Southern Indiana Life Sciences Training Institute Sengyong Lee Ph.D. Associate Professor/Program Chair Ivy Tech Community College Bloomington, IN BIO 2007

The State of Indiana and the city of Bloomington

Biotechnology in the State of Indiana  4.5 percent Life Sciences Job Increases rate  300,000 direct employees in health Industry  The second-highest concentration of biopharmaceutical jobs in the nation and ranking 8th in the nation in employment in biopharmaceuticals  Ranked 10th in the nation for projected biopharmaceutical job increases from 2004 to 2014  Top 10 in medical devices manufacturing in the country

South Central Indiana and the city of Bloomington  Major shift from traditional manufacturing to biotech manufacturing  Over 5,000 employees already in biopharmaceutical and medical device industries  New biotechnology programs at IU and ITCC  Strong regional partnership in promoting opportunities in Life Sciences industry and education

Biotech Companies in South Central Indiana  Contract Biomanufacturing  Medical Device Manufacturing BioConvergence TM

Ivy Tech Community College Bloomington Indiana  Community College System in Indiana 14 Regional Campuses with about 100,000 students  Bloomington Campus 14 th regional campus

Biotechnology Program at ITCC  Start up Grant from Lilly Endowment 2003 Skills and Knowledge Standards for Associate Degree in Biotechnology developed by Baxter, Eli Lilly, Roche Diagnostics, IHIF  Six regional campuses offering the new Biotechnology Program 2004 Bloomington, Evansville, Indianapolis, South Bend, Terra Haute, West Lafayette

Biotechnology Program at ITCC Bloomington  AS and AAS Degrees in Biotechnology AS – a degree transfer agreement with Indiana University AAS – technical training  Current Enrollment – 109 students 38 in AS and 71 in AAS  Certificate Programs Biomanufacturing & Medical Device Manufacturing Technician Certificate, BIO-HIRE, etc

Southern Indiana Life Sciences Training Institute Project at ITCC Bloomington  Strong local needs for Biotech workforce development 1,500 new jobs in next five years – by BLSP But limited training resources  A new Life Sciences Training Institute 25,000 ft 2, three classrooms, four labs, a training suite & offices Expected to be completed in 2008  Funding Sources $5 million from the local County Government ITCC Bloomington National Science Foundation ( Advance Technology Education)

Southern Indiana Life Sciences Training Institute Project at ITCC Bloomington

 Main Training Spaces Biomanufacturing Pilot Plant – Process Simulation Upstream process lab Downstream process lab QC analytical lab Device & Equipment Training suite

Southern Indiana Life Sciences Training Institute Project at ITCC Bloomington

 Curriculum & Certificates on Specific Topics BMTC, Aseptic Processing, Gowning, Metrology, Documentation, Environment Monitoring, Equipment operation, etc  Biomanufacturing Process Simulation (Pilot Plant) Contract manufacturing service Training & education opportunities using real manufacturing environment

Biomanufacturing Pilot Plant  Small to mid scale biomanufacturing facility; Upstream, downstream, filling, packaging, QA & QC, etc  A full time faculty, a lab assistant, and student interns – in house internship opportunity

Biomanufacturing Pilot Plant cGMP standard? Advisory board’s strong recommendation; Too much regulatory burden for an academic program to maintain Biomanufacturing Pilot Plant

 Biomanufacturing cGMP standard; API manufacturing for market or clinical trials cGMP compliance – FDA ISO 6 Class 1000 cleanroom, Testing & Documentation, etc Tight manufacturing schedule Biomanufacturing Pilot Plant

Limited access for trainees Biomanufacturing Pilot Plant

 cGLP Standard Biomanufacturing Pilot Plant Manufacturing for nonclinical lab study Contract manufacturing services for; Process development, nonclinical studies like agricultural, X-ray crystallography, etc  Reduces the regulatory burden on testing & paper work  Allows better access to trainees Biomanufacturing Pilot Plant

Extra Benefits;  Service learning opportunity; Providing DNA and protein samples to K-12 science labs  K-12 teachers professional development workshop  Career awareness - field trip opportunities for K-12 students Biomanufacturing Pilot Plant

 Collecting data from companies and users  Get hard information on the set up and optimization  Help to replicate in other places & raise awareness of things to think about before starting to build.