Fourth Annual Community College Program

1
Fourth Annual Community College Program

• Puerto Ricos Industry-Education Collaborative
  Initiatives
• Building Biomanufacturing Education and Training
  to Strengthen the Workforce Infrastructure
• --------------------------------------------------
  -----------------------------------------
• Carlos A. Tollinche, Ph.D.
• Director of Scientific Affairs and Cluster
  Liaison

BIO Internatioal Convention - Boston May 6,
2007
2
Agenda

• Introduction
• Overview of the Puerto Rico Life Science Industry
  
• INDUNIV Research Consortium
  
• The Clusters
• The Educational Infrastructure Committee

3
Introduction

• Puerto Rico has been successful for over 40
  years in attracting the high tech pharmaceutical
  manufacturing industry because among others
  aspects the incentives offered, the supply
  chain, and the pool of highly trained workforce
  developed for this regulated economic sector.
• In the last five years, the biopharmaceutical
  industry has invested over 4billion for the
  construction of super manufacturing facilities.
• Therefore, the entire infrastructure
  resources equation besides steel structures,
  cement blocks, pipe racks, systems automation,
  clean rooms, aseptic areas, and support labs,
  also includes the workforce development.
• The latter ecosystem mandates a well trained
  and technologically prepared technicians /
  professionals

4
Introduction

• Initially, the requirements for the skilled
  professionals have been fulfilled at the expense
  of the well-prepared workforce from the classical
  pharmaceutical industry sector.
• However, in order to sustain the demand, our
  institutions of higher learning are stepping up
  to the plate looking at their curriculum and
  seeking alternatives to address
• a) the immediate biomanufacturing scenario
  that mandates unique technological skills not
  readily found in the traditional academic
  programs
• b) start preparing the bachelors degrees and
  post graduate degree professionals required for
  the other subsectors of bioscience.

5
About Puerto Rico

• 3.8 million U.S. Citizens
• English and Spanish languages
• Gross National Product (GNP) 82.0 billion (FY
  2005)
• Labor Force 1.3 million people (2004)

U.S.A.

• No inbound travel restrictions
• No customs duties or quotas on shipments
• US Patent laws applied in Puerto Rico
• Federal income tax exemptions
• Products manufactured are "Made in the USA"

6
A Vibrant Life Science Sector

• More than 40 years of experience in
  pharmaceutical manufacturing.
• 14 of the top 20 prescription drugs sold in the
  U.S. are manufactured in Puerto Rico
• First biologics facility established in 1988
  (Ortho Biologics) for production of
  Erythropoietin Alfa (EPO).
• 25 of the global biologics manufacturing
  capacity the most anywhere in the world.
• Over 371,000 liters of bulk manufacturing
  capacity in biologics.
• Over 4 billion investment in bulk and
  fill/finish biotech facilities in the past 5 yr
• Strong supply chain network in the life sciences
  industry, including pharmaceutical and
  biotechnology.
• Educated, available workforce with significant
  experience in pharmaceutical manufacturing and
  being grown in biomanufacturing.
• Local resources with experience and technical
  expertise in the design, build, commissioning,
  and validation of biopharmaceutical facilities.

7
PR Biopharmaceutical Capabilities

• More than 40,000 direct jobs in the Life Sciences
  Industry, accounting for 8 of total U.S.
  employment in this sector.
• Over 100,000 indirect jobs serving the Life
  Sciences community in such areas as construction,
  project management, validations and
  commissioning, packaging, raw materials,
  financial and legal services, and others.
• Labor force with significant experience in
  biopharmaceutical technologies, such as API
  manufacturing (both biological and chemical
  synthesis), sterile parenteral formulation, fill
  and finish, lyophilization, solid dosage, and
  others.
• Significant expertise in cGMPs, process
  development, automation, quality
  control/assurance, FDA and EMEA regulatory
  compliance, packaging, warehousing, and others.
• There are 79 FDA approved pharmaceutical and 58
  medical device manufacturing plants
• Compliance Posture Biologics New Pre-approval
  Installations approved without observations
• One of only four U.S. jurisdictions considered
  specialized in three bioscience subsectors (Drugs
  and Pharmaceuticals, Medical Devices and
  Equipments, and Research). Source Growing the
  Nations Bioscience Sector State Bioscience
  Initiatives 2006, Battelle Technology Partnership
  Practice and STTI. http//www.bio.org/local/battel
  le2006/

8
The Regulated Life Science Sectors
Pharmaceutical and Biotech Companies
Medical Devices Companies
9
AgBio in Puerto Rico Seeds Winter Nurseries
AgReliant (Santa Isabel)
Monsanto (Isabela)
Rice Tec (Lajas)
Monsanto(Juana Díaz)
Bayer (Sabana Grande)
Syngenta (Salinas)
ICIA (Juana Díaz)
Mycogen (Santa Isabel)
Pioneer (Salinas)
Iowa State (Isabela)
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Profile of PR InstitutionsOffering Various
Degrees in ST

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• University of Puerto Rico at Bayamón
• BS Electronics Engineering Technology
• BS Natural Sciences-Biology
• BS Natural Sciences Human Approach
• AD Natural Sciences
• AD Instrumentation Technology
• AD Civil Construction Technology in Surveying,
  Roads and Structural
• AD Civil Engineering Technology in Construction
• AD Production Engineering Technology
• AD Industrial Engineering Technology
• AD Electronics Technology

• Tecnological Institute of Puerto Rico at San
  Juan
• AD Civil Engineering Technology
• AD Instrumentation Engineering Technology
• AD Electrical Engineering Technology
• AD Electronics-Biomedical Engineering Technology
• AD Mechanical Industrial Engineering Technology
• AD Chemical Engineering Technology
• AD Electronics Engineering Technology

• Tecnological Institute of Puerto Rico at Manatí
• AD Electrical Engineering Technology
• AD Electronics Engineering Technology
• AD Instrumentation Engineering Technology
• AD Engineering Technology-Industrial Maintenance
  Mechanics
• AD Chemical Engineering Technology

• San Juan Bautista School of Medicine
• MD Degree

• National College of Business and Technology at
  Arecibo
• AD Pharmacy Assistant

• National College of Business and Technology
• AD Pharmacy Assistant

• Interamerican University of Puerto Rico at
  Aguadilla
• BS Biology
• BS Electronics Technology
• GA Applied Sciences in Nursing

• San Juan Univesity College
• AD Instrumentation Technology
• AD Electronics Technology in Instrumentation

• Caribbean University at
• Bayamón
• BS General Sciences (Pre-Medical)
• BS Civil Engineering
• BS Electrical Engineering
• BS Industrial Engineering
• AD Drafter and Engineering Technology

• Pontifical Catholic University of Puerto Rico at
  Arecibo
• BS Biology
• BS General Sciences

• University of PR,
• at Aguadilla
• BS Quality Control in Manufacturing
• B Electronics Technology
• AD Natural Sciences
• AD Quality Control
• AD Electronics Technology

• University of Puerto Rico, Medical Sciences
  Campus
• BS Veterinary Technology
• Pharmacy Doctorate, MS Industrial Pharma
• BS Medical Technology
• Certificate Post BS Medical Technology
• Certifica Post BS Cytologic
• MD Degree
• Dentistry Degree
• Ph.D Public Health Specialty in Environmental
  Health
• Ph.D. Biomedical Sciences

• Univ. of PR at San Juan ( Río Piedras )
• BS Specialty in Environmental Sciences
• BS, MS Mathematics
• BS, MS Physics (Material Sciences)
• BS, MS, Ph.D. in Chemistry
• BS, MS, Ph.D. Biology
• BS in General Sciences

• University of Puerto Rico,
• at Arecibo
• BS Biology
• BS Industrial Chemical Process Technology
• AS Applied Sciences in Animal Health
• AD Nursing

• Bayamón Central University
• BS Biology
• BS Environmental Sciences
• BS Chemistry

• Interamerican University of Puerto Rico at
  Bayamón
• BS Biology
• BS Electrical Engineering
• BS Industrial Engineering
• BS Mechanical Engineering
• BS Electronics Engineering
• BS Chemical Technology

• Interamerican University of Puerto Rico at
  Arecibo
• BS Biology
• BS Nursing Sciences
• BS Chemistry
• BS Chemistry Technology
• AD Sciences Applied in Chemistry Technology

• Electronic Data Processing College
• of PR, at Hato Rey (San Juan)
• AD Electronics Technology

• Central Universityof the Caribbean
• MD Degree
• MS Biomedical Sciences

• Antillean Adventist University
• BA Biology
• BA Chemistry
• BS Cardio-pulmonary
• BS Biology

• Interamerican University of PR Metro Campus
• BA Mathematics
• BS Biology
• BS Chemistry
• BS Medical Technology

• Metropolitan Univ. at Cupey
• BS Applied Mathematics
• BS Chemistry
• BS Natural Sciences General
• BS Applied Physics
• AD Environmental Quality
• AD General Sciences

• Univ. of the Sacred Heart
• BS Biology
• BS Mathematics
• BS Chemistry
• BS Medical Technology

Aguadilla
San Juan
Manatí
Arecibo

• Polytechnic University of
• de Puerto Rico
• BS Surveying
• BS Mechanical Engineering
• BS Environmental Engineering
• BS Civil Engineering
• BS Electrical Engineering
• BS Industrial Engineering
• BS Chemical Engineering
• MS Civil Engineering
• MS Managerial Engineering
• MS Competitive Manufacturing

Bayamón
Carolina

• Pontifical Catholic University of Puerto Rico at
  Mayagüez
• BS Biology
• BS General Sciences
• AD General Sciences
• AD Optical Sciences
• AD Chemistry Technology Science

Fajardo
Gurabo
Mayagüez
Caguas

• Interamerican University of PR at Fajardo
• BS Biology

Barranquitas
Humacao
San Germán
Cayey
Ponce

• Turabo University
• at Gurabo
• BS Biology
• BS Eiectrical Eng.
• BS Mechanical Eng.
• BS Chemistry

Guayama

• Caribbean University
• at Carolina
• BS General Sciences Specialty in Pre- Medical

• University of Puerto Rico
• at Mayagüez
• BS Surveying and Topography
• BS Biology (Industrial Microbiology)
• BS Industrial Biotechnology
• BS Physicsl
• BS Pre-medical
• BS Physical
• BS Geology
• BS Mathematics
• BS Industrial Microbiology
• BS Chemistry
• BS Civil Engineering
• BS Electrical Engineering
• BS Industrial Engineering
• BS Mechanical Engineering
• BS Chemistry Engineering
• Ph.D. Marine Sciences
• Ph.D. Civil Engineering

• Interamerican University of Puerto Rico at
  Barranquitas
• BS Biology

• Interamerican University of Puerto Rico at San
  Germán
• BA Mathematics
• BS Biology
• BS Chemistry
• BS Electronics Technology

• Ponce School of Medicine
• MD Degree
• Ph.D. in Bio-Medical Sciences

• University Center Colombia
• AD Digital Electronics and Microprocessors

• University of Puerto Rico
• at Carolina
• AD Industrial Automatization
• AD Mechanics Engineering Specialty in Industrial
  Maintenance
• AD Automotive Technology

• University of Puerto Rico
• at Ponce
• AD Civil Engineering Technology in Construction
• AD Civil Engineering Technology in Architectonic
  Drafter
• AD Industrial Engineering Technology
• BS Biology (Biomed / Biodiversity)

• Technological Institute of Puerto Rico
• at Guayama
• AD Civil Engineering Technology
• AD Electrical Engineering Technology
• AD Electronics Engineering Technology
• AD Mechanical Engineering Technology in
  Industrial Maintenance
• AD Instrumentation Engineering Technology

• Technological Institute of Puerto Rico
• at Ponce
• AD Civil EngineeringTechnology
• AD Quality Control Engineering Technology
• AD Electrical Engineering Technology
• AD Electronics Engineering Technology
• AD Instrumentation Engineering Technology
• AD Bio-Medical Engineering Technology

• Huertas Junior College
• AD Electrical Technology
• AD Electronics Technology
• AD Industrial Technology

• Pontifical Catholic University of Puerto Rico at
  Ponce
• BS Biology
• BS General Sciences
• BS in Environmental Sciences
• BS Mathematics
• BS, MS Chemistry
• BS Medical Technology

• University of Puerto Rico
• at Humacao
• BS General Biology
• BS Marine Biology (Coast)
• BS Appplied Physics in Electronics
• BS Industrial Chemistry
• BS Biology- Specialty in Microbiology
• BS Nursing
• AD Electronics Technology
• AD Chemical Technology

• University of Puerto Rico
• at Cayey
• BA Secondary Education in Physics and Chemistry
• BS Biology / BS Chemistry
• BS Mathematics
• BS General Sciences Program

• Interamericana University of Puerto Rico
• at Guayama
• BS Biology
• BS Chemical Technology
• AD Sciences Applied in Nursing
• AD Sciences Applied in Chemical Technology

• Interamerican University of Puerto Rico at Ponce
• BS Biology
• BS Environmental Sciences

• Nova Southeastern University, Centro Ext. Univ.
  Católica e Ponce
• Pharmacy Doctorate (PharmD)

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A Leading Source of Engineering Talent
UPR at Mayagüez 1st graduating
Hispanics 2nd graduating Women 4th in
Chemical 8th in Industrial 14th in
Electrical 18th in Computer 20th in
Mechanical Source ASEE
13
The College of Natural Sciences Students -
Undergraduate

• 4 of all Hispanic Students who obtain their
  Ph.D. received their BS degree in UPR-Río
  Piedras.
• One of every 10 BS graduates from CNS goes on to
  complete a PhD in these fields. This rate of PhD
  completion is comparable to top colleges in the
  Mainland the average national rate is 1 in 20.

• Leading U.S. Baccalaureate Institutions Of U.S.
  Hispanic SE Ph.D.s
• (1999-2003)
• UPR-Rio Piedras 264
• UPR-Mayaguez 136
• Univ. California Berkeley 86
• Univ. of Texas Austin 72
• FIU 60
• Univ. California Los Angeles 58
• MIT 57
• Total of Degrees from US Institutions 6,189

14
Leading ST Programs
Number of Degrees Conferred in Science and
Technology 2001-2005

• Undergraduate Programs
• Industrial Biotechnology
• Biotechnology (molecular biology emphasis)
• Industrial Chemistry
• Chemical Engineering
• Medical Technology
• Advanced Degree Programs
• Applied Chemistry
• Chemical Engineering
• Computer Sciences
• Clinical Research
• Biology
• Physical Chemistry
• Biomedical Sciences
• Microbiology
• Biochemistry
• Pharmacology
• Physiology
• Pharmacy

Total 49,173
(partial list)
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• INDUSTRIAL BIOTECHNOLOGY PROGRAM AT UPR MAYAGUEZ
• The University of Puerto Rico at Mayagüez offers
  a Bachelors Degree in Industrial Biotechnology.
  The curriculum includes courses in biology,
  chemistry, engineering, mathematics, physics, and
  social studies/humanities. Moreover, students
  are required to conduct undergraduate research
  and to participate in an internship in Industry.
• Biotechnology Summer Camp for high school
  students.
• Industrial Biotechnology Learning Center (IBLC)
  Winner of the 2006 Southern Growth Policies
  Board Innovator Award
• Other Institutions have concentrated their
  Programs towards
• Associate Degrees Professional
  Certificates in Biotech

27
16
BIOPROCESS TRAINING AND DEVELOPMENT CENTER

• Facilities
• 17,300 sq ft Total 8,600 sq ft bioprocess
  research labs
• Wet lab multimedia workforce development
  service suites
• Microbial fermentation suite
• Mammalian cell culture suites
• Bio-analytical biochemical characterization
  labs
• Purification suite
• Warehouse/raw material storage
• Utilities
• Metrology lab
• Administration and amphitheater

• Capabilities
• Center will host over 20 researchers and
  technical personnel
• Process improvement
• Troubleshooting
• Technology transfer
• Process adaptation and optimization
• Consulting
• Contracting
• Workforce development services for small and
  large biotechnology industries

31
17
INDUNIV Research Consortium

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

18
INDUNIV Guiding Principles

• Catalyst to the Knowledge Economic
• Development
• Facilitator to enhance PR Manufacturing
• Industry competitiveness
• Integrator of Industry, Univ. Gov.
• Initiatives and actions must add value to
• Members

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INDUNIV Partners

• Southern Technology Council
  Representative
• BIO State Associations Organization
  Representative
• INTERPHEX , Reeds Exhibitions
  Member
• BIOPHEX, CA
• CORDIA, Vienna
• Penn Well Publications ( Clean Rooms )
  Member
• Alianza para el Desarrollo de PR
  Partner
• Pharma Manufacturing Magazine .
  Exchange
• CANIFARMA, Mexico
  Member
• Manufacturers Assn., ST Alliance
  Partner
• PR Chamber of Commerce
  Partners
• ISPE
  Collaborators
• BEACON
  Collaborators

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INDUNIV Scope

• Economic Development
• Clusters dev. administration
• Pharmaceutical Cluster
• Biotechnology Cluster
• Health Care Cluster ( Support )
• Medical Devise Cluster ( Support )
• PRIDCO Support
• Leads contacts match
• Pharma Bio consultants to PRIDCO
• Promotions at major conventions
• ( booth pavilions support)
• ST Promotion
• Life Science Roadmap development PR ST Global
  Network
• Science Park Strategies
• Roosevelt Road Proposal to LRA
• Primate Research Center Funding

• Educational / Research Dev.
• Innovation
• SAC RD Grants 2.5M
• Center of Excellence Dev.
• MCC
• CPPR
• CAPTech Product surety
• PAT Center of Excellence
• Bio-energy Center
• Future Workplace Dev. Center
• Technology Transfer Center
• Regulatory Compliance Center
• Curriculum, programs internship development
  through Industry Advisory Committees
• Conference, exhibitions, forums Technical
  Exchange Series
• Partnerships BIO, STC

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INDUNIV Members

• University of Puerto Rico System
• Polytechnic University of PR
• Pontificial Catholic University
• Ponce Medical School
• Inter-American University- Bayamon
• Caribbean Central U. Med. School
• Caribbean Industrial Construction
• Caribbean Project Management
• Washington Group
• Gilbane
• SKANSKA
• CH2MHILL- Lockwood Green
• Kelly Services
• Penn Well Publications, CleanRooms
• Plaza Consulting
• Praxair
• Pall Life Sciences
• Paciv
• INTERPHEX

• Pfizer
• Abbott Laboratories
• Lilly
• AMGEN
• GlaxoSmithKline
• Bristol Myers Squibb
• Wyeth
• Johnson Johnson
• Hewlett Packard
• MOVA / Pathion
• Monsanto
• Skanka
• Syngenta
• Merck Company
• Proctor Gamble
• Government of PR (PRIDCO )

22

Pharma ClusterVision
PR is the preferred location to grow and
establish new Pharmaceutical
operationsPriorities Improve Permitting
Process Supply Chain -
Reliability and Cost
Educational Alignment ( Workplace of the Future
) Pharma Inter-Institutional
agreement

• Board of Directors

Ing.Neil Ayward, Abbott Ing.Carlos del
Rio, Pfizer Lic.Elizabeth Plaza, Pharma Serv
Ing. Jorge Ross, Mc Neil Ing.Ivan Lugo,
INDUNIV Ing.Ileana Quinones, Mova Ing.
Americo Bortolozo, Wash. Group

• Lic.Boris Jaskille, PRIDCO Ing.Edgardo
  Fabregas, JJ
• Daneris Fernandez ( Chair)
• Dr.Jorge Velez Arocho, RUM
• Ing.Dave Carberry, PG
• Lic. Lesbia Hernandez, CPM
• Dr. Juan C. de los Santos

23

Biotech Cluster

• Vision PR the preferred Partner for
  Biotechnology
• Enterprises
  
• Priorities Provide forum for
  integration
• Promote Biotechnology (
  Press, Leg. , Conf., others )
• Grow Biotechnology
  Research ( pilot plant )
• Educational Development
  (PhD, Cert., Awareness )
• Advisory Board
• Dr.Ray Hernandez-Lilly Del Caribe
  Lucy Cruz, Ag BIO
• Ing. Juan Pablo Gutierrez - Amgen (Chair)
  Lic. Boris Jaskille -PRIDCO
• Dr.Carlos Tollinche-INDUNIV
  Dr.Rosa Buxeda-UPR-RUM
• Dr.Jose Torres, Ponce Med. School
  Dr. Brad Winner UPR RP
• Ing.Pablo Vila, Abbott
  Ing.Ramon Rijos, Ortho Bio.
• Ing.Julio Juarbe Pall Biomedics
  Ing. Jose Correa Taratec
• Dr. juan C. de los Santos Cluster Director
  Ing.Ivan Lugo- INDUNIV
• 
  

24
P.R. Health Council

• Vision Puerto Rico is the prefer location for
  health
• care services due to its quality
  of health,
• genotype and infrastructure.
• Priorities
• Health Care Disease Registry Development
• Clinical Research Initiative
• E-Health ( Telemedicine )
• Advisory Board
• Dr. Jose Torres Ponce medical school
• Mr. Carlos Bonilla, Lilly Del Caribe
• Mr. Carlos Bonilla, Lilly
• Dr. Miguel Vazquez, Pfizer ( chair)
• Dr. Jose Gregorio Quijada Merck
• Dr. Jorge Fronteras, UPR
• Dr. Manuel Lamboy, Wyeth
• Ms. Rosa Pérez Perdomo, Health Department
• Dr. Eddy Rios, Caribbean Medical School

• LIC. Boris Jaskille, PRIDCO
• Dr. Emma Fernández, UPR
• Dr. Jose Carlo- UPR-RCM
• Ing. Ivan Lugo INDUNIV
• Dr. Carlos A. Tollinche, INDUNIV

25
Clusters Initiatives Convergences
Pharma Cluster
Bioscience Alliance
Bioprocess Complex
Pharma Unit Operations Pilot
Ag Bio
Permits Time Reduction
Educational Infrastructure Committee
Workforce Development (WIA, CETA,Certifications)
Infrastructure Initiatives
Cogeneration Initiative
Construction Cluster
Supply Chain Forum
Environmental Energy Cluster
Clinical Trials
Biocompatibility Research
Medical Devices Cluster
Health Council
26
Why an Involvement In Educational Initiatives?

• Basis Background
• INDUNIV involvement in educational activities
  precedes the formation of the clusters
  consistent with its Initial Charter
• --------------------------------------------------
  -----------------------------------------------
• Insertion to the Global Competition requires
• Key attributes to succeed are Education,
  Collaboration and Innovation in moving PR to the
  Global Knowledge Economy
• Efforts towards enabling the re-alignment of the
  educational programs has increased significantly
• The commitment is fueled by
• education to engage next generation of
  professionals linked
• innovation
• collaboration to built a more vibrant and
  effective technical
• community
• innovation to create new companies and
  recreate our companies,
• our universities, and ourselves.

27
Scope of Workforce Development for All Sectors
Their Interconnection for Their Preparations

• Life Science Clusters

Government (PRIDCO / DE / WIA)

• Scholarship Programs
• Support to Learning
• Centers
• Commitments to Centers
• of Excellence

Scope
University
Industry
Suppliers

• Incipient Industries
• Suppliers Service
• Multinational Plants
• Industry Sector

• Dev. of Workforce
• Research
• Basic
• Applied

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Promoting a Culture of Continuous Interrelations
of the Sectors

• BASIC PRINCIPLES
• This is a joint effort. Academia, Industry and
  Government must work together to achieve this
  goal.
• Puerto Rico requires solid and sustainable
  partnerships among the sectors in order to create
  knowledge and resources
• Sharing a collaboration culture that promotes
  interrelationship will definitely enable us to
  compete in the global economy.

29
Educational Infrastructure Committee

• One the Standing Committee for the Life Science
  Clusters
• Have existed for close to Five (5) years
• Maintain communication and/or include
  representatives as needed from
• - any of the other organized cluster,
• - cluster committees or organizations
• pursuing initiatives related to the educational
  infrastructure

30
Goals - Education Infrastructure Committee

• Workforce Development life sciences
  (biotechnology) and other regulated industries
• Development of technical programs, strengthening
  of existent curricula and support of new ventures
  in education
• Participation on training programs and curriculum
  development (Industry Advisory Boards )
• Facilitate development of Internship Programs for
  faculty and students.
• Entice Puerto Rican talent/professionals back to
  the island and develop strategies to keep new and
  current talent.
• Educate and disseminate knowledge of the Life
  Sciences at primary and secondary school level.
• Enhance Research Faculty Industry Relationship
  and Contributions Through Applied Research
  (Inter-Institutional Agreement of Pharma Cluster)

31
Educational Infrastructure Perspective

• Pharma Cluster is Looking to Institutionalize the
  Infrastructure Resources for Development of
• Pharma Products,
• The Vision of the Clusters Education Committee
  and That of INDUNIV is Broader in Scope
  Perspective
• The Areas of Efforts Are as Follows
• - INDUNIV Conference Development Centers of
  Excellence
• - Clusters Colloquiums / Advisory Boards /
  Curricula
• Support Certification /
• - Collaborations with Local CHE (CES) / PRMA
  / SHRM / Etc.
• 
  Regional Organizations

32
Mission

• Mission
• Integrate Efforts from the Sectors Towards
  Strengthening the Academic Formation to Increase
  Competitiveness of the Life Science Workforce
• Goal
• The Committee Members are Focused Towards
  Ascertaining the Development and Strength the
  Educational Infrastructure of the Life Sciences
  Clusters

33
Educational Infrastructure Committee (CIE) Life
Science Sectors Involved
AdHoc Operational Committees According To
Initiatives
34
Areas of Focus (Interconnection of Sectors)

• Colloquiums Encuentros AcademiaIndustria
• August 2004 (CPM) Attendance 50
  persons (Chancellors, Deans,
• Directors and Industry
  Representatives including GMs)
• September 30, 2004 (Mayaguez Resort)
  Attendance 62 Persons from
• Industry / Academia / CES
  (Chancellors, Deans, Directors, GMs, others)
• August 25, 2005 (Amgen) Attendance 70
  Persons Representing Academia, Industry and
  Government (CES)
• September 23, 2005 (Zipperle) Attended
  by 55 Persons from Academia, Industry
  Government
• August 24, 2006 (Pfizer Caguas) Attended
  by 100 Persons from Academia,
  Industry Government (CES PRIDCO)
  Internships Coop Programs
• September 21, 2006 (UPR-M) Attended by 33
  Persons from Academia, Industry and Government
  (PRIDCO, CES, Juvempleo)- Closing the Gaps

35
Significant Accomplishments

• Fundamental Achievements
• Bridging the Differences between the Two Sectors
  and Identifying Areas for Collaborations and
  Partnering in Educational Offerings
• Update of the Map for Academic Offerings in the
  ST and Engineering Fields
• Identify and Synergize Inter-Sectorial Culture
  Challenges to Promote Effective Collaboration
• Forum for Presentation and Recognition of
  Academia for their Contributions to the
  Employability of the Human Resources to the
  Regulated Industry
• Showcase of Academic Programs that Support
  Workforce Development in the Regulated Industry

36
2006 Accomplishments

• BIO Chicago and BIO Boston Support for the PR
  Pavillion
• - Educational Component well Represented in The
  Delegation BioScience
• Destination Publication and the Info in
  the Presentation ran on Plasma Screens
• - Batelles State of Bioscience Initiatives
  Featured Key Talent Dev Programs
• Enhanced Education Via Collaborations
  Institutionalizing and Creating a Framework of
  Best Practices for Internships Coop Programs
• - Bringing the Success Stories
• - Steps Toward Implementation - Engaging Sectors
  (Creating Teams) to Close
• Gaps in Internships and COOP Attend Main
  Action Items
• Inventory of Initiatives and Agreements Academia
  with Industry (Viceversa)
• - On-going Efforts / Development of Survey Forms
  for Academia and Industry
• Collaborative Academy-Industry Regional
  Dissemination Activities During the Bio Week
• - Develop the Recognition Program for the
  Organizations
• Disseminating Life Sciences Information
• - Promoted and Supported the Legislature
  Regional Activities
• - Supported the Third Bio Congress (Session
  Chairs and Biolimpiadas)

37
2006 Accomplishments

• Conference Development
• - Interphex 2006
• - Latin Bio 2007 Conference Development and
  Technical Program
• Connections for Potential Collaborations with
  Entities such as Universia (University Portal
  Co.) and Governors Youth Office
• PRIDCO HR and Scholarship Program have Recognized
  the Synergies and the Value Added of
  Participation in the Committee
• Academia Has Continued to Make Presentations to
  the Committee of Programs under Development or
  Review

38
Accomplishments Local Alliances

• Active involvement in the Work Plan led by PRMA
  Educational Team
• Concentrating in Enhancing the Quality of
  K-12 Education
• with our Collaboration in the ST
  areas.
• Vocational - Tech School Education
  Internships Program for
• Teachers Currently working in the
  proposal
• To Organize a Summit to Showcase the ST
  Initiatives at K-12 from
• the Outreach Programs from all
  Sectors Private, Agencies, Academic
• Programs Professionals
  Organizations, others with the Intention to
• Measure Coverage Impact
• Preparation of a plan proposal for Mapping
  the K-12 ST Initiatives in
• the Schools per Municipality
  (PRIDCO-CES-INDUNIV-DE-maybe PIA)
• We are also Looking for PIA Education Committee
  to Become Part of the Collaboration in Areas of
  Synergies to Converge Efforts
• Liaison with the CES ( Evaluation Boards /
  Program College on Line Locator PRIDCO/CES
  Interphase of Educational Database)
• PRIDCO (Scholarship Program) Governors Youth
  Office (Internships)

39
Culture of Continuous Interrelations Focus on
Regional Alliances

• NSF Advanced Technological Education Centers with
  Skill Stds for Analysts, Chemical Technologists,
  Biotechnology Manufacturing Links Chem Tech
  Links, CAPT, Bio Link National Center of Biotech
  Workforce (NHTCC NE Network)
• Engaged with Mainland Universities with Global
  Programs and Key Areas of Convergence University
  of Wisconsin (Masters in Biotech for Industry
  Professionals) and GaTech CD4 (School of Chemical
  Biomolecular Engineering)

40
Biomanufacturing Requires Well Educated, Trained
and Talented Workforce!

• Executive and Site Selectors Gravitate to
  Jurisdictions Where Supply of Trained Workers
  Exists to Man New and Expanding Facilities
• While Top Executives are Mobile, Entry Level,
  Second Tier Employees, Supervisors Mgrs Are Not
• Sites Must Have Available a Pool of Technicians
  and Workers Familiar with GMPs, SOPs, other Bio
  Specialized Skills for Working in the Highly
  Regulated Sector
• Capital, Other Incentives and Tax Credits Cannot
  Address the Human Capital Needs for a 24 / 7 Bio
  Mfg Operation
• In Example - Availability of State of the Art
  Courses for as Little as 55 may also be
  attractive cost of training

41
Biotech Job Catalog Study by Hewitt
(Commissioned by PIA)

• Project Objectives
• Identify responsibilities, technical and
  educational requirements for typical positions in
  the biotechnology industry in Puerto Rico
• Develop an industry specific job catalog,
  focusing on
• Core positions and
• Hard-to-hire positions
• Provide background information to the PIA
  Education Committee to assist them in analyzing
• How the needs of the industry match the
  available talent pool,
• Industry recommendations/requests for the
  academia

42
Quick Summary of Findings

• Besides technical skills, the following are
  general skills required for most positions
• Good Manufacturing Practices (GMPs)
• Safety, Documentation, etc.
• Standard Operating Procedures (SOPs)
• Computer Skills (Microsoft Office)
• Investigation Skills
• Technical Writing Skills
• Bilingual (English and Spanish)
• Speak, read and write

43
Quick Summary of Findings

• Academic backgrounds for most entry-level
  positions
• Most positions in QA, Manufacturing and Process
  Development areas require a BS in Science (i.e.,
  Biotechnology, Biology, Microbiology, Chemistry,
  Medical Technology) or Engineering
• Sample technical skills for selected job
  families
• Engineering Refrigeration Systems (HVAC),
  Purified and Distilled Water System,
  Automation-computerized control systems
  knowledge, PLC-Programmable Logistic Controllers
• Quality and Validation Electrophoresis,
  immunoassays, molecular biology techniques, HPLC
  (High Performance Liquid Chromatography), GC (Gas
  Chromatography), and TFF (Tangential Flow
  Filtration)
• Tech Ops Purification, separation, cell culture,
  chromatography, protein expression, particle
  analysis

44
Summary of Findings

• For several job families, talent can be moved
  from pharma to biotech operations to fulfill
  labor needs
• Applicable for Quality, Validation
  Manufacturing
• With minor changes to the existing college
  curriculums, universities can prepare a more
  skilled entry-level talent, resulting in a
  reduction of on-the-job training. Some of these
  areas include
• Courses in Six Sigma and GMP principles
• Scientific investigation/technical writing
  courses for students majoring in English,
  Humanities or Communications

45
Pharma Cluster Inter-Institutional Agreement
46
Life Sciences Value Chain

• Focus
• Drug Development ( RO1 )
• Clinical trials ( Pre-Clinicals, Phase I, II,
  III, IV )
• Manufacturing ( TT, Clinical Lots, Validation,
  PAI, Launch )
• Commercialization ( Licensees, JV, Royalties,
  others )

47
R D / Supply Chain Major Events
Pharmaceutical Industry
Phase 0 Phase 1
Phase 2 Phase 3

PDP
Draft Prod. Dev. Proposal (PDP)
Updated PDP
Updated PDP
Product development process assessment feedback
Phase IIb Trials
Phase III Trials
RD
Select dose
Preliminary Product Defn.
Market Container Stability Studies / Formal
Stability Study
APPROVAL
Final Formulation Composition
1st MAJOR LAUNCH
Final Bulk Manufacturing Process Development
Final Bulk Manufacturing Process Optimization
Bulk Factory Demonstration Validation
Bulk Methods Transfer Lab Qualification
Biobatch
Pharm Methods Transfer Lab Qualification
Site PAI Readiness
SUPPLY CHAIN (process, cost logistics)
Pharmaceutical Manufacturing Process Development
Pharmaceutical Process Engineering Run Large
Scale
Pharmaceutical Process Demonstration Validation
Packaging Development Probe Pack
Stability Product Characterization
Packaging Sites Selection
Process Support Optimization
Manufacturing Sites Selection
Conceptual Design Capital Requirements Plan
Spec Order Equipment
Build/Modify Factory
48
Academia
Key Areas of Strength (collaboration opportunity)
49
Academia
Key Areas of Strength (collaboration opportunity)
50
Academia Industry Agreement Goals

• The AIA four (4) primary goals are to
• Increase the number of scientists and engineers
  readily available for recruitment by the
  BioPharma Industry.
• Increase the level of competency and preparedness
  of scientists and engineers to reduce lag time
  from recruitment to productivity.
• Strengthen academic offerings to address current
  gaps by
• Increasing interconnectedness between
  scientific disciplines
• Increasing curricular flexibility to promote
  multi-disciplinary skills
• development in a multi-campus scenario. (Ex
  Brown U.)
• Increase RD preparedness by increasing research
  experiences in academic and industry settings.
• Leverage and complement areas of expertise and
  infrastructure to avoid redundancy among
  institutions and maximize knowledge contributions.

51
Thank You!!!

• For more information please visit our website
  www.induniv.org
• www.bioscience.org
• Or contact
• Carlos A. Tollinche, Ph.D.
• Scientific Affairs Director
• INDUNIV Research Consortium
• Tel [phone]
• E-mail ctollinche_at_induniv.org

52
Pathforward Guiding Principles

• Continue the to Provide the Forums for
  Communication among the sectors in the areas of
  workforce development and knowledge creation to
  maintain PR competitive
• Seek ways to address the Challenges of the
  Interconnection of the Sectors particularly the
  Collaboration among Academic Institutions in the
  areas of need for the industry.
• - Look for ways of assuring the programs meet
  industry requirements and
• depth to sustain process knowledge and
  science based decisions required by
• the regulatory agencies
• Establish an infrastructure to expand the
  experience of the students in the areas of
  employment to smooth the transition and prompt
  their early contributions to their
  industry/employment position
• Expand the School Outreach Program to Include the
  Vocational Schools Technological Institutes
• Increase Participation of Sectors Directly or
  Through Collaborations/Alliances
• Contribute and Facilitate the Life Sciences
  Roadmap initiatives as well as the Government
  Vision for Strategic Projects that are Aligned
  with our Plans