session 4.em conference 6 18 09 ma

Golden LEAF Biomanufacturing Training & Education Center (BTEC)

North Carolinas Biopharma Environment

marcelo_anderson@ncsu.edu

NC Evolution

NC Educational EnvironmentThe Opportunities

What this means for you

NC Bioscience EnvironmentHistorical, Today & Tomorrow

Open Discussion

Agenda

Recruit Support Place

NC Evolution

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

Consortium Partners

Industry

State of North Carolina

>$50MM

$7MM/yr for

operations for BTEC

$MM in donations

•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)

•B.S. in Pharmaceutical Sciences,

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

•M.S. in Drug Discovery or Biomanufacturing

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.

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

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

Bioprocessing Suite(Large Scale)

BTEC Offices Labs(Bench Scale)

Floor Plan – 1st Floor

Classrooms

Bioprocessing Suite(Intermediate)

Aseptic Suite

NCCCS Offices

Floor Plan – 2nd Floor

Future BL2

Space

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

Student Breakdown

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

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

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)

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

NC Educational Opportunities

•What does this mean for you?

• Undergrad & Grad

• Sharpening or Retooling

• Business, Leadership, Innovation

• Joint projects

• Collaborative Research

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

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

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

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

The Future

GLOCAL Delivery

Open Discussion