Clinical Development & Regulatory

Portfolio & Product Lifecycle Management Made Easy.

We help you discover new product/portfolio opportunities by providing science-based, innovative solutions for unique strategic and executional challenges.

Portfolio Asset Management

Vault develops the most viable and medically-relevant assets by concentrating on your portfolio prioritization and disease area focus. We create your target product profiles and developmental plans that underscore differentiation potential, provide sufficient safety and efficacy data, and permit effective asset evaluation for “out-licensing” opportunities and support business development in-licensing activities by performing customized assessments of potential acquisition targets.

Product Realization Optimization

We create dynamic target product profiles for your asset and its competitors by analyzing available in-house data and assessing competitor developmental programs and product attributes. The resulting integrated product development plan focuses on streamlined safety/efficacy data gathering, executional efficiency, and achieving timely global approval with the best possible label and favorable pricing / reimbursement.

Lifecycle Management

Our lifecycle management strategy discovers novel ways to demonstrate product clinical benefits, providing differentiation versus existing or future therapies. Vault’s unparalleled experience allows us to identify areas for new product enhancement not previously realized. We support innovation through new technology identification and sourcing, design label optimization programs, and integrate clinical/commercial insights and regulatory success assessments. By performing in-depth data review and data mining efforts we can uncover additional asset optimization strategies. By working closely with you, Vault supports launch-related clinical, publication and KOL activities, and promotes competitive Phase 4 clinical trial strategies.

Developmental Risk Mitigation

Vault helps you assess the probability of success appropriate to the stage of development by identifying the major roadblocks to timely program completion, assessing risk to the developmental/approval process based on known class characteristics or the available pre-clinical pharmacodynamic and toxicologic data, proposing ways to mitigate challenges, identifying potential areas for safety concern, and planning appropriate surveillance/mitigation during the clinical trials.

Global Regulatory Agency Interaction

Vault provides you with expert reviews of core dossier documents and helps you define the regulatory path to approval across the full spectrum of geographies. We help you refine regulatory agency interaction and IND, NDA, CTD, and sNDA document strategies from the clinical development plan to permitting appropriate data collection for an efficient global registration process. We participate in planning/rehearsal sessions to prepare you for regulatory agency and Advisory Committee meetings, guide the Briefing Document strategy and preparation, participate at the regulatory agency meetings when needed, and provide perspective on meeting output and implications for the developmental program.

R&D Operational Excellence

We review operational efficiency and effectiveness, help you optimize organizational infrastructure and processes utilizing structured, proven performance metrics, and provide recommendations for shaping your R&D model.

Discover New Product & Portfolio Opportunities Today.

  • WHAT WE DO.

    Vault Bioventures creates, uncovers, & captures the value of your biopharmaceutical assets through marketplace adoption, investment decisions and operational execution.

  • HOW WE DO IT.

    By harnessing the power of integration, we align and facilitate your key organizational strategic and operational levers to deliver value driven solutions and break-through business performance.

  • WHY VAULT BIO.

    Our team guides you through stakeholder ecosystems by analyzing complex infrastructures, evaluating organizational patterns, & providing detailed, unrealized roadmaps.