Michael E. Margolies, President
Communications in Medicine

CURRICULUM VITAE

Medical writer and regulatory affairs specialist. More than 20 years' experience in preparing materials on clinical (Phases I-IV) and preclinical research, including corresponding sections of NDAs and other registration documents. Master of Science in Drug Regulatory Affairs. Certified by Regulatory Affairs Certification Board.

PROFESSIONAL EXPERIENCE

Communications in Medicine, LLC (1996 - Current)
Re-established Communications in Medicine, an independent writing and regulatory affairs consultancy.
Preparation of clinical and preclinical documents for FDA and international registration, journal articles, and marketing materials.

Forest Laboratories, Inc. (June 1995 - July 1996)
Senior Manager, Medical Writing
Established medical writing department. Responsible for direct relations with free-lancers and contract research organizations. Initiated policies on medical writing formats and standards. Participated in regulatory affairs decision making. Wrote and formatted documentation for individual study reports and other materials for FDA submissions including pre-NDA briefing documents. Assignments included attendance at pre-NDA meetings and participation in European meeting with company partner.

Pfizer, Inc. (July 1994 - June 1995)
Consultant Medical Writer
Prepared clinical study reports (Phases I-III) on site for Pfizer CSA in New York City.

Forest Laboratories, Inc. (April - July 1994)
Senior Medical Writer
Wrote and formatted IND and NDA documentation. Participated in regulatory affairs decision making.

Schiff and Company (1992 - 1994)
Director, Clinical and Regulatory Affairs
Directed medical writing. Managed staff. Wrote and formatted pre-IND, IND, NDA, IDE, etc., and corresponding international regulatory documentation. Advisor within company and to clients on regulatory affairs. Wrote column on regulatory affairs for monthly publication, The Schiff Report. Represented company at professional meetings.

Health and Sciences Research, Inc. (1991 - 1992)
Manager of Medical Writers
Directed medical writing. Managed staff. Wrote pre-IND, IND, NDA, IDE, PLA, etc., and corresponding international regulatory documentation. Participated in regulatory affairs decision making. Lectured internally on regulation of biologics and cosmetics. Represented the company at professional meetings.

Communications in Medicine (1984 - 1991)
Established independent writing and regulatory affairs consultancy.
Prepared clinical and preclinical documents for FDA and international registration, journal articles, and marketing materials.

Ayerst Laboratories (1979 - 1984)
Senior Medical Writer
Trained and supervised staff writers in clinical research department. Wrote clinical and preclinical NDA documents and journal articles.

Schering-Plough Research Division (1977 - 1979)
Medical Writer
Wrote clinical and preclinical NDA documents and journal articles.

PROFESSIONAL CERTIFICATION

Regulatory Affairs Certification Board (affiliated with Regulatory Affairs Professionals Society)

EDUCATION

MS in Drug Regulatory Affairs, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, 1996.
Graduate Courses in Biomedical Sciences, City University of New York (at Mount Sinai Hospital), 1976-1977.
BS in Biology, Excelsior College (Formerly Regents College, University of State of New York), 1976.
Bronx High School of Science.

HONOR SOCIETY

Rho Chi, pharmacy honor society, selected at Arnold & Marie Schwartz College of Pharmacy and Health Sciences, 1995.

PROFESSIONAL SOCIETIES

Regulatory Affairs Professionals Society
Drug Information Association (DIA)

INTELLECTUAL SOCIETIES

Mensa, Judge, New York Mensa Scholarship Committee, 1996
Intertel

THESIS FOR MASTER OF SCIENCE DEGREE

Medical Writers and the Principles of the Helsinki Declaration, 1996

PUBLICATIONS


Clinical Research
Over 50 ghost-written journal articles, monographs, and third-party publications

Regulatory Affairs
Articles
Margolies ME: Regulation of combination products. Applied Clinical Trials 1994;3:58.
Margolies ME, Rumore MM: From cosmetic to drug: Crossing the line. Drug Information Journal 1993;27:1205-1211.
Margolies ME: The regulation of biological products and the CBER-CDER Intercenter Agreement. Drug Information Journal 1993;27:925-931.

Columns
Margolies ME: Current good manufacturing practices for devices. The Schiff Report, Feb/March 1994, pp. 14-15.
Margolies ME: What is an IDE application? The Schiff Report, Jan 1994, pp. 14-15.
Margolies ME: What is a PMA? The Schiff Report, Nov/Dec 1993, pp. 14-15.
Margolies ME: What is a 510(k)? The Schiff Report, Oct 1993, pp. 14-15.
Margolies ME: Adulteration and misbranding. Part II: Examples of adulteration and misbranding. The Schiff Report, Sept 1993, p. 15.
Margolies ME: Adulteration and misbranding. Part I: A brief jurisdictional history. The Schiff Report, July/Aug 1993, p. 15.
Margolies ME: Drug labeling. The Schiff Report, June 1993, p. 15.
Margolies ME: What happens if a cosmetics manufacturer makes drug-like claims for a product? The Schiff Report, May 1993, p. 15.
Margolies ME: The regulation of cosmetics. The Schiff Report, April 1993, p. 15.
Margolies ME: Which FDA center will handle your product? The Schiff Report, Feb/March 1993, p. 15.
Margolies ME: The definitions of drug, device, and biological product. The Schiff Report, Jan 1993, p. 15.
Margolies ME: Who are the members of an institutional review board? The Schiff Report, Nov/Dec 1992, p. 15.
Margolies ME: The institutional review board and the protection of human subjects. The Schiff Report, Oct 1992, p. 15.

POSTER

Medical Writers and Good Clinical Practices. A Survey: Self-Assessment of Knowledge and Attitudes.

Presented at the 31st Annual Meeting of the Drug Information Association, 25-29 June 1995, Orlando, Florida.

EXAMPLES OF DRUGS/BIOLOGICS/DEVICES FOR WHICH I HAVE PREPARED DOCUMENTS

Agents for benign prostatic hyperplasia:

Doxazosin.

Antiasthma agents:

Albuterol, beclomethasone dipropionate, flunisolide, triamcinolone.

Antibacterial agents:

Ampicillin/sulbactam, cefoperazone/sulbactam, ceftibutin, gentamicin, netilmicin, olfloxacin, telithromycin.

Antihistamines:

Desloratadine, loratadine.

Antimycotic agents:

Clotrimazole, clotrimazole/betamethasone, miconazole, terconazole.

Antineoplastic agents:

Cetuximab (C225), 5-FU, flavopiridol, flutamide, photodynamic therapy.

Antismoking agents:

Nicotine transdermal system.

Antiviral agents:

Acyclovir, didandosine, interferon alfa-2b, lamivudine, stavudine, zalcitabine, zidovudine.

Autologous lymphocyte therapy

Cardiovascular agents:

Diltiazem, indapamide, labetalol, lercanidipine, nifedipine extended release, propranolol oral (immediate and extended release) and intranasal, propranolol/HCTZ, verapamil extended release.

Cytokine:

Interleukin-11.

Selective inhibitor of cytokine IL-1β

CNS agents:

Citalopram, escitalopram, memantine, physostigmine, sertraline.

Diagnostic agents:

Imaging agents, including by myocardial infusion.

Hormones:

Estrogens, including via transdermal patch, somatostatin analogs.

NSAIDs:

Etodolac, ibuprofen, piroxicam.

Narcotics:

Morphine, oxycodone, oxycodone/ibuprofen.

Ophthalmologic agent:

Sodium hyaluronate.

Platelet aggregation inhibitor

Pulmonary surfactant:

Infasurf.

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