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Project Manager

Location:
Westwood, NJ
Posted:
August 13, 2012

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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:

973-***-****

Route 22 West, PO Box 151, Somerville, NJ. 08876.

E-mail: wnaykh@r.postjobfree.com

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-***-**** wnaykh@r.postjobfree.com

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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