Camargo Pharmaceutical Services

• International Drug Development Consulting Firm

• World’s Expert - US 505(b)(2) regulatory pathway.

• Drug Development: Approximately 60 drugs under development (various stages). Projects last from 3 months to 3 years.

• Clients: top 5 companies in the world to a single person with one idea.

3Confidential

• Cross functional, integrated project teams• Committed customer advocates• Superlative client experience• 20 Ph.D.’s• Experience with all FDA Divisions

Culture and Talent

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505(b)(2) Success Factors

#1 Camargo Skill Set - Writing

• Know Audience

• Tell Story • data and critical points tied together• “IRAC”: Issue, Rule, Analysis, Conclusion• Complex made Simple

“Achiever Test”

• Mental Aptitudes ( 6 areas)• Personality Dimensions (10 areas)• Validity Scales (2 areas)

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Camargo Skill Sets and Knowledge Needs

• Area Expertise• Writing Skills [Simplify the Complex]• Strategic Thinking/Critical Thinking (to see what is not

there)• Initiative• Business Sense• Probing – Asking Questions• Planning (Project Management)• Social Interaction – Respectful of Time, Know

Audience• Sense of Urgency – Milestone/Timeline driven

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* = Initiation plus strategic thinking separates the top performers out

Thank You NDOGS

• www.camargopharma.com under the Careers link