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The Challenge for Pharmaceutical Industry...
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Demonstrate a product's value for money, beyond traditional safety & efficacy to
- Payers/Decision-makers
- Employers
- Providers
- Patients
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... A Mission for Health Outcomes
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Market Challenges
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Industry Needs
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Unmet medical needs
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→ Right endpoints
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Balance Benefit/Risk
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→ Right CT designs
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Rising healthcare cost
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→ Right patient
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Rapid reimbursement
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→ Right access
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Rapid patient access
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→ Right price
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Crowded market
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→ Right cost-effectiveness
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Rise of consumerism
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→ Right affordability
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SPC consultations could encompass the following, but not limited to:
- Critical evaluations of evidence generated to date and conduct gap analysis.
- Identifying effective outcomes research strategies for clinical trials, prospective and retrospective observational studies.
- Outline regulatory considerations for outcomes related endpoints in clinical trials and promotional messages.
- Implementation strategies for clinical trials and promotional messages as it relates to FDA Guidance on Patient Reported Outcomes.
- Evaluate and input into global and US formulary/reimbursement submission packages.
- Organize and develop international or US health outcomes advisory board to provide additional strategic input into research program.
- Identify and develop outcomes thought leaders.
- Identify strategies to increase internal stakeholder's understanding the value of outcomes data and communication mechanisms.
- Identify and outline strategies to effectively communicate, promote and leverage outcomes data.
- Formulate formulary and/or reimbursement negotiation strategies.
- Establish outcomes department/function within an organization.
- Identify process improvement for outcomes department/function.
- Develop training and development program for outcomes staff.
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