national center for therapeutics manufacturing m.pishko ccp13

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Technicians' Role in Growing the Bioeconomy

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Page 1: National center for therapeutics manufacturing m.pishko ccp13
Page 2: National center for therapeutics manufacturing m.pishko ccp13

• Academic Degrees• Certificate Programs• Professional Development• Industry Short Courses• Workshops• STEM Outreach Programs• Internships

PROGRAMS

To provide therapeutics manufacturing education, training, and outreach programs to support the development of an educated

and skilled pharmaceutical workforce proficient in process development,

production systems, standard operating procedures, and regulatory guidelines.

MISSION

NCTM

Page 3: National center for therapeutics manufacturing m.pishko ccp13

NCTM EDUCATIONAL FACILITY FEATURES:

NCTM

• Two teaching wet labs accommodating 40 students each

• A cell culture facility

• A 50 work station computer laboratory

• A 3,500 sq. ft. cubicle study/teaming area

• Locker facilities for 100 students

• Two large lecture halls for students & conferences

• A mock cGMP process suite with gowning facilities, Sartorius and GE bioreactors, and AKTA skids to simulate a commercial environment

The National Center for Therapeutics Manufacturing (NCTM) is a multi-disciplinary workforce education and biopharmaceutical manufacturing center focused on developing

skilled professionals for existing and emerging biotech and pharmaceutical industries. The

NCTM is located on the Texas A&M University campus in College Station, Texas.

Page 4: National center for therapeutics manufacturing m.pishko ccp13

NCTM PROGRAM DEVELOPMENT ACTIVITIES

NCTM

For more information about therapeutics manufacturing programs and training, please visit our website at:

http://nctm.tamu.edu/

Texas Workforce Commission grant awarded

DECEMBE

R

Phase I: Curriculum assessment & industry surveys

All core curricula completeM

ARCH

InitiatedInternship Program

FEBRUAR

Y

Phase III:Curriculum developmentJU

NE

Established program advisory board

MAY

MARCH Phase II:SME kick-off & course pre-work

Phase IV: Course finalization& submissionJA

NUAR

Y2010 20122011

Began outreach activitiesO

CTOBE

RHosted inaugural STEM summer campsJU

NE

Facilities equipping and preparednessFA

LL

Pilot short courses to begin

2013

SPRIN

G

SACS approved associate programsJU

LY

Page 5: National center for therapeutics manufacturing m.pishko ccp13

EDUCATIONAL PROGRAMS

NCTM

Page 6: National center for therapeutics manufacturing m.pishko ccp13

NCTM ACADEMIC PROGRAMSUndergraduate Certificate in

Therapeutics ManufacturingAssociate of Applied Science (AAS)

Degree in Therapeutics ManufacturingAdvanced Technical Certificate in

Therapeutics Manufacturing

Available now Available now Under development

A 12 credit hour certificate that educates engineering baccalaureate graduates on how to

economically, ecologically, and safely design and operate equipment used for the production

and separation of biological materials.

A 69 credit hour degree designed to be completed in two years. This AAS degree offers enhanced

training in cGMP, quality assurance and control, and biomanufacturing processes necessary for

pharmaceutical production.

A 21 credit hour certificate which will allow qualified students with an aligned associate or

bachelor’s degree to pursue a short-track educational path for immediate employment in the therapeutics manufacturing environment.

Required Course: Required Courses: Required Courses:MATH 1314: College Algebra BITC 1411: Introduction to BiotechnologyCHEM 1411: General Chemistry IBITC 1411: Introduction to Biotechnology

Choose One Additional Required Course: BIOL 1406: General Biology I BITC 2371: Facility Operations and SafetyBITC 2371: Facility Operations & Safety

BMEN 282: Engineering Biology BITC 2431: Cell Cultures TechniquesCHEN 382: Bioprocess Engineering BIOL 2421: Microbiology

Choose Two Electives:CHEN 436: Systems Biology

ISEN 303: Engineering Economical AnalysisSpeech ElectiveBITC 2374: Drug Product Manufacturing

CHEN 489/BAEN 489: Bioreactor Design BITC 2431: Cell CultureCHEN 489: Bioprocess Control BITC 2411: Biotech Lab InstrumentationCHEN 489: Designing for Flexibility BITC 2373: Drug Substance Manufacturing

Social Science ElectiveENGL 1301: Composition & RhetoricBITC 2471: cGMP Procedures & Humanities ElectiveBITC 2386: Internship in Therapeutics Manufacturing

BITC 1371: Introduction to Therapeutics Manufacturing

BITC 1375: Quality Systems for Therapeutics Manufacturing

BAEN 302: Biological and Ag Engineering Fundamentals II

CHEN 489/BAEN 489: Introduction to Bioseparations

BITC 1371: Introduction to Therapeutics Manufacturing

BITC 1302: Biotechnology Laboratory Methods & TechniquesCHEN 471/BAEN 471: Introduction to

Biochemical Engineering BITC 1375: Quality Systems in Therapeutics Manufacturing

ISEN 360: Lean Thinking/Lean Manufacturing in Biotechnology

BITC 1191: Special Topics in Therapeutics Manufacturing

CHEM 2470: Introduction to Organic & Biochemistry

CHEN 489: Safety in Pharmaceutical and Biotechnology Industries

BITC 2471: cGMP Procedures and Documentation

NCTM partners with a consortium of educators, including Texas A&M University, Blinn College, and the Texas A&M Engineering Extension Service, to provide these programs.

Available to students beginning in Fall 2013.

Program provides >110 contact hours of technical instruction

NCTM provides a broad spectrum of educational opportunities, including contract short courses, certificate and degree programs.

Page 7: National center for therapeutics manufacturing m.pishko ccp13

I’m Contagious…

…but I’m developing the cure!

This week-long camp is designed to provide high school students with an introduction to the pharmaceutical industry. We examine the R&D-to-commercialization pipeline that brings

a medical discovery to the market. Campers have the opportunity to participate in exciting hands-on laboratory projects, like working with recombinant DNA. They also experience

behind-the-scenes activities at local biotechnology and pharmaceutical companies and some of Texas A&M’s most elite centers, to learn more about careers in research, engineering, and biomanufacturing.

NCTM STEM SUMMER CAMPJune 4-8, 2012 and June 18-22, 2012

NCTM

Page 8: National center for therapeutics manufacturing m.pishko ccp13

NCTM

Page 9: National center for therapeutics manufacturing m.pishko ccp13

SubcontractingProduce Implementation ScheduleAssign Program PersonnelIdentify Specific Workforce Needs for CIADM

Q4

Q1

2012 2013Phase III CompleteBegin Phase IV: Finalization of CoursesQ1

Pilot Short Courses on Existing CurriculumBegin Phase II: Curriculum Development for New TrainingQ2

Phase II CompleteEquipment Purchases CompleteBegin Phase III: Curriculum Enhancement /Expansion

Q3

2014Distance Learning Education DevelopmentWorkforce Training ContinuesInternship Program ContinuesQ3

Phase IV CompletePilot Training on All Curriculum (Existing & New)Program Maintenance

Q2 Repeat Cycle for Continual ImprovementsMaintain Workforce Readiness Efforts

Q4Initiate Recruitment CampaignExpand Advisory BoardInternship Program Expansion & PilotingPhase I Complete

Training Needs Assessment for CIADM WorkforceBegin Phase I: Curriculum Inventory & AssessmentPurchase Equipment & SuppliesAssign Instructional Personnel

CIADM WORKFORCE DEVELOPMENT PROGRAMAUG 2012 – Texas A&M Engineering Experiment Station (TEES) was approved by the Department of Health and Human Services and awarded a $22.7 million subcontract by the A&M System to lead and manage the therapeutics manufacturing and advanced development workforce training programs for the Texas A&M Center for Innovation in Advanced Development and Manufacturing.

Q4