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: ctollinche@induniv.org

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