Medical Device Supervisor

Wendy Sowder Wippel

*** ******** **** *

Hernando, MS 38632

Home: 662-***-****

Cell: 901-***-****

Email: *****@**********.***

WORK EXPERIENCE

Freelance Medical Writing Experience

Ongoing Contractor for:

• Promed Communications, 8741 Apalachee Drive, Cincinnati OH 45249 (2001-present)

President: Zeinab Schwen, 513-***-****

• Medfocus, 8600 Bryn Mawr, Suite 700, South Chicago, IL 6063 Contact: Gail

Condon, 303- 979-0278

Other Clients:

• Smith and Nephew Orthopedics, Memphis, TN

• Orchid Stealth Orthopedics, Memphis, TN

• Lilly/ICOS, Seattle, WA

• Bayer Pharmaceuticals, Montville, NJ

• St. Jude Children's Hospital, Memphis, TN

• Gale Group, Farmington MI

• FirstConsult, London, UK

Publications in this position:

Regulatory: Medical Device

Laser scalpels (Ethicon Endosurgery) European Regulatory documents

Titanium porous-coated cups (ISO 9000 production protocol)

Zirconium porous-coated cups (ISO 9000 production protocol)

Titanium Foam (Master File)

Regulatory: Pharmaceutical

Investigational New Drug Applications:

Ketoprofen (Orudis®)

Investigator’s Brochures:

Oxymorphone (Numorphan®)

Safety Narratives

Gepirone hydrochloride (Gepirone®)

Sorafenib (Nexavar®)

Clinical Study Reports

Actonel® Pilot Study

Olay ® skin products

Zest ® skin products

Quench® body lotion

Cialis®

Clinical Study Protocols

Metamucil®

Ghostwritten Manuscripts for Publication in the Medical Literature

“Safety and Efficacy of MDL 101,146 as a Human Neutrophil Elastase Inhibitor in Chronic

Pulmonary Disease”. Submitted to Clinical Pharmacology and Therapeutics. Olestra: A

Summary of Available Data on Safety and Efficacy. Submitted to Journal of Obesity.

Vaginal Microflora and Mucosal Immunity During Menstruation with the Use of Various

Catamenial Products: A Literature Review. Submitted to Clinical Obstetrics and Gynecology.

Olestra: A Review of Market Experience. Submitted to Journal of Clinical and Regulatory

Submission

Uncomplicated Urinary Tract Infection: A Review of Current Practice and the Implication of

Antibiotic Resistance on Clinical Treatment. Submitted to :Canadian Family Physician

Effect of a Multiple Micronutrient-Fortified Beverage on the Nutritional Status of

Schoolchildren in the Philippines. Submitted to: Journal of Clinical Nutrition

Efficacy Trial Using a Multiple Micronutrient-Fortified Beverage in Pregnant Women in

Tanzania. Submitted to: Journal of Clinical Nutrition

A Meta-Analysis of Changes in Vaginal Microflora with Use of a Novel Layered-Fiber Tampon

in Menstruating Women in the US and the UK. Submitted to: Journal of Obstetrics and

Gynecology

A Naturalistic Study of Retrospective Data Evaluating the Safety and Efficacy of High Induction

Versus Indicated Induction Dose Asacol in the Treatment of Ulcerative Colitis. Submitted to:

American Journal of Gastroenterology

Nasal Cancer. In: Gale Group Encyclopedia of Cancer. Thackeray E. (ed)Thompson Gale, 2002

Osteosarcoma. In: Gale Group Encyclopedia of Cancer. Thackeray E. (ed) Thompson Gale,

2002

Germ Cell Tumors. In: Gale Group Encyclopedia of Cancer. Thackeray E. (ed) Thompson Gale,

2002

Immune Globulin. In: Gale Group Encyclopedia of Cancer. Thackeray E. (ed)Thompson Gale,

2002

Leukoencephalopathy. In: Gale Group Encyclopedia of Cancer. Thackeray E. (ed)Thompson

Gale, 2002

Ploidy analysis. In: Gale Group Encyclopedia of Cancer. Thackeray E. (ed)Thompson Gale,

2002

Craniopharyngioma. In: Gale Group Encyclopedia of Cancer. Thackeray E. (ed)Thompson Gale,

2002

Functional and physiological characteristics of the aging skin. Aging Clin Exp Res 20:pp.195-

200 (2008)

Incontinence in the aged: contact dermatitis and other cutaneous consequences. Contact

Dermatitis 57:pp.211-217 (2007)

Psychosocial and societal burden of incontinence in the aged population: a review. Arch Gynecol

Obstet 277:pp.285-290

Physiological changes associated with the menstrual cycle: a review. Obstet Gynecol Surv 2009;

64: 58-72

Clinical implications of the aging skin: overview of age-related non-specific inflammatory

dermatosis. Am J Clin Dermatol 2009;10(2):73-86

The effect of sex hormones on irritant and allergic response: possible relevance for skin testing.

Br J Dermatol 2009; 160: 58-72

Clinical implications of aging skin: cutaneous disorders in the elderly. Am J Clin Dermatol

2009; 10: 73-86

Neoplastic skin lesions in the elderly patient. Cutaneous and Ocular Toxicology 2008; 27: 213-

229

Sensory, Clinical, and Physiological Factors in Sensitive Skin: A Review. Contact Dermatitis

2006; 55 (1):1-14.

Structural Characteristics of the Aging Skin: A Review. Journal of Cutaneous and Ocular

Toxicology 2007; 26:343-357

Intrinsic and Extrinsic Factors in Skin Aging: A Review. Int J Cosmet Sci 2008; 30: 87-95

Dynamics of the Vaginal ecosystem--Hormonal Influences Infectious Diseases: Research and

Treatment 2010: 3: 1-15

Chronic pain of the vulva without dermatologic manifestations: Distinguishing among a

spectrum of clinical disorders. Clinical Medicine Insights: Women's Health 2010: 1-13

The possible relevance of sex hormones on irritant and allergic responses: their importance for

skin testing: Contact Dermatitis 2010; 62: 67-74

Normal Flora of the Vagina in Menopause. In: Textbook of Aging Skin, Farage M, ed. 2009 In

press.

Degenerative Changes of the Skin with Age. In: Textbook of Aging Skin, Farage M, ed. 2009 In

press)

Determinants of Skin Ageing. In: Textbook of Aging Skin, Farage M, ed. 2009 In press

Neoplastic Skin Disease of Old Age. In: Textbook of Aging Skin, Farage M, ed. 2009 In press.

Nonproliferative Skin Disease in Old Age. In: Textbook of Aging Skin, Farage M, ed. 2009 In

press.

Skin Testing in the Elderly. In: Textbook of Aging Skin, Farage M, ed. 2009 In press.

Sensitive Skin: Sensory, Clinical and Physiological Factors IN: Barel, Maye, Maibach (eds):

Handbook of Cosmetic Science and Technology, Third Edition.

A Disposable Intravaginal Device for the Treatment of Urinary Stress Incontinence. in review

PMS: A disease with an autoimmune component? in review

Cultural Determinants of Genital Hygiene in Adolescent Girls. in review

Sensitive Skin: Closing in on a Physiological Cause Contact Dermatitis, in press Documentation

of subclinical irritation produced by male shaving using a cross-polarized light visualization

system. in review

Skin Moisturization Effect by a Novel Emollient-treated Menstrual Pad with an Absorbent Foam

Core. in review

Ghostwritten Manuscripts for Publication in the Medical Literature: Medical Device

Laparoscopic Adjustable Banding: A Review of the Literature 1998-2001 Submitted to: Journal

of Obesity Surgery

“Bariatric Surgery: A Summary of the Literature 1990-2001” for inclusion in FDA submission

for the LapBand in bariatric surgery.

Marketing Support Documents:

Mode of Action of Calcium in the Treatment of PMS.

Matrix Metalloproteinases and Their Role in Periodontal Disease.

The Interaction of Prostaglandins and NSAIDS in Periodontal Disease.

A Critical Systematic Review of the Efficacy of Dioctyl Sodium Sulfosuccinate (Docusate) in the

Treatment or Prevention of Constipation.

Presentations:

The Role of Olestra in Weight Loss Regimens.

Use of Computer-Assisted Education in the Dental School Curriculum.

Employing the Internet in Your Dental Practice.

Websites:

Periostat® (http www.collagenex.com/oralpro/mmpbreak.htm)

FirstConsult Medifiles (http://www.firstconsult.com).

Juvenile rheumatoid arthritis

Influenza

Infectious mononucleosis

Rubella

Parvovirus B19

sickle cell disease

Cholera

Barotitis media

Temporomandibular joint disorders

Pediatric GERD

Cancer Care Online (Japanese): Interviews with Dr. Jeffrey Drazen ( editor-in-chief of NEJM),

Dr. John Smyth (editor-in-chief of European Journal of Cancer)

Employment in Full-Time Permanent Positions

8/1992-12/2000:

Research Biologist, Centers for Disease Control, National Institute for Occupational Safety and

Health, 4676 Columbia Parkway, Cincinnati, OH 45226. GS-11, 40 hrs/ week; ending salary

$50,000/yr.

Supervisor: Al Lunsford, 513-***-**** (OK to contact).

This research position involved research into occupational illness caused by biological pathogens

or allergens. Methodology used was primarily immunoassays, various methodologies for

assessing other, non-atopic biological responses (e.g. cortisol assays), microbiological testing .

Publications in this position:

• Biagini RE, Hull D, Johanning E, MacKenzie B, Phipps F, Wippel WS, Robertson S.

Immune System Function Response to Occupational Insults. NIOSH/FIOH Sixth

International Symposium, Finland.

• Wippel WS. “The Effects of Stress on Immunocompetence in Humans” NIOSH Internal

Review article.

• Wippel WS et al. “Goals for Working Safely with Mycobacterium Tuberculosis Complex

Species in Clinical, Public Health, and Research Laboratories” CDC Internal

Educational Document

• Wippel WS. Modulation of the Immune Response by Occupational Stress. NIOSH

Internal Research Proposal.

• Wippel WS. Trichloroethylene as an Occupational Hazard. NIOSH Internal Educational

Document

• Wippel WS. Latex Allergy: A Prevention Guide. NIOSH Publication No. 98-0113

7/ 1985-8/1992:

Jr. Research Associate, University of Cincinnati, Cincinnati, Ohio. This research position

involved research into the processes and pathogenesis of cartilage metabolism and included

experience in a wide variety of both in vivo and in vitro methodological approaches, including

cell culture, molecular and radiological assays, and immunoassays. 40 hrs/ week, ending salary

$27,000/yr

Supervisor: Jerome Herman, University of Cincinnati RHU 231 Albert Sabin Way, Cincinnati,

OH, 45267. Phone: 513-***-**** (OK to contact).

Publications in this position:

• Anderson D, Sowder W, Appel AM, Hopson CN, Herman JH. Polymethylmethacrylate-

Induced Release of Bone Resorbing Factors. Trans Orthopaedic Res Soc 12:225, 1987.

• Herman JH, Anderson D, Sowder WG, Appel AM, Hopson CN: Polymethylmethacrylate-

Induced Release of Bone Resorbing Factors. Arthritis Rheum 30:S79, 1987.

• Appel AM. Sowder WG, Hopson CN, Herman JH: Production of Mediators of Bone

Resorption by Prosthesis-Associated Pseudomembranes. Trans Orthopaed Res Soc

13:362, 1988.

• Herman JH, Sowder WG, Appel AM, Hopson CN. Prosthesis-associated

Pseudomembrane-Induced Bone Resorption. Arthritis Rheum 31:S70, 1988.

• Herman JH, Sowder WG, Anderson D, Appel AM, Hopson CN: Polymethylmethacrylate-

Induced Release of Bone-Resorbing Factors. Journal of Bone and Joint Surgery: 10:

1530, 1989.

• Appel AM, Sowder WG, Siverhus S, Hopson CN, Herman JH: Prosthesis-associated

Pseudomembrane-Induced Bone Resorption. British Journal of Rheumatology 29:32,

1990.

• Herman JH, Sowder WG, Bergstrand PP, Hess EV. Interleukin-1 Inhibitor in

Osteoarthritic Synovial Tissue can be Induced by Piroxicam. Revista Mexicana de

Rheumatologia 5 (suppl 1): 14, 1990.

• Herman JH, Sowder WG, Hess EV. Piroxicam Modulation of Prosthesis

Pseudomembrane-Induced Bone Resorption. Arthritis Rheum 33:S115, 1990.

• Herman JH, Sowder WG, Hess EV. NSAID Induction of Interleukin-1/Catabolin Inhibitor

Production by Osteoarthritic Synovial Tissue. J Rheumatol 18 (suppl 27): 234, 1991.

• Herman JH, Sowder WG, Hess EV. Nonsteroidal Anti-inflammatory Drug Modulation of

Prosthesis Pseudomembrane-induced Bone Resorption. J Rheumatology 21:338, 1994.

9/80-7/85:

Research Assistant, Department of Veterinary Pathobiology, The Ohio State University,

Columbus, Ohio. This research position involved investigations into oncogenesis related to

endogenous retroviruses, including co-carcinogenesis with other substances (e.g. jet fuels).

Methodologies included cell culture, cell transformation assays, and various immunoassays. 40

hrs/ week, ending salary $20,000/yr

Supervisor: James Blakeslee, The Ohio State University Department of Veterinary Pathobiology,

1900 Coffey Road, Columbus, OH 43210 Phone: 614-***-**** (OK to contact).

Publications in this position:

• Blakeslee, JR, Sowder WG, Baulu J: Wild African Green Monkeys are HTLV-negative.

Lancet March 2;1:8427, 1985

• Sowder WG: Human T-cell Leukemia Virus Type I infection in Subhuman Primates in the

United States. Thesis. June, 1985.

Adjunct Teaching Experience:

9/ 1994-1/1995

Adjunct Instructor, Cincinnati State Technical College, Cincinnati, Ohio. This position was

responsible for teaching introductory biology courses.

9/80-7/85:

Adjunct Instructor, Northwest Mississippi Community College. This position was responsible

for teaching introductory biology courses as well as courses in anatomy and physiology for

nursing students.

Education

1972-1976:

Wm. Mason High School, Mason, OH 45040. Graduation date 6/6/76

Valedictorian

9/1976-6/7/1980:

The Ohio State University, Columbus, OH 43210

• Awarded a Bachelor of Science Degree, with Honors

• Majors: Genetics and Russian.

• National Merit Scholar

9/1982-6/6/1985

• The Ohio State University, Department of Veterinary Pathobiology Columbus, OH

43210 Awarded a Master of Science Degree

• Major Emphases: Virology, Oncology, Immunology

OTHER TRAINING AND QUALIFICATIONS:

1992 Scientific Report Writing, NIOSH

1994 Epidemiology Report Writing, NIOSH

1998 PCR/Fingerprinting, Genentech

1999 Science of Scientific Writing, NIOSH

2000 Write it Easy to Read, University of New England

Contact this candidate