Archives: Agenda

• When there’s no playbook: Navigating clinical development for a first-of-its-kind therapeutic platform.
• Building the roadmap without getting lost: Making decisions when established endpoints, biomarkers, assays, and development pathways don’t fully apply.
• What founders learn the hard way: Practical lessons, unexpected bottlenecks, and decisions that look very different from inside an emerging biotech.
• AI as a force multiplier: Using AI to accelerate decisions, insights, and execution across clinical development.
• The founder as an orchestrator: Connecting science, CMC, regulatory, clinical, manufacturing, and business decisions when organizational boundaries are still forming.

• Overcoming inconsistent vendor and CRO budget templates and improving mapping into sponsor financial frameworks
• Strengthening financial planning early by streamlining internal approvals, aligning clinical budgets and preventing downstream misalignment and operational delays

Moderator: Kimberley D. Potter, Director of Clinical Operations, Alume Biosciences

• How hidden silos across the sponsor-CRO partnership allow risks to remain invisible until they become timeline, quality or delivery issues
• Why changing the outsourcing model rarely fixes the underlying problem when FSP, full service, milestone-based, outcome-based and hybrid partnerships can all encounter the same execution gaps
• How to close the gap between knowing about a risk and actually acting on it, with clearer ownership of who decides, who acts and when
• Practical ways sponsors can gain earlier visibility into capacity, quality signals, competing priorities and delivery risks without creating another layer of oversight
• How to manage the partnership itself as an operational workstream, with shared ownership of risks, decisions and outcomes rather than relying on governance meetings to create alignment

• Designing efficient start-up strategies that optimize timelines and balance speed, cost, and quality in lean biotech environments
• Making critical early decisions on study location, site selection, and operational setup to drive timelines and success
• Strategically aligning clinical plans with financing milestones, ensuring trials generate the right data to support valuation growth
• Building the right operating model by balancing internal capabilities with CRO and FSP partnerships
• Aligning clinical operations with key value inflection points to maximize investor confidence and long-term development impact

• Delay: Stalled trials can cost from $56,000 a day in early phase to millions a day late stage. Opening new sites adds months and cost.
• 24-hour activation: Go live in 24 hours on the sites you already have.
• Patient matching: Algorithmic matching, geolocated to your active sites. Highly screened AI-match referrals only. Quality over volume, to protect site workload.
• Specialist engagement: Referring specialists engaged, to streamline the site review process.
• Security and transparency: Salesforce Health Cloud, built to support sites from referral to enrollment and randomization. Full progress visibility for sponsors, CROs and sites.
• Commercial model: Risk-share fee structure.

• Understanding why patients decline or leave clinical trials beyond the reasons captured in trial data
• Exploring how trial design and patient burden can create barriers to participation
• Examining how sponsors and sites can build trust and better support patients
• Sharing practical ways to improve recruitment, retention and the overall patient experience

• How well‑designed digital measures deliver measurable ROI in clinical trials by reducing missing data, improving statistical power, accelerating timelines, and preventing costly trial rework or failure.
• How an end‑to‑end Wearable Sensor CRO delivery model integrates scientific strategy, operational oversight, and analytics to consistently produce regulatory‑ready datasets.
• Real‑world case examples showing how proactive compliance monitoring and fit‑for‑purpose algorithms dramatically improve data completeness and statistical power.
• The critical role of disease‑specific digital endpoint design versus off‑the‑shelf wearable algorithms in capturing meaningful treatment effects.
• Practical guidance for clinical operations and outsourcing teams on reducing sponsor burden while scaling wearable technologies across global trials.