Archives: Agenda

• Japan’s pharmaceutical market transformation: addressing drug lag and drug loss
• Regulatory and ecosystem reforms accelerating drug development in Japan
• Key trends and organizations supporting pharmaceutical innovation
• Strategic insights into Japan’s pharmaceutical business landscape
• Japan as a gateway to expansion across the Asian pharmaceutical market

• Reframe patient centricity from “initiative” → “operating model”
• Patient centricity is no longer a differentiator
  → It is a baseline expectation from regulators, investors, and patients
• Yet most organizations still treat it as:
  • A set of tools
  • A functional workstream
  • Or a late-stage overlay

• Patient centricity only scales when it is embedded into how we select, contract, govern, and operate with vendors

• Outsourcing decisions shape: study design feasibility, site experience, patient burden, speed, quality, and retention
• If patient centricity is not designed into outsourcing, it will not survive execution

• Shared operational foundations across rare oncology and other rare diseases
• Rare oncology–specific differences you must plan for in conducting and outsourcing clinical research

• Building biomarker operations functions that align with organizational scale and strategy
• Optimizing vendor and central lab partnerships
• Integrating biomarker data across translational and clinical pipelines
• Preparing for the next evolution of biomarker-driven clinical trials

The last mile of patient recruitment—connecting interested patients to sites—often breaks down. This session explores how PRPs such as Trialbee’s Honey Platform™ strengthens that handoff through invisible, backend infrastructure that reduces missed connections and improves enrolment at scale.

• Where patient-to-site handoffs fail
• Why a single backend matters across studies and regions
• How the Honey Platform improves conversion without changing the patient experience

• Building flexibility into outsourcing partnerships for scalability
• Cost, quality and efficiency trade-offs between different models
• Identifying which model fits different phases of clinical development
• What does transition look like to you and how feasible is it?

Moderator: Anca Copaescu, CEO, Clinical Maestro

• Define a clear indication and targeted patient population early by aligning the targeted product profile (TPP) with meaningful clinical outcomes and measurable endpoints.
• Build a comprehensive development roadmap that anticipates key inflection points from IND through pivotal trials, ensuring evidence generation stays aligned with approval requirements.
• Engage regulators early (e.g., Pre-IND meetings) to support gap analysis, de-risk development decisions, and refine a practical regulatory strategy.
• Embed Quality by Design (QbD) principles from the start to protect data integrity, ensure fit-for-purpose operational execution, and improve inspection readiness.
• Strengthen the likelihood of approval success by integrating indication clarity, regulatory alignment, and quality systems into a cohesive, proactive development approach.

• Decoding what FDA BIMO/PAI inspectors actually look for and why
• Designing inspection-ready systems that withstand real-world pressure
• Data integrity and story coherence: The real drivers of first-cycle approvals
• Communication choreography: Before, during, and after the inspection
• Tailored guidance: Differentiating strategies for small biotechs vs. mid-size companies