Case Studies Archive - Alacrita

Indication strategy and development plan for a microbiome company

Written by Cort | Jan 31, 2023 3:59:11 PM

Challenge

A clinical stage microbiome company developing a microbiome therapeutic for the treatment of recurrent C. Difficile infection (rCDI) was looking to identify promising opportunities for new microbiome therapeutics in other infectious diseases and beyond.  Alacrita was asked to augment the company’s initiative in identifying new indications to add to its early-stage pipeline through a two-stage process involving delivering an updated short-list of indications; conducting a ‘deep dive’ into selected indications; and developing a high-level project plan.

Solution

Alacrita revisited the company’s previous indication prioritization work to review the ‘knock-out’ criteria and technical and commercial ranking criteria, as well as re-evaluating the original shortlist of indications, and developing profiles for any newly selected indications.

Specifically, we:

  • Reviewed and updated, at a high level, profiles for the top 6 indications selected by the microbiome company
  • After another round of indication review, we conducted a deep-dive in to the top four indications, scoring them on criteria such as product differentiation in the indication; technical feasibility/accessibility of the clinical opportunity; development challenges; market potential (size/scale, prospective growth, pricing); level of unmet need; and competitive landscape/existing competing technologies.
  • We then brought onboard one of our expert Associates to develop a high-level project plan for the selected top indication. This involved more in-depth characterization of the indication in each of the scoring criteria listed above, as well as developing a list of potential partners.
  • Based on this, we developed, alongside our client, a strategy for a target product profile (TPP) and a plan for how the company could be best positioned in the top selected indication. The strategy included a high-level clinical and regulatory plan, as well as a project budget and associated timelines. Alacrita supported the company’s strategy team in presenting the plan to the senior leadership. 


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