Digestive & GI

Challenge: A disease area unit within a global biopharmaceutical company was charged with a mandate to seek out novel candidate assets in development to treat inflammatory bowel disease (IBD) and Celiac disease After a thorough internal review of the public biotech landscape, Alacrita was contacted to assist in their search and evaluation efforts for external innovation in all modalities, especially microbiome and tolerance induction, but not cell therapies. The stage of development of most interest to the client was primarily candidate stage assets within 18 months of an Investigational New Drug (IND) Application in the US and EU.

Solution: Alacrita consultants worked closely with the client to identify a stream of opportunities for further evaluation. An initial search of a commercial pipeline database was conducted focused on the client’s search criteria. Potential candidate assets were highlighted for the client and approved by in-house scientific team leaders for outreach. Non-confidential slide decks were requested from asset owners and further evaluated by Alacrita prior to determining whether to send to the client, depending on continued fit with the client’s search criteria. In parallel, secondary searches of technology licensing office and SBIR grant databases, as well as biotech incubators and venture capital portfolio companies were initiated. Over the three-month scouting campaign, >2,000 asset opportunities were evaluated and the client was provided with over 100 assets to approve for outreach, culminating in several attractive opportunities for further partnering discussions.

Challenge: A clinical stage pharma company with development and commercialization rights to a novel treatment for GI indications wanted to gain marketing authorization in Europe. However, the European market opportunity from the payer’s perspective was still unclear. Alacrita was asked to help the company better understand the payer perspective through primary research.

Solution: First, Alacrita reviewed documentation describing the product, the target product profile (TPP), market survey information, health economic data and points of product differentiation. We recruited payers currently or recently involved in Health Technology Assessment (HTA), reimbursement and pricing decisions, at national or regional level. We prepared a payer pre-read document that incorporated the TPP as well as evidence for differentiation, health economic arguments/data, evidence generation plan and a discussion guide. Alacrita obtained views on the product’s value given the disease burden, and prospective pricing for the product. We tested the evidence required to support proposed pricing and preferred formulary position, and the possibility of pursuing multiple indications; within those, the specific sub-patient populations payers feel have the biggest unmet need.

Challenge: A biotech company had developed an AI-driven drug discovery platform to discover phytocompounds and bioactives with the potential to impact human health. Alacrita was retained to conduct a due diligence of the platform and the initial molecules identified by it for NASH/NAFLD as well as other GI indications, and to make recommendations for how best to partner the technology with pharmaceutical companies.

Solution: Alacrita's starting point was a mock due diligence assessing both the compounds and the platform to identfy areas that would raise issues if/when pharmaceutical companies were to take an interest. We found that the client's pitch materials did not enable easy comparison of the client's compounds with the industry-accepted small molecule drug-like chemical space to inform decision-making on the value of the technology. This was a particular issue given that details of the underlying platform are not made explicit to potential partners, and pharma companies are wary of "Black Box" technology. Our recommendations highlighted the need to modify the pitch materials, possibly requiring generation of new drug discovery data and case studies in order to maximize potential interest from prospective partners.