STARTING A BIOTECHNOLOGY PROGRAM

WHERE DO I START?

• 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.

• 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

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.

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

Eye-balling and Traversing the Bioscience Industries Workforce Development Arena

-Observations Over the Past 15 Years-

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)

The Workforce Development Landscape

Federal

Agencies

Regional/City& CountyAgencies

StateAgencies

Constellation of Actors in the Theaterof Workforce Development

?????

County DD

NSF/NIH

DOL

City DD

StateEDD

CCDistrict

1-Stop Centers 1-Stop Centers

State CC Office

DOE

Cos & Non-Profits

County WIB

City WIB

DOC

Research and Product

Development

Manufacturing and Production

Technical Affairs

Information, Finance and

Administration

Sales and Marketing

Research and Product

Development

Manufacturing and Production

Technical Affairs

Information, Finance and

Administration

Sales and Marketing

Layers of Complexity

?????

CountiesCCDs

NSF/NIH

DOL

CitiesCDDs

StateEDD

CCDistrict

X 1 -Stop Centers

X 1 -Stop Centers

State CC Office

DOE

Cos & Non-Profits

Counties WIBs

Cities WIBs

DOC

The Take Home Lesson

Trade Organizations to the Rescue!

T-ORG

CountiesCCDs

NSF/NIH

DOL

City DD

StateEDD

CCDistrict

X 1 -Stop Centers

X 1 -Stop Centers

State CC Office

DOE

Cos & Non-Profits

Counties WIBs

Cities WIBs

DOC

Human Capital

IntellectualCapital

Financial Capital

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

Regional Integrator

Industry Cluster Industry Cluster

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

T-ORGs

County DD

NSF/NIH

DOL

City DD

StateEDD

CCDistrict

1-Stop Centers 1-Stop Centers

State CC Office

DOE

Non-Profits

County WIB

City WIB

DOC

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

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

WIB, etc. & Naïve Understanding of the Biotech Industry

RecombDNA

1990

MonoclonalAntibodies

GeneTherapy

SmallMoleculesAntisense

RecombDNA

MonoclonalAntibodies

1985

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

Knowledge of Training Ingredients?

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

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

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

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

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?

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

another agenda at work?….

Trade Organizations to the Rescue!

T-ORG

CountiesCCDs

NSF/NIH

DOL

City DD

StateEDD

CCDistrict

X 1 -Stop Centers

X 1 -Stop Centers

State CC Office

DOE

Cos & Non-Profits

Counties WIBs

Cities WIBs

DOC

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