Pallassana V Narayanan 908-217-1904 PallassNar@aol.

com
Research and Development Scientist / Engineer / Project Leader accomplished in pure and applied crossfunctional research, advanced concept and technology demonstration, and global commercialization in stringent regulatory environments. Areas of expertise include drug and device combinations for vascular applications, drug delivery, tissue engineering, regenerative medicine, thin film coatings, surface modification technologies, portfolio management and stage-gate project management process. MBA in finance contributes to leveraging R&D with industry trends for competitive impact. Subject Matter Expert Thought Leader Strategic Thinker Process Excellence Intellectual Property Developer Team Developer Risk Prevention Assessment Design Control WORK EXPERIENCE New Jersey Center for Biomaterials, Rutgers University, Piscataway, NJ 2007 - 2013 Chief Operating Officer for RESBIO Research Program / Associate Research Professor Developing and implementing infrastructure for managing a cross-disciplinary intra- and inter-university research program funded by National Institute of Biomedical Imaging and Bioengineering for studying cell-material interactions leading to tissue engineering and regenerative medicine applications. Infrastructure development and implementation to achieve program deliverables. Cordis Corporation, a Johnson and Johnson Company, Warren, NJ 1988 2007 Global vascular device developer and manufacturer generating in excess of $4 billion in revenues annually. First to introduce Drug Eluting Stents(DES) to cardiology market. Engineering Fellow Managerial Experience Managed a group of five PhD level material scientists and engineers involved in material selection, process development, and test method development for a drug-device combination product. Developed the infrastructure to generate FDA regulatory data to enable clinical trial initiation in 2008 for a technology breakthrough new disruptive product concept. Worked across functional divisions that spanned QA, Regulatory, Operations, Marketing, Finance and Clinical groups to assess Net Present Value (NPV) of new product development projects for management decisions on project funding of $11 million for 2007. Managed key outsourced external partnerships in Canada and Sweden, and coordinated activities with Cordis, Netherlands that resulted in successful execution of a safety clinical trial outside the United States for a new product line extension of first Drug Eluting Stent. Project projected to release company from critical material dependency on a key external provider. Nominated as an annual J&J Credo champion analyzing survey results and identifying action items for organizational improvement reducing barriers of innovation. The outcome not only set the course for individual productivity increase and job satisfaction, but also for approximately $ 500,000 in cost-savings. Invited to lead the developmental Leadership Initiative networking committee for 2006 and organize several events interfacing senior executives from both Cordis and other J&J companies with associates at all levels to improve organizational networking, personal and professional development, and crosspollination of ideas and talents. This successful program has become a model for the whole organization. Project Leadership Proved product concept feasibility, and functioned as engineering project leader for the First-in-Human clinical trial of the industry-first Drug Eluting Stents. Coordinated global activities of project teams in Netherlands, Italy, and US. After commercialization product went on to create a $4B market.

Pallassana Narayanan Developed detailed project plans that were used to clarify expectations and deliverables of national and international project teams and external partners and ensure initiation of clinical trials on time and on budget. Worked cross-functionally with QA, Clinical, and Regulatory divisions leading to four clinical trials with drug-device products assuring trials were in compliance with US and European regulatory guidelines. Medical Devices R&D Drug Eluting Stents, Bioabsorbable Devices, Balloon Catheters, Guiding Catheters, Diagnostic Catheters, Catheter Sheath Introducer Provided extensive R&D knowledge and leadership across Material Science, Surface Modification Technology and Coatings Technology areas that touched on every Cordis product being used in cath labs. Developed a key patented heparin coating process for vascular stents to reduce clotting and improve product safety which was a critical part of the intellectual property portfolio in the acquisition of Cordis by Johnson & Johnson. Demonstrated the concept feasibility of a bio-absorbable drug-eluting device. Investigated and implemented processes that improved drug stability in drug-device combination products. Coordinated and implemented test methods related to drug content, elution and stability in this drug-device combination product. Led an international product development team and wrote a subject matter expert (SME) memo on a production issue that prevented products worth more than $10M from being scrapped. Commercially launched the first heparin coated diagnostic catheter in Europe that generated $ 3 million in additional incremental revenues over a six-year product life cycle. Developed lubricious coatings for guidewires and balloon catheters that significantly improved the deliverability of these devices to vascular lesions and increasing medical procedure successes. Initiated and completed the timely and cost-effective substitution of Freon usage across all global Cordis operations meeting governmental timelines and regulations. Implemented a cleaning process in the extrusion line that increased throughput, decreased waste, and eliminated the need for new capital investment of millions of dollars. Team-commercialized the first-ever drug eluting coronary stent.

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Eastman Kodak, Rochester, NY 1981 1988 World leader in manufacturing and distribution of photographic films and papers, and electronic imaging products. Coating Technology (Fundamental) Research Invented a new method of coating photographic film and paper products that increased throughput and reduced waste. Technology Implementation Researched and implemented a new surface treatment technology that reduced defects in photographic paper products. Surface Modification Technologies (RF Plasma, Vacuum Technologies) Working with Kodak Australia team, investigated and implemented a Radio Frequency Plasma surface treatment process in a pilot production line for the manufacture of photographic paper products. Developed surface analytical methodologies that established process controls for the surface treatment process. Developed a Radio Frequency Plasma deposited polymer coating for improving the corrosion resistance and lubricity of high-density magnetic recording tapes.

Pallassana Narayanan Rensellaer Polytechnic University, Troy, NY

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1978 1981

Post-doctoral research fellow in the Department of Chemical Engineering: under a National Science Foundation grant, developed and experimentally verified a computer model to simulate fluid flow in a spouted-bed reactor, then built, installed and operated the reactor which verified the model. Guided a PhD student during the experimentation part of the dissertation. REVIEW BOARD AND ADVISORY COMMITTEE AFFILIATIONS Member - Industrial Advisory Board for the Center for Biomaterials Research, Rutgers University, NJ. Provide input to increase the effectiveness of the Center maximizing its support of local industrial members. Presented industry experience on the development of a drug-device combination product at the Academic-FDA-Industry forum organized by the Center. Liaison for Johnson & Johnson Focused Funding Grants research projects at Cornell University and University of Texas at Arlington. Liaison for a Cordis sponsored research at Washington University, St Louis, MO. EDUCATION MBA Finance, Nova Southeastern University, Ft. Lauderdale, FL PhD Chemical Engineering, University of Wales, UK MS Chemical Engineering, Indian Institute of Technology, New Delhi, India BS Chemical Engineering, University of Madras, Madras, India PROFESSIONAL EDUCATION Regulatory Affairs, and management training programs. Computer Skills Microsoft Office Professional Product Suite including Project, Access, and PowerPoint. MINITAB and SigmaStat regulatory statistical applications. PUBLICATIONS AND PATENTS (DETAILS IN FOLLOWING PAGES) 15 papers in peer-reviewed journals and conference proceedings Over 40 issued or filed US patents and many more overseas filings AWARDS AND RECOGNITIONS Invited lecturer at University of Wisconsin titled "RF Plasma Processing for Medical Devices. Cordis Team Excellence Awards and plaques for several patent filings. MEMBERSHIP AFFILIATIONS Member of American Institute of Chemical Engineers, American Heart Association, American Chemical Society. ADDITIONAL INFORMATION Fluent in German. Have lived on three different continents. Comfortable working in a global environment and enjoy interacting with diverse people.

Pallassana Narayanan Published articles 1.

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Edward Phillip Jr., N. Sanjeeva Murthy, Das Bolikal, Pallassana Narayanan and Joachim Kohn, Linda Lavelle , Stanko Bodnar and Kurt Pricer, Ethylene oxides role as a reactive agent during sterilization: Effects of polymer composition and device architecture, Journal of Biomaterials Science-Polymer Edition, In Press Peng Meng Kou, Narayanan Pallassana, Rebeca Bowden, Barry Cunningham, Abraham Joy, Joachim Kohn, Julia E. Babensee, Predicting biomaterial property-dendritic cell phenotype relationships from the multivariate analysis of responses to polymethacrylates, Biomaterials 33 (2012) 1699-1713 Klugherz BD Llanos GH, Lieuallen W, Kopia GA, Papandreou G, Narayan P, Sasseen B, Adelman SJ, Falotico R, Wilensky RL. Twenty-eight-day efficacy and pharmacokinetics of the sirolimus-eluting stent. Journal of Coronary Artery Diseases. 2002;13:183-188. Carter AJ TF, Bailey L, Siegel J, Gallagher L, Suzuki T, Narayanan P, Dooley J, Spaltro J, Kopia G. A sirolimus eluting smart stent reduces inflammation and neointimal formation in a canine model. Circulation 104 (17 Supplement). 2001:pII 764. Klugherz BD, Llanos GH, Lieuallen W, Kopia GA, Papandreou G, Narayanan P, Levengood T, Sasseen BM, Adelman S, Carter AJ, Falotico R, Wilensky RL, Intramural kinetics of sirolimus eluted from an intracoronary stent. Circulation 102 (18 Supplement). 2000:pII.733 Suzuki T, Bailey LR, Kopia GA, Llanos G, Falotico R, Narayanan P, Papandreou G, Tio FO, Carter AJ, Synergistic efficacy of anti-proliferative and anti-inflammatory therapies delivered by a stent. Circulation 102 (18 Supplement). 2000:pII.566 Narayanan P. Surface functionalization by RF plasma treatment of polymers for immobilization of bioactivemolecules. Journal of Biomaterials Science, Polymer Edition. 1994;6:181-193. Narayanan PV, Frictional characteristics of radio-frequency plasma polymerized films from tetrafluoroethylene monomer. Proceedings of the ACS Division of Polymeric Materials: Science and Engineering, Publ by ACS, Books & Journals Division, Washington, DC, USA. 1990;62:553-557. Narayanan PV, Correlation of electron energy distribution function to mechanical properties of thin polymer films prepared by plasma polymerization. Conference Record - Abstracts: 1987 IEEE International Conference on Plasma Science. 1987:122.

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10. Littman H, Morgan MH III, Narayanan PV, Seung JK, Jenn-Yuan D, An axisymmetric model of flow in the annulus of a spouted bed of coarse particles. Model, experimental verification and residence time distribution. Canadian Journal of chemical Engineering. 1985;63:188-194. 11. Dhingra SC, Gunn DJ, Narayanan PV, The analysis of heat transfer in fixed beds of particles at low and intermediate Reynolds numbers. International Journal of Heat and Mass Transfer. 1984;27:2377 - 2385. 12. Gunn DJ, Narayanan PV Axial thermal dispersion and particle to fluid transfer in packed-fluidized beds. International Journal of Heat and Mass Transfer. 1981;24:1405 - 1411. 13. Gunn DJ, Narayanan PV, Particle-fluid heat transfer and dispersion in fluidised beds. Chemical Engineering Science. 1981;36:1985-1995. 14. Littman H, Narayanan PV, Tomlins AH, Friedman ML, A complete theoretical model for a first order isothermal catalytic reaction in a spouted bed. AICHE E SYMP. SER. 1981;77:174 -183. 15. Gunn DJ, Narayanan PV, Heat transfer in fixed beds of particles at low and intermediate reynolds numbers. Int Heat Transfer Conf, 6th, Toronto, Ont, Aug 7-11 1978 1978;4:19-24.

Pallassana Narayanan Issued Patents [1]

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Davila LA, Llanos GH, Mendez JO, Narayanan PV... MEDICAL DEVICES, DRUG COATINGS AND METHODS FOR MAINTAINING THE DRUG COATINGS THEREON, US7056550, 2006. P. Narayanan, METHOD OF COATING MEDICAL DEVICES, US6919100, 2005. Llanos GH, Roller MB, Narayanan PV, Scopelianos A, COATINGS FOR MEDICAL DEVICES, US6746773, 2004. Narayanan PV, Cook D, Leidner J, DEVICE AND PROCESS FOR COATING STENTS, US6723373, 2004. Leone JE, Narayanan PV, CATHETER SYSTEM HAVING FULLERENES AND METHOD, US6468244, 2002. Papandreou G, Narayanan PV, METHOD FOR TARGETING IN VIVO NITRIC OXIDE RELEASE, US6171232, 2001. Narayanan PV, RADIOFREQUENCY PLASMA TREATED POLYMERIC SURFACES HAVING IMMOBILIZED ANTI-THROMBOGENIC AGENTS, US5591140, 1997. P. Narayanan, RADIOFREQUENCY PLASMA BIOCOMPATIBILITY TREATMENT OF INSIDE SURFACES US5486357, 1996. Narayanan PV, RADIOFREQUENCY PLASMA TREATED POLYMERIC SURFACES HAVING IMMOBILIZED ANTI-THROMBOGENIC AGENTS, US5409696, 1995. Narayanan PV, Stanley KD, TREATMENT OF METALLIC SURFACES USING RADIOFREQUENCY PLASMA DEPOSITION AND CHEMICAL ATTACHMENT OF BIOACTIVE AGENTS, US5336518, 1994. P. Narayanan, RADIOFREQUENCY PLASMA BIOCOMPATIBILITY TREATMENT OF INSIDE SURFACES OF MEDICAL TUBING AND THE LIKE, US5244654, 1993. Narayanan PV, RADIOFREQUENCY PLASMA TREATED POLYMERIC SURFACES HAVING IMMOBILIZED ANTI-THROMBOGENIC AGENTS, US5132108, 1992. Yacobucci PD, Gerard JT, Narayanan PV, MAGNETIC RECORDING ELEMENT, US4849291, 1989.

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Patents under prosecution / filed [1] J. Borges, M. Carballo, P. Narayanan, . . . , COATING FOR CONTROLLED RELEASE OF A THERAPEUTIC AGENT, US20050033417A1,2004. J. Borges, M. Carballo, P. Narayanan, . . . , A COATING FOR CONTROLLED RELEASE OF A THERAPEUTIC AGENT, EP1504775A1, 2005. R.C. Burgermeister, Contiliano Joseph H., Dave Vipul, Li Yufu, . . . , POLYMERIC STENT HAVING MODIFIED MOLECULAR STRUCTURES, US20070134289A1, 2007. R.C. Burgermeister, Contiliano Joseph H., Dave Vipul, Li Yufu, . . . , POLYMERIC STENT HAVING MODIFIED MOLECULAR STRUCTURES IN BOTH THE HOOPS AND SELECTED SEGMENTS OF THE FLEXIBLE CONNECTORS, US20070135901A1, 2007. R.C. Burgermeister, Contiliano Joseph H., Dave Vipul, Li Yufu, . . . , POLYMERIC STENT HAVING MODIFIED MOLECULAR STRUCTURES IN SELECTED REGIONS METHOD FOR MAKING THE SAME, US20070132156A1, 2007.

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Pallassana Narayanan [6] R.C. Burgermeister, Contiliano Joseph H., Dave Vipul, Li Yufu, . . . , POLYMERIC STENT HAVING MODIFIED MOLECULAR STRUCTURES IN SELECTED REGIONS OF THE FLEXIBLE CONNECTORS, US20070134296A1, 2007. R.C. Burgermeister, Contiliano Joseph H., Dave Vipul, Li Yufu, . . . , POLYMERIC STENT HAVING MODIFIED MOLECULAR STRUCTURES IN SELECTED REGIONS OF THE HOOPS METHOD FOR INCREASING ELONGATION AT BREAK, US20070132155A1, 2007. R.C. Burgermeister, Contiliano Joseph H., Dave Vipul, Li Yufu, . . . , POLYMERIC STENT HAVING MODIFIED MOLECULAR STRUCTURES IN THE FLEXIBLE CONNECTIONS, US20070135902A1 2007. R.C. Burgermeister, Contiliano Joseph H., Dave Vipul, Li Yufu, . . . , POLYMERIC STENT HAVING MODIFIED MOLECULAR STRUCTURES IN THE FLEXIBLE CONNECTORS AND IN THE RADIAL STRUTS AND THE RADIAL ARCS OF THE HOOPS, US20070135900A1, 2007. R.C. Burgermeister, Contiliano Joseph H., Dave Vipul, Li Yufu, . . . , POLYMERIC STENT HAVING MODIFIED MOLECULAR STRUCTURES IN THE FLEXIBLE CONNECTORS AND THE RADIAL STRUTS OF THE HOOPS, US20070135899A1, 2007. R.C. Burgermeister, Contiliano Joseph H., Dave Vipul, Li Yufu, . . . , POLYMERIC STENT HAVING MODIFIED MOLECULAR STRUCTURES IN THE FLEXIBLRADIAL ARCS OF THE HOOPS, US20070135898A1, 2007. R.D. Burgermeister, Dave Vipul, Narayanan Pallassana V., . . . , POLYMERIC STENT HAVING MODIFIED MOLECULAR STRUCTURES IN BOTH THE HOOPS AND SELECTSEGMENTS OF THE FLEXIBLE CONNECTORS, US20070135895A1, 2007. R.D. Burgermeister, Dave Vipul, Narayanan Pallassana V., . . . , POLYMERIC STENT HAVING MODIFIED MOLECULAR STRUCTURES, US20070134295A1, 2007. R.D. Burgermeister, Dave Vipul, Narayanan Pallassana V., . . . , POLYMERIC STENT HAVING MODIFIED MOLECULAR STRUCTURES IN SELECTED REGIONS OF THE FLEXIBLE CONNECTORS, US20070134294A1, 2007. R.D. Burgermeister, Dave Vipul, Narayanan Pallassana V., . . . , POLYMERIC STENT HAVING MODIFIED MOLECULAR STRUCTURES IN THE FLEXIBLE CONNECTIONS, US20070135894A1, 2007. R.D. Burgermeister, Dave Vipul, Narayanan Pallassana V., . . . , POLYMERIC STENT HAVING MODIFIED MOLECULAR STRUCTURES IN THE FLEXIBLE CONNECTORS AND IN THE RADIAL STRUTS AND THE RADIAL ARCS OF THE HOOPS, US20070135892A1, 2007. R.D. Burgermeister, Dave Vipul, Narayanan Pallassana V., . . . , POLYMERIC STENT HAVING MODIFIED MOLECULAR STRUCTURES IN THE FLEXIBLE CONNECTORS AND THE RADIAL ARCS OF THE HOOPS, US20070135893A1, 2007. R.D. Burgermeister, Dave Vipul, Narayanan Pallassana, V., . . . , POLYMERIC STENT HAVING MODIFIED MOLECULAR STRUCTURES IN SELECTED REGIONS OF THE HOOPS, US20070135905A1, 2007. R.D. Burgermeister, Dave Vipul, Narayanan Pallassana V., ... POLYMERIC STENT HAVING MODIFIED MOLECULAR STRUCTURES IN THE FLEXIBLE CONNECTORS AND THE RADIAL STRUTS OF THE HOOPS, US20070135899A1, 2007. R. FALOTICO, KOPIA Greg A., LANDAU George, LLANOS Gerard H., . . . , DELIVERY DEVICES FOR TREATMENT OF VASCULAR DISEASE, EP1280571B1, 2005.

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Pallassana Narayanan [21]

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R. Falotico, Kopia Greg A., Landau George; Llanos G.H., . . . , DRUG COMBINATIONS AND DELIVERY DEVICES FOR THE PREVENTION AND TREATMENT OF VASCULAR DISEASE, US20010029351A1, 2001. R. Falotico, P. Narayanan, INTRALUMINAL DEVICE AND THERAPEUTIC AGENT COMBINATION FOR TREATING ANEURYSMAL DISEASE, US20070083258A1, 2007. R. FALOTICO, KOPIA Gregory, A., LANDAU George, LLANOS Gerard H., . . , DELIVERY DEVICES FOR TREATMENT OF VASCULAR DISEASE , EP1280571A1, 2003. H. Halleriet, Narayanan Pallassana V., KIT FOR APPLYING DRUG COATING TO A MEDICAL DEVICE WITH A LATEX EMULSION, EP1625860A1, 2006. H. Halleriet, Narayanan Pallassana V., KIT FOR APPLYING DRUG COATING TO A MEDICAL DEVICE IN SURGEON ROOM, US20050038504A1, 2005. H.N. Halleriet, Narayanan Pallassana, V., METHOD FOR APPLYING DRUG COATING TO A MEDICAL DEVICE IN SURGEON ROOM, US20050037133A1, 2005. Leone James E, P.V. Narayanan, CATHETER SYSTEM HAVING FULLERENES AND METHOD, US6468244B1, 2002. G.H. Llanos, Narayanan Pallassana V., Papandreou George, HEPARIN BARRIER COATING FOR CONTROLLED DRUG RELEASE, EP1609494A1, 2005. Narayanan Pallassana V, Zhao Jonathon Z., AMPHIPHILIC COPOLYMER COMPOSITIONS, US20070122443A1, 2007. P. V. Narayanan, Zhao Jonathon, Z., AMPHIPHILIC POLYMERIC COATING, US20070122550A1, 2007. P.V. Narayanan, SYSTEM FOR TREATING ANEURYSMAL DISEASE, EP1749545A3, 2007. G. PAPANDREOU, Pallassana V. Narayanan, MEDICAL DEVICE FOR (IN VIVO) NITRIC OXIDE RELEASE, EP1018984A4, 2003.

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