Clinical Development Strategy

When entering a new therapeutic area hinged on a well-reasoned clinical development strategy and market assessment, a large biotech company relied on Health Advances to show the way.


  • Our client sought to expand the indications for an anti-inflammatory protein therapeutic in late-stage clinical trials for two indications.
  • Based on the mechanism of action, the client believed this protein could also be developed for inflammatory bowel diseases (IBD), but was unfamiliar with clinical trial design, regulatory hurdles, and patient segmentation for this indication.
  • Prior to beginning clinical development in IBD, the company needed to fully assess the market potential, competitive landscape, clinical trial requirements, and anticipated efficacy that would determine the uptake of their new agent.

Critical Questions to Address

What advantages could the client’s drug have over current treatments?
Which patients are most likely to benefit from this therapy? Was Crohn’s disease or ulcerative colitis the most appropriate path forward, and which patient groups should be selected?

  • What results are necessary to move on to the next phase of development, and what is the overall likelihood of success?
  • What are the overall market opportunities for this therapy, based on multiple potential product attributes?
  • How should the clinical development strategy support the product attributes that are most critical for differentiation and success?

Health Advances Approach

  • Worked closely with a cross-functional client team to leverage existing preclinical data, scientific knowledge, and safety/PK data from other indications.
  • Determined the addressable population, market size, and potential product positioning for different subsets of IBD. Performed in-depth interviews with practicing gastroenterologists to quantify likely adoption based on variation of the product profile.
  • Based on extensive consultation with IBD KOLs and supported by historic and ongoing trials and scientific literature, formulated a clinical development plan from proof-of-concept through pivotal trials, including study designs and potential safety risks.
  • Conducted a day-long KOL advisory board meeting to refine the design of each phase of clinical trials and the product positioning.


  • Produced a clinical development plan detailing Phase I and II trials with higher-level Phase III designs, coupled with scientific and commercial rationale to support investment in the program.
  • Provided realistic target product profiles based on scientific rationale and proposed clinical studies.
  • Created a patient flow model to forecast uptake in the target indications based on dynamic product attributes and lines of therapy in IBD.