As an emerging biopharmaceutical organization, you need to build a commercially viable supply chain. The challenge is building a full technical operations function of your business while simultaneously trying to balance everything else that comes along with the launch of your product. Moving from hundreds of subjects in clinical trials to tens of thousands of patients, and the regulation and complexity that comes with this requires strong, purposeful supply chain planning. Your drug needs to get to patients on time, every time with unimpeachable quality.
In order to achieve patient success, you need a robust, economically feasible, and predictable plan that informs your next steps in a way that will serve you well now and in the future. Moving from a focus in clinical development and clinical product supply to commercial product supply is like managing two totally different worlds and issues. One of the greatest challenges is in aligning cross-functional groups of people on dozens of topics who are unfamiliar with working together. These groups need to come together to compliantly ensure enough product is in channel, soon after approval. Our supply chain assessment process confronts these issues through process mapping of your current state, what might be missing, and what you need to do next, in a clear, practical, and efficient way.
Supply Chain Assessment and Planning
Supply Chain Systems Design and 3rd Party Project Management
Supply Chain Managed Services
Our Supply Chain Assessment and Planning process supports first-time launchers and established companies launching next product or indication. We thoroughly assess your current processes to uncover unknown gaps and risks, where opportunities lie to reduce cost and cycle times, and the guidance you need to meet demand and expiration requirements. The Assessment and Planning process provides you with a roadmap and action plan that informs your current state, what may be missing, and actionable next steps that put you on a reliable path forward.
Despite a team’s clinical supply experience, problems can surface in early stages of supply chain establishment out of a lack of familiarity with the nuances and complexity of a commercial business. Scheduling, logistics, timing issues, and trade-offs need to be considered when designing upstream operations, most of which involve entirely new responsibilities for a CMC team. Resources and expertise are stretched thin at a time when building out this function of the organization is the most critical.
The solution to these challenges is found in an organization’s ability to get ahead by mapping out their processes, identifying where their team needs help, and dodging probable obstacles. Our solutions directly confront these challenges to support the supply chain infrastructure. This process is a requirements-focused and practical approach to selecting fit-for-purpose partners and systems, and leverages standard players and relationships based on decades of experience.
We also offer implementation support for tools and automated processes used to capture necessary data early in the process using inexpensive, scalable, and secure methods that grow with your business and reduce risk.
Our Supply Chain managed services alleviate staff workload and/or support in selecting, onboarding, and integrating 3rd parties and systems. We support your business needs, eliciting and documenting specific requirements, solution design, vendor selection, assessment, contracting, implementation, testing, and post go-live support (including BPO and development operations).
Verastem was referred to SVA Consulting as a Phase 3 biopharmaceutical company with 30 employees and promising data. SVA was brought in to help Verastem Oncology with the launch planning around the operations and processes, as well as helping to plan all of Verastem’s systems, which prior to SVA, their “systems” were email and a server.Read More
Exact Sciences was referred to SVA Consulting when they were a startup medical device company. In lightning speed of 19 months, Exact Sciences grew from 36 employees to over 700, moving from developing Cologuard, their pre-screening test for colon rectal cancer, to human trials, FDA approval and then to the international marketplace.Read More
MyoKardia engaged SVA Consulting at the end of its Phase 3 program to evaluate the commercial capabilities of their financial systems. The question at hand was whether MyoKardia should take on the implementation of a new ERP system, or whether their current ERP system would support a commercial company.Read More