National center for therapeutics manufacturing m.pishko ccp13


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Technicians' Role in Growing the Bioeconomy

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National center for therapeutics manufacturing m.pishko ccp13

  1. 1. • Academic Degrees• Certificate Programs• Professional Development• Industry Short Courses• Workshops• STEM Outreach Programs• InternshipsPROGRAMSTo provide therapeutics manufacturingeducation, training, and outreach programsto support the development of an educatedand skilled pharmaceutical workforceproficient in process development,production systems, standard operatingprocedures, and regulatory guidelines.MISSIONNCTM
  2. 2. 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 environmentThe National Center for TherapeuticsManufacturing (NCTM) is a multi-disciplinaryworkforce education and biopharmaceuticalmanufacturing center focused on developingskilled professionals for existing and emergingbiotech and pharmaceutical industries. TheNCTM is located on the Texas A&M Universitycampus in College Station, Texas.
  3. 3. NCTM PROGRAM DEVELOPMENT ACTIVITIESNCTMFor more information about therapeuticsmanufacturing programs and training,please visit our website at: WorkforceCommissiongrant awardedDECEMBERPhase I:Curriculumassessment& industrysurveysAll corecurriculacompleteMARCHInitiatedInternshipProgramFEBRUARYPhase III:CurriculumdevelopmentJUNEEstablishedprogramadvisoryboardMAYMARCHPhase II:SME kick-off &course pre-workPhase IV:Coursefinalization& submissionJANUARY2010 20122011BeganoutreachactivitiesOCTOBERHostedinaugural STEMsummer campsJUNEFacilitiesequipping andpreparednessFALLPilot shortcourses tobegin2013SPRINGSACS approvedassociateprogramsJULY
  5. 5. NCTM ACADEMIC PROGRAMSUndergraduate Certificate inTherapeutics ManufacturingAssociate of Applied Science (AAS)Degree in Therapeutics ManufacturingAdvanced Technical Certificate inTherapeutics ManufacturingAvailable now Available now Under developmentA 12 credit hour certificate that educatesengineering baccalaureate graduates on how toeconomically, ecologically, and safely designand operate equipment used for the productionand separation of biological materials.A 69 credit hour degree designed to be completedin two years. This AAS degree offers enhancedtraining in cGMP, quality assurance and control,and biomanufacturing processes necessary forpharmaceutical production.A 21 credit hour certificate which will allowqualified students with an aligned associate orbachelor’s degree to pursue a short-trackeducational path for immediate employment inthe therapeutics manufacturing environment.Required Course: Required Courses: Required Courses:MATH 1314: College Algebra BITC 1411: Introduction to BiotechnologyCHEM1411: General Chemistry IBITC 1411: Introduction to BiotechnologyChoose One Additional Required Course: BIOL 1406: General Biology I BITC 2371: Facility Operations and SafetyBITC 2371: Facility Operations & SafetyBMEN 282: Engineering Biology BITC 2431: Cell Cultures TechniquesCHEN 382: Bioprocess Engineering BIOL 2421: MicrobiologyChoose Two Electives:CHEN 436: Systems BiologyISEN 303: Engineering Economical AnalysisSpeech ElectiveBITC 2374: Drug Product ManufacturingCHEN 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 ManufacturingSocial Science ElectiveENGL 1301: Composition & RhetoricBITC 2471: cGMP Procedures &Humanities ElectiveBITC 2386: Internship in TherapeuticsManufacturingBITC 1371: Introduction to TherapeuticsManufacturingBITC 1375: Quality Systems forTherapeutics ManufacturingBAEN 302: Biological and Ag EngineeringFundamentals IICHEN 489/BAEN 489: Introduction toBioseparationsBITC 1371: Introduction to TherapeuticsManufacturingBITC 1302: Biotechnology LaboratoryMethods & TechniquesCHEN 471/BAEN 471: Introduction toBiochemical Engineering BITC 1375: Quality Systems in TherapeuticsManufacturingISEN 360: Lean Thinking/LeanManufacturing in BiotechnologyBITC 1191: Special Topics in TherapeuticsManufacturingCHEM2470: Introduction to Organic &BiochemistryCHEN 489: Safety in Pharmaceutical andBiotechnology IndustriesBITC 2471: cGMP Procedures andDocumentationNCTM partners with a consortium ofeducators, including Texas A&MUniversity, Blinn College, and the TexasA&M Engineering Extension Service, toprovide these programs.Available to students beginning in Fall2013.Program provides>110 contact hoursof technical instructionNCTM provides a broad spectrum ofeducational opportunities, includingcontract short courses, certificate anddegree programs.
  6. 6. I’m Contagious……but I’m developing the cure!This week-long camp is designed to provide high school students with an introduction to thepharmaceutical industry. We examine the R&D-to-commercialization pipeline that bringsa medical discovery to the market. Campers have the opportunity to participate in excitinghands-on laboratory projects, like working with recombinant DNA. They also experiencebehind-the-scenes activities at local biotechnology and pharmaceutical companies and some of TexasA&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, 2012NCTM
  7. 7. NCTM
  8. 8. SubcontractingProduce ImplementationScheduleAssign Program PersonnelIdentify SpecificWorkforce Needs forCIADMQ4Q12012 2013Phase III CompleteBegin Phase IV:Finalization ofCoursesQ1Pilot Short Courses onExisting CurriculumBegin Phase II:Curriculum Developmentfor New TrainingQ2Phase II CompleteEquipment PurchasesCompleteBegin Phase III:Curriculum Enhancement/ExpansionQ32014Distance LearningEducation DevelopmentWorkforce TrainingContinuesInternship ProgramContinuesQ3Phase IV CompletePilot Training on AllCurriculum (Existing &New)Program MaintenanceQ2Repeat Cycle forContinualImprovementsMaintainWorkforceReadiness EffortsQ4Initiate RecruitmentCampaignExpand Advisory BoardInternship ProgramExpansion & PilotingPhase I CompleteTraining Needs Assessment forCIADM WorkforceBegin Phase I: CurriculumInventory & AssessmentPurchase Equipment& SuppliesAssign Instructional PersonnelCIADM WORKFORCE DEVELOPMENT PROGRAMAUG 2012 – Texas A&M Engineering Experiment Station (TEES) was approved by the Department ofHealth and Human Services and awarded a $22.7 million subcontract by the A&M System to lead andmanage the therapeutics manufacturing and advanced development workforce training programs forthe Texas A&M Center for Innovation in Advanced Development and Manufacturing.Q4