Project Manager
Resume:
RITA PRAJAPATI, Ph.D.
Employment Information:
Contact Information:
STAFF SCIENTIST at Johnson & Johnson (J&J)
** **** ******, ***-*, Chatham, NJ. 07928.
Advanced Technologies & Regenerative Medicine, LLC. (ATRM) Tel:
Route 22 West, PO Box 151, Somerville, NJ. 08876.
E-mail: ****.*********@*****.***
SUMMARY
Staff Scientist who excels at project management, quality systems
compliance, product innovation and strategic oversight of cross functional
teams for multi-disciplinary projects in Medical Device, Combination
Biologics and Regenerative Medicine programs.
Experienced with Discovery Science R&D, Process Development and Pre-
Clinical Research.
Manages and executes technical aspects of programs including development,
testing, study execution, including surgical support and evaluation.
. Completed platform technology evaluation and bio-analytical
characterization of Tissue Engineered and
Stem Cell concepts for Soft Tissue - Biologics product development for
Regenerative Medicine, Nanotechnology, Neurobiology, Sports Medicine,
Orthopedics, Spine and Wound Healing.
. Developed Cell, Bioactive, Growth Factor, Scaffold based technologies
for use in musculoskeletal tissue repair for Sports Medicine,
Intervertebral Disc repair and MSC-Healos concepts.
. Utilized GMP/GLP and Design Control Procedures for Cell culture
techniques, Cell based assays, Biochemical assays, and Qualification -
Validation assays.
. Planned and executed studies based on Design of Experiments,
statistical analysis with Six Sigma and Process (Design) Excellence
(Black Belt) methodologies.
. Established collaborative programs with key opinion leaders within J&J
and Academia.
. Planned and organized Mini-Summit between J&J MD&D and Pharma Sector
for Remicade and RenuDisc Teams.
. Evaluation of novel product concepts based on Nanotechnology and
Tissue Engineering principles.
. 1 Patent, Data for 2 further Patent applications.
. 3 Grant Awards.
EDUCATION & TRAINING
Post-Doctoral Research Fellow CLEVELAND CLINIC FOUNDATION,
Cleveland, OH. 2000 - 2001
Microsurgery Lab, Department of Plastic and Reconstructive Surgery
Post-Doctoral Research Fellow CLEVELAND CLINIC FOUNDATION,
Cleveland, OH. 1998 - 2000
Connective Tissue Research Group, Department of Biomedical Engineering
Ph.D., Cell Biology and Biochemistry UNIVERSITY COLLEGE LONDON, London,
UK. 1995 - 1998
Tissue Repair Unit, Department of Plastic and Reconstructive Surgery
Thesis: Regulation of proteases and mechanical loading during
fibroblast populated collagen lattice contraction
M.S., Medical Biochemistry BRUNEL UNIVERSITY, Uxbridge, UK.
1993 - 1995
Thesis: Cellular engineering of fibronectin based materials for human
grafting, to improve epidermal grafting in the management of Epidermolysis
Bullosa
B.S., Natural Sciences (Joint Honors) BRUNEL UNIVERSITY, Uxbridge, UK.
1990 - 1993
Major: Biology and Biochemistry
Thesis: Monitoring the effects of various extracellular matrices on
cellular adhesion molecules of metastatic cells
PROFESSIONAL HISTORY
JOHNSON & JOHNSON: ADVANCED TECHNOLOGIES & REGENERATIVE MEDICINE, LLC
2004 - 2012 July
Staff Scientist 2011 - 2012
Senior Research Scientist 2004 - 2011
ORTEC INTERNATIONAL, INC., New York, NY.
2001 -
2004
Senior Research Scientist
WORK EXPERIENCE
J&J: ADVANCED TECHNOLOGIES & REGENERATIVE MEDICINE, LLC
2004 - 2012
aka: J&J Regenerative Therapeutics; DePuy Biologics
Staff Scientist 2011 - 2012
Senior Research Scientist 2004 - 2011
Key member of multi-disciplinary project teams working on Medical Device
and Combination Biologics programs.
Project Lead and Core Team Member for Discovery Science R&D, Process
Development and Pre-Clinical Research. Strategic oversight for planning,
development, testing, study execution, including surgical support and
evaluation.
PROJECT HISTORY:
Cell and Molecular Biology Group & Process Development Group - Bio-
Analytical Division 2008 - 2012 Project Lead
DePuy Codman, DePuy Spine & Nano-Technology Program
. For Hydrocephalous Shunts & Catheters: Evaluation of Nano-Anti-fouling
surfaces for prevention of bio-films and cell adherence
. For Enhanced-tissue integrated implantable devices: Evaluation of Nano-
surfaces absorbable & non-absorbable materials
. Involved with all stages of planning and execution: DOE studies,
material - polymer plasma treatments and evaluation, biological method
development, cellular analysis and characterization, data review and
statistical analysis with Six-Sigma/ Process Excellence methodologies
. Data for 2 patent applications
Core Team member
Stem Cell Technologies, Kidney Program and Stroke Program
. For Cellular-Point-of-Care Applications - Cellular isolation and
expansion of primary tissue sources, cell banking
Supplements: serum-free-media; growth factors of animal-free
origin
. Evaluation, cellular analysis and characterization of ATRM cells
Natural Scaffolds Program
. For Natural material scaffold development, involved with Tissue de-
cellularization and Sterilization strategy
Project Team member
2008 - 2009
RenuDisc Program
. For Patient sample assessments: Involved with rhGDF-5 Neutralization
Assay development & rhGDF-5 Bio-Assay
. Qualification assays following GMP/GLP and Design Control Procedures
. Co-authored rhGDF-5 Neutralization Assay Design History File
. Evaluation of Healos-rhGDF-5 patient samples by Neutralization Assay
. Evaluation of BMP receptors
DePuy Mitek
. Evaluation of osteoarthritis formulations by rhGDF-5 Bio-Assay
(product release assay)
DePuy Spine
. Executed and completed Mesenchymal Stem Cells & Healos
studies
Pre-Clinical Group, J&J Regenerative Therapeutics, LLC.
2007 - 2008
Project Team member
RenuDisc Program
. For Local-Delivery-of-Biologics: Assessed relationship of pain
cytokines in Intervertebral Disc (IVD) repair
. Evaluation of commercially available Anti-Inflammatory agents (IL's &
TGF?)
. Evaluation of alternative Anti-Inflammatory compounds for IVD repair
. Planned and organized Mini-Summit between J&J MD&D and Pharma Sector
for Remicade and RenuDisc Teams
Parkinson's Disease Program
. Project Lead and initiated academic collaboration - rhGDF-5 and In
vitro dopamine cultures
DePuy Spine
. Completed Healos 5-8mm rabbit PLF manuscript
Sports Medicine Group: Tendon & Ligament Division, DePuy Biologics
2004 - 2007
Project Lead - For Cell and Growth Factor based technologies in Tendon &
Ligament repair programs involved with planning, development, execution
including surgical support, study evaluation, data review, & statistical
analysis
. rhGDF-5 coated sutures for Achilles Tendon repair (rat model)
. rhGDF-5 for Rotator Cuff repair (rat model)
. rhGDF-5 for Anterior Cruciate Ligament repair (goat model & SCID mouse
model)
. Minced Anterior Cruciate Ligament in Scaffold (goat model)
J&J COLLABORATIVE ACTIVITIES:
2004 - 2012
Taskforce Project Manager - Established Shared Drive for ATRM (JJRT -
DePuy Biologics) (2004 & 2006)
Taskforce Team member - JJRT web activities and Communication
taskforces (2007, 2010)
- ARTM News Letter
(2010-2012)
Team member - All Hands Meeting year end event (2005)
J&J DePuy Franchise - Cross company group events and activities with SAPNA
affinity group
. DePuy Technology Summit: Collaboration (2007); Convergence (2008),
Emerging Markets (2009)
. Diversity event (2008)
ORTEC INTERNATIONAL, INC., New York, NY.
2001 - 2004
Senior Research Scientist, Research and Development Department
. For an artificial dermal equivalent - Bio-analytical characterization
of Tissue-Engineered living skin replacement product, OrCel(,
artificial skin grafting material and components: cell lines, collagen
matrices and raw materials
. Involved with Developing, Qualifying and Validating test procedures
for cytokines, growth factors, metallo-proteases, extracellular matrix
products, and other related bio-molecules
. Involved with Cytokine & Growth factor section for USP Monograph and
Cytokine-OrCel publication
. Interaction with research groups for wound healing research studies
and development of novel Tissue-Engineered and biomaterial products
CLEVELAND CLINIC FOUNDATION, Cleveland, OH.
1998 - 2001
Post-Doctoral Research Fellow, Microsurgery Lab, Dept. of Plastic and
Reconstructive Surgery (2000 - 2001)
For Transplantation research - Responsible for all Basic Science Research,
including investigations relative to Composite Tissue Allograft (CTA)
Transplantation and Angiogenesis
. CTA Transplantation study awarded 1st prize for Basic Clinical
Research at 20th Annual Research Day,
Cleveland Clinic Foundation, October 2000
. CTA Transplantation data used to obtain external funding- American
Heart Association & Wilson Fnd.
. Established research lab with following techniques - Flow cytometry,
Immuno-histochemistry and Immunological assays
Post-Doctoral Research Fellow, Connective Tissue Research Group, Dept. of
Biomedical Engineering (1998 - 2000)
Project I - Effects of Iron overload in the initiation and progression of
osteoarthritis, for OA and Hemophilia studies
. Data suggest chondrocyte pericellular matrix disruption may initiate &
eventually lead to joint destruction
. Results led to possible mechanisms by which iron can disrupt cell-
matrix communication, thereby, depriving cartilage of its mechanism
for maintaining structural integrity
. Research was further developed into a clinical study - canine knee
joints were subjected to hemorrhage
. Preliminary findings presented at 10th Annual Orthopedic Research Day
at Cleveland Clinic Foundation,
June 2000 and study awarded 1st prize for Basic Clinical Research
Project II - Repair-remodeling of meniscus and of characterization of
meniscus cells (ex-vivo organ-cultures)
. Preliminary data used to obtain NIH funding for work on repair and
remodeling in the meniscus
EDUCATION
Ph.D., Cell Biology and Biochemistry UNIVERSITY COLLEGE LONDON, London,
UK. 1995 - 1998
Tissue Repair Unit, Department of Plastic and Reconstructive Surgery
Thesis: Regulation of proteases and mechanical loading during
fibroblast populated collagen lattice contraction
. For Wound healing indications: Data suggest that the effect of
applying force onto collagen gels, which represents the tension
generated during wound contraction, were shown to regulate the
production of the matrix metallo-proteinases and serine-proteinases
. Implications: matrix metallo-proteinases and serine-proteinases were
responsible for degradation of collagen, indicating that mechanical
loading caused remodeling of the collagenous matrix
. Implications: important to control wound contraction during healing-
too rapid a contraction leads to excessive scarring, as in skin burns,
and too slow a contraction can lead to open wounds, such as ulcers
M.S., Medical Biochemistry BRUNEL UNIVERSITY, Uxbridge, UK.
1993 - 1995
Thesis: Cellular engineering of fibronectin based materials for human
grafting, to improve epidermal grafting in the management of Epidermolysis
Bullosa
B.S., Natural Sciences (Joint Honors) BRUNEL UNIVERSITY, Uxbridge, UK.
1990 - 1993
Major: Biology and Biochemistry
Thesis: Monitoring the effects of various extracellular matrices on
cellular adhesion molecules of metastatic cells
ADDITIONAL PROFESSIONAL DEVELOPMENT
GMP/GLP
. Current Good Laboratory Practices Current Good Manufacturing Practices
. Writing effective standard operating procedures and other process
documents
. Effective Laboratory Safety Management
QUALITY SYSTEMS
. FDA cGMP for Finished Pharmaceuticals (21CFR 210 & 211)
. FDA cGMP Medical Devices (ISO 9000 SERIES; ISO 13485:2003; MDD, CMDR
and JPAL)
. Quality System Requirements (21CFR 820); Internal Audits
PROCESS (DESIGN) EXCELLENCE
. Six Sigma Black Belt Training
. Advanced statistical problem solving methods
PROJECT MANAGEMENT
. Strategic Change Management
. Project-Portfolio Management
. Project-Change Management
. High Performance Teamwork
TEACHING EXPERIENCE
. Tissue Engineered Skin Substitutes
. Connective Tissue Disorders - Epidermolysis Bullosa
. Immuno-Techniques
AWARDED GRANTS, PATENT & PUBLICATIONS
. 3 Grant awards
. 1 Patent, Data for 2 Patent further applications
. 10 Peer reviewed Publications
. 11 Abstracts
TECHNICAL EXPERTISE
. Cell culture techniques, Isolation and growth of human and rodent
primary cultures, Cell lines and Stem cells
. Ex-vivo organ-cultures and 3-D culturing techniques, Large batch scale
cell grow-up and cell banking
. Cell imaging techniques, Immuno-histochemistry, SEM
. Assay development, Cell based assays, Cell receptor analysis,
Characterization, Biochemical assays, Bio-Assay
. Flow cytometry, ELISA, SDS-PAGE, Western blot, method development
. High Throughput Screening of Samples and Treatments
RITA PRAJAPATI, Ph.D.
55 Main Street, Apt-1, Chatham, New Jersey. 07928.
973-***-**** ****.*********@*****.***
ADDENDUM
PATENT
. DEP-5505CIP Method of intra-operative coating of therapeutic agents
onto sutures, composite sutures and method of use.
PUBLICATIONS
. Dines J.S., Weber L., Razzano P., Prajapati R., Timmer M., Bowman
S., Bonassar L., Dines D.M., Grande D. 2007. The effect of
Growth and Differentiation Factor-5 coated sutures on tendon repair
in a rat model. J. Shoulder Elbow Surg. 16: 215S-221S.
. Windsor M.L, Choi C., Prajapati R., McDonald L.J., Eisenberg M.,
Silberklang M.L. 2003. Cytokine productivity In Vitro and In Vivo
by OrCel, An engineered skin wound healing product.
. Prajapati R. Advances in Tissue Engineering and Stem Cell Research.
2003. Alpha Vision.
. Ozer K., Oke R., Gurunluoglu R., Zielinski M., Izycki D., Prajapati
R., Siemionow M. 2003. Induction of tolerance to hind limb
allografts in rats receiving cyclosporine A and anti-lymphocyte
serum: effect of duration of the treatment. Transplantation. 75:
31-36.
. Siemionow M, Oke R, Ozer K, Izycki D, Prajapati R. 2002. Induction
of donor-specific tolerance in rat hind-limb allografts under
antilymphocyte serum and cyclosporine A protocol. J Hand Surg
(Am). 27: 1095-1103.
. Siemionow M., Ortak T., Izycki D., Oke R., Cunningham B., Prajapati
R., Zins J. 2002. Induction of tolerance in composite tissue
allografts. Transplantation. 74:1211-1217.
. Prajapati R., Chavally B, Herbarge D, Eastwood M, Brown R.A. 2000.
Mechanical loading regulates protease production by fibroblasts in
three-dimensional collagen lattices. Wound Repair and Regeneration.
8: 226-237.
. Prajapati R., Eastwood M, Brown R.A. 2000. Duration and orientation
of mechanical loads determine fibroblast cyto-mechanical-
activation: monitored by protease release. Wound Repair and
Regeneration. 8: 238-246.
. Brown R.A., Prajapati R., McGrouther D.A., Yannas I.V., Eastwood M.
1998. Tensional homeostasis in dermal fibroblasts: mechanical
responses to mechanical loading in 3-D substrates. J. Cell
Physiol. 175: 323-332.
. Prajapati R., Al-Ani S., Smith P.J., Brown R.A. 1996. Fibronectin
mats assessed in an in vitro model for keratinocyte grafting.
Cell. Eng. 1: 143-149.
ABSTRACTS
. Prajapati R. (Mistry R.), Hwang J., Geesin J. 2008. rhGDF-5
Rotator Cuff Repair. 54nd Orthopedic Society Research Transactions.
33: 0786.
. Dines J., Prajapati R., Timmer M., Razzano P., Jiang K., Hammer J.,
Eyerly S., Owens G., Bowman S., Bonassar L., Grande D. 2007.
Influence of mechanical environment on tendon repair. 53nd
Orthopedic Society Research Transactions. 32: 0027.
. Pantazopoulos C., Gould S., Mandel K., Prajapati R., Timmer M.,
Razzano P., Grande D. 2007. The effects of varying concentrations
of Growth and Differentiation Factor-5 on tendon fibroblasts in
vitro. 53nd Orthopedic Society Research Transactions. 32: 0869.
. Dines J., Weber L., Prajapati R., Timmer M., Razzano P., Jiang K.,
Bowman S., Gates M., Babalola O., Bonassar L., Grande D. 2006.
Influence of mechanical environment on tendon repair. 52nd
Orthopedic Society Research Transactions. 31: 1057.
. Timmer M., Razzano P., Prajapati R., Bowman S., Grande D. 2005.
Method of coating recombinant Growth and Differentiantion Factor-5
onto sutures for soft tissue repair. 51st Orthopedic Society
Research Transactions. 30
. McDevitt C., Li H., Zaramo C., Prajapati R. 2001. The isolation of
a cell-pericellular matrix complex from meniscus fibrocartilage:
The Fibrochondron. 47th Orthopedic Society Research Transactions.
26: 0384.
. Prajapati R., Eastwood M., Brown R.A. 1998. Dermal fibroblasts
respond to strained duration of mechanical (un)loading, but not
rate loading. Wound Rep. Reg. 6: A510.
. Prajapati R., Eastwood M., Brown R.A. 1997. Protease induction
during mechanical contraction. Wound Rep. Reg. 5 (3): A285.
. Prajapati R, Eastwood M, Brown R. Induction of proteases by
mechanically loaded fibroblasts during contraction. Int. J. Exp.
Pathol. 77: A1-25; 1996.
. Eastwood M., Prajapati R., McGrouther D.A., Brown R.A. 1996.
Fibroblasts responses within mechanically loaded collagen lattices.
Wound Rep. Reg. 4: A150.
. Eastwood M., Prajapati R., McGrouther D.A., Brown R.A. 1995. Effect
of microtubule disruption on collagen contraction by human dermal
fibroblasts. Wound Rep. Reg. 3: A88.
J&J MEETINGS
. Cooper K., Chen J., Adams M., Elmouelhi N., Lim C., Lowenhaupt B.,
Natarajan S., Prajapati R., Vyakarnam M. Nanotechnology Platform
Overview at ATRM: Nanosurfaces and Miniaturized Devices. J&J Global
Surgery R&D Conference. 2012 April, Somerset, NJ. & 2012 May,
Somerville, NJ.
. Kihm A., Contiliano J., Choi J., Fang C., Lopez E., Wang Z., Yang
C., Seyda A., Kramer B., Colter D., Buensuceso C., Gray M.,
Prajapati R., Gosiewska A., Dhanaraj S. Natural Scaffolds Research
at ATRM. J&J Global Surgery R&D Conference. 2012 April, Somerset,
NJ. & 2012 May, Somerville, NJ.
. Prajapati R., Vetrecin R., Natarajan S., He L., Schorn G., Creasy
K., Cooper K. Surface Texturing and Plasma Treatments for Codman
Hydrocephalous Shunt. J&J Excellence in Science. 2011 November, New
Brunswick, NJ.
. Prajapati R., Natarajan S., Cooper K. Nanotechnology Program:
Surface Plasma Treatments and Cellular Responses. ATRM R&D
Conference. 2010 September, Boston, MA.
. Prajapati R., Natarajan S., Cooper K. Nanotechnology Program and
Surface Plasma Treatments. J&J Nanotechnology Symposium. 2010
October, New Brunswick, NJ.
GRANTS AWARDED
. Co-Investigator - Wilson Foundation Grant 2001-2003,
Principal Investigator: Dr Siemionow
Project Title: Novel approach to induce tolerance in composite
tissue allografts
. Co-Investigator - American Heart Association Grant-In-Aid 2001-2003,
Principal Investigator: Dr Siemionow
Project Title: Novel approach to induce tolerance in composite
tissue allografts
. Co-Investigator - NIH 2000-2003 Grant Number: 5R21AR046991-03
Principal Investigator: Dr McDevitt
Project Title: Haptotactic repair of the meniscus
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