Puerto Rico: Strategic Location for Pharmaceutical Manufacturing

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Puerto Ricos Life Sciences Roadmap
UP-DATE Presented at the prtec Forum 8/12/
04 Ponce Hilton Ivan Lugo
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INDUNIV VISION

• Puerto Ricos is the preferred location for
  new business opportunities and knowledge creation
  in the Pharmaceutical, Biotechnology, Medical
  Device, Health Care, Electronic and Allied
  Industries

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INDUNIV MEMBERS

• Pfizer
• Abbott Laboratories
• Lilly
• AMGEN
• GlaxoSmithKline
• Bristol Myers Squibb
• Wyeth
• Johnson Johnson
• Merck Co
• Hewlett Packard
• MOVA Pharmaceuticals

• Proctor Gamble Pharmaceuticals
• Government of PR ( PRIDCO )
• University of Puerto Rico System
• Politechnic University of PR
• Pontificial Catholic University
• Ponce School of Medicine
• SUAGM
• Caribbean Industrial Construction
• Gilbane
• Kelley Services
• Penn Well Publications
• INTERPHEX

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Partnerships

• Southern Technology Council
  Representative
• INTERPHEX , Reeds Exhibitions
  Member
• BIOPHEX, CA CORDIA, Europe
• Penn Well Publications ( Clean Rooms )
  Member
• Puerto Rico 2025
  Co-chair
• PHARM TECH, Advance Star Com.
  Exchange
• CANIFARMA, Mexico
  Member
• PRMA
  Partnership
• Oxford University, ISIS Park
  Advisors
• ISPE
  In progress
• BEACON
  In progress
• Bio State Organization
  Representatives
• Michigan State Univ. Perdue Univ.
  Agreements

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A Sense of Urgency Where Fear and Opportunity
Meet
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Innovation Lifecycle Bringing Economics and
Science Together
Knowledge Creation
Technology Transfer
Incubation/ Research Parks
Proof of Concept Testing
Licenses
Venture Capital
Patents
Clinical Trials
Universities Research Institutions
Collaborations/ Partnerships
Federal RD
Conception
Formation
Regulatory Environment
Regulatory Approval
Growth
Maturity
Industry Consortia Partnerships
Business Planning
Industry RD
Job Creation
MA Activity
IPOs/Gazelles
Product Pipeline
Labor Market/ Graduates
Economies of Scale
Value-add
Clusters Networks
Commercialization
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Health Clusters Roadmap

•  Why a Roadmap?
•  The four health clusters identified major
  impediments or gaps which need to be addressed in
  order to grow their sectors.
• Many of the same gaps have been identified by
  more than one of the cluster steering committees.
  
• The success of all of these cluster promotion
  efforts will require significant resources and
  coordination by the private sector.

• Pharma Cluster
• Health Council
• Biomedical Devices
• Biotechnology Alliance

• . The roadmap will
• Identify Existing strengths and weaknesses
  (SWOT).
• Identify primary opportunities for short long
  term growth.
• Outline the public and private sector investments
  necessary in order to assure continuous expansion
  of our health sector over the long term.

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Health Clusters Roadmap

• Organization
• Led by a steering committee mostly made up of
  representatives of key institutions that share
  the cost of the consulting contracts.
• Working committees and an advisory board created
  to tackle the background research and the
  preparation of preliminary drafts of the
  document.
• The whole effort requires 9 months.

• Focus
• High Tech Job Creation
• Strengthen Research Community
• Foster Innovation
• Promote start-up enterprises
• Engage international Alliances (Global Hub or
  Global Node)

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Health Clusters RoadmapEXPECTED OUTCOMES

• List of prioritized opportunities and gaps that
  strategically stimulate job creation and quality
  of life.
• Identify global Hubs and Nodes.
• Clear action plan and timetable to implement the
  initiatives.
• Identify resources ( costs) associated with
  implementation.
• Firm commitment of stakeholders for
  implementation of Roadmap. (Who does what!)

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Health Clusters Roadmap

• PRMA
• PRTEC
• Abbott, Amgen, Lilly, Pfizer
• PRIDCO
• UPR
• CES
• Dept. of Health
• INDUNIV

• PARTNERS
• Stakeholders from the Academia, Government,
  Pharmaceutical, Biotechnology, Medical Device and
  the Healthcare Care Industries.

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The Puerto Rico Life Science Road Map Linking
and Leveraging Actions and Initiatives for Results
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Health Clusters Roadmap Strategies for
Results

• Leveraging Existing Initiative Cluster Mapping
  
• - Telemedicine, Smart Card, Clinical
  Research, Bio-pilot Plant, Molecular Science
  Complex, NCI Cancer Center, CAPTech, RR Science
  Park, CIT MAESTI, COBRE, EPSCOR, others
• Resident Expertise in Pharma, Biotech, MD and
  Health
• Bio Manufacturing, Facility Management,
  Regulatory Compliance, Construction, others
• Position PR as a Global Best Practice Center,
  Expatriate Networking for ST
• Workforce, Skills and Competencies
• -Technology Transfer, Regulatory Compliance,,
  Pharma and Bio processing, Materials Sciences,
  Molecular sciences, Basic Core Skills in ST
  COBRE, EPSCOR, others
• Branding, Marketing, Positioning PR as Global
  Hub/Node

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Clusters Mapping Leveraging Existing Initiatives

• Telemedicine, Smartcards, CIT cluster studies
  have been conducted but sustaining and leveraging
  results has been a challenge. In turn, new
  incentives have been put in place for Sec. 936,
  clinical trials, bioprocess pilot plant,
  molecular science complex, science parks and
  other related infrastructure.
• Healthcare challenges remain for Puerto Rican
  citizens.
• To improve the economy without ties to improving
  the quality of life and health for Puerto Ricos
  citizens would be irresponsible
• Some of the globally best minds in health care
  are indirectly linked to Puerto Rico through the
  bio, pharma, and IT sectors and therefore can
  offer potential insight and council.
• Puerto Rico creates a global best practice model
  in health care by linking clinical discovery and
  research to reduce the developmental cost of new
  products that will jumpstart health initiative
  in a 21st century comprehensive Puerto Rico.
• The promise of telemedicine, Smartcards, health
  information catalyzes a new cluster convergence
  to serve the needs of all citizens and leading to
  significant improvements in the treatment and
  diagnosis of diabetes, cancer, and hypertension
  illnesses.

Background
Why Selected
PR Scenario
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Cluster Map A Sample of Stakeholders
External Focused
University Research Centers
Federal Labs
Industry/Firms
Incubators Eco Develop
Local Venture Cap
Legal/ Accounting
Contract Research
Local Suppliers
Entrepreneurs
Equipment Sales Servicing
Manufacturers
Supportive Local Infrastructure
Transportation
Facilities and Related Spaces
State Agencies
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Resident Expertisein Pharma-Bio Manufacturing,
Facilities construction, tech. transfer and
others

• Global pharmaceutical manufacturing in Puerto
  Rico (60B in infrastructure)
• 2nd largest FDA office
• Facilities design, construction,
  management/operations leadership
• Regulatory-responsive manufacturing, operations,
  and logistics
• Puerto Rico among a handful of pharmaceutical
  manufacturing centers, but other regions
  aggressively positioning themselves to
  attract/recruit manufacturing operations
• Puerto Rico should exercise its knowledge on the
  world stage beyond the brick and mortar of
  facilities its the knowledge in and around the
  building that is essential
• Partnering with other key academic and industry
  organizations throughout the world will create a
  place for Puerto Rico in the future
• Negative Puerto Rico does not want to be the
  21st Century textiles ghost town if and when
  the consolidation of pharmaceuticals and
  biotechnology occurs, thus impacting future
  expansion of manufacturing operations
• Positive Puerto Rico does want to make itself
  into a knowledge hub around its expertise by
  sharing its understanding (for a fee!) with
  regions developing their own manufacturing
• Positive Puerto Rico does want to identify,
  before other regions, both the threats and
  opportunities to make manufacturing competitive

Background
Why Selected
PR Scenario
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A New Regional Model Emerging
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Position PR as a Global Best Practice Center,
Expat. Net
Background

• Population centers of Puerto Ricans in the
  United States
• Examples of research/technology/industry in
  those locations
• Puerto Rico Federal Affairs regional offices
• Famous Puerto Ricans in key agency positions
• Example of United Kingdom strategy for
  expatriates
• AT Kearney analysis of key brain-drain and
  intellectual flight to other locations
• Key resources off the Island provide critical
  link to passionate/committed Puerto Ricans
• Population demographics are becoming vital
  research strengths in genomic/proteomics
• A global network of scientific, technological,
  and entrepreneurial resources is created to
  advance both the investment in and results of
  Puerto Ricos innovation lifecycle
• Puerto Rico as a brand for science and
  technology is achieved by leveraging on and off
  island relationships

Why Selected
PR Scenario
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Branding, Marketing, Positioning As A Global
Hub/Node

• Dollars spent on promoting Puerto Rico are not
  aligned to key messages of new economic drivers.
• Anecdotal perspective on Puerto Rico as seen
  through the eyes of visitors in airport gateways
  beaches, casinos, rum, golf but not science and
  technology!
• Puerto Ricos competitiveness is often defined
  by incentives vs. strengths in knowledge creation
  or competencies.
• To position Puerto Ricos science and technology
  future citizens, visitors, and targeted interests
  must be made aware of current strengths to
  attract jobs and investment dollars.
• Disparate messages and tactics do not leverage
  resources mixing quality of life and
  technological innovation.
• 25-40 of Puerto Ricos branding budget is spent
  on the education and awareness of the islands
  scientific and technological activities.
• The hospitality and tourism industries are vital
  partners with industry and academia in designing
  and delivering the business, scientific, and
  entrepreneurial offerings.
• Surveys on the future identify Puerto Ricos life
  sciences among culture, arts, music, food, and
  quality of life as reasons to relocate and/or
  expand Puerto Rico operations.

Background
Why Selected
PR Scenario
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Constructing the Road Map Scenario
Hot Teams

• Examine the data, the ideas and recommendations
  from the initial report and conduct a market
  examination around the ideas to craft two-page
  business plans for each potential initiative
• Create business plans that are very specific and
  include detailed plans with performance metrics
• The business plans will then be prioritized to
  create an Innovation portfolio that has the 3-5
  most critical Big Ideas for advancing Puerto
  Ricos competitiveness
• The Project Advisory Group will participate as
  liaisons to the Hot Teams to ensure the work is
  done, is of the highest value and assists in
  prioritizing next steps
• In turn, the Project Advisory Group will begin to
  identify the resources necessary for funding and
  sustaining the Hot Teams business plans
• The Consultants will co-facilitate the Hot Team
  sessions, provide outside counsel to the business
  plan process, and identify any additional Subject
  Matter Experts that will assist in the completion
  of the work.

Project Advisory
Consultants/ Experts
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Suggested Performance Metrics Milestones

• Number of new jobs created
• Number of expanded physical plants and facilities
• Percentage of wage increase and wealth generated
  that advances Puerto Rico in United Nations,
  other benchmarks
• Improvement in shareholder value by being located
  in Puerto Rico
• Process or technological improvements that reduce
  measured costs
• Broader spectrum of employed Puerto Ricans
• Reductions in disease and death from major
  health care challenges
• A sense of pride among Puerto Ricans for its
  contribution to global life science and health
  care solutions
• A sense of community, of social capital created
  among partners
• This is not the first report, first strategy,
  first consulting team in Puerto Rico to discuss
  these issues and challenges. Make it one of the
  last by ensuring the Road Map and the Process
  meet expectations.
• What are those expectations? Be very specific in
  your explanation. Be very realistic in your
  terms. And be very aggressive in advancing the
  Commonwealth.

Economic
Societal
Expectations
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The Private-Public Sector Asset Mapping Alignment
Industry Research Entrepreneurs
Biotech, Pharma, Device, Other Enterprises
Drivers
Large Employers, Insurers, Providers
Inventory of RD areas
Inventory of Assets
Output from Investments
Mechanisms for Collaboration
New Discoveries
Private Sector
Public Sector
Recognition of Role of Discovery, Entrepreneurs,
Investors
Inc Investment in the State Cluster Approach
Encourage Univ/ Institution Commercialization
Policies
Facilitate Process for Partnering
Co-Invest in Trends Initiatives
Tech-Sci Center Programs
Regional Efforts, Networks
Define Health Burdens/ Eco Dev Agendas
Drivers
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Next Steps / Hot Teams
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The Coalitions Importance to the Road Map

• Government should be a stakeholder not THE driver
• Industry MUST be the driver for the good of the
  Commonwealth and self-interest of their members
  and firms
• Entrepreneurs and CEOS of high-growth firms are
  critical
• Broader business stakeholders MUST KNOW how they
  BENEFIT
• Shift the view of Puerto Rico from third world
  to global competitor
• Identify EVERY available dollar to invest in
  Puerto Rico global philanthropy, global
  alliances, global institutions
• Leverage Puerto Ricos expatriate networks
• Link and update the economic development
  incentives, investments and institutions into a
  more competitive position
• What are the expectations for the Road Map? Be
  very specific in your explanation. Be very
  realistic in your terms. And be very aggressive
  in advancing the Commonwealth.
• We have some thoughts on engaging the Coalition
  to build a critical Partnership for
  Implementation.

Changing Perspectives
Tactics for Implementation
Expectations
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Healthcare Roadmap

• Next Steps
• Based on the work plan, the Roadmap should be
  ready for publication and implementation by
  October 2004.

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PR Life Sciences Road Map

• YOU ARE Welcome to join the Hot Teams
• Contact INDUNIV at
• 355 Roosevelt Ave.
• Suit 302, Hato Rey, PR
• [phone]
• ILUGO_at_INDUNIV.ORG
• Thank You for Your Attention