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

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)

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.

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.

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)

Four centuries of medical-communications experience

• Writers: 272 years

• Editors: 128 years

• Total: 400 years

N= 18 Consultants

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.

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

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

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

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

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

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

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)

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.

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.