Clinical

An emerging European biotech received FDA priority review for their first US product, leaving only five months to build commercial supply infrastructure. Converge conducted a Readiness Assessment, developed a launch strategy and roadmap, then executed critical workstreams including commercial packaging and artwork, 3PL selection, serialization, supply and demand analysis, S&OP process development, and logistics solutions. Working as a fully integrated team, Converge helped build a US commercial supply network in under six months, enabling product launch with commercial availability within five business days of FDA approval.

A commercial biopharmaceutical company preparing for their second product launch needed to comply with CARES Act supply chain risk management requirements while building supplier redundancy plans. Converge conducted a formal Clinical and Commercial Manufacturing Supplier Risk Assessment across their global supplier network using weighted scoring methodology, then developed a comprehensive Risk Management Plan with individual redundancy plans for each supplier. The client now has a robust process for managing supply risks, meets CARES Act compliance requirements, and is considering expanding into full Supplier Relationship Management.

An emerging pharmaceutical company conducting a pivotal Phase III trial needed to assess whether a multimillion-dollar manufacturing run was necessary, but their internal supply planner was blinded to maintain study integrity. Converge conducted a supply availability assessment confirming the need for additional manufacturing, then developed integrated planning tools that provided real-time visibility into their clinical supply chain. This enabled proactive supply management and gave leadership confidence to accelerate geographic expansion while Converge continues managing the planning process from strategy to execution.

An emerging biologics company launching a global Phase III trial needed stronger clinical supply management and commercial readiness. Converge designed a stage-appropriate Demand & Operational Planning (D&OP) process that mapped their virtual supply network, established inventory targets, and aligned cross-functional teams around critical supply decisions. This disciplined approach transformed the organization's ability to plan, react to changes, and make strategic decisions—keeping them aligned as they progress toward commercialization.

When a client's project's timeline was in jeopardy due to a lack of communication between the vendor and the client, DHC’s project management services were added to support overall project governance.

This case study exemplifies proactive project management of cross-functional program details; specifically, those that occur at the interface of CMC and clinical operations.

Our clients may experience a variety of situations that lead to a leadership gap within their organizations. Senior staff at Dark Horse possess years of leadership experience and can help fill the gap and keep operations moving forward. With senior staff available for nearly any technical or strategic need (and the ability for each of them to call upon 40+ technical SMEs for additional support), this has become a common request for DHC.

A investor client with a target identified for potential investment required DHC support to engage and convene top-tier Clinical Key Opinion Leaders (KOLs) to evaluate a therapeutic candidate’s clinical data package in order to inform a determination regarding the asset’s current status and path to licensure relative to client’s investment thesis and risk appetite.

Experienced regulatory writers at DHC can provide a range of support from full authorship of regulatory submissions to gap analysis and editing of existing documents. A simple regulatory writing request can occasionally uncover unexpected gaps. In this example, as part of meeting package development and remediation of another consultancy’s work, Dark Horse experts identified a path to accomplish the client’s goals in a way that met the crucial initial timeline constraints and set them up for clarity in how to achieve their ultimate regulatory goals.