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Golden LEAF Biomanufacturing Training & Education Center (BTEC) North Carolinas Biopharma Environment [email protected]

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About BTEC and Why to relocate to NC

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Page 1: Session 4.Em Conference 6 18 09 Ma

Golden LEAF Biomanufacturing Training & Education Center (BTEC)

North Carolinas Biopharma Environment

[email protected]

Page 2: Session 4.Em Conference 6 18 09 Ma

NC Evolution

NC Educational EnvironmentThe Opportunities

What this means for you

NC Bioscience EnvironmentHistorical, Today & Tomorrow

Open Discussion

Agenda

Recruit Support Place

Page 3: Session 4.Em Conference 6 18 09 Ma

NC Evolution

Page 4: Session 4.Em Conference 6 18 09 Ma

Evolution -RTPNumber of Employees 1997 2007>10,000 1 15,000-1,000 1 11,000-4,999 3 7500-999 5 5250-499 7 8<250 93 150Did not report 18 0Total 128 172

Page 5: Session 4.Em Conference 6 18 09 Ma
Page 6: Session 4.Em Conference 6 18 09 Ma

Consortium Partners

Industry

State of North Carolina

>$50MM

$7MM/yr for

operations for BTEC

$MM in donations

Page 7: Session 4.Em Conference 6 18 09 Ma

•Capstone (Wake Tech CC)

•Bioprocessing (Pitt CC)

•BioEd (Gaston CC)

•Pharmaceutical Center (Forsyth CC & Guilford Tech CC)

•BioAg (Robeson CC)

•BioBusiness (Asheville-Buncombe Tech CC)

•Validation Academy (Wake Tech)

Page 8: Session 4.Em Conference 6 18 09 Ma

•B.S. in Pharmaceutical Sciences,

• Concentration in bioanalytical chemistry, protein separation sciences or molecular cloning

•M.S. in Drug Discovery or Biomanufacturing

Page 9: Session 4.Em Conference 6 18 09 Ma

BTEC MissionThrough its unique facilities and excellent staff, the Golden LEAF Biomanufacturing Training and Education Center (BTEC) provides a wide variety of high-quality educational and training opportunities to

develop skilled professionals for the biomanufacturing industry, thus contributing to the social and economic wellbeing of the industry and the state.

Page 10: Session 4.Em Conference 6 18 09 Ma

BTEC Advisory Board

Industry• Biogen-Idec• Biolex• Catalent• Diosynth• Eisai• GSK• KBI BioPharma• Merck• Novartis• Novo-Nordisk• Novozymes• Talecris Biotherapeutics• Wyeth NCCCS

• Econ. Dev.• BioNetwork

NCCCS• Econ. Dev.• BioNetwork

NCBCNCBC

Suppliers• ABB• Sartorius-Stedim

Suppliers• ABB• Sartorius-Stedim

NCBIO/BMFNCBIO/BMF

Golden LEAF FoundationGolden LEAF Foundation

BRITEBRITE

NCSU• Dean, College of Engineering• VC, Research & Grad. Studies• Dept Head, Genetics• Director, Biotechnology Program

Page 11: Session 4.Em Conference 6 18 09 Ma

BTEC OrganizationDirector

Assoc. Director, Strategic Support

Asst Director, Student Coordinator

Mgr, Student Programs

Operations Managers

Asst. Director, F&AIT Support

Purchasing Admin Support

Sr. Instructional Designer

Media Developer

Lab Manag

ers

Assoc. Director, Academic

Programs

Faculty Lecturers

Executive Asst. DirectorExecutive Assistant

Assoc. DirProcess

Development

Asst. DirAnalytical

NCSU 16/36 = 44%

Other Academia = 4/36 = 12%

Industry = 16/36 = 44%

Pre-BTEC Experience

Page 12: Session 4.Em Conference 6 18 09 Ma

Bioprocessing Suite(Large Scale)

BTEC Offices Labs(Bench Scale)

Floor Plan – 1st Floor

Classrooms

Page 13: Session 4.Em Conference 6 18 09 Ma

Bioprocessing Suite(Intermediate)

Aseptic Suite

NCCCS Offices

Floor Plan – 2nd Floor

Future BL2

Space

Page 14: Session 4.Em Conference 6 18 09 Ma

Current Capacity = current space, equipment, headcount

Proposed Capacity = after up-fitting additional space, equipment purchases, hiring

EnrollmentsCourse

Summer/ Fall 2007

Spring2008

Summer/ Fall 2008

Spring 2009

Current Capacity

Proposed Capacity

SCIBLS 12 n/a 15 n/a 15 20

Intro to Drug Dev & Careers 12 37 38 29 100 200

Bench-scale courses 11 26 56 59 75 120

Animal Cell Culture (BIT) n/a 22 16 37 25 45

Intermediate-scale courses 8 8 4 38 40 75

Large-scale courses 20 16 7 18 35 50

New Courses: Expression Systems, Tissue Eng.,CC Eng. , BIT 463, BIT 495

n/a n/a 9 43 50 50

Advise CHE 451 groups n/a 23 n/a 25 25 25

Undergraduate Independent Research Projects

0 5 2 2 5 10

Total 63 137 147 260 300 545

Page 15: Session 4.Em Conference 6 18 09 Ma

Student Breakdown

Page 16: Session 4.Em Conference 6 18 09 Ma

FDA Contract

• Bioprocessing – Onsite COMPLETED on May 20 - 22

• QC/Analytical - Onsite COMPLETED on August 12-14

• Engineering - Onsite COMPLETED on November 18 - 20

• Aseptic Processing

• Negotiating for subcontract with NCCCS (Wake Tech) for development work

• Onsite COMPLETED on February 24-26

• FDA picked up option year

Page 17: Session 4.Em Conference 6 18 09 Ma

Short Courses• Format

• 0.5 - 4 days duration

• >50% laboratory

• Completed

• Chromatography, Ferm Engineering & Operations

• Available

• Bioreactors for Cell Culture : 6/23 - 6/25/2009

• Biologic Formulation Science Fundamentals : 6/30- 7/01/09

• cGMP Fermentation Operations : 7/07- 7/09/09

• Single-Use Bioreactor Technology : 7/14 - 7/16/09

• Fermentation Engineering : 7/21 - 7/23/09

Page 18: Session 4.Em Conference 6 18 09 Ma

Corporate Outreach

• Development projects

• Testing agreements (5)

• Laboratory space use (2)

• Sponsored development (5)

• Training plans

• Boot camp (2)

• Customized training (DHS & FDA)

• Senior Design Projects (14)

• Apprenticeships (10)

Page 19: Session 4.Em Conference 6 18 09 Ma

Recruit Support Place• HS Students• NCCCS Transfers• Industry Professionals

Industry- Ready

Graduates

• Career Fairs• Teacher Workshops• Recruiting Trips• Promotional Literature• SCIBLS• Tours

• One-on-one• ISPE Student Chapter• Student Projects• Presentation Skills

• Co-op/Internship Options• Industry Information• Job Fairs• Resume Help• Interview Practice

Creating Value for Students and Industry

Page 20: Session 4.Em Conference 6 18 09 Ma

NC Educational Opportunities

•What does this mean for you?

• Undergrad & Grad

• Sharpening or Retooling

• Business, Leadership, Innovation

• Joint projects

• Collaborative Research

Page 21: Session 4.Em Conference 6 18 09 Ma

NC Bioscience• #3, >520, >$82,000, $1 & $45 Billion

• Amino Acid, Biofuel, BioPharma, Biotechnology, CRO, Dairy, Devices, Diagnostics, DNA, Enzyme, Food Products, Bioag, Tox and Vaccines

• Academic Research Centers

• NCBC, 7 Science Parks & NCBIOIMPACT

• Fastest Growing, Most Profitable

Source NC Biotech Center

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1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 -

100

200

300

400

500

600

165 177

209 215 227

259

318

356

421

482

526 f(x) = 3.22610722610723 x² − 2.04055944055942 x + 168.842424242424R² = 0.993487147363117

NC Bioscience Companies

P<1e-6

Source NC Biotech Center

Page 23: Session 4.Em Conference 6 18 09 Ma

Mountains to the Sea

Source NC Biotech Center

1-45-1011-2021-100>100

Eastern Region (17) - 74

Southeastern Region (6) - 64

Western Region (17) - 48

Greater Charlotte Region (10) - 197

Piedmont Triad Region (11) - 175

RTP Region (10) - 941

1499 Companies State-wide

Page 24: Session 4.Em Conference 6 18 09 Ma

Mountains to the Sea

North-Carolina-Map.org

Functional Foods1.5 billion, NC Research Campus

Nutraceuticals#2 Biodiversity

Bioinformatics, Charlotte Research Institute, University Research Park

Regenerative Medicine, Gateway University Research Park, Piedmont Triad Research Park

RTP & Centennial Campus

Marine Science

Biofuels Center

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The Future

GLOCAL Delivery

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Open Discussion