Quality Assurance Clinical

CURRICULUM VITAE

Janet Marsden-Salisbury Gress

Address: ***** ******* *** *****

Darnestown, Maryland 20787

Home Phone: 301-***-****

Cell Phone: 240-***-****

Education:

Brigham Young University

Bachelor of Science, Nursing

Certification: Nursing

Licensure: Maryland: R062405

Professional Interest/Skills:

Regulatory Affairs: Clinical trial design and analysis; Biologic

drug/agents; Bioresearch Monitoring; regulatory policy

Clinical Research: Hepatitis, Viral, Autoimmune, Infectious;

Communicable disease; Bone Marrow Transplantation;

Antimicrobial Agents for Immuno-Compromised Hosts/Patients

Teaching: Johns Hopkins Oncology Programs-community programs

Community Programs for Clinical Research-NIAID, NIH

Clinical Reviewer/Nurse Consultant, Division of Clinical

Trials Design and Analysis (DCTDA), Office of Therapeutics

Research and Review (OTRR), Center for Biologics Evaluation

and Review (CBER), Food and Drug Administration, Rockville

Maryland

Professional Experience:

A. Clinical Reviewer/Nurse Consultant, Division of Clinical

Trials Design and Analysis ( DCTDA), Office of Therapeutics

Research and Review (OTRR), Center for Biologics Evaluation and

Review (CBER), Food and Drug Administration, Rockville, Maryland

Duties

I serve as a member of an interdisciplinary team of scientist and medical

officers to evaluate pre-market and market evaluation of new and

investigational biologic drugs for safety and effectiveness in humans.

Associated with these primary functions are activities concerned with

review and regulation of labeling and advertising, evaluation of adverse

reactions, advancement of research and evaluation of practices, and

development of policy as expressed in regulations and "points to consider"

documents.

Investigational New Drug (IND) applications for all biological products are

submitted to the above office. Duties include ascertaining that the

proposed clinical trial is adequate and of appropriate design to permit

collection of the necessary evidence to determine both safety and

effectiveness of the experimental biologic, and directing the IND

(Investigational New Drug) through the clinical trial phases (I, II, Pre-

phase III and III) of study giving regulatory, statistical and drug

evaluation at the appropriate time-points. With submission of a Biologics

License Application to CBER, continued scientific and administrative

contact with the sponsor is maintained to assure internal consistency with

the laws and policies of the agency. Coordination and development of agency

position and requests for advisory opinions from industry, non-government

health related organizations are necessary to finally complete approval of

the biologic product.

Activities

Chair of Hepatitis Focus Group

Ad hoc consultant ICH Efficacy 6, Good Clinical Practice FR Notice for

GCP: Investigator Brochure

CBER Representative ICH, GCP San Francisco

FR Notice for GCP: Essential Documents for the Conduct of a Clinical

Trial International Congress for ICH: CBER Representative, Washington

D.C. The Third International Conference on Harmonization: Yokohama

Symposia In Clinical Trials: CBER, Speaker

CBER Representative, Efficacy 6, Good Clinical Practice

Good Clinical Practice Document Completed Signed by CBER/CDER,

Japanese and European Union Delegates

Consensus Conference for Hepatitis C; Washington D.C., Planning

Committee

Activities. continued

Clinical Trial Design and Analysis Symposia; speaker Gene Therapy

Conference; speaker, GCP

Ad hoc consultant American Association for the Study of Liver

Diseases, Washington. D.C.

AASLD, Chicago

AASLD, Dallas

BLA Committees 1994:1995: 1996: 1997: 1998: 1999: 2000-2002: Member,

Clinical Reviewer, Interferon alfa 2a for the treatment of Hepatitis

C.

Member. Clinical Reviewer, Interferon alfa 2b for increased treatment

duration 18-24 months, Hepatitis C.

Chair. Clinical Reviewer, Interferon alfa 2b for the treatment of

Pediatric Patients with Hepatitis B.

Chair, Clinical Reviewer, Interferon alfa-nl (lymphoblastoid) for

the treatment of Hepatitis C.

Chair, Clinical Reviewer for Pegylated Interferon alfa 2b for the

treatment of Hepatitis C.

Member, Clinical Reviewer for Pegylated Interferon alfa 2b +

ribavirin for the treatment of Hepatitis C.

Member, Clinical Reviewer for Pegylated Interferon alfa 2b+

ribavirin for the treatment of Hepatitis C.

B. Nurse Consultant, CPCRA, Community Programs for Clinical

Research Associates, Community Research Branch, National Institute of

Allergy and Infectious Diseases, National Institutes of Health,

Bethesda, MD

Duties

I served as Project Officer for the CPCRA component of Division-wide, site-

monitoring activities by the Community Site Monitoring Group. In this, I

was responsible for identifying problematic areas through the site

monitoring contract and working effectively to resolve problems and propose

solutions with the CSMG contract, CPCRA sites, and appropriate DAIDS staff.

I served as the coordinator of the CPCRA-wide Quality Assurance Program. I

reviewed established procedures, identified areas requiring policy or

procedural guidance, and developed corrective measures in all areas of

quality assurance. I evaluated each CPCRA site (17 primary-170 satellite);

internal quality assurance plans, and developed

recommendations to improve local quality assurance efforts. I coordinated

the activities of the CPCRA Quality Assurance and Control Committee and

oversaw/monitored the quality of the data being collected at individual

sites. I prepared sites for FDA inspections and audits.

I participated with education and training for overall programmatic

responsibilities in providing clinical education and training to CPCRA unit

staff as it related to quality assurance. I worked directly with the

operations center, the monitoring group, and the CPCRA statistical centers

to determine the training needs for quality assurance for each site.

Activities

Internal Quality Assurance: Guidance for Physicians for the Conduct of

Clinical Trials In Community Settings

Presentation to Site Visit Committee

Guidance to Sites: Communication with IRB's

Participated in data quality preparation for NDA submissions ddC

Bibliography available upon request.

C. Research Nurse Specialist, Pediatric Branch, National Cancer

Institute, National Institutes of Health, Bethesda MD

Duties

I was responsible for the coordination, supervision, and implementation of

a variety of clinical trials within the Branch relating to the protocolized

investigation of immunocompromised hosts. Among the many responsibilities

inherent in the position were the following: Branch Liason for Clinical

Staff Associates and Fellows in protocol implementation; consultant to

caregivers concerning the management of the study populations; monitoring

patients for response to therapy and communicating findings to Principle

Investigators with recommendations for action, analyzing, summarizing,

publishing and presenting results of clinical trials. Extensive clinical

knowledge and experience was gained in providing care to individuals with

cancer that were immunocompromised and receiving sophisticated and complex

therapy for their disease and symptom management. Collection, processing

and analysis of resultant data from the clinical trials became a

subspecialty within the institution and outside the NIH. Projects included

submission of data for NDA ddl (approval 1991) and submission of data for

NDA AZT (approval 1989).

*Bibliography available upon request

D. Instructor, Community Programs, The Johns Hopkins Oncology

Center, The Johns Hopkins Hospital, Baltimore MD

Duties

This position required working with advisory committees in hospitals

throughout the State of Maryland to develop, design, organize, and present

cancer education programs that offered continuing education units from the

Maryland Board. I developed a needs assessment to ascertain learning needs

of staff caring for cancer patients. I collaborated with colleagues to

develop a newsletter, audio-visual learning materials, and instructional

manuals.

E. Head Nurse, Bone Marrow Transplantation Unit: Johns Hopkins

Oncology Center, Johns Hopkins Hospital, Baltimore, MD

Duties

I implemented and directed nursing care for patients receiving allogeneic

and autoiogous marrow transplant therapy. Intensive care was integrated

into the unit which was designed to offer full support to individuals with

common or extreme complications of transplant treatment. I identified the

need for formal nursing care protocols and initiated nursing processes to

improve care for these patients. I also carried out administrative and

personnel management issues related to nursing support in the transplant

unit.

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