fourth annual community college program puerto rico’s industry-education collaborative initiatives...
TRANSCRIPT
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
• 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)
• 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"
U.S.A.
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.
– 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 cGMP’s, 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 Nation’s Bioscience Sector: State Bioscience Initiatives 2006, Battelle Technology Partnership Practice and STTI. http://www.bio.org/local/battelle2006/
Pharmaceutical and Biotech Companies
Medical Devices Companies
The Regulated Life Science Sectors
Monsanto (Isabela)
Syngenta (Salinas)
Pioneer (Salinas)
AgReliant (Santa Isabel)
Mycogen (Santa Isabel)
Monsanto(Juana Díaz)
ICIA (Juana Díaz)
Bayer (Sabana Grande)
Rice Tec (Lajas)
Iowa State (Isabela)
AgBio in Puerto RicoSeeds – Winter Nurseries
Profile of PR Institutions
Offering Various Degrees in S&T
San Juan
Carolina
Gurabo
Caguas
Hum
acao
Fajard
o
Guayama
Cayey
Bayamón
Barranquitas
ManatíArecibo
Ponce
San Germán
Mayagüez
Aguad
illa
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
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
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
Interamericana University of Puerto Rico at Guayama
•BS Biology•BS Chemical Technology•AD Sciences Applied in Nursing•AD Sciences Applied in Chemical 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)
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
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
Pontifical Catholic University of Puerto Rico
at Mayagüez•BS Biology•BS General Sciences•AD General Sciences•AD Optical Sciences•AD Chemistry Technology Science
Antillean Adventist University
•BA Biology•BA Chemistry•BS Cardio-pulmonary•BS Biology
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
Interamerican University of Puerto Rico at San Germán
•BA Mathematics•BS Biology•BS Chemistry•BS Electronics Technology
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
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
Interamerican University of PR at
Fajardo•BS Biology
Turabo University at Gurabo
•BS Biology•BS Eiectrical Eng.•BS Mechanical Eng.•BS Chemistry
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
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
Ponce School of Medicine• MD Degree• Ph.D. in Bio-Medical Sciences
Nova Southeastern University, Centro Ext. Univ. Católica e Ponce
• Pharmacy Doctorate (PharmD)
Interamerican University of Puerto Rico at Barranquitas
•BS Biology
Interamerican University of Puerto Rico at Ponce
•BS Biology•BS Environmental Sciences
San Juan Univesity College • AD Instrumentation Technology• AD Electronics Technology in Instrumentation
San Juan Bautista School of Medicine
• MD Degree
Electronic Data Processing College
of PR, at Hato Rey (San Juan)
•AD Electronics Technology
Caribbean University at Bayamón
•BS General Sciences (Pre-Medical)•BS Civil Engineering•BS Electrical Engineering•BS Industrial Engineering•AD Drafter and Engineering Technology
National College of Business and Technology
•AD Pharmacy Assistant
Bayamón Central University•BS Biology•BS Environmental Sciences•BS Chemistry
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
Central Universityof the Caribbean
•MD Degree•MS Biomedical Sciences
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
Huertas Junior College•AD Electrical Technology•AD Electronics Technology•AD Industrial Technology
University Center Colombia
•AD Digital Electronics and Microprocessors
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
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
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
Univ. of the Sacred Heart
•BS Biology•BS Mathematics•BS Chemistry•BS Medical Technology
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
A Leading Source of Engineering Talent
UPR at Mayagüez1st graduating Hispanics2nd graduating Women4th in Chemical8th in Industrial14th in Electrical18th in Computer20th in Mechanical
Source: ASEE
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 S&E 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 Institutions6,189
Leading S&T Programs 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)
Number of Degrees Conferred in Science and Technology
2001-2005
Total: 49,173
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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.
•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
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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
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”
• 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 Guiding Principles
• 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., S&T Alliance Partner• PR Chamber of Commerce Partners• ISPE Collaborators• BEACON Collaborators
INDUNIV Partners
INDUNIV Scope• Educational / Research Dev.
– Innovation• SAC R&D 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
• 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)• 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 • 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- BayamonCaribbean Central U. Med. School•Caribbean Industrial Construction•Caribbean Project Management •Washington Group•GilbaneGilbane•SKANSKASKANSKA•CH2MHILL- Lockwood GreenCH2MHILL- Lockwood Green•Kelly Services •Penn Well Publications, CleanRoomsPenn Well Publications, CleanRooms•Plaza ConsultingPlaza Consulting•PraxairPraxair•Pall Life SciencesPall Life Sciences•PacivPaciv•INTERPHEX
Board of Directors: 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
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
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
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 -PRIDCODr.Carlos Tollinche-INDUNIV Dr.Rosa Buxeda-UPR-RUMDr.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 – TaratecDr. juan C. de los Santos Cluster Director Ing.Ivan Lugo- INDUNIV
Biotech Cluster
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, PRIDCODr. Emma Fernández, UPR Dr. Jose Carlo- UPR-RCMIng. Ivan Lugo INDUNIVDr. Carlos A. Tollinche, INDUNIV
Clusters & Initiatives ConvergencesPharma
ClusterBioscience Alliance
Bioprocess Complex
Educational Infrastructure Committee
Pharma Unit Operations Pilot
Permits Time Reduction
Infrastructure Initiatives
Supply Chain Forum
Cogeneration Initiative
Environmental & Energy Cluster
Biocompatibility ResearchClinical Trials
Workforce Development (WIA, CETA,Certifications)
Medical Devices Cluster
Health Council
Construction Cluster
Ag Bio
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
Industry
Government (PRIDCO / DE / WIA)
UniversitySuppliers
Dev. of WorkforceResearch• Basic • Applied
•Incipient Industries•Suppliers & Service •Multinational Plants Industry Sector
Scope
Scope of Workforce Development for All Sectors & Their Interconnection for Their Preparations
• Scholarship Programs• Support to Learning Centers • Commitments to Centers of Excellence
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.
Promoting a Culture of Continuous
Interrelations of the Sectors
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 - 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
Other Clusters• Medical Device• & Health Council
Collaborations with
PRMA & Others
AdHoc Operational Committees According
To Initiatives
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
• 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
• 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)
Accomplishments “Local 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)
Culture of Continuous Interrelations Focus on Regional Alliances
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
• 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 )
Basic Research &
Drug Discovery
Academic Research
Drug Development
Clinical Trials Manufacture QA/QC
Sales Marketing
Distribution
Screening Diagnostics Treatment
Point of Care Administratn Payment
Universities & Research Institutes
Bio-Pharmaceutical Business
Medicine & Healthcare Management
Insurance Business or Public Funding
R & D / Supply Chain Major Events
Product development process assessment & feedback
PDP
Phase IIb Trials
SU
PP
LY
CH
AIN
(pro
cess, co
st & lo
gistics)
R&
D
Draft Prod. Dev. Proposal (PDP)
Phase 0 Phase 1 Phase 2 Phase 3
Updated PDP
Select dose
Phase III Trials
Updated PDP
Preliminary Product Defn. Market Container Stability Studies / Formal Stability Study
Pharmaceutical Manufacturing Process Development
Final FormulationComposition
Final Bulk ManufacturingProcess Development
Final Bulk ManufacturingProcess Optimization
Bulk Methods Transfer& Lab Qualification
Packaging DevelopmentProbe Pack Stability
Product Characterization
Biobatch
Pharmaceutical Process Engineering Run Large Scale
Pharmaceutical Process Demonstration & Validation
Pharm Methods Transfer& Lab Qualification
Site PAI Readiness
Manufacturing SitesSelection
Bulk Factory Demonstration & Validation
Packaging SitesSelection Process Support
& Optimization
Conceptual Design & Capital
Requirements Plan
Spec & OrderEquipment
Build/ModifyFactory
APPROVAL
1st MAJOR LAUNCH
Pharmaceutical Industry
DRUG DISCOVERY PRE-CLINICAL PHASE I-II-III-IV UPR-RCM Pharmacy Medicine
UPR-RCM Animal Primate Center
UPR-RCM Ponce School of Medicine
UPR-RP Chemistry Computer Business
UPR-RP Chemistry Biology
SUPPORT: UMET: Nursing UPR-RCM: Public Health U Católica: Nursing
UPR-M: Nursing UMET Science & Technology
Ponce School of Medicine
UPR-RP: Enfermería y Natural Science
UPR-M Química Mathematics and Science
UMET Universidad Del Este
INTER-BAYAMON Natural Science
TURABO Chemistry
TURABO School of Health Sciences
TURABO School of Health Sciences
Academia
Key Areas of Strength (collaboration opportunity)
DRUG DEVELOPMENT
API / FORMULATION
MANUFACTURE COMMERCIALIZATION
UPR-RP Chemistry
UPR-M Chemistry Chem. Eng.
TURABO UPR-RP Business School
UPR-RCM Pharmacy
UPR-RCM Pharmacy
POLYTECHNIC
UPR-M Chemistry Chem. Eng.
POLYTECHNIC Science & Technology
UPR-M Chem. Eng.
TURABO Chemistry
UPR-RP Chemistry Science & Technology
UPR-RCM Pharmacy
INTER-Bayamon: Engineering
Univ. Pontificia Católica
TURABO Chemistry / CETA Biology
Key Areas of Strength (collaboration opportunity)Academia
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