Dhanuraj Shetty

Jersey City, NJ~ua4mix@r.postjobfree.com~ 732-***-****

OBJECTIVE: To utilize my extensive experience in the Medical Device/Regenerative Medicine industry in a challenging position within the HealthCare industry

Summary Core Competencies

Innovative R&D professional with over 11 years of experience in the medical device & regenerative medicine industry with 2 issued and 17 filed patents

Knowledge of the intersection of life sciences, engineering and applied sciences

Demonstrated ability to connect technologies with business needs and to translate concepts into at least three commercial product opportunities

Research and Product Development capabilities • Technology Assessment & Due Diligence

• R&D Project & Portfolio Management

• Strategy Planning and Alliance Management

• Expertise in Medical Device & Regenerative Medicine

• Research and New Product Development Leadership

• New idea generation and Intellectual Property Assessment (Issued:2, Filed: 19)

EDUCATION

MS Plastics Engineering, University of Massachusetts, Lowell, MA, USA (Dec, 1999)

• Thesis: Changes in red blood cells (RBC) when stored in Polyvinyl chloride bags

• Student Leader of the Year Award (1998-1999)

B. Sc Polymer Science and Engineering, University of Pune, India. (June 1996).

PROFESSIONAL EXPERIENCE:

Kinetic Concepts Inc [KCI]: Center for Advanced Research and Technology (ART) Branchburg, NJ

Technology Assessment Manager & Portfolio Manager: (April 2011- February 2012)

• Assist senior management in formalizing and implementing the organizational structure and strategy for ART group and develop strategic plans internal programs for regenerative medicine opportunities

• Responsible for the search, identification and evaluation of internal & external emerging technologies in the following areas of tissue engineering, regenerative medicine & wound healing and stimulate exploratory activities and grow the portfolio of enabling platform technologies. Identified over ten new technologies by scouting various sources such as: technology transfer offices, scientific and clinical literature, academic COE and articulate to senior management how emerging technologies can benefit the division and applied to existing and new products

• Support cross functional team members and executives in evaluating new technologies and associated business opportunities.

• Conducted appropriate due diligence of at least one technology and develop recommendations for technology acquisitions, licensing and research collaborations on new technologies

• Collaborated with key internal stakeholders across KCI divisional units in the identification and development of technical strategies to ensure that the company maintains industry leadership

• Establish collaborative relationships with R&D groups, clinical and business development groups and work closely to implement strategy

• Drive execution of project plans and maintain project/portfolio plans, timelines, agendas, budgets, resource requirement and other planning tools required to facilitate coordination of the various projects and contribute to the bottom line and ensure effective, accurate and timely communications of project and portfolio activities across functional areas

Kinetic Concepts Inc - LIFCELL: Branchburg, NJ

Senior Product Development Engineer: (April 2010 – April 2011)

Project Envelop – Technical Team Leader

• Managed technical team for the product development of a Tissue Expander and developed and established technical strategy for the development of a Tissue Expander and LTM. Strategy included establishing potential preclinical studies, packaging & sterilization. Lead brainstorming sessions to establish ideas for attaching tissue matrix to the Tissue Expander leading to filing three idea memos and a patent filing

• Identified and established test methodologies for characterization of Tissue Expanders as per FDA guidance document

• Identified and collaborated with external consultants and vendors for the development of tissue expander. Worked with external design house to fabricate bench top anatomical mastectomy breast model to evaluate product concepts and for sales training

Product Development Implementation Process -- Core Team Member

• Part of senior management team responsible for implementation the Global Product Commercialization Program process within LifeCell. Reviewed existing product development process within the organization and identified gaps for a product development process

• Provided solutions to streamline the phase gate process as per the requirements of nature of the program and Collaborated with the team to chart R.A.C.I for project deliverables

JOHNSON & JOHNSON: (Multiple Roles: 1999- 2010)

Advanced Technologies and Regenerative Medicine, a subsidiary of: Somerville, NJ

Senior Engineer/ Project Leader: (Jan 2008- April 2010)

Collaborative Programs for Global (Emerging) Market – Core Team Member & Consultant

• Worked with JNJ research group in India on two product concepts targeting the local market

• Provided feedback and assistance for biomaterial requirements

Tissue Engineering Scaffold Strategy Research Team Leader

• Responsible for creating a new scaffold strategy for the group. Identified key resources within the organization to form a team. Identified gaps within the current scaffold strategy. Identified potential external collaborators to work with. Created a research proposal for future scaffold strategy

• Developed strong academic collaborations and partnerships (Drexel University) for three dimensional scaffolds

JOHNSON & JOHNSON Regenerative Therapeutics, LLC, Somerville, NJ

Senior Engineer/ Project Leader: (March 2006- 2008)

Bladder Repair and Regeneration Project- Project Leader

• Managed and lead cross-functional and cross-company teams through various stages of feasibility testing and product development for new products in urological tissue engineering, specializing in bladder and other urinary tract soft tissues. Responsible for directing preclinical studies, managing research budgets and developing project plans for new products. Observed surgeries, participate in discussions and coordinated with Op-co marketing to obtain voice of customer input into product designs.

• Provided technical support for evaluating external intellectual property and products for impact on current products and potential for license or acquisition.

• Provided technical expertise to marketing and sales groups for products on market.

• Designed and developed biodegradable, synthetic product for a urological application.

• Defined product specifications by designing systems for testing the mechanical properties of native and healing tissues.

• Formulated product strategy by managing marketing study involving urologist surgeons to evaluate potential of new products in bladder repair/regeneration surgery market.

• Inventor of 6 patent applications related to Bladder repair and regeneration (pending submission and patent office action)

Kidney Repair and Pelvic Floor Repair - Scaffold Consultant

• Acted as consultant and advisor for the above teams and provided feedback for their scaffold development strategy

• Inventor of a patent application relating to the use of scaffold as Tissue Engineering approach for Kidney repair and regeneration (pending submission and patent office action)

• Key inventor on a concept and prototype leading to development as a Tissue Engineering matrix for Pelvic floor repair.

JOHNSON & JOHNSON: Center for Biomaterials and Advanced Technologies, Medical Devices Group, Ethicon Inc. Somerville, NJ

Engineer/Project Leader Coordinator: (January 2004 – March 2006)

R&D Project Leader for Cartilage Repair, Meniscus Repair & Rotator Cuff Repair-

• Effectively lead cross functional team members for the three tissue engineering programs

• Supported IDE application by providing technical expertise for device designed to regenerate cartilage. Product based on patented absorbable scaffold and minced tissue technology.

• Developed second-generation scaffold for the same product and developed injectable version of biosynthetic scaffold

• Coordinated a product strategy with external marketing study involving 25 surgeons to evaluate new products in orthopedic surgery market

• Key inventor on the final selected prototype

• Directed and coordinate characterization and optimization activities directed to final scaffold prototype selection

ETHICON WOUND MANAGEMENT- Hemostat (Scaffold Consultant/Inventor)

• Key inventor on a concept and prototype leading to development as a component of a hemostasis device for Ethicon Wound Management (Multi-Billion dollar product).

• Inventor on three patent applications (pending patent office action).

Johnson & Johnson: Center for Biomaterials and Advanced Technologies, Medical Devices Group, Ethicon Inc., Somerville, NJ

Associate Engineer/Scientist: (November 1999-January 2004)

• Developed and optimized new procedures and protocols for existing conventional related to the polymer and materials engineering aspects of medical devices.

• Conducted Research for the development of new processes and served as a cross-functional team member to fabricate components of medical device prototypes and finished device using traditional plastics processing techniques.

PATENTS:

The following applications have been filed and issued with the patent office

ISSUED

1. Reinforced Absorbable Multilayered fabric for use in medical devices (Issued Feb. 23, 2010)

2. Reinforced absorbable multilayered fabric for use in tissue repair and regeneration (Issued July 6th, 2010)

FILED

1. Breast Prostheses, Methods of Manufacturing Breast Prostheses, and Methods of Treatment using Breast Prostheses (Filed Jan.13th, 2012)

2. Reinforced Absorbable Synthetic Matrix for Hemostatic Applications (Filed May 17th, 2010)

3. Reinforced Absorbable Multi-layered fabric for Hemostatic applications (Filed May 17th, 2010)

4. Method of Making Suture-less Hollow Scaffolds (Filed June 30th, 2009)

5. Device for Repair of Urological Structures (Filed June 30th, 2009)

6. Thick Foams for biomedical application and methods of making (Filed March 31st, 2009)

7. Composite Enterocystoplasty (Filed March 26th, 2009)

8. Biocompatible Fiber based device for Guided Tissue Regeneration (Filed Dec. 15th, 2008)

9. Tissue Engineering Devices and Methods for Lumnial Organs (Filed Apr. 22ned, 2008)

10. Engineered Renal Tissue (Filed Apr. 22nd, 2008)

11. Optimum Density Fibrous Matrix (Filed Dec.11th, 2007)

12. Multi Layered Composite for Organ Augmentation and Repair (Filed Sep.18th, 2007)

13. Regenerative Medicine Device and Melt-Blown Methods of Manufacture (Filed Sep.18th, 2007)

14. Regenerative Medicine Devices and Foam Methods of Manufacture (Filed Sep.18th, 2007)

15. Localized Delivery of A Therapeutic Agent by Barbed Sutures (Filed Dec. 21st, 2006)

16. Nonwoven Tissue Scaffold (Filed June 29th, 2006)

17. Method for Making a Reinforced Absorbable Multilayered Fabric for use in Medical Devices (Filed Oct.17th, 2005)

PUBLICATIONS:

1. Dhanaraj Sridevi, Wang Ziwei, Kong Wei, Shetty Dhanuraj, Hwang Julia, Geesin Jeffrey, “ RhGDF-5 promotes new tissue formation in scaffolds placed between Meniscal Tissue and implanted into SCID mice”. 52nd Annual Meeting of the Orthopaedic Research Society, 2006, Paper No. 0029.

2. Brian J.Cole. MD, MBA, Sridevi Dhanaraj PhD, Ed Yiling Lu PhD, Ziwei Wang MD, Dhanuraj Shetty MS, Dino Bradley PhD, Francois Binette PhD, “Minced Autologous articular cartilage versus cartilage bone paste: Investigation of a novel Single-Stage Approach for the treatment of cartilage defects”. Annual Meeting of the American Orthopaedic Society for Sports Medicine (AOSSM),, 2005, July14-17, Keystone, Colorado

3. Yiling Lu, Sridevi Dhanaraj, Ziwei Wang, Dino Bradley, Steve M. Bowman, Brian Cole, Francois Binette, “Minced Cartilage without cell culture serves as an effective intraoperative cell source for cartilage repair”. Journal of Orthopaedic Research, 2006, JOR-W05-125 (20135) (ACKNOWLEDGEMENT)

4. Murty Vyakarnam, David Dalessandro, Mark Roller, Dhanuraj Shetty, Joseph Hammer, John Dooley, Steve Arnold, ” Elastomeric Foam Buttress Material for Soft Tissue Repair”. Annual Society for Biomaterials Meeting, 2003

ORAL PRESENTATIONS

1. Dhanuraj Shetty, “Synthetic absorbable biomaterials and its use as scaffolds I Tissue engineering/regeneration applications”, American Chemical Society National Meeting, San Francisco, CA, September 2006.

POSTER PRESENTATIONS:

1. Dhanaraj S, Binette F, Wang, Z, Shetty D, Lin X, Lu E, Geesin, J, “Cartilage fragments, but not bone cartilage paste-loaded scaffolds form uniform cartilage-like tissue following implantation into SCID mice”. 51st Annual meeting of the Orthopaedic Research Society, Washington DC, 2005

2. Shetty Dhanuraj, Dhanaraj Sridevi, Binette Francois, Wang Ziwei, Lin Herrick, Lu Ed, Geesin Jeffrey, “Cartilage fragments, but not bone cartilage paste-loaded scaffolds form uniform cartilage-like tissue following implantation into SCID mice”. Gordon Conference on Biomaterials: Biocompatibility/Tissue Engineering, New Hampshire, 2005

3. Bruce Lowenhaupt, Dhanuraj Shetty, Neil Cowley, Sridevi Dhanaraj, Wei Kong, Ziwei Wang, Jeff Geesin, Eric Pannenborg, Julia Hwang,“ MAVRX: A Novel Intraoperative Treatment of Meniscal Injuries Synthetic and rhGDF-5 Enhanced Resorbable Scaffolds” ETHICON R&D Conference, Somerville, NJ, October 2005.

4. Murty Vyakarnam, David Dalessandro, Mark Roller, Dhanuraj Shetty, Joseph Hammer, John Dooley, Steve Arnold, “Elastomeric Foam Buttress Material for Soft Tissue Repair”, Society for Biomaterials Conference, Reno, NV, April 2003.

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