Jerri Barden Perkins' CV, PERKINS & PERKINS INCORPORATED, Medical and Regulatory Consultants

JERRI BARDEN PERKINS, M.D.
8806 Liberty Lane
Potomac, Maryland 20854
(301) 983-0395

SUMMARY

In 1984, after eight years as a medical officer at the Food and Drug Administration (FDA), Dr. Jerri Perkins established Perkins & Perkins, Inc. (PPI). PPI offers medical and regulatory assistance to the pharmaceutical and medical device industries. As president of PPI, she has written protocols, prepared companies to meet with FDA staff, participated in FDA meetings with companies, served on a Data Safety Monitoring Boards, and assisted companies in preparing IND, NDA, ANDA, IDE, PMA and 510(k) submissions. These submissions have included both drug/device and biologic/device products. She has actively participated in regulatory issues involving AIDS, helped companies get their first patient into clinical trials, identified regulatory issues in submissions prior to FDA submission, and developed strategy for propelling a product from non-approval to approval without additional data.

In addition, Dr. Perkins has conducted pre-FDA audit inspections in the US and Europe. Her audit reports have been used successfully to prepare sites for FDA inspections.

EXPERIENCE

1984-present	Founder and President of Perkins & Perkins, Inc.
1982-84	Medical Officer, HHS, FDA, NCDB, ONDE, DAIDP (Drugs)
1980-82	Medical Officer, HHS, FDA, OHA (Commissioner's Office)
1976-80	Medical Officer, HEW, FDA, BMD (Medical Devices)
1973-74	Consultant, HEW, NIH, NIAMDD
1972	Volunteer for Ralph Nader's Consumer Research
1971	Medical Officer, HEW, NIH, NIAMDD
1970-71	Medical Officer, HEW, HSMHA
1969-70	Staff Microbiologist, Hazelton Labs, Inc.
1966-69	Staff Fellow, HEW, NIH, NIAID
1965-66	Research Trainee, Medical College of Virginia

PUBLICATIONS

Perkins, Jerri B. "How Does a Medical Officer Review an NDA Submission?" RAPS, June 1995

Perkins, Jerri B. and John C. "Preventive Strategies in Sexually Transmitted Diseases." JAMA, Jan. 8, 1988.

Perkins, Jerri Barden. "Tips on PMA Preparation/Presentation." MDDI, June 1985.

Perkins, Jerri Barden. "Streptokinase Treatment for Acute Myocardial Infarction and the DRG Payment System." Prepared for the Office of Technology Assessment U.S. Congress, Washington, D.C., December 1984. Published in Medicare's Prospective Payment System (Strategies for Evaluating Cost, Quality and Medical Technology), October 1985.

Health Letter, The Washington Clinic Medical Center, Washington, D.C., 1986 through 1989. Monthly patient newsletter for multispecialty medical group.

PRESENTATION AND WORKSHOP HIGHLIGHTS

1991- 2002 Management Forum, London, England; Clinical study requirements for FDA

1999-2001 ACRP Annual Meetings; Presentations on Preparing for an FDA Inspection

1999-2001 Management Forum, London, England; FDA Pediatric rule

1999 DIA Annual Meeting in Baltimore, MD; Presentation on Pre-FDA Audits

1995 PDA invited speaker, Rockville, MD

1994 Speaker at the state Pharmaceutical Administration of China (SPAC) and the Department of Science and Technology for Social Development, the state Science and Technology Commission of the PRC; On the topic of FDA requirements for marketing drug and medical devices in the US

1993 IX International Conference on AIDS, Berlin, Germany, "Compliance Rate for Universal Precautions Among Non-Professional and Professional Health Care Workers in a Free Clinic in Washington, D.C." Perkins, J., Grandin, J. and Korniewicz, D.

1992 Johns Hopkins Univ. School of Nursing Guest lecturer on "Barrier Protection."

1992 DIA, "Overview of FDA Clinical Trial Regulations," Philadelphia, PA

1992 "Making Effective FDA Medical Device Submission,"Barnett International, Washington, D.C.

1991 Speaker at FDA/DSMA Design and Clinical Validation of Medical Devices, Boston, MA

1987-92 RAPS (Regulatory Affairs Professional Society)
--Speaker on "Advertising Regulations," Chicago (March1992) and Newport Beach, CA (Sept.1992)
--Chaired 1990 Meeting, "Clinical Studies: How to Successfully Resolve Clinical Problems to Achieve FDA Approval," with presentation on a Case Study Analysis
--Co-chaired 1989 conference in San Diego on theme "How to Prepare for and Conduct a Clinical Investigation: Drug and Device Requirements" with presentation on Study, Implementation, Monitoring, Evaluation and Presentation to the Agency
--Initiated Clinical Program (1987) and chaired first program 1988)

1988 HIMA representative who testified at the Assembly Health Committee of the State of California on Prophylactics Bill.

EDUCATION

Post-Doctoral Training

Harvard U. School of Public Health 1992 Risk Analysis in Occupational and Environmental Health

National Institutes of Health 1984 Infectious Disease Course

Johns Hopkins University 1980-81 Public Health Administration in Management (3 hours credit)

National Institutes of Health 1979 Statistical Methodology Course in Clinical Trials

National Institutes of Health 1966-69 Staff Fellow, Laboratory of Infectious Diseases, HEW, NIH, NIAID

Pre-Doctoral Training

Medical College of Virginia 1966 M.D.

Medical College of Virginia 1965-66 NIH Research Trainee

Catholic University 1962-63 Graduate Courses in Microbiology (22 hours credit)

Mary Washington College of the University of Virginia 1961 B.S.

COMMUNITY SERVICE

Volunteer, Zacchaeus Free Medical Clinic in Washington, D.C., 1988-present

Member, Medical Committee, Zacchaeus Free Medical Clinic, 1992-present

Member, Board of Directors, Zacchaeus Free Medical Clinic, 1992-93

HONORS AND AWARDS

Mary Washington College Scholarship

Alpha Phi Sigma (honor society)

Chi Beta Phi, Kappa Sigma chapter (scientific fraternity)

Mycoplasma pulmonis "JB" strain (National Type Tissue Collection)

FDA EXPERIENCE

1982-84 (20 hours/week)

Anti-Infective Drugs, Bureau of Drugs

Medical officer responsible for initiating labeling revisions for the drug Ketoconazole (anaphylactic reaction, refer to FDA Drug Bulletin, vol.14, no. 2, August 1984).

Reviewed and made recommendations on new drug applications (NDA) before the Agency; e.g., cephalosporins, penicillins, anti-fungals, etc.

Reviewed and made recommendations on investigational new drugs (INDs) before the Agency.

Reveiwed Adverse Events (AEs)

Presented on behalf of FDA before one of FDA's Advisory Panels.

Civil Service Representative for FDA to the Physician Professional Advisory Committee (PPAC) to Surgeon General C. Everett Koop, M.D.

Special Assignment

Served as FDA ophthalmologist, performing 30-day safety reviews for ophthalmic drugs for six months.

1980-82 (20 hours/week)

Office of Health Affairs (Medicine), Office of the Commissioner (Dr. Gerald Goyan)

Staff expert and medical advisor to the Deputy Associate Commissioner for Health Affairs in Medicine. Advised the Deputy Commissioner in evaluating studies and initiatives related to Agency and Departmental medical and health policies. The studies provided the basis for major policy decisions involving complex quasi-legal, scientific and medical issues or having long range or major effects on FDA medical/enforcement activities. Many of the studies or initiatives involved controversial and precedent setting policy issues and involved work in new and/or controversial areas in which there was little or no background information.

Operating in these highly sensitive areas required professional and judgmental skill. My advice assisted the Deputy Associate Commissioner in providing prompt, accurate, comprehensive and effective responses on a wide range of requests concerning medical issues from consumer groups, other agencies or departments within the Government, and private citizens. These responses were accepted as authoritative statements of FDA policies or positions.

Significant duties and responsibilities included:

1. Represented the Agency in communications with other Government agencies dealing with medical policies, medical programs, health care technology, and the role of FDA-regulated products in the practice of medicine.
2. Toxic Shock Syndrome (TSS) Task Force

Initiated a "Dear Doctor Lctter" from FDA sent to 250 professional organizations as result Adverse Events (AEs).
Coordinated international information with 24 countries by working with CDC and the National Academy of Sciences, Institute of Medicine.
Represented the Agency on a local one-hour live television talk show (Morning Break) on TSS.
Drafted TSS warning label for tampons.
Worked with one company on a "Dear Doctor letter" to be sent by the company to physicians on TSS.
Assisted in developing TSS tampon proposed regulation; TSS public service announcements; TSS in FDA Drug Bulletin.

3. Provided advice on identifying needs for and the development of new legislation which impacts Agency medical policies and public health. Developed plans for Agency actions required by new legislation.

Tissue Banks
HHS Health initiative Smoking Task Force
End Stage Renal Disease Planning Committee

4. Advised the Deputy Associate Commissioner for Health Affairs (Medicine) and other key Agency officials, including the Commissioner, of human protection needs and of initiatives which will affect Agency activities in regard to human protection. Provided staff support to the "Research Involving Human Subjects Committee."

5. Proposed resolutions to inter-bureau program problems related to medical practices and policies. Evaluated the effectiveness of initiatives and actions affecting major medical policies.

6. Provided medical reviews of evidentiary hearing requests and proposed findings of fact and conclusions of law as recommended by the Administrative law Judge after evidentiary hearings on drugs.

7. Served as Agency focal point for the coordination of specific issues in patient care, particularly those related to the approval of new products having significant impact on health care practices, activities of other federal agencies, and costs.

1978-79 (20 hours/week)

Orthopedics (Acting Division Director for DSRD during March, July, November and December 1979), Bureau of Medical Devices

510K Medical review (the only medical officer)
Transitional devices
Clinical guidelines for implants
Reviewed PMAs and IDES for orthopedic devices

Special Assignments

Review of Classification Documents for Devices

Toxicology Advisory Panel for the Commissioner establishing Guidelines for FDA

Contract Reviewer

Intraocular lenses
Dialysis program
Orthopedic devices

1977 (20 hours/week)

Ophthalmology Division (the only medical officer), Bureau of Medical Devices

Drafted warning letter to 12,000 ophtalmologists on intraocular lenses (IOL) as result of Adverse Events (AEs)
Medical advisor on the article in the Drug Bulletin on intraocular lenses
Medical reviewer for the IDE Fed. Reg. Nov.1977 on IOLs
Chairman, workshop_,AAMI, Nov.1977 on IDE regs
Medical monitor on adverse reactions and complications for intraocular lenses and recalls
Medical reviewer for the first 12 IDEs on IOLS
Medical reviewer for Tentative Final for IDE regs. for IOLs

1976 (15-20 hours/week)

Special Advisor for the Acting Associate Director for Device Evaluation, Bureau of Medical Devices

Associate Executive Secretary to the following panels:

Hematology/Pathology
Microbiology
Ophthalmology
Immunology
Toxicology
ENT

Clinical Chemistry - assisted on panel

Special Assignments

Clinical guidelines for intraocular lenses

Particulate bibliography

RESEARCH EXPERIENCE

MEDICAL RESEARCH AND PUBLICATIONS

Decker, J.L. and Barden, J.A. "Mycoplasmal Arthritis in the Pig." Int. Symposium on Inf. and Imm. in Rheum. Dis. Oxford, England. 191-93, 1976.

Decker, John and Barden, Jerri. "Mycoplasma hyorhinis Arthritis in Swine: A Model for Rheumatoid Arthritis?" Rheumatlology. 6, 338-45, 1975.

Barden, Jerri; Decker, John; Dalgard, Dan and Aptekar, Robert. "Mycoplasma hyorhinis Swine Arthritis III." Inf. and Imm. 8, 887-90, 1973.

Barden, Jerri and Prescott, Benjamin. "Chemical and Serological Properties of Mycoplasma hyorhinis Fractions." Inf. and Imm. 7, 937-40, 1973

Barden, Jerri, A. and Decker, John L. "Mycoplasma hyorhinis Swine Arthritis I." Arth. and Rheum. 14, 193-201, 1971.

Ennis, Robert; Dalgard, Dan; Willerson, James; Barden Jerri and Decker, John. "Mycoplasma hyorhinis Swine Arthritis II." Arth. and Rheum. 14, 202-11, 1971.

Decker, John L. and Barden, Jerri A. "Mycoplasma hyorhinis Swine Arthritis. Communication." Arth. and Rheum. 14, 781, 1971.

Barden, Jerri and Tully, Joseph. "Experimental Arthritis in Mice with Mycoplasma pulmonis". J. Bact.100, 5-10, 1969.

Barden, Jerri; Mullinax, Franklin; Waller, Marion. "Immunoglobulin levels in Patients with Rheumatoid Arthritis." Arth. and Rheum. 10, 228-34,1967.

RESEARCH PRESENTATIONS

"Mycoplasma hyorhinis Arthritis in Swine." Bureau of Biologics, NIH Campus. May 1975.

"Evolution of Mycoplasma hyorhinis Arthritis in Swine." XIIth International Congress on Rheumatology. Prague, Czech. October 1969.

"Mycoplasma hyorhinis Arthritis in Swine: Course of Acute Infection." American Rheumatism Association. Atlanta, Georgia, December 1968.

"Mycoplasma and Arthritis." Connective Tissue Section, Department of Medicine, Medical College of Virginia. Richmond, Va. February 1968.

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1991- 2002	Management Forum, London, England; Clinical study requirements for FDA
1999-2001	ACRP Annual Meetings; Presentations on Preparing for an FDA Inspection
1999-2001	Management Forum, London, England; FDA Pediatric rule
1999	DIA Annual Meeting in Baltimore, MD; Presentation on Pre-FDA Audits
1995	PDA invited speaker, Rockville, MD
1994	Speaker at the state Pharmaceutical Administration of China (SPAC) and the Department of Science and Technology for Social Development, the state Science and Technology Commission of the PRC; On the topic of FDA requirements for marketing drug and medical devices in the US
1993	IX International Conference on AIDS, Berlin, Germany, "Compliance Rate for Universal Precautions Among Non-Professional and Professional Health Care Workers in a Free Clinic in Washington, D.C." Perkins, J., Grandin, J. and Korniewicz, D.
1992	Johns Hopkins Univ. School of Nursing Guest lecturer on "Barrier Protection."
1992	DIA, "Overview of FDA Clinical Trial Regulations," Philadelphia, PA
1992	"Making Effective FDA Medical Device Submission,"Barnett International, Washington, D.C.
1991	Speaker at FDA/DSMA Design and Clinical Validation of Medical Devices, Boston, MA
1987-92	RAPS (Regulatory Affairs Professional Society) --Speaker on "Advertising Regulations," Chicago (March1992) and Newport Beach, CA (Sept.1992) --Chaired 1990 Meeting, "Clinical Studies: How to Successfully Resolve Clinical Problems to Achieve FDA Approval," with presentation on a Case Study Analysis --Co-chaired 1989 conference in San Diego on theme "How to Prepare for and Conduct a Clinical Investigation: Drug and Device Requirements" with presentation on Study, Implementation, Monitoring, Evaluation and Presentation to the Agency --Initiated Clinical Program (1987) and chaired first program 1988)
1988	HIMA representative who testified at the Assembly Health Committee of the State of California on Prophylactics Bill.

Harvard U. School of Public Health	1992	Risk Analysis in Occupational and Environmental Health
National Institutes of Health	1984	Infectious Disease Course
Johns Hopkins University	1980-81	Public Health Administration in Management (3 hours credit)
National Institutes of Health	1979	Statistical Methodology Course in Clinical Trials
National Institutes of Health	1966-69	Staff Fellow, Laboratory of Infectious Diseases, HEW, NIH, NIAID

Medical College of Virginia	1966	M.D.
Medical College of Virginia	1965-66	NIH Research Trainee
Catholic University	1962-63	Graduate Courses in Microbiology (22 hours credit)
Mary Washington College of the University of Virginia	1961	B.S.