innovative and new programs in biotechnology and biomanufacturing

83
ia Wallman cutive Director, NBC2 uary 13, 2012 – Bio-Link Conference Partnerships

Upload: bio-link

Post on 31-Oct-2014

783 views

Category:

Documents


3 download

DESCRIPTION

This year’s panel features programs noteworthy in their approach to biotechnology/biomanufacturing education and training and the workforce. Panelists include leaders of the Lone Star Biotechnology Institute at Lone Star College working with the local biomedical and biofuels industry in Houston, TX; the Biomass Production Training Certificate at Mira Costa College part of the EDGE (Educating and Developing Workers for the Green Economy) initiative for San Diego County, CA; the SoCalBio Biomanufacturing Consortium to develop biomanufacturing technician education and training programs to support the maturation of the industry in Los Angeles/Orange Counties, CA; and a new program, Biotechnology and Compliance, focusing on biomanufacturing and partnered with local industry at Quincy College in Quincy, MA

TRANSCRIPT

Page 1: Innovative and New Programs in Biotechnology and Biomanufacturing

Sonia WallmanExecutive Director, NBC2January 13, 2012 – Bio-Link Conference

Partnerships

Page 2: Innovative and New Programs in Biotechnology and Biomanufacturing

Partnerships

Community colleges traditionally have been tasked to support local industry by providing apt education and training for their industries.Key to this role are academia-industry partnerships and grants that support the development of such strategic alliances (NSF ATE and DOL ETA grants, for instance).Research questions that arise to understand these relationships are:What are the characteristics of effective partnerships and collaborations?How are they developed and how are they sustained?

Page 3: Innovative and New Programs in Biotechnology and Biomanufacturing

NBC2 Partnerships Case Study12 partners were interviewed by Dr. Joanna Kile,

their conclusions were: Have a product and stay focused on delivering it.

Partnerships exist in the relationship: the more points of connection the stronger the relationship

Build trust by committing and then following throughRecognize that a successful partnership is a long-term commitment

Identify champions within the group Solicit the opinion of all partners

Be prepared to give more than to receive Share your success stories

Forget what you have done in the past; find out what you need in order to be in business five years from now.

Page 4: Innovative and New Programs in Biotechnology and Biomanufacturing

NBC2 Biomanufacturing Products

GBC Laboratory Manual generic and customized Introduction to Biomanufacturing textbook Biofuels Production and Analysis textbook and lab manual Protein is Cash Teachers Workshop BIOMAN Annual Conference Adult 360hr/12wk Biomanufacturing Certificate Hybrid post-baccalaureate 120hr/15wk BIOMAN Certificate Future = modular curriculum to suit local biomanufacturing

needs; provision of supplies for teaching the modules

Page 5: Innovative and New Programs in Biotechnology and Biomanufacturing

Virtual Biomanufacturing Production

Page 6: Innovative and New Programs in Biotechnology and Biomanufacturing

Panelists Introduction

Danny Kainer from Lonestar Community College in Houston, TX

Bruce Van Dyke from Quincy College in Quincy, MA

Steve Dahms from SoCalBio in Los Angeles/Orange Counties, CA

Page 7: Innovative and New Programs in Biotechnology and Biomanufacturing

A thumbnail sketch of our college

system

• Is now the 2nd largest community college system in Texas

• Opened in 1973 (as North Harris College) with anenrollment of 613 students and 15 staff members

• ~80,000 credit students; >90,000 if one includesCE!

• The LSC System coversover 1,400 square miles& includes 11 memberschool districts!

Page 8: Innovative and New Programs in Biotechnology and Biomanufacturing

My personal favorite…

• >13,000 students

LSC-Montgomery• Only biotechnology program in

the LSC system, which is the oldest in the state & is recognized by TSSB

Page 9: Innovative and New Programs in Biotechnology and Biomanufacturing

LSCBI – AAS & ATC Programs

SECOND YEAR

Page 10: Innovative and New Programs in Biotechnology and Biomanufacturing

LSCBI - Graduates

Page 11: Innovative and New Programs in Biotechnology and Biomanufacturing

LSCBI – Outreach

Page 12: Innovative and New Programs in Biotechnology and Biomanufacturing

LSCBI Partners (a sampling)

Page 13: Innovative and New Programs in Biotechnology and Biomanufacturing

Taking our Biotechnology

Institute in a New Direction

Page 14: Innovative and New Programs in Biotechnology and Biomanufacturing

On Campus Research

Opportunities1. Algae-to-Oil

http://community.middlebury.edu/~cri/biodiesel_cycle.png

http://www.inhabitat.com/wp-content/uploads/algae6.jpg

http://www.freepatentsonline.com/6923914-0-large.jpg

http://ejournal.vudat.msu.edu/images/thumb232.jpg

2. Oil-to-Biodiesel3. Water Remediation4.Microbial Fuel Cells

Page 15: Innovative and New Programs in Biotechnology and Biomanufacturing

Received Generous Donations & Loans from

local algae entrepreneurs (Thanks!)

Page 16: Innovative and New Programs in Biotechnology and Biomanufacturing

Algal Culture

Page 17: Innovative and New Programs in Biotechnology and Biomanufacturing

PBR Construction (lab scale)

Page 18: Innovative and New Programs in Biotechnology and Biomanufacturing

PBR Construction (mid-scale)

Page 19: Innovative and New Programs in Biotechnology and Biomanufacturing

The “Tea Cup” PBR

Page 20: Innovative and New Programs in Biotechnology and Biomanufacturing

PBR Construction (mid-scale)

Page 21: Innovative and New Programs in Biotechnology and Biomanufacturing

PBR Construction (commercial scale)

Page 22: Innovative and New Programs in Biotechnology and Biomanufacturing

Inoculation

Page 23: Innovative and New Programs in Biotechnology and Biomanufacturing

Flow Cytometry (with a visual

twist!)

Page 24: Innovative and New Programs in Biotechnology and Biomanufacturing

Flow Cam Project –Contamination

DetectionContamination detection (wow – that Chlorella vulgaris sure is robust!)

Page 25: Innovative and New Programs in Biotechnology and Biomanufacturing

Flow Cam Project – Cell

Count Validation

Page 26: Innovative and New Programs in Biotechnology and Biomanufacturing

Flow Cam Project – Nile

Red Lipid Analysis

http://omlc.ogi.edu/spectra/PhotochemCAD/html/nilered.html

Page 27: Innovative and New Programs in Biotechnology and Biomanufacturing

Algal Nutraceuticals

Page 28: Innovative and New Programs in Biotechnology and Biomanufacturing

WVO-to-Biodiesel Project

Page 29: Innovative and New Programs in Biotechnology and Biomanufacturing

WVO-to-Biodiesel Project

FeedstockLibrary Biodiesel

Library

LowerToxicity

Page 30: Innovative and New Programs in Biotechnology and Biomanufacturing

WVO-to-Biodiesel Project

Page 31: Innovative and New Programs in Biotechnology and Biomanufacturing

Biodiesel Project - Biorefinery

Page 32: Innovative and New Programs in Biotechnology and Biomanufacturing

Biorefinery

http://oilgae.com/includes/site_img/origin_oil.jpg

Page 33: Innovative and New Programs in Biotechnology and Biomanufacturing

WVO-to-Biodiesel Project

Page 34: Innovative and New Programs in Biotechnology and Biomanufacturing

MFCs: Electricity From Mud!

http://i.treehugger.com/images/2007/10/24/microbial%20fuel%20cell-jj-001.jpghttp://i.treehugger.com/images/2007/10/24/microbial%20fuel%20cell-jj-001.jpg

http://parts.mit.edu/igem07/index.php/Image:Spbfc.jpg

Page 35: Innovative and New Programs in Biotechnology and Biomanufacturing

Microbial Fuel Cell Project

Page 36: Innovative and New Programs in Biotechnology and Biomanufacturing

Molecular Biology & Microbial Fuel

Cells?

Page 37: Innovative and New Programs in Biotechnology and Biomanufacturing

WaterBioremediatio

n

Page 38: Innovative and New Programs in Biotechnology and Biomanufacturing

Water Remediation Project

Page 39: Innovative and New Programs in Biotechnology and Biomanufacturing

Water Remediation Project

Page 40: Innovative and New Programs in Biotechnology and Biomanufacturing

Bionanotechnology?

Page 41: Innovative and New Programs in Biotechnology and Biomanufacturing

Nanotech & Algae?

Page 42: Innovative and New Programs in Biotechnology and Biomanufacturing

Nanotechnology & Microbial Fuel

Cells?

Page 43: Innovative and New Programs in Biotechnology and Biomanufacturing

Nanotechnology & Microbial Fuel

Cells?

Page 44: Innovative and New Programs in Biotechnology and Biomanufacturing

Nanotechnology & Microbial Fuel

Cells?

Page 45: Innovative and New Programs in Biotechnology and Biomanufacturing

Nanotechnology & Water

Remediation?

(http://www.gizmag.com/go/6448/)“Nano Rust”

Page 46: Innovative and New Programs in Biotechnology and Biomanufacturing

Thanks for your attention!

Page 47: Innovative and New Programs in Biotechnology and Biomanufacturing

STARTING A BIOTECHNOLOGY PROGRAM

WHERE DO I START?

Page 48: Innovative and New Programs in Biotechnology and Biomanufacturing

• College Performs a Gap Analysis – What is missingType of training

Research (biomedical, environmental, biofuels)Manufacturing (drugs, medical devices)

First Things First

Will the college support the program?FinanciallyFaculty Support

• Primary Purpose of the ProgramGet students job after completing the program?Prepare them to transfer to a university to obtain a B.S.

Page 49: Innovative and New Programs in Biotechnology and Biomanufacturing

• Incumbent worker training – Short CoursesExpanding your student baseState and local biotechnology initiative grants

• Make sure the program aligns with industry needsYou can’t do this on your ownWhat state and local organizations track biotechnology

• Focus the program – Do not dilute student learning by being to broad based

• Corporate Partners – Who you know and who they knowThe primary way of getting in the doorThis opens the door to internships

Page 50: Innovative and New Programs in Biotechnology and Biomanufacturing

The most surprising aspect of starting the Biotechnology &

Compliance program

The willingness of companies to work with me on every aspect of the program and to make commitments of time and resources to enable the program to produce competent students ready to enter the workforce.

Page 51: Innovative and New Programs in Biotechnology and Biomanufacturing

Developing New Workforce Training Programs and Platforms: The Catalytic Role of Bioscience Trade Associations in Defibrillating Companies, College

Administrators and Faculty, WIBs, 1-Stop Centers and Government Agencies

A. Stephen Dahms President and CEO Emeritus, Alfred E. Mann Foundation

Vice President Academic, Industry and Government Affairs, So. California Biomedical Council Member Federal Emerging Technology and Research Advisory Committee

Page 52: Innovative and New Programs in Biotechnology and Biomanufacturing

Eye-balling and Traversing the Bioscience Industries Workforce Development Arena

-Observations Over the Past 15 Years-

Page 53: Innovative and New Programs in Biotechnology and Biomanufacturing

SEC DisclaimerChair, WF/Education Committees 1995-2006 (BODs)

– BIOCOM, BayBio, SoCalBio– California Healthcare Institute– Addressed the full span of regional WF development

activities -> national and international level, including the medical device arena (AdvaMed)

Chair, BIO WF Development Committee 1996-2007 (BIO/ECS BOD and BOD Committees 1994-2008)

– DOC, DOE, NSF, DOL, NIH, BLS, GAO, Beltway groups– House and Senate Science/Labor Committees– NRC/NAS/IOM/NAE: GUIRR, Federal Demonstration Pship– International organizations: EU and OECD (1998-2008) – Professional scientific societies– H1B visas, Skills Standards, training needs (#s and areas)

Page 54: Innovative and New Programs in Biotechnology and Biomanufacturing

The Workforce Development Landscape

FederalAgencies

Regional/City& CountyAgencies

StateAgencies

Page 55: Innovative and New Programs in Biotechnology and Biomanufacturing

Constellation of Actors in the Theaterof Workforce Development

?????County DD

NSF/NIH

DOLCity DD

StateEDD

CCDistrict

1-Stop Centers

State CC Office

DOE

Cos & Non-Profits

County WIB

City WIB

DOC

Page 56: Innovative and New Programs in Biotechnology and Biomanufacturing

Research and Research and Product Product

DevelopmentDevelopment

Manufacturing Manufacturing and Productionand Production

Technical Technical AffairsAffairs

Information, Information, Finance and Finance and

AdministrationAdministration

Sales and Sales and MarketingMarketing

Page 57: Innovative and New Programs in Biotechnology and Biomanufacturing

Research and Research and Product Product

DevelopmentDevelopment

Manufacturing Manufacturing and Productionand Production

Technical Technical AffairsAffairs

Information, Information, Finance and Finance and

AdministrationAdministration

Sales and Sales and MarketingMarketing

Page 58: Innovative and New Programs in Biotechnology and Biomanufacturing

Layers of Complexity

?????

CountiesCCDs

NSF/NIH

DOL

CitiesCDDs

StateEDD

CCDistrict

X 1 -Stop Centers

State CC Office

DOE

Cos & Non-Profits

Counties WIBs

Cities WIBs

DOC

Page 59: Innovative and New Programs in Biotechnology and Biomanufacturing

The Take Home Lesson

Page 60: Innovative and New Programs in Biotechnology and Biomanufacturing

Trade Organizations to the Rescue!

T-ORG

CountiesCCDs

NSF/NIH

DOLCity DD

StateEDD

CCDistrict

X 1 -Stop Centers

State CC Office

DOE

Cos & Non-Profits

Counties WIBs

Cities WIBs

DOC

Page 61: Innovative and New Programs in Biotechnology and Biomanufacturing

Human Capital

IntellectualCapital

Financial Financial CapitalCapital

The Trade Organization: Integrator of Regional Inputs to Build Industry Clusters

Regional IntegratorRegional Integrator

Industry ClusterIndustry Cluster Industry ClusterIndustry Cluster

Page 62: Innovative and New Programs in Biotechnology and Biomanufacturing
Page 63: Innovative and New Programs in Biotechnology and Biomanufacturing

T-ORGS: a WF development coordinator, organizer, catalyst and nucleating device…often a defibrillator

T-ORGsCounty DD

NSF/NIH

DOLCity DD

StateEDD

CCDistrict

1-Stop Centers

State CC Office

DOE

Non-Profits

County WIB

City WIB

DOC

Page 64: Innovative and New Programs in Biotechnology and Biomanufacturing

Problems Facing T-ORGs in WF Development-Cities and Counties-

• Often naïve understanding of the playing field by the players: understanding of technology…some still bemoaning the loss of the buggy-whip industry

• Layers of complexity…especially in megacities• Pre-existing, high-walled political bailiwicks• Historical partnering among the players and segmentation

difficult to change: breaking up the “party”…divorces are difficult

• Time-lines for completion of projects: triage vs. long-term solutions

• “Project Product”: sustainability vs. triage• Players lack of understanding of the necessary resources

Page 65: Innovative and New Programs in Biotechnology and Biomanufacturing

Problems Facing T-ORGs in WF Development-Cities and Counties-

• Unreasonable expectations of the WF development arena regarding companies

• CC’s: administrators, role of non-academic training operations, multiple CC’s aiming for the same targets, unrealistic expectations of companies, survey impacts, moving off the “molecular biology” raison d’etre dime

• T-ORG BOD’s: regional, state, and national• 2-year -> 4-year institutional programs: regionally-approved,

industry validated layered, stackable certificates• Research universities: often a considerable problem:

understanding the critical role of CC’s, intrusion into CC space, sparse laboratory training in some universities

• A battle of wills…and entrenched public service organizations very adept at survival

Page 66: Innovative and New Programs in Biotechnology and Biomanufacturing
Page 67: Innovative and New Programs in Biotechnology and Biomanufacturing
Page 68: Innovative and New Programs in Biotechnology and Biomanufacturing

WIB, etc. & Naïve Understanding of the Biotech Industry

RecombDNA

1990

MonoclonalAntibodies

GeneTherapy

SmallMoleculesAntisense

RecombDNA

MonoclonalAntibodies

1985

Page 69: Innovative and New Programs in Biotechnology and Biomanufacturing

Complexity of the Biotech Industry 2009-27 Years after 1986-

DNA-basedcomputation

Bioinformatics(Data management &

Data mining)

Proteomics- Computationalexpression analysis drug design

Genetic Novel Profiling Pharmacogenomics chemistries

Micro-arrays &nanotechnologies

Combinatorialchemistry

Biosensors

Highthroughputscreening

Genetherapy

RecombinantDNA technologies

Anti-sense RNAi, etc.

MAbs& phage display

Multiplexed Array of Technologies

Page 70: Innovative and New Programs in Biotechnology and Biomanufacturing
Page 71: Innovative and New Programs in Biotechnology and Biomanufacturing
Page 72: Innovative and New Programs in Biotechnology and Biomanufacturing

Knowledge of Training Ingredients?

Page 73: Innovative and New Programs in Biotechnology and Biomanufacturing
Page 74: Innovative and New Programs in Biotechnology and Biomanufacturing

Wouldn’t It Be Nice If It Were This Easy!!

Page 75: Innovative and New Programs in Biotechnology and Biomanufacturing

Regulatory Affairs Clinical AffairsQuality Built into core business courses for all

center degrees

5.0 FDA Compliance 3.3 Optimizing of chromatographic techniques4.5 IND, NDA and other regulatory submissions 3.3 Pharmacokinetics4.5 cGMP, GCP and GLP 3.3 Pharmacodynamics4.2 Clinical trial design and modeling 3.3 Drug discovery-Conventional & rational drug design4.1 Technical writing 3.3 Functional genomics4.1 cGMP documentation 3.3 Proteomics4.1 Process validation 3.3 Small molecule manufacturing & scale-up issues4.0 Project management 3.3 Toxicology and toxicokinetics4.0 Team-based approaches 3.3 Sterilization4.0 Analytical methods development and validation 3.2 Facility design4.0 Materials and document control 3.2 Principles of industrial hygiene4.0 cGMP training 3.2 Biotechnology and drug design3.9 Quality and production 3.2 General pharmaceutical science3.9 Regulatory strategies and negotiation 3.2 Design controls3.9 Clinical trial statistical analysis 3.2 Facility management3.9 Principles of information systems 3.2 Basic biochemical engineering3.8 Clinical data management 3.2 Combinatorial chemistry3.8 Implementation of clinical trials 3.1 Pharmaceutical delivery systems3.8 Control systems 3.1 Manufacturing execution systems3.8 Clinical trials administration 3.1 Separation and purification3.8 Team-based approaches in biotech. dev. & production 3.1 Protein stability and formulation3.8 cGMP audits 3.0 Statistical process control3.7 International regulatory affairs and ISO-9000 3.0 Pharmacoeconomics3.7 Systems documentation 3.0 Manufacturing personnel training3.6 Facility validation 2.9 Instrumentation in downstream monitoring3.6 Global CMC (chemistry, manufacturing and control) 2.9 Bio/pharmaceutical technology mgmt.3.6 Clinical trials audits 2.9 Mgmt. of development & tech.-based innovation3.5 Corporate partnering 2.8 Combinatorial biology3.5 Regulatory affairs professional training 2.8 Bio/pharmaceutical marketing3.5 CRA training 2.8 Computers in bioprocess engineering3.5 Process development strategies 2.8 Mammalian cell perfusion reactors3.5 Bioinformatics 2.7 Fermentation strategies3.5 Good statistical practices in drug development 2.7 Drug release technology3.5 Statistical process control 2.6 Robotics in drug discovery3.4 Hazardous waste management 2.6 Mgmt. & organizational behavior3.4 Electronic document management and submissions 2.4 Biochemical reactor design & configuration3.4 Pharmaceutical formulation and stability 2.3 Intelligent biomanufacturing3.4 Pharmacogenetics3.4 Computer and software validation3.4 Communications3.4 Manufacturing process technologies3.4 Operation scheduling

Page 76: Innovative and New Programs in Biotechnology and Biomanufacturing

Points of Attack of T-ORGs in WF Development“Sector Intermediary Role”

-Cities and Counties-

• Facilitating an increased understanding of the playing field • Removing layers of complexity…especially in megacities• Circumventing or removing high-walled political bailiwicks• Expanding partnering among the technologically-naïve players• Encouraging departure from total reliance on triage approaches• Demanding sustainability• Educating the players on the true costs of training in the 21st century• Embracing CC administrators and engaging them in solutions• Catalyzing applied research and manufacturing programs: faculty training• Stimulation of specialized training facilities, especially in the megacities• Education of T-ORG boards of directors• Creating regionally-approved, industry validated layered, stackable certificates• Constant education of the research universities• Outreach to federal agencies• Triage of the DOL

Page 77: Innovative and New Programs in Biotechnology and Biomanufacturing

Problems Facing T-ORGs-Operating In the Sphere of the DOL, one person’s experiences-

• Hooray…T-ORGs are recognized as Sector Intermediaries, but...there are DOL focal problems

– Little DOL concept of need for sustainability

– Little DOL concept of training costs– Entry-level employee predominant

focus– Reorientation of Congressional

mandates– “Spread the Geld” political mentality– Reviewers: Invaders from Planet X

• Underdeveloped appreciation of true vs. interpolated WF needs

– H1B Training Skills RFP case in point

Page 78: Innovative and New Programs in Biotechnology and Biomanufacturing
Page 79: Innovative and New Programs in Biotechnology and Biomanufacturing

H1B’s in the Biotechnology Industry 2000-2007

• 6-10% of the biotech WF = 18,000• 80% passed through US higher education• Degrees: in red, composition of the US biotech WF

– 40% PhD (19%)– 35% MS (17%)– 20% BS (50%)– 5% MD– 0% AA/AS/vocEd (14%)

• 85% acquired permanent residency ($150M)• And the role of the DOL is exactly what in addressing this

dependency upon foreign nationals?

Page 80: Innovative and New Programs in Biotechnology and Biomanufacturing

What is/was the DOC Thinking? Is it really making the H1B problem go away…or is there

another agenda at work?….

Page 81: Innovative and New Programs in Biotechnology and Biomanufacturing

Trade Organizations to the Rescue!

T-ORG

CountiesCCDs

NSF/NIH

DOLCity DD

StateEDD

CCDistrict

X 1 -Stop Centers

State CC Office

DOE

Cos & Non-Profits

Counties WIBs

Cities WIBs

DOC

Page 82: Innovative and New Programs in Biotechnology and Biomanufacturing

T-ORGs: A Firm Foundation on Which to Coordinate and Facilitate Workforce Development

Page 83: Innovative and New Programs in Biotechnology and Biomanufacturing