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Medical Mental Health

Midland Park, New Jersey, United States
November 05, 2018

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Stephen W. Gutkin


*** ******** ***.

Midland Park, NJ 07432

Professional Profile

• Confident client-facing leader who supports launch and commercialization of innovative therapies via sound, evidence-based publication planning and execution.

• Process- and results-oriented professional who has contributed 200 papers to peer-reviewed journals, culminating enduring relationships with 2 of the top 5 global life sciences companies.

• Noted authority on medical writing and ethical disclosures according to consensus guidelines (e.g. CONSORT, GPP3, ICMJE, PRISMA, STROBE) and other quality-control standards.

• Author of an encyclopedic textbook on principles of quality, drafting most types of manuscripts, understanding study design, and employing and disclosing biostatistics.

• Self-motivated strategic thinker with high scientific aptitude, minute attention to detail, and a discerning prose sensibility.

• Leading research team builder who has collaborated with more than 500 key opinion leaders (KOLs) and other investigators from São Paulo to Shanghai, including non-native-English speaking Medical Directors

(Therapeutic Area Heads) and other professionals with life sciences companies. Professional Experience

Rete Biomedical LLC, Midland Park, NJ July 2018 - Present Independent Medical Publications Professional

• Supporting the following professional activities by life sciences companies and academic institutions: study design, protocol writing, publication planning, and tactical execution

• Completed Writing High-Quality Medical Publications: A User’s Manual (published in August 2018 by CRC Press; Taylor & Francis) and facilitated workshops to teach its principles to members of the American Medical Writers Association and postdoctoral students with Weill Cornell Medicine (each in New York). WG Group LLC (London and New York) February 2016 - June 2018 Senior Market Access Writer (a health economics and outcomes research [HEOR] and communications consultancy)

• Spearheaded communications on the value of innovative health technologies in fulfilling unmet patient needs, collaborating with a team of health economists, physicians, project managers, and other professionals.

• Opened two new corridors of business: 1) contract research organization (CRO) type activities such as study design and protocol development and 2) collaborating with medical directors/therapeutic area heads and other representatives of a Latin American affiliate. Researched, drafted, and edited:

• Study protocols, congress communications, and manuscripts concerning diagnosis and management of hematologic malignancies (e.g. multiple myeloma, non-Hodgkin’s lymphoma).

• Published systematic literature reviews on the clinical, public-health, and economic dimensions of schizophrenia and treatment-resistant major depressive disorder.

• AMCP Formulary Dossiers supporting innovative therapies, including a semisynthetic bile acid analogue for primary biliary cholangitis (first new medication in decades), a nitroimidazole antimicrobial for bacterial vaginosis, and a CD38-directed cytolytic antibody for multiple myeloma. 2

• Global Value Dossiers for a cervical-cancer diagnostics franchise and two commercially available PD-L1 immunohistochemistry platforms.

• Delivered journal-, payor-, and regulatory-ready work while effectively managing time and other resources.

• Developed standard operating procedures and supervised consultants.

• Facilitated workshops on medical writing and biostatistics. Rete Biomedical Communications Corp and Rete Biomedical LLC April 1992 - January 2016 President

Executive Summary

• Formulated, managed, and executed publication plans to support successful launch and commercialization of billion-dollar brands across product life-cycles.

• Employed pivotal methods in health economics and outcomes research (HEOR), including cost- effectiveness and cost-utility analyses and budget impact models, as well as communications related to these analyses, such as AMCP Formulary Dossiers, Global Value Dossiers, and publications. This knowledge was amassed via 15 years of collaborating with life sciences companies’ HEOR groups and academic researchers.

• Contributed 200 articles to peer-reviewed journals, culminating collaborations with more than 500 KOLs and other researchers.

• Developed a standard operating procedures manual for writer consultants to meet quality standards and integrate work with client protocols. (This work served as the foundation for my recently published textbook: Writing High-Quality Medical Publications: A User’s Manual.) CONSULTING RELATIONSHIPS

Client and Account Summary

Consultant: Bristol-Myers Squibb (Plainsboro and Lawrenceville, NJ) Accounts

• Orencia



o Supported launch and commercialization of a selective T-cell costimulation modulator (fusion protein) for rheumatoid arthritis (RA).

o Prepared study protocols utilizing data from an RA patient registry. o Collaborated with researchers at Brigham and Women’s Hospital and BMS to prepare patient registry study reports published in peer-reviewed journals.

• Pravachol



o Prepared two peer-reviewed publications on lipid lowering in coronary prevention: one each on treatment of an underserved population and drug-drug (pharmacokinetic) interactions. Consultant: Eli Lilly (Indianapolis, IN)


• Cialis



o Supported global launch and commercialization of one of Lilly’s most successful brands, collaborating with approximately 50 company MD/PhD researchers, statisticians, and KOLs. o Coordinated publication planning for the brand, which included articles accepted by first journals targeted (e.g. British Journal of Urology International, Clinical Therapeutics, Diabetes Care, European Heart Journal, European Urology, Journal of Clinical Psychopharmacology, Journal of the American Academy of Nurse Practitioners, Journal of the American Geriatrics Society, Journal of Urology). o Coauthored four papers in peer-reviewed journals and contributed a total of approximately 50 (study reports, reviews) articles to the published literature on management of erectile dysfunction. 3

o Researched, developed, and produced scores of congress abstracts, posters, slide-lecture kits, and three journal supplements supporting successful launch.

• Strattera



o Coauthored two study reports in peer-reviewed journals. o Served as an investigator and author for one of these studies (attended Investigator Meeting before study onset).

Consultant: Merck (Whitehouse Station and Kenilworth, NJ) Accounts

• Vytorin


/Simvastatin-Ezetimibe and Zetia



o Coauthored four papers in peer-reviewed journals and contributed a total of approximately 40 articles

(study reports, meta-analyses, systematic literature reviews) on the management of hypercholesterolemia/dyslipidemia to peer-reviewed journals. o Researched, developed, and/or produced:

Global Value Dossiers.

Congress abstracts, posters, and slide-lecture kits.

Cost-effectiveness analyses.

Journal supplement.

• Januvia




o Researched, developed, and/or produced:

AMCP Formulary Dossier.

Journal supplement supporting launch.

Real-world evidence study report manuscripts published in peer-reviewed journals.

• CordaptiveTM/Laropiprant

o Coauthored review article in Journal of Cardiovascular Pharmacology. o Contributed proof-of-concept and other study reports to peer-reviewed journals.

• Maxalt



o Contributed a study report to Cephalalgia (International Headache Society journal). Consultant: Janssen-Cilag Farmacêutica Ltd/Janssen Latin America (São Paulo, Brazil; Bogotá, Colombia; and Buenos Aires, Argentina)


• Stelara


/Ustekinumab, Invokana


/Canagliflozin, Invega


/Paliperidone, Resotrans



o Developed and submitted (to peer-reviewed journals) pharmacoepidemiologic (real-world-evidence) study report manuscripts related to management of constipation, plaque psoriasis, and schizophrenia. Recent study report was accepted by a highly ranked peer reviewed journal with no requested revisions. o Collaborated with a Janssen Medical Director (Endocrinology Therapeutic Area Head) and consulting biostatistician to develop a clinical-trial protocol. o Developed journal-ready editorial content while collaborating with non-native-English speakers. Recent Writing Experience by Therapeutic/Disease Category Cardiovascular

• Hypercholesterolemia/dyslipidemia (statins, NPC1L1I). Central Nervous System


• Major depressive disorder/treatment-resistant depression (investigational NMDA receptor antagonist for suicide prevention).


• Migraine (triptan).

• Schizophrenia (atypical antipsychotic).


• Diabetes mellitus (incretin mimetics, SGLT2I).


• Erectile dysfunction (PDE5I).

Immune-mediated inflammatory diseases

• Psoriasis (IL-12/IL-23I mAb; retinoids).

• RA (selective T-cell costimulation modulator).


• Hematologic malignancies: BTKI for chronic lymphocytic leukemia/lymphoma, CD38 mAb for multiple myeloma.

• Immune checkpoint (PD-1/PD-L1) inhibitors for NSCLC.

• Prostate cancer (17 α-hydroxylase/C17,20-lyase inhibitor for metastatic castration-resistant and high-risk castration-sensitive disease).

• Renal-cell carcinoma (PD-1/PD-L1I; mTORI).

Core Skills

• Prepare reports of different types of studies according to consensus guidelines, including CONSORT for randomized controlled trials, STROBE for observational studies, and PRISMA for systematic literature reviews and meta-analyses (PRISMA).

• Design clinical and observational studies, applying knowledge of sample size calculations and inferential biostatistics. Produce regulatory-ready study protocols based on this work.

• Develop and implement standard operating procedures, templates, and checklists to ensure journal- acceptable editorial quality.

• Supervise and/or mentor editorial personnel and lead educational workshops. Additional Editorial Experience:

McGraw-Hill Healthcare Group, New York, NY 1987 - 1989 Copy Chief

• Supervised copyediting and proofreading of all editorial content for two monthly medical journals.

• Edited continuing-medical-education monographs and other print materials.

• Wrote study report summaries for monthly journal. Additional Scientific Experience:

Psychiatric Diagnostic Laboratories of America, Summit and South Plainfield, NJ 1983 – 1987 Research Scientist

• Developed and implemented high-performance liquid chromatographic assay for a psychiatric biomarker.

• Devised and instituted gas-liquid chromatographic assays for therapeutic drug monitoring.

• Served on Research Committee and assisted in preparing reports for journal publication. 5


• BA (summa cum laude), psychology (+ biology/chemistry), Duke University, Durham, NC, 1983. Society Memberships

• American Association for the Advancement of Science.

• American Medical Writers Association (AMWA).

• International Society for Medical Publication Professionals (ISMPP).

• Phi Beta Kappa.


Textbook on writing for peer-reviewed medical journals Gutkin SW. Writing High-Quality Medical Publications: A User’s Manual. Boca Raton, FL: CRC Press, an imprint of Taylor & Francis (Oxford, UK). Published August 2018.

Peer-Reviewed Journal Publications

• Abdel-Maksoud M, Sazonov V, Gutkin SW, et al. Effects of modifying triglycerides and triglyceride-rich lipoproteins on cardiovascular outcomes. J Cardiovasc Pharmacol. 2008; 51:331 51.

• Althof SE, Buvat J, Gutkin SW, et al. Sexual satisfaction in men with erectile dysfunction: correlates and potential predictors. J Sex Med. 2010; 7:203 15.

• Assmann G, Kannenberg F, Ramey DR, Musliner TA, Gutkin SW, Veltri EP. Effects of ezetimibe, simvastatin, atorvastatin, and ezetimibe-statin therapies on non-cholesterol sterols in patients with primary hypercholesterolemia. Curr Med Res Opinion. 2008; 24:249 59.

• Brock G, Chan J, Carrier S, Chan M, Salgado L, Klein AH, Lang C, Horner R, Gutkin SW, Dickson R. The treatment of erectile dysfunction study: focus on treatment satisfaction of patients and partners. Br J Urol Int. 2007; 99:376 82.

• Dickson RA, Maki E, Gibbins C, Gutkin SW, Turgay A, Weiss MD. Time courses of improvement and symptom remission in children treated with atomoxetine for attention-deficit/hyperactivity disorder: analysis of Canadian open-label studies. Child Adolesc Psychiatry Mental Health. 2011; 5:14.

• Jacobson TA, Gutkin SW, Harper CR. Effects of a global risk educational tool on primary coronary prevention: the Atherosclerosis Assessment Via Total Risk (AVIATOR) Study. Curr Med Res Opinion. 2006;22:1065 73.

• Jameson K, Zhang Q, Zhao C, Ramey DR, Tershakovec AM, Gutkin SW, Marrett E. Total and low-density lipoprotein cholesterol in high-risk patients treated with atorvastatin monotherapy in the United Kingdom: Analysis of a primary-care database. Curr Med Res Opin. 2014; 30:655 65.

• Lebwohl M, Feldman SR, Walther R, Shelk J, Morgan P, Gutkin SW. Clinical management of psoriasis: principles and practice. Cutis. 2001;67:1 15.

• Sadovsky R, Brock G, Gray M, Jensen PK, Gutkin SW, Sorsaburu S. Optimizing treatment outcomes with phosphodiesterase inhibitors for erectile dysfunction: opening windows to enhanced sexual function and overall health. J Am Acad Nurse Practitioners. 2011; 23:320 30. 6

• Sadovsky R, Brock GB, Gutkin SW, et al. Toward a new "EPOCH": optimizing treatment outcomes with phosphodiesterase type 5 inhibitors for erectile dysfunction. Int J Clin Pract. 2009; 63:1214 30.

• Van Gaal LF, Gutkin SW, Nauck MA. Exploiting the antidiabetic properties of incretins to treat type 2 diabetes mellitus: glucagon-like peptide 1 receptor agonists or insulin for patients with inadequate glycemic control? Eur J Endocrinol. 2008; 158:773 84.

• Van Ganse E, Laforest L, Alemao E, Davies G, Gutkin SW, Yin D. Lipid-modifying therapy and attainment of cholesterol goals in Europe: the Return on Expenditure Achieved for Lipid Therapy (REALITY) study. Curr Med Res Opinion. 2005; 21:1389 99.

• Wilens TE, Adler LA, Tanaka Y, Xiao F, D'Souza DN, Gutkin SW, Upadhyaya HP. Correlates of alcohol use in adults with ADHD and comorbid alcohol use disorders: exploratory analysis of a placebo-controlled trial of atomoxetine. Curr Med Res Opin. 2011; 27; 2309 20.

• Zhang W, Amos TB, Gutkin SW, Lodowski N, Giegerich E, Joshi K. A systematic literature review of the clinical and health-economic burden of schizophrenia in privately insured patients in the United States. ClinicoEcon Outcomes Res. 2018; 10:309 20.

(A total of 176 papers have been published in peer-reviewed journals with my assistance since 2001.)

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