41509 Retebiomedcapabilities Dc
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Transcript of 41509 Retebiomedcapabilities Dc
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Capabilities presentation
Stephen W. Gutkin, President
The Grace Building
191 Godwin Ave., Suite 1
Wyckoff, NJ 07481
www.retebiomed.com
201 891 8205
Biomedical Communications
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President Stephen W. Gutkin
• 22 years of experience in editorial management– 1987-1992: Served as Editorial Manager, McGraw-Hill
Healthcare and Health Learning Systems; and Project Manager, Health Science Communications
• 1992: Incorporated Rete Com
• 1992–present: Coauthored several papers in medical journals
• 2007–2009: Delivered lectures on medical writing, by invitations from the Center for Business Intelligence (12/07) and Johnson & Johnson (2/09)
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Our clients’ needs
• “Efficacy”
– Effectively educate prescribers, policymakers, and patients, conveying key findings and messages in a credible and fair-balanced manner.
• “Safety”
– Avoid off-label claims and other offenses punishable by FDA, journal peer reviewers, or accrediting institutions.
• “Tolerability”
– Do the above while working independently, managing (“driving”) review and other editorial processes, and causing minimal “bother” to client.
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Rete geometry: “squaring the circle”Our stakeholders and our promise*
Journal/
peer reviewersAuthor/KOL
Pharma or other
grantor Price Time
Quality
RETE
RETE
*Top-notch communications, on-time deliverables, competitive prices.
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Fulfilling the promiseRete (L.) = network
• Rete Communications = electronic network of medical publishing professionals
– MD, PhD writers with rich and diverse experience from bench-top to the bedside
– ELS–certified editors and QC systems
– On-demand MD peer reviewers (professors and emeritus professors of medicine)
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Four centuries of medical-communications experience
• Writers: 272 years
• Editors: 128 years
• Total: 400 years
N= 18 Consultants
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Organization and workflow
Client
President
Managing Editor
Writer
Copy editor
MD peer reviewer (on demand)
Writer Writer
Copy editor
KOL Author
“Afferent arm” “Efferent arm”
Unit of workflow = rete (network)
Rete 1: CNS
Rete 2: CVD
Rete 3: Hem-onc.
Rete 4: Misc.
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Medical communications across the product life cycle
Preclinical Phase I Phase II Phase III/Launch Mature product
Study
reports
Regulatory
documents
• Protocol
• CSR
• ISS/ISE
Drug dossier
Journal supplement
Pharmacoepidemiologic
study report
Pivotal and other clinical
study reports
Product monograph
Sales training
“Stage-setting” review
CME
Competitive intelligence
“Data mining”
Outcomes research
Pharmacoeconomic
analyses
Post-marketing
surveillance
Abstracts, Posters, Slide-lecture kits, Review articles
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Publication planning
The Rete Index of Publications’ Efficiency
(RIPE)SM
• RIPE = I.F. x (Circulation 1,000)
Average lead time (wk)
• Desirable for 1st-line submission:
– RIPE > 5.0
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Selected accomplishments: 2008
• 31 papers accepted and/or published in indexed, peer-reviewed journals
• Two ~5,000-word review articles published in consecutive issues of Mayo Clinic Proceedings
• Articles frequently cited as Editor’s Choices, disseminated to wider audiences via e-portals, and/or among top 5 most downloaded articles
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Recent work: selected multispecialty journals
• BMC Res Notes
• Curr Med Res Opin
• Drug Safety
• Drugs of the Future
• Int J Clin Pract
• Mayo Clin Proc
• Value in Health
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Recent work: selected specialty journals
• Am J Cardiol
• Arch Neurol
• Arch Ophthalmol
• Diabetes Care
• Diabetes, Obesity and Metabolism
• Eur Heart J
• Eur J Endocrinol
• J Am Acad Child Adolesc Psychiatry
• J Child Adolesc Psychopharmacol
• J Sex Med
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Capabilities in a nutshell: what Rete can do for you
Feature
• Rigorous training and publications savvy; editorial expertise, medical knowledge
• Advanced analytical-reasoning skills
• Efficient QC systems
Corresponding benefit
• Client objectives advanced credibly
• Well-argued and substantiated communications
• On-time deliverables with >80% first-target journal publication rate
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Principles of quality
• Clarity
• Economy (verbal economy)
• Fidelity– External fidelity (veracity): manuscript accurately
represents data and references
– Internal fidelity (consistency): data in Abstract match data in Results text, which match data in Tables and Figures
• Integrity (scientific integrity/fair balance)
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RAPT*Rete Academy for Pharma Training
• In-service education
– Lectures
– Workbooks + interactive CDs/DVDs
• Software
– Software package to support QC of documents by in-house pharma writers
*Service mark pending.
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Summary
• Rete Com= network of savvy scientific wordsmiths producing credible, fair-balanced medical communications
• Meeting the needs of clients, KOLs, journals, accrediting institutions, FDA, professional societies, readers, and patients
• “Friend to pharma”: helping maximize ROI by providing writing, editorial, and other forms of support for both outsourced and “in-housed” communications
• We are the turn-key solution for all your medical-communications needs.