Halloran Insights

  1. Raw Material Control For Biotechs (Part 2): Clinical Development Considerations 5/15/2024

    Take a deep dive into several strategies being used to enhance raw material control to facilitate successful regulatory submissions and commercialization efforts.

  2. Leadership Considerations To Enable Clinical Development Success 5/15/2024

    Explore several leadership examples that underscore the value of assembling the right expertise across organizations, facilitating successful outcomes, and cultivating a favorable track record for future investment opportunities.

  3. Success Planning For An Original NDA/BLA Submission 4/15/2024

    Experts in regulatory strategy, operations, and program leadership provide strategies for initiation triggers, team coordination, submission processes, and Electronic Submission Gateway (ESG).

  4. Should You Bring Your Trial Master File In-House? 4/15/2024

    Deciding whether to bring the TMF in-house or contract with a CRO depends on the sponsor's specific needs and resources, and it's important to consider the implications beforehand.

  5. Preparing Now For FDA's START Program For Rare Disease Drug Developers 3/14/2024

    Delve into this overview of the START pilot program, expectations to consider if you are applying to the program, and early preparation considerations.

  6. Bringing In Vitro Diagnostics To Market With Real-World Evidence 3/14/2024

    Explore the potential of real-world evidence in enhancing the regulatory decision-making process to facilitate the market entry of IVDs.

  7. 5 Broad Implications For FDA's Project Optimus 3/1/2024

    While formal guidance on the reform the dose optimization and dose selection is still pending, review five common themes that could help sponsors prepare for these changes.

  8. The Value Of Artificial Intelligence To Support Inspection Readiness 3/1/2024

    Review three common inspection findings for overseeing all data and processes and ways that Artificial Intelligence can be integrated into an inspection readiness strategy.

  9. Diversity In Clinical Trials: Shifting To Innovation Opportunities 3/1/2024

    Get an overview of the evolving landscape of clinical trials, where diversity and inclusivity are increasingly recognized as vital components of effective and comprehensive healthcare research.

  10. Pulling The Thread On FDA's Master Protocol Draft Guidance 3/1/2024

    Review this analysis of the draft guidance and its potential implications, as well as recommendations for companies planning to use master protocols in their clinical trials.