Medical Manager

EDWARD V AVAKIAN, MA, PHD

**** ****** ***** *****, *********, CA 92058

Tel: 760-***-**** (office); 619-***-**** (cell)

abl7kt@r.postjobfree.com

SUMMARY OF QUALIFICATIONS

Twenty-six years biomedical writing, research, and teaching experience in

pharmaceutical biotechnology industry and academic medicine. Proven ability

to write, review, and edit all scientific regulatory documents for drug and

device approval, journal manuscripts, grant proposals, posters, slide kits,

study protocols, CME materials. Established investigator: advanced

analytical, problem-solving, and critical thinking skills; expertise in

research methods, experimental design, statistics, data analysis,

interpretation and presentation. Thorough understanding of drug development

process, GLP, GCP, and ICH/FDA guidance. Excellent communication,

organizational, managerial, and computer skills. Experience in all

therapeutic areas.

PROFESSIONAL EXPERIENCE AND EMPLOYMENT

Freelance Medical Writer and Research Scientist

San Diego, CA (1998-

present)

Senior Medical Writing Consultant

Falcon

Consulting Group LLC, Exton, PA (2008-2009)

Senior Medical Writing Specialist

i3 Statprobe (UHG Pharmaceutical Services), Ann

Arbor, MI (2005-2008)

Medical Writing Projects Manager

Allergan LLC,

Irvine, CA (2003-2004)

. Senior Research Scientist (New Product Development)

NAMSA Inc, Irvine, CA

(1997-1998)

. Professor of Physiology

St George's University School of Medicine, Grenada, West

Indies (1994-1996)

. Associate Professor of Physiology

Ponce School of Medicine, Ponce, PR (1992-1994)

Assistant Professor of Physiology and Pharmacology

School of

Pharmacy, University of the Pacific, Stockton, CA (1985-1991)

Assistant Professor of Physiology and Pharmacology

Bowman Gray School of

Medicine, Winston-Salem, NC (1983-1985)

SUMMARY OF MEDICAL SCIENTIFIC WRITING EXPERIENCE

Regulatory Submissions

. NDA /CTDs, PMAs, BLA:

o Nonclinical Overview and Summaries of PD, PK, and Toxicology

o Clinical Overview and Summaries of Efficacy Safety and

Pharmacology

. Clinical Study Reports (phases 1-4), Study Protocols, ICFs, Package

inserts

. INDs, Executive Summaries, Briefing Documents, Literature Reviews

. Toxicology Reports, PSURs, Safety and Risk Assessment Analyses

. Investigator Brochures, Technical Reports, Annual Reports, SOPs

Scientific Publications and Medical Education

. Manuscripts for publication in peer reviewed journals (32 of original

research findings)

. Technical Reports, Slide and Poster presentations, Manuscript Slide

Decks, White Papers

. CME Monographs, Reviews, Study guides, Examination questions

. Grant Proposals (NIH, DOD, and Private Foundations)

. US Medical Licensing Examination Questions (Physiology,

Pathophysiology)

EDUCATION

. BA, Religious Studies, University of California Santa Barbara

. MA, Pharmacology, Dept Ergonomics, University of California Santa

Barbara

. PhD, Exercise Physiology, University of Oregon, Eugene, Oregon

. 1978-1980 - NIH Postdoctoral Fellowship in Human Physiology

Institute of Environmental Stress, University of California Santa

Barbara

PROFESSIONAL MEMBERSHIPS

American Medical Writers Association

. American Physiological Society

Sigma Xi Pharmaceutical Research Honor Society

. Western Pharmacology Society

PROFESSIONAL ACTIVITIES AND ACCOMPLISHMENTS (selected)

45 Publications in peer-reviewed journals (32 of original research

findings)

Editorial reviewer for 10 peer-reviewed scientific, biomedical journals

. NIH Biopsychology Study Section ad hoc primary grants reviewer

. Recipient of 7 NIH and private foundation research grant awards

. National scientific recognition and press release for significant

public health research findings on "cocaine abuse, exercise and the

heart", FASEB, 1987

PUBLICATIONS

1. Avakian EV, Evonuk E. Effect of Panax Ginseng extract on tissue glycogen

and adrenal cholesterol depletion during prolonged exercise. Planta

Medica 1979; 36:43-48.

2. Avakian EV, Horvath SM. Effect of marijuana smoking on cardiorespiratory

responses to submaximal exercise in chronic marijuana smokers. Med Sci

Sports Exer 1979; 11:87 (Abstract).

3. Michael ED, Burke E, Avakian EV. Laboratory Experiments in Exercise

Physiology. Movement Publications, Ithaca, New York 1979.

4. Avakian EV, Horvath SM, Michael ED, Jacobs S. Effects of Marihuana

smoking on cardio respiratory responses to submaximal exercise. Clin

Pharmacol Ther 1979; 26:174-179.

5. Avakian EV, Horvath SM. Sympatho-adrenal medullary activity

in response to starvation and cold exposure. Physiologist 1979;

22(11):4 (Abstract).

6. Avakian EV, Horvath SM. Marijuana smoking and exercise performance. J

Cardiovasc Pulm Tech 1980; 8(3):39-43.

7. Avakian EV, Sugimoto RB, Wagner J. Effect of Panax Ginseng extract on

blood energy substrates during exercise. Fed Proceedings 1980;

39(3):287 (Abstract).

8. Avakian EV, Horvath SM. Plasma catecholamine responses to tyrosine

hydroxylase inhibition and cold exposure. Life Sci 1980; 26(20):1671-

1679.

9. Avakian EV, S.M. Horvath. Starvation suppresses sympatho-adrenal

medullary response to cold exposure in rats. Amer J Physiol (Endocrinol

Metab) 1981; 4:E316-320.

10. Avakian EV, Horvath SM. Marijuana smoking and pulmonary responses to

exercise. Respiratory Ther 1981; 11(6):61-64.

11. Avakian EV, Horvath SM. Influence of age and tyrosine hydroxylase

inhibition on tissue levels of norepinephrine during stress. J. Gerontol

(Biological Sciences) 1982; 37(3):352-357.

12. Avakian EV, Horvath SM. Age-related effects of cold exposure and

tyrosine hydroxylase inhibition on plasma catecholamine levels and liver

glycogenolysis in the rat. Fed Proceedings 1982; 441(5):1674 (Abstract).

13. Avakian EV, Colburn RW, Horvath SM. Influence of age and cold stress

on plasma catecholamine levels in rats. J Autonom Nerv Sys 1984;

10:127-133.

14. Avakian EV, Sugimoto RB, .Taguchi S, Horvath SM. Effect of Panax

Ginseng extract on energy metabolism during exercise in rats. Planta

Medica 1984;50(2):151-154

15. Avakian EV, Brilla L, Colburn RW, Horvath SM, Evonuk E. Effects of

dietary magnesium deficiency and exercise training on adrenal

catecholamine concentration. Fed Proceedings 1984; 43(4):801

(Abstract).

16. Taguchi S, Avakian EV, Borgia JF, Horvath SM. Effects of perinatal

hypobaric hypoxia on biochemical indices of energy metabolism in rats.

Fed Proceedings 1984; 43(4):906 (Abstract).

17. Byrnes WC, Ulrich M, Taguchi S, Avakian EV, Horvath SM.

Histochemical adaptations to hypoxia in genetically-similar Sprague-

Dawley rats. Med Sci Sports Exer 1984; 11(4):1150- 1156

15. Avakian EV. Impact of age on pineal gland N-Acetyl Transferase

activity and adrenal catecholamines after exercise. Fed Proceedings

1985; 44(3):465 (Abstract).

16. Hagan RD, Avakian EV, Grundy S. Increases in serum lipid and

lipoprotein levels with movement from the supine to standings

positions. Fed Proceedings 1986; 44(5):1510

17. Hagan RD, Upton SJ, Avakian EV, Grundy S. Increases in serum lipid and

lipoprotein levels with movement from the supine to standing

positions. Prev Med 1986; 15:18-27.

18. Avakian EV. Effect of chronic cocaine administration on adrenergic and

metabolic responses to exercise. Fed Proceedings 1986; 45(4):1060

(Abstract).

19. Avakian EV, Horvath SM, McCafferty WB. Effect of fasting on

physiological responses to submaximal exercise in non-obese women. J

Sports Med Phys Fit 1987;27(3):303-309

20. Avakian EV, Dunlap CE, Zoltosky RK, LeRoy MS. Effects of chronic

cocaine administration on cardiac beta-adrenoceptor concentration in

rats. Proc West Pharmacol Soc 1987; 30:299-301.

21. Avakian EV, Manneh VA. Cardiac responsivity to epinephrine following

chronic

Cocaine administration. Proc West Pharmacol Soc 1987; 30:281- 284

.

22. Avakian EV, LeRoy MS, Bracken ME, Malone MH. Effects of chronic cocaine

and brief withdrawal from cocaine on cardiac automaticity rhythmicity

and coronary flow in response to adrenergic stimulation. Faseb J 1988;

42(6):8843 (Abstract).

23. Bracken ME, Avakian EV. The effect of chronic cocaine on cardiac auto-

rhythmicity in isolated rabbit hearts following chronic cocaine

administration. Faseb J 1988; 42(5):7094 (Abstract).

24. St. John-Allen K, Vulliet R, Avakian EV. Effects of chronic cocaine on

rat cardiac and splenic norepinephrine levels. Proc West Pharmacol Soc

1989; 30(4):189-191.

25. Avakian EV, LeRoy MS, St. John-Allen K, Sayre FW, Malone MH. Effects of

chronic cocaine administration and cocaine withdrawal on coronary flow

rate and heart rate responses to epinephrine in isolated rat hearts.

Life Sci 1990; 6(22):1569-1574.

26. Mass HJ, Pirazzi B, Gonzalez P, Fitzovich D, Avakian EV. N-Acetyl

Cysteine diminishes injury induced by balloon -angioplasty of the

carotid artery in rabbits. Biochem Biophys Res Comm 1995; 215(219):613-

619.

27. Avakian EV. Plain English Guide to Environmental Endocrine Disruptors.

Reason Public Policy Research Foundation, pp 27, 2000.

28. Avakian EV. Plain English Guide to Genetically Modified Organisms.

Reason Public Policy Institute Research Foundation, pp 24, July 2000.

29. Flores J, Joyal SV, Avakian EV. A retrospective report on the efficacy

of sibutramine for treatment of fibromyalgia syndrome in an office

practice. J Pain 2000; 4:666 (Abstract).

Guest Author Manuscripts and Posters

Small DS, Payne CD, Kothare PA, Yuen ES, Farid NA, Natanegara F, Loh

MT, Winter s KJ, Ni L, Li YG, Jakubowski JA, Salazar DE, Kelly RP.

Comparison of pharmacokinetics and pharmacodynamics of prasugrel and

clopidogrel loading doses in healthy Chinese and Caucasian subjects.

ASCPT, Orlando, FL 2008. Poster

Small DS, Kothare PA, Yuen ES, Lachno RD, Winters KJ, Farid NA, Ni L,

Salazar DE, Payne CD. The pharmacokinetics and pharmacodynamics of

prasugrel in healthy Chinese, Japanese, and Korean subjects compared

with healthy Caucasian subjects. Angioplasty TST Summit, Seoul, Korea,

April 23-25 Poster 2008 (and ASCPT, Orlando, FL)

Tashima K, Staszewski S, Nelson M, Rachlis A, Skiest D, Stryker R,

Bessen L, Overfield S, Ruiz N, Wirtz V. Efficacy and tolerability of

long-term efavirenz plus nucleoside reverse-transcriptase inhibitors

for HIV-1 infection. AIDS 22(2):275-279, 2008

Hanefeld M, Avakian EV. Control of Postprandial Hyperglycemia is Good

Clinical Practice in the Management of Type 2 Diabetes. 2006

Lin CC, Xu C, Zhu N, Yeh LT. Absorption, metabolism, and excretion of

[14C] viraminidine in humans. Antimicrob Agents Chemother 2006 Jul;

50(7):2368-73.

Kraus CN, Carman WJ, Still G, Avakian EV. The Effects of Formulary

Changes Involving Piperacillin/Tazobactam on Drug Resistance: A

Literature Survey. J Hospital Infection, 2006

Liu Y, Xu C, Yeh LT, Lin C. Sensitive and Specific LC-MS/MS Method for

the simultaneous measurement of Viramidine and Ribavirin in Human

Plasma. J Chromatogr B Analyt Technol Biomed Life Sci 2006 Feb17;

832(1):17-23.

Vollmer TL, Phillips JT, Goodman AD, Agius M, Libonati MA,

Giachino JL, Grundy JS. An open-label safety and drug interaction

study of natalizumab (antegren in combination with interferon-beta

in patients with multiple sclerosis. Mult Scler 2004 Oct; 10(5):511-

520.

Yancy C, Abraham WT. Noninvasive Hemodynamic Monitoring in Heart

Failure:

Utilization of Impedance Cardiography Congest Heart Fail 2003 Sep-Oct;

9(5):241-50.

Sharma, D Krebs WB. Improvement of blood pressure control in essential

hypertension with impedance cardiography-directed treatment. 2002.

Poster.

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