Mobile: (303) 260-8111
US Citizen
Email: ylshi@hotmail.com
Sept.1999-May 2003 Ph.D.
Major: Applied Biomedical Engineering
Department of Biomedical Engineering/Department of Chemical and Biomedical Engineering
Cleveland Clinic Foundation /Cleveland State University, Cleveland, OH
2011 Best Spine Technology Awards from AAOS in the category of Biomaterials and Biologics
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Mini MBA at Denver University (2014)
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Situational leadership training (2012)
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Executive leadership training/coaching (2010)
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Project management (2008)
AlloSource, Centennial, CO
Director, Living Cell and Tissue Group
May 2008 to Nov. 2015
January 2014 to Nov. 2015
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Directing all activities for cell-based products from bench study to scale up to commercialization
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Leading a team of 5 people for technology/product innovation
• Generating IP and managing IP strategy with patent lawyers
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Managing project budget up to $1M and non-project budget up to $0.25M
Working with marketing on product map/vision in 5 years
• Granted 4 patents
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Providing CMC and preclinical studies to support IND submission for AlloStem
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Generated descriptions of manufacturing process and process controls
®
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Leading process development, scale up and technology transfer to manufacturing
Managing stage gate process to support product launch
Developed cell/tissue culture process to meet Biologics standard
Developed potency assays for product characterization/release criteria
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Working with independent labs to validate potency assays
Managed 8 animal studies with 3 different organization for safety and efficacy
Working with independent labs to validate potency assays
Involved in direct/indirect conversations with FDA on product characterization
Developing assays to address FDA product characterization questions for phase III clinical trials

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Supporting Manufacturing
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Introducing new technology for process improvement
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Performing studies for yield improvements
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Generating memos/performing studies to address NCRs
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Supporting Marketing and Sales
• Generating white papers to support sales group
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Working with key opinion leaders to address key questions and feedback for new products
Forming strategy to differentiate our product from competitors
R&D Manager
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Invented AlloStem
May 2008 to December 2013
®
- a stem-cell based bone growth substitute for spinal fusion, non-union and foot and ankle etc.
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Invented ProChondrix
®
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Brought both AlloStem
- a chondrocytes based live cartilage product
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and ProChondrix
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from concept to scale up to commercialization
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Interacted with people across the company such as Marketing & Sales, Operations and Regulatory etc. during AlloStem
® product launch
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Demonstrated great leadership skills, people and project management skills
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Led a team of 3 people for invention, scale up, transfer and launch
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Managed project budget up to $0.5M
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Won 2011 Best Spine Technology Awards from AAOS in the category of Biomaterials and Biologics
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AlloStem created more than $10M sales annually
Spectranetics, Colorado Springs, CO
Senior Scientist/Engineer May 2006 to Nov. 2007
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Managed project team investigating new technologies for ablating atherosclerotic lesions
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Set-up company-wide histopathology and microscopic imaging resource center
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Responsible for the planning and budgeting of new R&D projects
Children’s Hospital of Los Angeles January 2004 to May 2006
Senior Research Associate
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Responsible for planning, administering and conducting cardiovascular tissue engineering
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Conducted animal microsurgery, cell harvesting and cell isolation
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Trained on culturing ES cells under proposition 71
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Prepared and submitted research grants, abstracts and manuscripts for publication
East China University of Science & Technology , Shanghai, China Sept.1996-Jul.1999
Research Associate
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Cloned high productivity IgG cell line (WuT3 hybridoma cells)
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Developed serum-free media for hybridoma cell culture
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Developed inclined settling system of cell retention for hybridoma perfusion culture
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Studied the growth and metabolism of WuT3 hybridoma cells in perfusion culture
1.
“Allografts combined with tissue derived
stem cells for bone healing” Y.Shi
WO 2010059565 A3
2.
“Consistent calcium content bone allograft systems and methods” Y.Shi. US 20140255489 A1, 2014
(Application)

3.
“Methods of combining mesenchymal stem cells and cartilage containing allografts, and products of combined mesenchymal stem cells and cartilage containing allografts” S. Bogdansky, Y. Shi, B. Atkinson.
US20140024115 A1, 2014 (Application)
4.
“Minced Cartilage Systems and Methods”, WO2014078705 A1, 2014
5.
“Cartilage Mosaic systems and methods”, C. Barrett and Y. Shi, WO2014130883 A2 2014
6.
“Perforated osteochondral allograft compositions” Y. Shi and C. Barrett, WO 2014151939 A1
7.
“Tissue engineered mitral valve chordae and methods of making and using same” K. Grande-Allen, Y. Shi,
WO2002102237 A3, 2003 (Application)
1.
“Characterization of human adipose derived stem cells combined with demineralized bone matrix.” Y.
Shi, Niedzinski JR, Samaniego A, Bogdansky S, Atkinson BL, Tissue Eng Part A. 2012 Jul;18(13-
14):1313-21, 2012
2.
“Characterization of statically loaded tissue-engineered mitral valve chordae tendineae.” Y. Shi and I.
Vesely. J.Biomed.Mater.Res. 69A(1): 26-39, 2004
3.
“Fabrication of tissue engineered mitral valve chordae using directed collagen gel shrinkage.” Y. Shi and I. Vesely. Tissue Engineering, 9(6), 1233-42, 2003
4.
“Loss of chondroitin 6-sulfate and hyaluronan accompany structural deterioration of porcine bioprosthetic valves.” K.J. Grande-Allen, W.J. Mako, A. Calabro, Y. Shi, N.B. Ratliff, I. Vesely.
J.Biomed.Mater.Res. 65A(2):251-9, 2003
5.
“Towards tissue engineering of a composite aortic valve.” Y. Shi, A. Ramamurthi, I. Vesely.
Biomedical Sciences Instrumentation. 38, 35-40, 2002.
6.
“Use of directed collagen gel shrinkage in the development of tissue-engineered mitral valve chordae.”
I. Vesely, Y. Shi. Proceedings of the Second International Symposium on Tissue Engineering for Heart
Valve Substitutes, 2001
7.
“Growth and metabolism of hybridoma cells in semicontinuous perfusion culture.” Y. Shi, Y. Zhang, H.
Shen, S. Zhang. Chinese Journal of Biotechnology, 16: 70-74, 2000
8.
“Use of directed collagen gel shrinkage in the development of tissue engineered mitral valve chordae.” I.
Vesely, Y. Shi. Proceedings of the Second International Symposium on Tissue Engineering for Heart
Valve Substitutes, 2001 (invited)
Dynamic straining bioreactor in collagen-based tissue engineering (2006)