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Integrated Development Plans

 

 

An Integrated Development Plan (IDP) intricately merges an organization's nonclinical, chemistry, manufacturing and controls (CMC), regulatory, quality, and clinical strategies. It functions as a cohesive roadmap, aligning executive management and program teams on advancing new drugs, devices, or targets through the life sciences development process. Key features include:

  • Roadmap for Progress: Providing a clear path from discovery to commercialization
  • Alignment Tool: Ensuring coherence among stakeholders, outlining milestones, successes, and challenges
  • Fundraising Support: Assisting in M&A discussions and grant proposals
  • Optimized Timelines: Guiding asset development efficiently
  • Risk Management: Offering program-wide risk assessments and mitigation strategies

Applicable across all development stages, from startups to global life sciences companies, the IDP revolves around the Target Product Profile (TPP), outlining product characteristics and development objectives.

The IDP's scope can encompass the entire development program or focus on specific milestones like an Investigational New Drug (IND) filing. Continuously evolving, it adapts to emerging data, changing assumptions, and evolving risks.

Central to the IDP's efficacy is its ability to align stakeholders, enhancing development process efficiency and effectiveness.

OUR PROCESS

  • Gap Analysis: Identifying program weaknesses and strengths
  • TPP Drafting: Crafting a strategic product profile
  • Lifecycle Management: Customizing plans based on strategy, timing, budget, and regulatory options
  • Benchmarking: Evaluating past and current studies
  • Competitive Intelligence: Analyzing disease or indication landscape

WHY HALLORAN?

  • Expertise: Offering both high-level and comprehensive IDPs tailored to your needs
  • Industry Experience: Consultants with diverse life sciences expertise

The IDP's importance lies in its strategic guidance, regulatory compliance, risk management, stakeholder alignment, resource optimization, and informed decision-making support, guiding companies through various product development stages.

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Halloran has the team and the experience to help you in your lifecycle journey. Contact us today to learn more about how we can help you!