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Indication Assessment & Prioritization

How we help with Indication Assessment & Prioritization

We help many early-stage clients identify which development pathway is right for their business goals. Halloran helps to identify which assets and indications to prioritize and de-prioritize based on the client’s desired timeline, budget, early preclinical data, and clinical, regulatory, and commercial attributes. As part of this work, a Risk-Benefit Analysis for developing a drug or device in the indications under consideration can be provided as a guide to help mitigate potential pain points during the development.


  • This comprehensive webinar offers an insightful exploration into the intricate landscape of New Drug Applications (NDAs) and Biologics License Applications (BLAs), elucidating the pivotal regulatory procedures imperative for pharmaceutical companies seeking approval for novel drugs and biologics. Its primary objective is to equip participants with the requisite knowledge and resources essential for navigating the intricate […]

  • The U.S. Food and Drug Administration’s (FDA) draft guidance, Master Protocols for Drug and Biological Product Development, released on December 21, 2023, provides expanded recommendations on the design and analysis of trials conducted under a master protocol. A master protocol is a protocol designed with multiple substudies, which may have different objectives and involve coordinated […]

  • The journey from research to development is a critical milestone for any biotech startup. This transition signifies the company’s progression from proving a drug’s potential efficacy to preparing for clinical trials, a pivotal step that underscores the startup’s early success. For many biotech or pharma leaders, especially those experiencing this shift for the first time, […]