Medical Device Quality Assurance

Norian Corporation Cupertino, CA Orthopaedic Trauma and Craniofacial Applications

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Vice President, Clinical & Regulatory Affairs Start-up Class III orthopaedic medical device company.

Managed U.S. and international staff of 13 members and all regulatory submissions (3-IDEs approved for distal radius,

intertrochanteric hip, and tibial plateau fractures, 1-PMAA [Norian SRS], 510K [Norian CRS]) domestic &

international (Canadian & CE Mark), and European post-marketing surveillance,

Recruited EU clinical investigators, wrote regulatory applications for research approvals in The Netherlands, Sweden,

Germany, etc., commenced studies in distal radius, tibial plateau, calcaneus, intertrochanteric and femoral neck clinical

applications,

U. S. Committee Chairperson company representative for Japanese joint venture partner [Mochida Pharmaceuticals] to

develop US/Japanese clinical strategy and trial initiation to achieve Ministry of Health commercial approval,

Presented to FDA’s ODE reviewers and Deputy Director, regulatory strategy, and study design before multicenter

clinical study commencement of a {323 subjects} prospective, randomized, multicenter US and EU clinical trial.

Develop documents for regulatory submittals, Investigator Brochures for EU studies, & received FDA approval to

commence feasibility and randomized multicenter trials,

Advised President on Humanitarian Device Use while under clinical investigation,

Received Administrative PMAA approval for Class III orthopedic device, with subsequent PMA approval,

Develop and negotiate budgets and contracts, strategize and identify financial data to establish reimbursement or cost-

effectiveness studies, wrote/edit protocols, hire, and direct clinical/regulatory personnel on a worldwide basis. Met

with European regulators in preparation of Medical Device Directives (Economic Community evolving MDD

approval) and medical device registration (CE Mark),

Wrote technical monographs/white papers, draft publications, meet with venture capitalists and present clinical

applications and data to outside agencies. Ongoing communication with Marketing, Finance, Engineering, and R & D

members; report to the CEO and Board of Directors,

Filed and received Premarket Notification clearance for craniofacial applications,

Presented and met with venture capitalists, Board of Directors, potential investigators, potential investors, and attorneys

in preparation for regulatory documents for public offering.

Alameda, CA In Vitro Diagnostics (IVD) for Ovarian & Breast Cancer

Triton Diagnostics, Inc.

1991-1992

Small In Vitro diagnostic company.

Manager, Clinical Research

Responsible for clinical research budgets, initiate Class III multi-center feasibility clinical trials for ovarian and breast

cancer for PMAA approval,

Designed clinical data base for statistical analysis, recruit investigators, negotiate contracts, IRB approvals, protocol

design and the writing of regulatory reports,

Worked with Marketing & Project Managers for multiple projects, Shell Oil's Legal Consultant for contract

negotiation,

Managed and reorganized Human Specimen Bank to increase efficiency while responsible for the management and

collection of clinical specimens within R & D to meet American Association Tissue Banks (AATB) Standards,

Chair the Research Collaboration Committee comprised of Marketing and R & D scientists. Company acquired by

CIBA Corning Diagnostics.

Urosystems, Inc. Sunnyvale, CA

1991 Urological indications-stress incontinence

Start-up company to treat various forms of stress incontinence.

Director, Clinical Affairs

Developed and responsible for research budget, ensure regulatory compliance for PMAA submission, managed clinical

database, identify and categorize subjects to generate monthly reports,

Met with FDA Inspector as part of a strategic team,

Hired, oriented, & organized research staff, audited the clinical department for FDA and facility inspection, conducted

field audits,

Managed seven domestic and seven international clinical sites. Investor funding not available and the technology was

re-acquired by Medical Device Supplier.

San Jose, CA Interventional neuroradiology & peripheral radiology

Target Therapeutics, Inc.

1989-1991

Clinical Research Director & Acting Regulatory Affairs

New interventional radiology & cardiology angioplasty catheter start-up

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Responsible for the development and management of IDE compliant clinical trials for un-operable brain aneurysms &

AVMs,

Medical Device Reporting (MDR/GMP), annual reports, database development, and commercial product evaluations

for regulatory filings,

Interacted with management and FDA in development of Premarket Notification (510K) and IDE(s),

Field trained CRA's to monitor trials according to Good Clinical Practice(s) and perform internal audits,

Collaborated with research engineers on multiple projects during product development to clinical trials or

commercialization,

Developed and revised Standard Operating Procedures (SOP) in collaboration with Quality Assurance. Developed

budgets & contracted with appropriate consultants,

Wrote and submitted international submissions for research and registrations with subsequent approvals.

Danville, CA

Advanced Biosearch Associates

1988-1989 Clinical and Regulatory Affairs Consultant

Private FDA Regulatory Consulting Firm

Director, Clinical Research

Managed up to 7 internal staff in the clinical research department & co-managed client clinical departments,

Generated budgets and client proposals, trained clinical monitors for field audits according to GCP(s),

Project director for multiple contracted client activities for the development & management of various clinical trials,

Wrote protocols, annual reports, and documents for regulatory submissions, drafted a laser Premarket Notification (510

K) with supporting clinical data acquired under an IDE, received subsequent FDA clearance,

Participated in the writing of IDE(s), device reclassification of a transition device for sutures, attended and prepared

experts' presentations for FDA panel meetings.

Collagen Corporation Palo Alto, CA Dermatology & Plastic Surgery, Oral Surgery, & Orthopaedics

1985-1988

Clinical Research Associate (Senior)

Wrote protocols, safety and efficacy PMA sections, and regulatory reports, interacted with IRB(s), opened and

monitored ~20 clinical domestic Canadian sites, reviewed statistical data, identify experts for contractual work and

negotiate contracts, prepared and monitored study budgets,

Company received PMAA approval for Alveoform for alveolar ridge augmentation; company clinical representative

and collaborated with Zimmer on IDE study for Collagraft,

Oriented/educated new clinical monitors, research assistants, and regulatory affairs personnel, wrote SOP(s), wrote

safety section for PMAA Submission,

Attended FDA Panel meeting as clinical resource, drafting & review of product labeling,

Formally train sales personnel, and represented Medical Affairs at sales and medical meetings.

Collagen Corporation Post-Market Surveillance for Class III bovine collagen dermal filler

1984-1985

Safety Medical Monitor

Collected and monitored data for complaint files and adverse reactions Zyderm, analyzed data for FDA reports,

Completed Phase IV monitoring, designed report forms for data entry and computerized reports, oriented new Monitors

and sales personnel to safety profile of commercialized products,

Maintained complaint files for potential product liability action and collaborate with the Director, Quality Control,

Met with FDA Investigators during quarterly complaint file audits, prepared and monitored budget,

Communicated and educated physicians customer end-users and their patients about the immunological response to

bovine collagen implant during telephone interviews and data collection.

Lieutenant Commander (LCDR) US Navy Nurse Corps (Permanently Inactive)

MILITARY STATUS

George Mason University Fairfax, VA 1982-83 Masters of Science Administration 1982-83

EDUCATION

Marymount College of Virginia Arlington, VA Bachelor of Science in Nursing 1980-82

Cum Laude Marymount College of Virginia

HONORS

President's Cup for outstanding performance

Sales and Marketing award for outstanding clinical performance

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PUBLICATIONS

Reactions to Injectable Collagen: Results in Animal Models and Clinical Use. F. De Lustro, S. T. Smith, J. Sundsmo, et al

Plastic and Reconstructive Surgery: April 1987, 79, 581-592.

Evaluation of Collagen/Hydroxylapatite for Augmenting Deficient Alveolar Ridges: A Preliminary Report. D. Mehlisch,

T. Taylor, D. Leibold, R. Hiatt, D. Waite, P. Waite, D. Laskin, S. T. Smith, & M. Koretz J Oral & Maxillofac Surg, 1987, 45,

408-413.

Collagen/Hydroxylapatite for Augmenting Deficient Alveolar Ridges: 12 Month Results. D. Mehlisch, T. Taylor, D.

Leibold, R. Hiatt, D. Waite, P. Waite, D. Laskin, S. T. Smith J Oral & Maxillofac Surg, 1988, 46, 839-843.

A Process for the In Situ Formation of the Mineral Phase of Bone. B. Constantz, I. Ison, M. Fulmer, R. Poser, S. T. Smith,

M. Van Wagoner, J. Ross, S. Goldstein, J. Jupiter, D. Rosenthal Science, 1995, 267, 1796-1799.

Repair of Five Distal Radius Fractures with Investigational Cancellous Bone Cement: A Preliminary Report. J. Jupiter,

S. Winters, S. Sigman, C. Lowe, C. Pappas, A. Ladd, M. Van Wagoner, S. T. Smith. Journal of Orthopaedic Trauma, 1997,

2,110-116.

Bioactive Materials in Orthopaedic Surgery-Overview and Regulatory Considerations. Bauer, T & S. T. Smith,

Current Orthopaedics and Related Research, Vol. 395, pp 11-22, February 2002.

PRESENTATIONS/Guest Speaker

Guest speaker: Northern California Pharmaceutical Discussion Group

Sales and Marketing for new product introductions and regulatory oversight

FDA & Sponsor Meetings for Pre-IDE and PMA preparations

Women in Science Palo Alto, CA

CONTINUING EDUCATION

Good Clinical Practices 4/14-16/86, Preparing Clinical Protocols & Managing Clinical Investigations 3/88 Regulatory

Compliance GMP/QA/QC/SOP 11/14-18/88, Process Validation 10/89 Good Manufacturing Practices (GMPs) 4/90; FDA

Medical Workshops GMP/Sterile Devices 6/13-14/90; FDA Workshop In Vitro Diagnostic Devices 6/21/90; Drugs & Devices

1991: Current Regulatory Issues 11/7-8/91; Registration of Medical Devices in Europe 7/20-22/92 Good Manufacturing

Practices/Preproduction Quality Assurance 11/13/92, Regulation & Reimbursement of Medical Devices 6/15/93; Designing

Clinical Trials for Approval & Reimbursement 4/18-19/94; European Registration System for Medical Implants (Holland) 6/2-

3/94, Reimbursement Planning & Technology Assessment for Devices 12/5-7/94 Current Good Manufacturing Practice (QSR)

for Medical Devices 3/5-7/01; Combination Products 3/25-26/04, RAPS 2004 Western Symposium (International Regulatory

and new standards), Technology Transfer for Emerging Technologies 5/29-31/07, Medical Device Congress 4/26-28/08,

American Orthopaedic Association of Sports Medicine July 10-13, 2008, RAPS Horizons 3/30-4/3/09, Florida Manufacturer’s

Medical Device 4/7-8/09, & RAPS Annual Meeting 9/13-16/09, FDA Clinical Trial Requirements Regulations, Compliance

and Good Clinical Practices (GCP) 11/4/5/2010, Risk Management for Medical Devices: Applying 14971 Effectively Using

Risk Assessment and Reliability Tools, Advanced Process Validation 3/16-17/2011, & Advanced Site Management: Finance &

Productivity 3/24-25/2011.

PROFESSIONAL ORGANIZATIONS

Regulatory Affairs Professional Society (RAPS),

Society for Clinical Trials,

Society of Clinical Research Associates (SoCRA)

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