes • Define reported adverse events profile from FDA in the public record to show low frequency of issues and strong lack of illness track record (over 1 billion meals served and only 10 reported events to the FDA) www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 19. Case 1: The Result • Rogue competitor shutdown in 3 months • Company returned to industry leading status in category www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 20. Case 2: Moving Right Along • Company with an insoluble oat hull fibre wanting novel fibre claim applicable across multiple food categories for the US and Canada • Precedent had not been set for one submission covering this many applications in various cereals, breads and pastas www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 21. Case 2: Product-Specific Data Difference • Create systematic literature review on scientific rationale for metabolic controlled diets • Design a ‘free range human’ study with assessment of 9 product arms following subjects for 5 months • Use Radio Opaque rings to track stool volume and transit time www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 22. Case 2: The Result • Most widely applicable novel fibre claim ever approved in North America • Company can transfer related claims up to the end user on the supply chain for food and dietary supplement applications • IP around process technology allows company to retain IP and tie claim back into IP www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 23. Case 3: Breast is Best • Company required an implied breast cancer prevention claim • Breast Cancer claims in Canada are a Schedule A disease claim typically reserved for large scale pharmaceutical development • What to do next? www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 24. Case 3: Product-Specific Data Difference • Systematic literature review to confirm theoretical formula optimization and biomarker identification based on published literature • Health Claim strategy around brand name and actual claims relating to estrogen metabolite levels and ratios • Clinical trial in pre and post menopausal women specific to health claim strategy and regulatory filing www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 25. Case 3: The Result • The only Natural Health Product ever licensed in Canada with implied breast cancer prevention health claims • A publication in an oncology journal • ‘Immeasurable ROI’ according to the client www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 26. 4 Stages of Product Development: > Systematic Scientific Literature Reviews > Product Analytics > Clinical Trials > Health & Marketing Claims www.nutrasource.ca Booth # 176
  • 27. Strategies and Tactics: Systematic Scientific Literature Reviews • Assessment biomarkers of interest for your formula and claims • Theoretical formula optimization from a claims perspective • Jurisdictional assessments of level of aggressiveness around the claim • Assessing the research gap of where you are vs. where you need to be for claims substantiation www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 28. Strategies and Tactics: Product Analytics • • • • Contamination assessments Stability assessments Active ID and Concentration Characterization of formula and unique attributes www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 29. Strategies and Tactics: Human Clinical Trials • • • • • Efficacy assessments Safety assessments Publication strategy Biomarker strategy Study design to answer as much as possible!!! www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 30. Strategies and Tactics: Health/Marketing Claims • • • • • Marketing collateral IP strategy Certification strategy Government approval/compliance strategy Label messaging strategy www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 32. Strategies and Tactics: ROI for New Product with Clinical Trial Dietary Supplement - Enhanced Competitive Positioning The Scenario $500 $150,000 New Positioning Revenue $350,000 Baseline Revenue Growth 5.5% Revenue Growth Increase 0.0% Change in Profitability 0.0% $300 Discount Rate Net Present Value Internal Rate of Return Payback 10% $54,939 45% 3.0 years Current Positioning $200 $100 $0 Year 0 $35,000 The Business Case New Positioning $400 Investments in $K Investments Net Profit and Revenue $K Baseline Revenue Year 1 $30 $20 Phase IIa Study $10 Phase I Study $0 Sources: Frost & Sullivan (2005); NHP Insider (March 2012) www.ifosprogram.com www.nutrasource.ca Year 2 Booth # 176 Year 3 Year 4 Year 5
  • 33. Strategies and Tactics: ROI for New Product with Clinical Trial • Such an investment would yield a 45% return and a 3 year payback generating a Net Present Value (NPV) of $54,939 • The NPV is a measure of how much profit the investment produces in today’s dollars and is determined by adding the discounted cash flows of the project over its lifetime www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 34. Strategies and Tactics: ROI for Existing Product with Clinical Trial Nutraceutical (OTC) Supplement - Enhanced Competitive Positioning The Scenario $4.0 $1,000,000 New Positioning Revenue $3,000,000 Baseline Revenue Growth 13.8% Revenue Growth Increase 0.0% Change in Profitability 0.0% $2.0 $1.0 Year 0 $400,000 The Business Case Discount Rate Net Present Value Internal Rate of Return Payback 10% $511,387 32% 5.8 years New Positioning Current Positioning $3.0 $0.0 Investments in $K Investments Net Profit and Revenue $M Baseline Revenue Year 1 $300 $200 Phase IV $100 Phase III $0 Sources: Frost & Sullivan (2005); NHP Insider (March 2012) www.ifosprogram.com www.nutrasource.ca Booth # 176 Year 2 Year 3 Year 4 Year 5
  • 35. Strategies and Tactics: ROI for Existing Product with Clinical Trial • Such an investment would yield a 32% return and a 5.8 year payback generating a Net Present Value (NPV) of $511,387 • The NPV is a measure of how much profit the investment produces in today’s dollars and is determined by adding the discounted cash flows of the project over its lifetime www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 36. Additional Information About Nutrasource and Our Services www.nutrasource.ca Booth # 176
  • 37. Our Memberships & Affiliations NDI is a proud and active member of: www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 38. Our Testing & Certification Programs • Nutrasource is also the developer and exclusive provider of testing and certification program for: • Fish oils – International Fish Oil Standards Program (IFOS™) “ IFOS played a significant role in Renew Life’s ability to grow in the omega-3 category in 2013 despite the category’s decline of approximately 10%. – Peter Agostino, Renew Life ” www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 39. Our Testing & Certification Programs • Nutrasource is also the developer and exclusive provider of testing and certification program for: • Krill oils – International Krill Oil Standards Program (IKOS™) • Sports & fitness supplements – International Fitness Ingredient Testing Program (IFIT™) www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 40. Diteba: Analytical and Bioanalytical Laboratory • Testing performed in accordance with the U.S. FDA 21CFR Part 210 & 211, Health Canada GMP guidelines and ICH guidelines • Licensed by Health Canada as a GMP drug establishment (#102117-A) and registered as a Drug Establishment with the FDA and licensed by Health Canada to handle controlled drugs and substances. www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 41. Have a product you’d like to launch or re-launch? We can help! Stop by the Nutrasource booth #176 for a one-on-one consultation with myself or a member of my team to discuss your product R&D and marketing strategy. www.ifosprogram.com www.nutrasource.ca Booth # 176
  • 42. Thank you! William Rowe, BA President & CEO wrowe@nutrasource.ca Connect with Nutrasource: www.nutrasource.ca facebook.com/nutrasourcediagnostics @Nutrasource_NDI linkedin.com/company/nutrasource-diagnostics-inc. © Nutrasource Diagnostics Inc. www.ifosprogram.com www.nutrasource.ca Booth # 176

Editor's Notes

  1. Add quote – “IFOS played a significant role in Renew Life’s ability to grow in the omega-3 category in 2013 despite the category’s decline of approximately 10%.” – Peter Agostino, Renew Life
  2. Add quote – “IFOS played a significant role in Renew Life’s ability to grow in the omega-3 category in 2013 despite the category’s decline of approximately 10%.” – Peter Agostino, Renew Life
  3. Final slide