This document discusses strategies and opportunities for outsourcing pharmaceutical product development and manufacturing services from Latin America. It notes that Latin America has the potential to become a key global outsourcing hub for these activities in the next 5-10 years due to benefits like industry growth, innovation, and capabilities to address local health needs. It highlights several Latin American countries' strengths in areas like clinical research capabilities, manufacturing infrastructure, and a growing biotech industry. It also discusses expectations for the region to close gaps in areas like regulatory environments and intellectual property protections.

1. Strategies and Opportunities for Outsourcing of
Product Development and Manufacturing Services
from Latin America
Drug Development Latin America
March 9-10, 2009
Miami, Florida
Daisy Rivera-Muzzio, R Ph, MS, MBA
Senior Director, EP Product Licensing
Portfolio Development
Established Products Business Unit Pfizer, Inc
1

2. Business Opportunity
Latin America has the potential to
become a key global outsourcing
hub for the development and
manufacturing of pharmaceutical
products in 5-10 years
• Benefits / Outcomes
– Industry Growth
– Innovation
– Robust low cost Product
Development capabilities
– Infrastructure to address local
health needs in Latin America
Working together for a healthier world
2

3. Key points to discuss
• Global Outsourcing Drivers
and Opportunities
• LA Strengths / Capabilities
• Expectations vs Gaps
• Concluding Thoughts
3

4. Outlook: Steady increase in Pharma
Contract Manufacturing Services
Global pharma contract ~30% of manufacturing output
manufacturing revenue forecast1 produced by third parties by 20102
$B
60 Total 2007
20 2010
52 Biotech 30
6 Packaging
Medical 24
40
35 devices 33
4 24
Bulk and Generic 26
47 dosage
20 24
form drugs Branded
31 35
21
Total 29
0
2006 2011 0 10 20 30 40
Manufacturing output produced
by third parties (%)
1BCC research; 'Contract Pharmaceutical Manufacturing, Research, and Packaging,' August 2007
2AMR Healthcare Value Chain Survey 2007, Q: What percentage of your company's manufacturing output is produced through third
parties today? What percentage of your company's manufacturing output is produced through third parties in 2010?, n=275 companies
4

5. Challenges Facing Pharmaceutical
Manufacturing Operations
Growing product portfolio More dynamic market
complexity environment
è Increased need for flexibility è Develop/launch products quickly;
and specialized capabilities Respond to pricing, supply
changes
Pharma
More stringent and complex Growing technological
Operations complexity
regulatory requirements
è Upgrades/investment required to è Increasingly diverse
meet compliance audits technology and need to
increase internal expertise
Severe pressure on margins
è Increased need to reduce COGS
and justify capex investments
Source: The Boston Consulting Group
5

6. Key Drivers for External Sourcing
Facilities/
Cost Market Pipeline
Expertise network
advantage presence maintenance
availability
R&D
Manu-
facturing
Sales
6

7. Pharma External Sourcing Trend Follows
Other Industries
External sourcing industry lifecycle curve:
Pharmaceutical versus other industries
Consumer
products and
retail Financial
Adoption institutions
stage Automotive
Pharmaceutical
Stage 1 Stage 2 Stage 3 Stage 4 Stage 5
capacity proof of value strategic supplier global operating
augmentation concept realization management model
Source: Pharmaceutical Technology. Outsourcing Resources issue. 2005
7

8. Latin American
Strengths and Capabilities
8

9. Latin America Country Attractiveness Assessment
AT Kearney / Destination Latin America: a Near Shore Alternative
Country Argentina Brazil Chile Mexico Colombia Costa Rica
Cost
attractiveness
Availability of
skilled labor
Language
capabilities
Political and
economic stability
Government
support
Cultural affinity
Total
attractiveness
Key highlights • Lowest wages • Significantly • Remarkable • Closest to the • Stable economy • Very good bilingual
(pros and cons) for skilled labor outnumbers stability of United States with available skills
in the region country peers in political and • More developed labor • Strong presence of
• Political and call center and business market for BPO • Reputation impact large international
economic ITO industries, environment in the region, although crime (captive) service
stability for a though it has a • Limited especially in rates in Bogotá centers and
relatively short strong domestic availability of finance and are lower than in vendors
time compared focus professionals accounting São Paulo, the • Limited workforce
to neighboring • Limited number fluent in English • Key costs (salary, country s availability given
countries of English and real estate) are reputation population size and
Spanish higher than most reduces the inflow potential saturation
speakers peers of investments
Sources: A.T. Kearney s 2007 Global Services Location IndexTM, Datamonitor, ADI Argentina, Invest@Chile, Least Most
CINDE, best cities ranking by America Economia, Mercer Global Pay Summary, Colliers International, Attractive Attractive
Gartner Group and A.T. Kearney analysis.
9

10. Latin America Pharmaceutical
Market Value
($ US MM)
40,000
$34,773
35,000
$29,782
30,000 $25,898
25,000
20,000
15,000
10,000
5,000
0
2005 2006 2007
Years
Reference IMS Health
10

11. Latin American Pharmaceutical
Market Characterization - 2007
Peru (1.8%) Others (0.8%)
Chile (2.9%)
Colombia (5.8%)
Venezuela (8.4%)
Mexico (36.6%)
Argentina (15.3%)
Brazil (28.4%)
Reference IMS Health
11

12. Key Latin American Markets
Characterization of Pharmaceutical Industry in LA
Brazil Mexico Argentina
Total Population 190,010,647a 108,700,891a 40,677,348a
Total Pharmaceutical US$ 9,870 MM US$ 12,730 MM US$ 3,600 MM
Market
Units 1,660 MM units 984 MM units 500 MM units (24% OTC,
76% Ethical)
Laboratories ~252 labs 224 labs 254 active labs
19% foreign owned, Mostly foreign 64% domestic firmsb
81% domestically owned companies with a
including 12 state owned few domestics labsb
labsc
R&D Spent US$ 200 MM/year US$ 78 MMd US$200 MM/year
(US$100MM - by CRO s)
Importation US$ 4,200 MM US$ 52 MM US$ 1,096 MM
Exportation US$ 961 MM US$ 1,300 MM US$ 700 MM
(63% to LA; 37% rest of
the world)
Estimated Growth Rate 9.7% 7.2% 4.5%
2007-2012
Comparative growth rate in R&D spent USA 9.5% , LA 13%
aThe World Factbook, Central Intelligence Agency,
bLead Discovery
c2008 IMS Market prognosis in LA : Brazil update
dRefers to 2008 spent on clinical trials only
12

13. Which opportunities of the Product
Development & Manufacturing Cycle
can be captured in LA
Opportunities for
Mexico Process and Product
Development
Brazil
• Reformulations
Commercial scale
Manufacturing • Line Extensions
Process and Product
Process Product • Combination Products
Development
Development
Clinical Trials • Prescription to OTC
Safety and Efficacy
• Packaging
Drug Discovery Presentations
NCE (Biotech) Argentina
13

14. Highlights Biotech Industry in LA
• Brazil is a gene rich country, host to 24% of known primate species,
between 10 and 15 million of species of insects and 22% of the world
higher plant species.1
– Government Investment:
• Annual spent on biotech drugs US $95MM
• National Biotechnology Policy -10 billion Brazilian reais investment over the next
ten years on both biomedical and agricultural biotechnology
– Major Research Centers
• Amazonian Technology center – research center supported by the Ministry of
Science and technology
• Butantan Institution in Sao Paulo – dedicated to production of vaccines
– Dengue vaccines expected by 2010
– 4 year project to develop a vaccine against HIV (US$15.3 million investment)
1 Medicinal
plant genetic resources and international cooperation : The Brazil Perspective Journal of Ethnopharmacology,
April 1996,vol.51 no.1-3
14

15. Highlights Biotech Industry in LA
• Brazil is a gene rich country, host to 24% of known primate species,
between 10 and 15 million of species of insects and 22% of the world
higher plant species.1
• Mexico2
– November 2008 – Probiomed Biotechnology Complex, the largest biotech plant
opened in Latin America. 100% Mexican owned, benefited from an investment
of more than US$100 million.
– The Mexican Council for Science and Technology (Conacyt) – country's top
institution for the funding of scientific research projects
• 2002, US$44 million fund to support 200 national biotechnology projects;
• 2008 funding 38 billion pesos (US$3.5million).
1 Medicinal
plant genetic resources and international cooperation : The Brazil Perspective Journal of Ethnopharmacology,
April 1996,vol.51 no.1-3
2 Global insight 2008-IHS Global Insight Report: Mexico (Healthcare and Pharma)
15

16. Expectations vs Gaps
16

17. Contract manufacturing
Changing Dynamics in Mfg Outsourcing
What is the industry looking for?
Changing industry dynamics... Approach to creating value
Traditional Drivers • Depth of experience
• Capacity: companies unwilling/unable to • Proprietary / specific technology
hold capacity to buffer demand surges (process or drug delivery system)
• Risk: new drug attrition; manage risky • Confidentiality
investments in production facilities
• Cost effective network
• Flexibility: shorten time to market
• Highly qualified organization (project
managers, technical capability)
New Drivers
• Complexity management capability
• Operating Costs: Increasing price pressure
forcing lower operating costs
• Regulations: Increasingly complex mfg
regulatory and documentation issues
• Emerging markets: Need to establish
presence in growing markets
• Virtual companies: Small biopharma
companies (R&D only capabilities)
Source: BCC Inc. – Pharmaceutical Contract Manufacturing and Research
17

18. Cost Differences Drive Focus on
Outsourcing
Typical China / India landed costs ~60% US and ~70% LA
Comparison for a typical manufactured product (%)
100%
Overhead/support/GA 10 Landing costs to US/Western Europe
(transportation, taxes,
Depreciation 5 add'l logistics, ...)
Repair & maintenance 5
Tooling 4
Utilities 4 72%
Supplies 5
57%–62% 10
5–10 5
3
Direct material 30 6 3
2
2
4 3
3
3
3 25
4
Labor 37 21
19
8
US (typical manufacturing China/India Latin America
cost elements) (combined estimate) (combined estimate)
18

19. External Sourcing Is Not A Panacea
Savings Reduced by Additional Costs and Risks
Additional costs Risks
Savings of conv cost (%) Country related risks
50 • Foreign exchange
42 7
• Expropriation
40
• Catastrophe/Stability
2
2
• Taxation/Regulation
2 • Infrastructure
2
30 27
Product related risks
20 • Intellectual property
• Technology transfer
10 • Regulatory re-registration
• EHS standards
0 • Quality
Gross Residual Logistics QA costs Duties Product Net • Supply assurance
Savings plant cost costs and taxes support savings • Price stability
• Vendor viability
Risks and mitigation approaches must be
investigated and integrated into strategy
19

20. adual Improvements in the Regulatory
Gr
Environme nt in Latin America
Office
Contact: HHS Press
News Release (202) 690-6343HHS
LEASE
FOR IMMEDIATE RE
7, 2009
Wednesday, January
America
• Opening of First FDA office in Latin
Safety
on Import
– President s Action Plan
e United States
• Key trade partners for th
t in Region
– Costa Rica is the firs
ico in 2009
– South America and Méx
prove
sence in the region will im
• An HHS/FDA pre partnership and hasten
the flow
en our
collaboration, strength
rkets.
of q uality goods to our ma
– Secretary Leavitt
.P.H.
• Paul Seligman, M.D., M ffice for OIP
Latin America Regional O
– Director of the FDA
20

21. adual Improvements in the Regulatory
Gr
Environme nt in Latin America
ericas
• Document of the Am
elines
– Clinical practice guid
• Regulatory agencies
• Investigators
• Ethics committees
• Universities
• Businesses
ials*
• Latin America clinical tr
– 1993, 2.1%
– 1997, 5.1%
– 2000, 7.5%
ia fo r
• Establish harmonized criter
clinical practice
*IMS Health
21

22. adual Improvements in the Regulatory
Gr
Environme nt in Latin America
BIO Jan 2008
• Argentina- apeutic in dex.
ements fo r drugs with narrow ther
– Bioequivalence requir
• Brazil g requiremen ts
uivalence and bioavailability testin
– Introduction of bioeq d similars
for all new drugs, branded copies an
f Brazil to
it is in the long term interests o
– BIO firmly believes property standards
and practices
ectual
adopt stronger intell p r o te c ti o n to e n c o
urage
e n t p a te n t
in c lu d in g e n fo r c e m ustry.
igen ous biotechnology ind
development of its ind
22

23. adual Improvements in the Regulatory
Gr
Environme nt in Latin America
• Mexico
eneral de Salud
1995- Article 376 Ley G
bility studies for all
• Compulsory bioavaila
the country
medicines produced in l new drugs
irement in al
• Bioequivalence requ
– Program to be
and renewal of licenses
completed by 2010
ngeable generic
1998 Introduction of intercha 2012
designation Government
program
ission Federal para
2003 COFEPRIS – (Com Universal health
Sanitarios)
la Proteccion de Riesgos care coverage
al for products
• Does not grant approv
ed by the
that infringe patents issu
strial
Mexican Institute of Indu
property (IMPI)
23

24. Is Latin American pharmaceutical manufacturing
industry ready to be a global competitor?
Some Leaders Perspective
I agree with your vision about Latin America s potential to be a key global
competitor of outsourcing pharmaceutical services in the next decade. We bring
a number of strengths such as excellence in service, quality and a significantly
lower cost than the one from developed countries. …Two key areas of
opportunities to strengthen our global competitiveness are production
infrastructure and process controls...
JP Bago, President Laboratorios Bago- Argentina
I see a tremendous effort in Latin America to improve the regulatory environment and improve global competitiveness of the region
A tangible result of these efforts is the creation of the "Good Clinical Practices: Document of the Americas' from PAHO/PANDRH .
P Seligman, MD Director of the FDA Latin America Regional Office
The two key challenges that LA is facing to improve its global competitiveness are :
1. Sub optimal scale of manufacturing plants that prevents them from yielding globally competitive costs.
2. Lengthy, complex, people dependant regulatory approval process that is not aligned with the agility required to meet current
emerging market dynamics.
Carlos del Rio, VP /TL Pfizer, PGM, Latin America and Puerto Rico
24

25. Is Latin American pharmaceutical manufacturing
industry ready to be a global competitor?
Some Leaders Perspective
I agree with your vision about Latin America potential to be a key global competitor of outsourcing pharmaceutical services in the
next decade. We bring a number of strengths such as excellence in service, quality and a significantly lower cost than the one from
developed countries. Two key areas of opportunities to strengthen our global competitiveness are production infrastructure and
process controls..
JP Bago, President Laboratorios Bago- Argentina
I see a tremendous effort in Latin America to improve the regulatory
environment and improve global competitiveness of the region A tangible result
of these efforts is the adoption of the "Good Clinical Practices: Document of
the Americas' from PAHO/PANDRH .
P Seligman, MD Director of the FDA Latin America Regional Office
The two key challenges that LA is facing to improve its global competitiveness are :
1. Sub optimal scale of manufacturing plants that prevents them from yielding globally competitive costs.
2. Lengthy, complex, people dependant regulatory approval process that is not aligned with the agility required to meet current
emerging market dynamics.
Carlos del Rio, VP /TL Pfizer, PGM, Latin America and Puerto Rico
25

26. Is Latin American pharmaceutical manufacturing
industry ready to be a global competitor?
Some Leaders Perspective
I agree with your vision about Latin America potential to be a key global competitor of outsourcing pharmaceutical services in the
next decade. We bring a number of strengths such as excellence in service, quality and a significantly lower cost than the one from
developed countries. Two key areas of opportunities to strengthen our global competitiveness are production infrastructure and
process controls..
JP Bago, President Laboratorios Bago- Argentina
I see a tremendous effort in Latin America to improve the regulatory environment and improve global competitiveness of the region A
tangible result of these efforts is the creation of the "Good Clinical Practices: Document of the Americas' from PAHO/PANDRH .
P Seligman, MD Director of the FDA Latin America Regional Office
The two key challenges that LA is facing to improve its global competitiveness
are :
1. Sub optimal scale of manufacturing plants that prevents them from yielding
globally competitive costs.
2. Lengthy, complex, people dependant regulatory approval process that is not
aligned with the agility required to meet current emerging market dynamics.
Carlos del Rio, VP /TL Pfizer, PGM, Latin America and Puerto Rico
26

27. Is Latin American pharmaceutical manufacturing
industry ready to be a global competitor?
Some Leaders Perspective
In Argentina, we need to address our scale as well as our technological
capabilities. In response, there is an ongoing effort to build a state of the art
laboratory supported by private investment of 13 domestic firms and the
Argentinean Ministry of Science and Technology. It is a collective effort to
provide advanced analytical and product development technology to promote
innovation that otherwise could not be afforded by individual companies.
Dr. Marcelo Carlos Nacucchio,
Professor- Academia Nacional de Farmacia y Bioquímica, BA, Argentina
Each country in LA brings different capabilities to offer outsourcing services of pharmaceutical development and commercial
manufacturing. Argentina in particular is prepared to offer product development services specially in the development of innovative
drug delivery systems. There are not enough incentives to invest in commercial scale manufacturing to compete globally.
Key challenges to become a global competitor: Need to strengthen public policy to enforce Intellectual Property Laws and
Regulatory controls.
Dr. Rodolfo Rubio-Garcia, Associate Director, BioEliga Consulting, Argentina
27

28. Is Latin American pharmaceutical manufacturing
industry ready to be a global competitor?
Some Leaders Perspective
In Argentina, we need to address our scale as well as our technological capabilities. In response, there is an ongoing effort to build a
state of the art laboratory supported by private investment of 13 domestic firms and the Argentinean Ministry of Science and
Technology. It is a collective effort to provide advanced analytical and product development technology to promote innovation that
otherwise could not be afforded by individual companies.
Dr. Marcelo Carlos Nacucchio, Professor- Academia Nacional de Farmacia y Bioquímica, BA, Argentina
Each country in LA brings different capabilities to offer outsourcing services
of pharmaceutical development and commercial manufacturing. Argentina in
particular is prepared to offer product development services specially in the
development of innovative drug delivery systems. There are not enough
incentives to invest in commercial scale manufacturing to compete globally.
Key challenges to become a global competitor: Need to strengthen public policy
to enforce Intellectual Property Laws and Regulatory controls.
Dr. Rodolfo Rubio-Garcia,
Associate Director, BioEliga Consulting, Argentina
28

29. Key Considerations to achieve
global competitiveness
• Manufacturing Scale
– Challenge to align scale with global markets
requirements
• Cultural transformation
– Quality and technical perspective
• Embrace conceptual global regulatory/ technical
advances on PAT, ICH, QbD
• Regulatory standards harmonization FDA,
EMEA, ICH
• Enforcement of Regulatory and IP laws
• Local Salary taxes (Brazil)
29

30. Addressing the gaps for an effective
contract manufacturing relationship
• Due diligence
– Risk assessment
– Cost/benefit
• Collaborative relationships
to address technical and
regulatory gaps
• Mutual accountability
30

31. Concluding thoughts
• Latin America has potential capabilities to capture global outsourcing
opportunities for product development and pharmaceutical
manufacturing
– Brazil and Mexico - Biotech
– Argentina - Development of drug delivery systems
31

32. Concluding thoughts
• Latin America has potential capabilities to capture global outsourcing
opportunities for product development and pharmaceutical
manufacturing
• Commercial manufacturing scale needs to be developed to produce
cost that are competitive at a global scale however the currently
available scale could be used
– a) to serve emerging markets requiring similar volume as LA markets
– b) to capitalize product development capabilities to enable post LOE
strategies
32

33. Concluding thoughts
• Latin America has potential capabilities to capture global outsourcing
opportunities for product development and pharmaceutical
manufacturing
• Commercial manufacturing scale needs to be developed to produce
cost that are competitive at a global scale however the currently
available scale could be used
• Ongoing efforts to harmonize regulatory standards, active collaboration
between FDA and local regulatory agencies will have a positive effect
on the LA global competitiveness
• Synergistic collaboration of regulators, industry leaders, academia and
government is required to address the gaps and promote the use of LA
capabilities to provide outsourcing pharmaceutical manufacturing
services
• Promotion of Low Cost pharmaceutical R&D is required to address
unmet needs of neglected regional diseases.
33

34. ?
Questions?
Preguntas?
Perguntas?
34