Fourth Annual
Community College Program
Puerto Rico’s Industry-Education Collaborative
Initiatives
Building Biomanufacturing Education and Training to Strengthen
the Workforce Infrastructure
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Carlos A. Tollinche, Ph.D.
Director of Scientific Affairs and Cluster Liaison
BIO Internatioal Convention - Boston
May 6, 2007
Agenda
• Introduction
• Overview of the Puerto Rico Life Science Industry
• INDUNIV Research Consortium
• The Clusters
• The Educational Infrastructure Committee
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
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.
About Puerto Rico
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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)
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No customs duties or quotas on shipments
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US Patent laws applied in Puerto Rico
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No inbound travel restrictions
Federal income tax exemptions
Products manufactured are "Made in the USA"
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.
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.
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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.
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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.
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Significant expertise in cGMP’s, process development, automation, quality control/assurance, FDA
and EMEA regulatory compliance, packaging, warehousing, and others.
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There are 79 FDA approved pharmaceutical and 58 medical device manufacturing plants
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Compliance Posture: Biologics New Pre-approval Installations approved without
observations
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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 Nation’s
Bioscience Sector: State Bioscience Initiatives 2006, Battelle Technology Partnership Practice and
STTI. http://www.bio.org/local/battelle2006/
The Regulated Life Science Sectors
Pharmaceutical and Biotech Companies
Medical Devices Companies
AgBio in Puerto Rico
Seeds – Winter Nurseries
AgReliant (Santa Isabel)
Monsanto (Isabela)
Rice Tec (Lajas)
Bayer (Sabana Grande)
Monsanto(Juana Díaz)
Syngenta (Salinas)
ICIA (Juana Díaz)
Mycogen (Santa Isabel)
Iowa State (Isabela)
Pioneer (Salinas)
Profile of PR Institutions
Offering Various Degrees in S&T
Interamerican University of Puerto
Rico at Aguadilla
•BS Biology
•BS Electronics Technology
•GA Applied Sciences in Nursing
University of PR,
at Aguadilla
•BS Quality Control in Manufacturing
•B Electronics Technology
•AD Natural Sciences
•AD Quality Control
•AD Electronics Technology
Antillean Adventist
University
•BA Biology
•BA Chemistry
•BS Cardio-pulmonary
•BS Biology
National College of Business and
Technology at Arecibo
•AD Pharmacy Assistant
Pontifical Catholic University of
Puerto Rico at Arecibo
•BS Biology
•BS General Sciences
University of Puerto Rico,
at Arecibo
•BS Biology
•BS Industrial Chemical Process
Technology
•AS Applied Sciences in Animal Health
•AD Nursing
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
Caribbean University at
Bayamón
•BS General Sciences (PreMedical)
•BS Civil Engineering
•BS Electrical Engineering
•BS Industrial Engineering
•AD Drafter and Engineering
Technology
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
Arecibo
Pontifical Catholic
University of Puerto Rico
at Mayagüez
•BS Biology
•BS General Sciences
•AD General Sciences
•AD Optical Sciences
•AD Chemistry Technology
Science
National College of Business
and Technology
•AD Pharmacy Assistant
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
Bayamón Central University
•BS Biology
•BS Environmental Sciences
•BS Chemistry
Central Universityof the
Caribbean
•MD Degree
•MS Biomedical Sciences
Manatí
Bayamó
n
San
Jua
n
Carolina
Gurabo
Mayagüez
Caguas
Barranquitas
San
Germán
Cayey
Ponce
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
•Ph.D. Chemical Engineering
•MS Biology
•MS Mathematics
•MS Applied Mathematics
•MS, Ph.D. Chemistry
•MS Managerial Systems
Guayama
Interamerican University of
Puerto Rico at San Germán
•BA Mathematics
•BS Biology
•BS Chemistry
•BS Electronics 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
Tecnological Institute of Puerto Rico at San
Juan
•AD Civil Engineering Technology
•AD Instrumentation Engineering Technology
San Juan Univesity College
•AD Electrical Engineering Technology
• AD Instrumentation
•AD Electronics-Biomedical Engineering
Technology
Technology
• AD Electronics Technology in
•AD Mechanical Industrial Engineering Technology
Instrumentation
•AD Chemical Engineering Technology
Univ. of PRTechnology
at San Juan ( Río
•AD Electronics Engineering
University of Puerto Rico, Medical
Piedras )
Sciences Campus
•BS Specialty in Environmental
• BS Veterinary Technology
Sciences
• Pharmacy Doctorate, MS Industrial
•BS, MS Mathematics
Pharma
•BS, MS Physics (Material
• BS Medical Technology
Sciences)
• Certificate Post BS Medical
•BS, MS, Ph.D. in Chemistry
Technology
•BS, MS, Ph.D. Biology
• Certifica Post BS Cytologic
•BS in General Sciences
• MD Degree
Electronic Data Processing
• Dentistry Degree
College
• Ph.D Public Health Specialty in
of PR, at Hato Rey (San Juan)
Environmental Health
•AD Electronics Technology
• Ph.D. Biomedical Sciences
Interamerican University
Metropolitan Univ. at
Univ. of the Sacred
of PR Metro Campus
Cupey
Heart
•BA Mathematics
•BS Applied Mathematics
•BS Biology
•BS Biology
•BS Chemistry
•BS Mathematics
•BS Chemistry
•BS Natural Sciences
•BS Chemistry
•BS Medical Technology
General
•BS Medical Technology
•BS Applied Physics
Polytechnic University of
•AD Environmental Quality
de Puerto Rico
•AD General Sciences
•BS Surveying
•BS Mechanical Engineering
•BS Environmental Engineering
•BS Civil Engineering
•BS Electrical Engineering
•BS Industrial Engineering
•BS Chemical Engineering
•MS Civil Engineering
Interamerican
•MS Managerial Engineering
University of PR at
•MS Competitive Manufacturing
Fajardo
•BS Biology
San Juan Bautista School
of Medicine
• MD Degree
Ponce School of Medicine
• MD Degree
• Ph.D. in Bio-Medical Sciences
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
Nova Southeastern University, Centro
Ext. Univ. Católica e Ponce
• Pharmacy Doctorate (PharmD)
Turabo University
at Gurabo
•BS Biology
•BS Eiectrical Eng.
•BS Mechanical
Eng.
•BS Chemistry
Interamerican University of
Puerto Rico at Barranquitas
•BS Biology
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)
Interamerican University of
Puerto Rico at Ponce
•BS Biology
•BS Environmental Sciences
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
Interamericana University of Puerto Rico
at Guayama
•BS Biology
•BS Chemical Technology
•AD Sciences Applied in Nursing
•AD Sciences Applied in Chemical
Technology
University Center
Colombia
•AD Digital Electronics
and Microprocessors
Huertas Junior College
•AD Electrical Technology
•AD Electronics Technology
•AD Industrial Technology
University of Puerto Rico
at Cayey
•BA Secondary Education in
Physics and Chemistry
•BS Biology / BS Chemistry
•BS Mathematics
•BS General Sciences
Program
Caribbean
University
at Carolina
•BS General
Sciences –Specialty
in Pre- Medical
University of Puerto Rico
at Carolina
•AD Industrial Automatization
•AD Mechanics Engineering
Specialty in Industrial Maintenance
•AD Automotive 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
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
The College of Natural Sciences
Students - Undergraduate
Leading U.S. Baccalaureate Institutions Of
U.S. Hispanic S&E Ph.D.s
(1999-2003)
UPR-Rio Piedras
UPR-Mayaguez
Univ. California Berkeley
Univ. of Texas Austin 72
FIU
Univ. California Los Angeles
MIT
264
136
86
60
58
57
Total of Degrees from US Institutions
6,189
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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 S&T Programs
Number of Degrees Conferred
in Science and Technology
2001-2005
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
S&T
19,290
39%
Total:
49,173
Other
29,883
61%
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
(partial list)
INDUSTRIAL BIOTECHNOLOGY PROGRAM AT UPR MAYAGUEZ
• The University of Puerto Rico at Mayagüez offers a Bachelor’s 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.
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• 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
BIOPROCESS TRAINING AND DEVELOPMENT CENTER
Facilities
Capabilities
• 17,300 sq ft Total;
8,600 sq ft bioprocess research labs
• Center will host over 20 researchers and technical
personnel
• Wet lab & multimedia workforce development service
suites
• Process improvement
• Microbial fermentation suite
• Mammalian cell culture suites
• Bio-analytical & biochemical characterization labs
• Purification suite
• Warehouse/raw material storage
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• Utilities
• Metrology lab
• Administration and amphitheater
• Troubleshooting
• Technology transfer
• Process adaptation and optimization
• Consulting
• Contracting
• Workforce development services for small and large
biotechnology industries
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”
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
INDUNIV Partners
• Southern Technology Council
• BIO State Associations Organization
• INTERPHEX , Reeds Exhibitions
– BIOPHEX, CA
– CORDIA, Vienna
• Penn Well Publications ( Clean Rooms )
• Alianza para el Desarrollo de PR
• Pharma Manufacturing Magazine .
• CANIFARMA, Mexico
• Manufacturers Assn., S&T Alliance
• PR Chamber of Commerce
• ISPE
• BEACON
Representative
Representative
Member
Member
Partner
Exchange
Member
Partner
Partners
Collaborators
Collaborators
INDUNIV Scope
• Educational / Research Dev.
– Innovation
• SAC R&D Grants > $2.5M
– Center of Excellence Dev.
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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
• Economic Development
– Clusters dev. & administration
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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)
• S&T Promotion
• Life Science Roadmap development
PR S&T Global Network
– Science Park Strategies
• Roosevelt Road Proposal to LRA
• Primate Research Center Funding
INDUNIV Members
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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 )
•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
Pharma Cluster
Vision:
PR is the preferred location to grow and
establish new Pharmaceutical operations
Priorities: 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, J&J
Daneris Fernandez ( Chair)
Dr.Jorge Velez Arocho, RUM
Ing.Dave Carberry, P&G
Lic. Lesbia Hernandez, CPM
Dr. Juan C. de los Santos
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
Ing. Juan Pablo Gutierrez - Amgen (Chair)
Dr.Carlos Tollinche-INDUNIV
Dr.Jose Torres, Ponce Med. School
Ing.Pablo Vila, Abbott
Ing.Julio Juarbe – Pall Biomedics
Dr. juan C. de los Santos Cluster Director
Lucy Cruz, Ag BIO
Lic. Boris Jaskille -PRIDCO
Dr.Rosa Buxeda-UPR-RUM
Dr. Brad Winner UPR – RP
Ing.Ramon Rijos, Ortho Bio.
Ing. Jose Correa – Taratec
Ing.Ivan Lugo- INDUNIV
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:
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Dr. Jose Torres – Ponce medical schoolLIC. Boris Jaskille, PRIDCO
Dr. Emma Fernández, UPR
Mr. Carlos Bonilla, Lilly Del Caribe
Dr. Jose Carlo- UPR-RCM
Mr. Carlos Bonilla, Lilly
Ing. Ivan Lugo INDUNIV
Dr. Miguel Vazquez, Pfizer ( chair)
Dr. Carlos A. Tollinche, INDUNIV
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
Clusters & Initiatives Convergences
Pharma Cluster
Bioscience Alliance
Pharma Unit Operations Pilot
Bioprocess Complex
Ag Bio
Permits Time Reduction
Educational Infrastructure Committee
Workforce Development (WIA, CETA,Certifications)
Cogeneration Initiative
Environmental &
Energy Cluster
Infrastructure Initiatives
Supply Chain Forum
Construction Cluster
Clinical Trials
Biocompatibility Research
Health Council
Medical Devices
Cluster
Why an Involvement In Educational
Initiatives?
Basis & Background:
• INDUNIV involvement in educational activities precedes
the formation of the clusters consistent with its Initial
Charter
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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.
Life Science Clusters
Scope of Workforce Development for All Sectors &
Their Interconnection for Their Preparations
Government (PRIDCO / DE / WIA)
Scope
University
Dev. of Workforce
Research
• Basic
• Applied
• Scholarship Programs
• Support to Learning
Centers
• Commitments to Centers
of Excellence
Industry
Suppliers
•Incipient Industries
•Suppliers & Service
•Multinational Plants
Industry Sector
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.
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
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)
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
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
Educational Infrastructure Committee (CIE)
Life Science Sectors Involved
Core Committee
Life Science Clusters
Bioscience
Cluster
Pharmaceutical
Cluster
AdHoc Operational
Committees According
To Initiatives
Collaborations with
PRMA & Others
Other Clusters
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•
Medical Device
& Health Council
Areas of Focus (Interconnection of Sectors)
• Colloquiums “Encuentros Academia–Industria”
** August 2004 (CPM) – Attendance 50 persons (Chancellors, Deans,
Directors and Industry Representatives including GM’s)
** September 30, 2004 (Mayaguez Resort) – Attendance 62 Persons from
Industry / Academia / CES (Chancellors, Deans, Directors, GM’s, 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
Significant Accomplishments
Fundamental Achievements
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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 S&T 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
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
- Batelle’s 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)
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
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 S&T areas.
** Vocational - Tech School Education – Internships Program for
Teachers – Currently working in the proposal
** To Organize a Summit to Showcase the S&T 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 S&T 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) & Governor’s Youth Office (Internships)
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)
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 GMP’s, SOP’s, 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
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
Quick Summary of Findings
Besides technical skills, the following are general
skills required for most positions:
• Good Manufacturing Practices (GMP’s)
–Safety, Documentation, etc.
•
•
•
•
•
Standard Operating Procedures (SOP’s)
Computer Skills (Microsoft Office)
Investigation Skills
Technical Writing Skills
Bilingual (English and Spanish)
–Speak, read and write
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 system’s
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
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
Pharma Cluster –
Inter-Institutional Agreement
Life Sciences Value Chain
Universities
& Research
Institutes
Academic
Research
Bio-Pharmaceutical
Business
Medicine & Healthcare
Management
Basic
Sales
Research &
Drug
Clinical Trials Manufacture
Screening
Marketing
Drug
Development
QA/QC
Diagnostics
Distribution
Discovery
Insurance
Business
or Public
Funding
Point of Care
Treatment Administratn
• 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 )
Payment
Pharmaceutical Industry
R & D / Supply Chain Major Events
Phase 0
Phase 1
Draft Prod. Dev.
Proposal (PDP)
Phase 2
PDP
Phase 3
Updated PDP
R&D
Phase IIb Trials
Updated PDP
Product development process
assessment & feedback
Phase III Trials
Select dose
Preliminary Product Defn.
Market Container Stability Studies / Formal Stability Study
APPROVAL
Final Formulation
Composition
SUPPLY CHAIN
(process, cost & logistics)
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
Pharmaceutical Manufacturing Process Development
Packaging Development
Probe Pack Stability
Product Characterization
Manufacturing Sites
Selection
Site PAI Readiness
Pharmaceutical Process
Engineering Run Large Scale
Packaging Sites
Selection
Conceptual Design
& Capital
Requirements Plan
1st MAJOR
LAUNCH
Spec & Order
Equipment
Pharmaceutical Process
Demonstration & Validation
Process Support
& Optimization
Build/Modify
Factory
Academia
Key Areas of Strength (collaboration opportunity)
DRUG DISCOVERY
PRE-CLINICAL
PHASE I-II-III-IV
UPR-RCM
Pharmacy
Medicine
UPR-RP
Chemistry
Computer
Business
UPR-RCM
Animal
Primate Center
UPR-RP
Chemistry
Biology
UPR-RCM
Ponce School of Medicine
UMET
Science & Technology
UPR-M
Química
Mathematics and Science
INTER-BAYAMON
Natural Science
TURABO
Chemistry
Ponce School of Medicine
SUPPORT:
UMET: Nursing
UPR-RCM: Public Health
U Católica: Nursing
UPR-M: Nursing
UPR-RP: Enfermería y
Natural Science
UMET
Universidad Del Este
TURABO
School of Health Sciences
TURABO
School of Health Sciences
Academia
Key Areas of Strength (collaboration opportunity)
DRUG
DEVELOPMENT
UPR-RP
Chemistry
UPR-RCM
Pharmacy
UPR-M
Chemistry
Chem. Eng.
TURABO
Chemistry
API /
FORMULATION
UPR-M
Chemistry
Chem. Eng.
UPR-RCM
Pharmacy
POLYTECHNIC
Science &
Technology
UPR-RP
Chemistry
Science &
Technology
INTER-Bayamon:
Engineering
TURABO
Chemistry / CETA
Biology
MANUFACTURE COMMERCIALIZATION
TURABO
POLYTECHNIC
UPR-M
Chem. Eng.
UPR-RCM
Pharmacy
Univ. Pontificia
Católica
UPR-RP
Business School
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 R&D 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.
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: 787-772-4604 / 787-772-9011
E-mail: [email protected]
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
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Educational Infrastructure Committee - Bio-Link