Expert Details

Biocompatibility Testing and Biomaterials for Medical Devices

ID: 721780 New Jersey, USA

Consulting experience in the set up and protocols for biological tests, pre-clinical evaluation submission summaries (regulatory), product (medical device) cleaning validation, GLP laboratory set up and management, biocompatibility/ toxicilty testing

Strategy for the pre-clinical evaluation / toxicity testing of an implantable medical device [many] test selection, test justitfication, scientific justification for not performing a test, writing of regulatory summary.

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Education

Year	Degree	Subject	Institution
Year: 1985	Degree: MS plus PhD work in Pathology and Toxicology	Subject: Biology	Institution: University of Bridgeport/ UMDNJ/ Rutgers
Year: 1970	Degree: BS	Subject: Microbiology	Institution: Syracuse University

Work History

Years	Employer	Title	Department
Years: 1995 to 2000	Employer: Cordis Corporation, a Johnson and Johnson Company	Title: Staff Scientist	Department: Research and Development
Responsibilities: Cardiovascular device development. Pre clinical evaluation of devices and device-drug combination products. Biocompatibility test management. Scientific justifications for regulatory submission. Biological safety testing and test development. Technical expert for six ISO TC 194 Working Groups (International Standards for Biological Safety of Medical Devices.)
Years	Employer	Title	Department
Years: 1986 to 1995	Employer: Ohmeda	Title: Senior Scientist	Department: R & D
Responsibilities: Development of novel biomaterials and coatings for medical devices. Biocompatibility and hemocompatibility test development. Development of novel antimicrobial catheter coating. Technical expert for five ISO TC 194 Working Groups (International Standards for Biological Safety of Medical Devices.)

International Experience

Years	Country / Region	Summary
Years: to Present	Country / Region: worked for 2 international companies- where products were manufactured, approved & distributed world	Summary:

Career Accomplishments

Associations / Societies
Society for Biomaterials ASTM

Licenses / Certifications
MT/ASCP, NY State Teaching License

Awards / Recognition
J& J Acheivement Awards BOC Technolgy Award

Publications and Patents Summary
Publications and Presentations Buscemi P, Expert A. Protein Adsorption from Plasma SDS Electrophoresis to Clinically Used Polymers. Presented at the meeting of the Society for Biomaterials, New York, 1987. Jansen R, Expert A. Reducing Complications of Central Venous Catheterization: Importance of the Catheter Material. Proc. of Adv..Intens. Care, 1990, 121-132. Klima S, and Expert A. Characteristics and Blood Compatibility of Diol Extended Polyurethanes. Transactions of Soc. for Biomaterials, 1990, p.269. Presented at the Society for Biomaterials Meeting, Charleston, SC. Expert A. Analysis of Platelet Responses to Polyimide Siloxane Polymers, Transactions of Society for Biomaterials, 1991, p.42. Presented at the Society for Biomaterials Meeting, Scottsdale, Arizona. Expert A., In-Vitro Hemocompatibility Screening Method for Biomaterials, Transactions of the World Congress for Biomaterials, 1992, pg 669. J. Bandekar and A. Expert. FTIR Spectroscopic Studies of Polyurethanes V: Studies of the Effect of The Presence of Processing Aids on the Hemocompatibility of Polyurethanes, Journal of Biomaterial Science Polymer Ed. Oct. 1995. Expert A., Scott I., Laksin 0. I; Transactions of Society for In-Vitro Hemocompatibility Assays Predict In-Vivo Response for Hydromer-Coated and Uncoated Polyimide Tubing, Society for Biomaterials Meeting 1993, Transactions p.38. Presented at 1993 meeting. Expert A., Bandekar J.. Examination of Wax on the Surface of Extruded Pellethane by SEM, ATR-IR, and XPS and Its Importance in Blood Compatibility. Presented at the Topical Conference on Biomaterial Interfaces, November 15-16, 1993. Published in J. Vac. Sci. Technol. A. 12(5)pp/ 2966-2970, Sept/Oct 1994. Tebbs TE, Expert A .and Elliott TSJ. The Influence of Surface Morphology on In-vitro Bacterial Adherence to Central Venous Catheters. Published in the British Journal of Anaesthesia 1994; 72; 587-591. Expert A. Analysis for IUPAC Working Party on Interactions of Polymers With Living Systems--Activation of the Complement System. Submitted June 1994; published in the IUPAC Journal. Expert A., Gerristead W., and Link L. Comparison of SEM and Environmental SEM for the Evaluation of Blood/ Polymer Interactions. presented at Scanning Microscopy International, Toronto, May 1994. Published in Cells and Materials. Expert, A., Hemocompatibility Testing of Medical Devices, presented at the IBC Conference on Biocompatibility of Blood Contacting Devices; June 27, 1995, Boston and published in proceedings. Guest lecturer for Biomaterials course 1995, University of Miami, Miami, Fl.. Expert A., Pottinger-Cooper E.. Analysis of Complement Activation Testing Methods for Medical Materials; Presented at the Society for Biomaterials Meeting, April 1997 and published in 1997 Transactions of Society for Biomaterials Meeting. Expert A., ISO 10993 Biological Safety Evaluation of Medical Devices, presented at Medical Design and Manufacturing Conference, Minneapolis, MN, November 1997 and published in meeting proceedings. Expert A, Gorbet M, Pottinger-Cooper E, Black JP, Sefton M, Screening the Thrombogenicity of Plasma Modified Materials: PTT, SEM, Complement, and Blood Cell Activation, to be presented at April 1998 Society for Biomaterials Meeting, Expert A., In-Vitro Thrombogenicity Test System, Presented at the J &J Biological Research Committee, April 1998. Expert A., J &J Corporate Biocompatibility Database, presented at the J & J Polymer and Biomaterial Sub Committee Symposium, November 1998. Sefton MV, Expert A, Gorbet M, Black JP, Cheng E, Gemmell C, Cooper E, Does Surface Chemistry Affect Thrombogenicity of Surface Modified Polymers?, submitted to J Biomed Mater Res, July 2000.

Publications and Patents Summary

Publications and Presentations

Buscemi P, Expert A. Protein Adsorption from Plasma SDS Electrophoresis to Clinically Used Polymers. Presented at the meeting of the Society for Biomaterials, New York, 1987.

Jansen R, Expert A. Reducing Complications of Central Venous Catheterization: Importance of the Catheter Material. Proc. of Adv..Intens. Care, 1990, 121-132.

Klima S, and Expert A. Characteristics and Blood Compatibility of Diol Extended Polyurethanes. Transactions of Soc. for Biomaterials, 1990, p.269. Presented at the Society for Biomaterials Meeting, Charleston, SC.

Expert A. Analysis of Platelet Responses to Polyimide Siloxane Polymers, Transactions of Society for Biomaterials, 1991, p.42. Presented at the Society for Biomaterials Meeting, Scottsdale, Arizona.

Expert A., In-Vitro Hemocompatibility Screening Method for Biomaterials, Transactions of the World Congress for Biomaterials, 1992, pg 669.

J. Bandekar and A. Expert. FTIR Spectroscopic Studies of Polyurethanes V: Studies of the Effect of The Presence of Processing Aids on the Hemocompatibility of Polyurethanes, Journal of Biomaterial Science Polymer Ed. Oct. 1995.

Expert A., Scott I., Laksin 0. I; Transactions of Society for In-Vitro Hemocompatibility Assays Predict In-Vivo Response for Hydromer-Coated and Uncoated Polyimide Tubing, Society for Biomaterials Meeting 1993, Transactions p.38. Presented at 1993 meeting.

Expert A., Bandekar J.. Examination of Wax on the Surface of Extruded Pellethane by SEM, ATR-IR, and XPS and Its Importance in Blood Compatibility. Presented at the Topical Conference on Biomaterial Interfaces, November 15-16, 1993. Published in J. Vac. Sci. Technol. A. 12(5)pp/ 2966-2970, Sept/Oct 1994.

Tebbs TE, Expert A .and Elliott TSJ. The Influence of Surface Morphology on In-vitro Bacterial Adherence to Central Venous Catheters. Published in the British Journal of Anaesthesia 1994; 72; 587-591.

Expert A. Analysis for IUPAC Working Party on Interactions of Polymers With Living Systems--Activation of the Complement System. Submitted June 1994; published in the IUPAC Journal.

Expert A., Gerristead W., and Link L. Comparison of SEM and Environmental SEM for the Evaluation of Blood/ Polymer Interactions. presented at Scanning Microscopy International, Toronto, May 1994. Published in Cells and Materials.

Expert, A., Hemocompatibility Testing of Medical Devices, presented at the IBC Conference on Biocompatibility of Blood Contacting Devices; June 27, 1995, Boston and published in proceedings.

Guest lecturer for Biomaterials course 1995, University of Miami, Miami, Fl..

Expert A., Pottinger-Cooper E.. Analysis of Complement Activation Testing Methods for Medical Materials; Presented at the Society for Biomaterials Meeting, April 1997 and published in 1997 Transactions of Society for Biomaterials Meeting.

Expert A., ISO 10993 Biological Safety Evaluation of Medical Devices, presented at Medical Design and Manufacturing Conference, Minneapolis, MN, November 1997 and published in meeting proceedings.

Expert A, Gorbet M, Pottinger-Cooper E, Black JP, Sefton M, Screening the Thrombogenicity of Plasma Modified Materials: PTT, SEM, Complement, and Blood Cell Activation, to be presented at April 1998 Society for Biomaterials Meeting,

Expert A., In-Vitro Thrombogenicity Test System, Presented at the J &J Biological Research Committee, April 1998.

Expert A., J &J Corporate Biocompatibility Database, presented at the J & J Polymer and Biomaterial Sub Committee Symposium, November 1998.

Sefton MV, Expert A, Gorbet M, Black JP, Cheng E, Gemmell C, Cooper E, Does Surface Chemistry Affect Thrombogenicity of Surface Modified Polymers?, submitted to J Biomed Mater Res, July 2000.

Additional Experience

Training / Seminars
GLP Biocompatibilty Testing Biocompatibility Test Management ISO/ FDA Biocompatibility Testing

Vendor Selection
material selection, sourcing of vendors for medical devices

Marketing Experience
competitor testing, reporting and publication

Fields of Expertise