Agenda August 02, 2016 Welcome • Recognition of Sponsors • Update ACC Biotechnology and Medical Devices Program • Nishi Viswanathan, Dell Medical School Health Product Innovation Team • Networking Break • Patti Rossman “It’s All About Timing Establishing Your QMS” • Rebecca Jones McKnight J.D. DLA Piper Update On Current Issues Surrounding The Medical Device Community • Med TechTx 2016 Update Adjourn
Thank you to our sponsors August 2, 2016
Biotechnology at ACC Sangeetha Krishnan
Overview of Biotech Department • Works with the local bioscience industry to educate students in basic laboratory skills, math skills, genetic engineering, protein purification, cell culture, quality assurance and quality control principles, regulations, bioinformatics, computer skills, ethics, documentation, and teamwork
Overview of Biotech Department Students are educated to work in a variety of • positions that span different kinds of fields including pharmaceutical, molecular diagnostics, manufacturing, research and cancer research, fisheries and wildlife, and cell culture
Overview of Biotech Dept • The Biotechnology Program has a separate preparation room, and cell culture and storage room at both facilities and a shared lecture and instrumentation room • Students are taught on equipment such as real-Time PCR machines, HPLCs, FPLCs, GCs, laminar flood hoods, fluorescent scopes, bioreactors and fermenters, NanoDrop spectrophotometers, and bioanalyzers
Current Programs Level One – Certificate in Biotechnology • • Level Two – Certificate in Biomanufacturing • Associates of Applied Science in Biotechnology • Advanced Technical Certificate in Biotechnology
Level One Certificate in Biotechnology Entry level • • Provides students basic laboratory training in a regulated environment • Prepares students to function as entry level lab technicians in biosciences labs 18 credit hours •
Level Two Certificate in Biomanufacturing Entry level • • Provides students the basic skills for a biomanufacturing job • Enter the workforce quickly • 44 credit hours
Associates of Applied Science (AAS) in Biotechnology • Comprehensive two-year program • Includes general academics and specialized biotech training for working in biosciences laboratories • Provides students with more advanced knowledge in cell culture, instrumentation, and molecular techniques such as qPCR • Internship in industry required • 60 credit hours
Advanced Technical Certificate in Biotechnology Designed for graduate-level students who already • hold a bachelor’s or associate’s degree • For students who are interested in updating their skills or transitioning into a biotech career • Advanced hands-on training 30 credit hours •
New Biomedical Devices Program • Will commence in 2017 • Innovative, first of its kind, hands on program designed with input from area employers • Enables students to gain mid-level technical skills appropriate for Biomedical Device careers • Intended to meet the needs of continued growth of expanding numbers of biomedical companies in the Central Texas area • Offers a one-year Certificate, a Level Two Certificate, and an AAS degree in Biomedical Devices
New Biomedical Devices Program • Courses include: • Introduction to Medical Devices • Introduction to 3-D Fabrication • Instrumentation and Data Analysis • Establish a Biomedical device laboratory with industry appropriate state-of-the-art equipment
Texas Health Catalyst & Health Product Innovation @ Dell Medical School TMDA meeting August 2 nd , 2016 Nishi Viswanathan, MBBS, MBA Associate Director, Translational Research & Innovation Dell Medical School
Health Product Innovation Team Ruben Rathnasingham, PhD Asst. Dean, Health Product Innovation rubenr@austin.utexas.edu Nishi Viswanathan, MBBS, MBA Associate Director, Translational Research & Innovation nishi.viswanathan@austin.utexas.edu Robin Richardson Project Manager, Health Product Innovation robin.richardson@austin.utexas.edu
Health Innovation Product Goals • Identify promising ideas and support their translation toward clinically and commercially viable solutions that improve health outcomes • Create a pipeline of healthcare innovation at UT that commercialization partners are eager to take to market. • Strategy – solve unmet needs, as opposed to supporting technologies – invite industry to participate in defining the target profiles of clinically and commercially viable solutions that solve these unmet needs create an ecosystem to maximize success – • First initiative: Texas Health Catalyst
Texas Health Catalyst Awards Process
Texas Health Catalyst Awards Process
Texas Health Catalyst Awards Process
#TXHealthCatalyst Partners Eligibility UT Austin faculty Seton Healthcare clinicians Dell Medical School clinical affiliates What about companies?
Texas Health Catalyst Advisors Leveraging Central Texas healthcare ecosystem to: Evaluate UT inventions Identify out-licensing opportunities Provide reality check on out-licensing terms and potential for success > 100 volunteer members with diverse expertise Industry Academia Clinicians Venture Capital IP/Clinical/Regulatory
Multidisciplinary Advisors Luminex Corporation Pfizer Johnson & Johnson Texo Ventures UT Austin & Dell Med Popper & Co. GlaxoSmithKline PTV Healthcare Capital Vermillion Drug Dynamics Integra Austin Technology Incubator Institute Sante Ventures Genentech Seton Healthcare System True Wealth Innovations Cognitive Scale TechStars Medical Innovation BioMarin Labs Superior Health Plan Center for Health Mirna Therapeutics DreamIt Ventures Communication Aeglea Biotherapeutics Live Oak Ventures United Healthcare Mystic Pharmaceuticals TVA Medical Ottobock Spindletop Capital Capital Factory McCombs Business School ARM Endomag Asuragen
#TXHealthCatalyst Selected 2015-16 Awardees Treatment for Intraoperative Assessment for Heart-Health Neurodegenerative Surgical Removal of Skin Cancers Monitoring Sensor Disorders − James W. Tunnell, PhD College of Natural College of Natural Cockrell School of Engineering Sciences Sciences − Jason Reichenberg, MD − Stephen Martin, PhD − Richard Crooks, PhD Dell Medical School & − James Sahn, PhD Seton Healthcare Family
#TXHealthCatalyst
Texas Health Catalyst 2.0: How can we maximize the likelihood of success? Key Implementation Steps • Begin with health priorities • Identify gaps • Articulate problem statements • Invite multidisciplinary innovators to develop solutions • Enable clinical validation
2016-17 Clinical Focus Areas Women’s Health Musculoskeletal Conditions Examples of problem statements: Examples of problem statements: • Measuring post-partum blood loss • Improve effectiveness of rehab • Improving care before, during and after • Lower readmissions & revisions pregnancy • Implant positioning/monitoring • Better contraceptive methods (e.g. IUDs) tools (not “better implants”) • Cancer diagnosis and treatment • Appropriate patient selection • Cost-effective implants Future focus areas: Neurology, Oncology, Psychiatry/Mental Health, Pediatrics…….
#TXHealthCatalyst 2016-17 Proposal Review Criteria • Scientific rationale • Clinical unmet need • Commercial attractiveness • Development feasibility • Intellectual property potential • New: Ability to improve value of care
Texas Health Catalyst Process 5 mths 1 – 3 yrs Identify Support Enable Call for applications/review Customized support Metrics • Specific problem • Mentor and iterate • R&D milestones statements • Demo day • Intellectual property • Expert panel reviews • Funding (up to $100,000) • Customers/partnerships • Select most promising • Follow-on funding projects based on specific • Clinical validation criteria • Academic exit through licensing or startup creation
Long Term View #TXHealthCatalyst Pilot Co- Innovate Texas Health Iterate/ Partner Catalyst Validate Incubate Invest Procure
It's All About Timing - Establishing Your QMS Patti Rossman, President, Globiox
Rebecca Jones McKnight Industry Update From DLA Piper
Panels of Key Stakeholder Groups Clinical Leaders: “Begin With the End in Mind” Value Examiners: Focus on the “Triple Aim” C-Suite: “How Much Should They Matter to You?” Industry Leaders: “Predicting the Future” Entrepreneur Reality Check: “Lessons from the Front Lines”
Register Today! www.Medtechtx.org
Check out the NEW TMDA website at: www.texmda.org Follow Us on LinkedIn, Facebook and Twitter Email tridenhour@texmda.org if you wish to be listed as a participant or if you are interested in becoming a sponsor.
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