ADDITIONAL SERVICES
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Develop Medical Strategy and Integrated Medical Affairs Plans in alignment with overarching band strategy
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Integrate and leverage payer insights to become a strategic partner to Market Access
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Data generation support:
o Phase IIIb & IV
o IIS/IITs
o RWE
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Secondary data generation (ex: subgroup, post hoc, meta-analysis)
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Data dissemination & HCP education:
o Create Publications Strategic plan
o Create Medical education Strategic plan
o Develop Physicians and Healthcare providers focused training programs to optimize product use and treatment success.
o Congress planning and execution
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Design strategic approach to KOL identification and engagement
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Develop REMS (Risk Evaluation and Mitigation strategies)
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Organizational Effectiveness:
o Establish/support Medical strategy groups within medical affairs teams
o Enhance medical affairs effectiveness by compliantly improving cross-functional alignment within the overall company’s/franchises’ business objectives
o MSLs support
o Define scope/approach and KPIs to help demonstrate Medical Affairs team’s value in a compliant manner
o Develop training / on-boarding plan for “New to Industry” MDs to help them integrate well and deliver value to the organization while being engaged and motivatedWith warm regards,
MEDICAL AFFAIRS
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Establish/Support of strategy groups within R&D teams
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Develop of short-, mid- and long-term Disease Area strategic plans and prioritization tools to drive focused R&D and Business development investments into compounds with the highest potential of success through development and on market
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Strategic development approach to true focus on the patient needs and development of the packaged offerings beyond just treatment (Beyond the pill)
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Develop target product profiles (TPPs), minimally acceptable product profiles (MAPPs) and optimal product profiles (OPPs) based on a deep understanding of:
o Key future market drivers & trends
Existing science
o Evolving market access environment
o Validated outlook of future unmet needs
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Enhance R&D effectiveness by compliantly improving cross-functional effectiveness within the overall company’s/franchises’ business objectives
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Strategic approach to clinical trial planning and design to ensure that phase III data supports not only regulatory approval but also maximizes commercial potential at launch
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Clinical development teams support with programs execution from strategic decisions to implementation/day-to-day management needs.
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Organizational realignment/resource optimization
R&D/CLINICAL DEVELOPMENT
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Evaluation of commercial potential of your products in preparation for partnership discussions with potential partners/investors
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Portfolio prioritization with the goal of selecting compounds or indications with highest medical value and commercial potential
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Develop strategic roadmap and launch plan to guide clinical development plan/milestones and endpoints
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Develop TPPs, MAPPs and OPP based on a deep understanding of:
o Key future market drivers & trends
o Existing science
o Evolving market access environment
o Validated outlook of future unmet needs
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Support most critical strategic, clinical and medical activities to accomplish your next development goals /milestones
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Support efforts to find optimal pharma partners or advance your product through internal development with available resources
BIOTECH
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Evaluation of commercial potential of your products/research strategies
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Develop presentations to potential partners/investors & support team preparations for such interactions
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Support efforts to find optimal pharma partners/investors or advance your product through internal development with available resources