James M. Kadushin

Personal:

Married with two children.

Education:

1973-1974	Biology Major, University of Michigan
1974-1977	Bachelor of Science (Zoology), Michigan State University

Employment:

1978-1983

Histocompatibility Lab Technologist, University Hospitals of Cleveland

Performed HLA typing, cellular immunological assays, serological detection of antibody. Developed new clinical tests and procedures made available to the Bone Marrow and Renal Transplantation Programs. Set up an ancillary reagent procurement program that resulted in up to $100,000 of additional revenue per year. Instructed Medical Technology and Medical School students in the Immunology Laboratory course curriculum.

1983-1989

Histocompatibility Lab Supervisor, University Hospitals of Cleveland

Supervised three full time and 5-7 part time employees in the duties of a clinical HLA laboratory. Performed fiscal budget and space planning for a new laboratory. Co-designed and programmed a complete laboratory Database Management System (DBMS) that was eventually commercialized and sold to other clinical laboratories through a licensed limited partnership corporation of which I was co-founder and partner. Director, Product Development. Gen Trak, Inc., Plymouth Meeting, Pennsylvania Managed and participated in the development of immunology in-vitro diagnostic tests.

1989-1993

Accomplishments:

• Designed and programmed three software products designed to complement clinical products for organ Plantation testing though data analysis and database functions.
• Re-engineered a frozen cell tray product that was previously removed from the market due to poor performance. The product was re-launched with an increase of sales of 120%.
• Re-designed an cytotoxicity antibody detection test utilizing a fluorescent label detection system. A 250% increase of sales resulted within one year of re-launch.
• Designed and set up a molecular biology laboratory for the development of Gen Trak's HLA DNA typing assay. Began development of an ELISA DNA microtiter tray based hybridization assay.

1993-

Current Vice-President, Operations and Research and Development, Gen Trak, Inc.

Assumed responsibility for all manufacturing, quality control. quality assurance. regulatory affairs, validation and product development functions.

Accomplishments:

Completed development of the CQuentials HLA DNA Typing Kit, including DNA probe design and qualification, manufacturing system design and validation, in-process procedures and SOPS, materials selection, specification definitions, and writing the submission of the 5 10(k) to the Food and Drug Administration (FDA). Market clearance was approved by the FDA in seven months without questions (May 1995). The CQuentials product was the first HLA DNA IVD product cleared by the FDA.

• Designed and implemented a DNA probe screening process that is 8 fold more efficient than the original process. This process allows new DNA hybridization products to be designed and ready for validation in 3 -6 months.
• Re-designed and instituted a new lymphocyte cell separation process. improving product yield by over 100% and reducing product manufacturing costs by 25%. The improvement of quality resulted in an increase of sales of 160% in first half 1996.
• Managed a $2.5 million manufacturing and R&D budget, with 6 direct reports and 24 total employees.
• Designed the analysis algorithm and format for a new Windows based DNA testing software. Validation was performed according to FDA guidelines. This product was released for sale in August 1996.
• Developed the CQuentials HLA DQ DNA Typing Kit capable of detecting 17 unique DQB1 was completed in less than four months, below budget in the commercial launch in October 1996.

Interests & Activities:

Home repair, computer programming, reading, fishing, children's school activities, exercise. study of herpetology.

COMPUTER SELLS:

Expert programming skills with Foxbase and compatible database languages (10 years experience). Also accomplished in QuickBasic, Basic, and some C++. Thorough knowledge of Lotus 123 (WYSIWYG), DOS commands. MS-Works, MS-Word, MS-Project. Excel, WordPerfect, Windows and miscellaneous other programs.

• Designed and programmed a comprehensive data management and test data analysis system (DBMS) for clinical laboratories.
• Designed and programmed four DOS and Windows applications for use with Trak IVD products.
• Experience in setting up and maintaining a Novell LAN version 3.15 with 25 workstations.