Case Studies Archive - Alacrita

Pre-Due Diligence Analysis of Women's Health Startup Partnership

Written by Cort | Jul 2, 2025 9:26:32 AM

Challenge:

A pharmaceutical company was actively searching for strategic partnering opportunities to expand its pipeline and had commissioned Alacrita to conduct a comprehensive pre-due diligence analysis of a promising women's health startup that had recently come across its business development radar.

The biotech company had developed what appeared to be an innovative therapeutic approach targeting a significant unmet medical need in women's health. However, given the complexities inherent in this therapeutic area and the early stage of development, the mid-cap pharma needed expert guidance to make an informed decision.

The primary objective was to provide a thorough, evidence-based recommendation about whether to proceed with initiating full a due diligence process, based upon a careful assessment of:

  • The inherent scientific and commercial risk profile
  • Likely development timescales and regulatory pathways
  • Anticipated resource requirements for successful advancement through clinical development

Solution:

Working closely with a highly experienced and versatile former Chief Medical Officer who possessed extensive background and deep domain expertise in women's health therapeutics, our consulting team conducted a comprehensive assessment that examined multiple critical dimensions of the opportunity.

Our analysis evaluated:

  • The underlying scientific rationale and mechanism of action
  • All available preclinical proof-of-concept data packages
  • Detailed scrutiny of the non-human primate studies completed to date

Through this rigorous evaluation process, we identified several key gaps in the preclinical development program. Our analysis revealed that the startup would need to:

  • Conduct additional safety pharmacology studies
  • Complete comprehensive toxicology packages
  • Address outstanding questions regarding the therapeutic's mechanism of action and potential off-target effects

We concluded that considerable additional preclinical work would be required before IND-enabling studies could realistically be considered. Based on these findings, we determined that timeframes for successful clinical development and potential commercialization were significantly longer than initially anticipated, fundamentally altering the risk-return profile of the potential partnership opportunity.

Pre-Due Diligence Assessment Services:

Alacrita empowers pharmaceutical and biotech companies to make confident, well-informed decisions when evaluating external partnership opportunities across diverse therapeutic areas. Our multidisciplinary team of seasoned industry experts conducts rigorous pre-due diligence assessments that systematically evaluate:

  • Scientific rationale and mechanism validation
  • Development timelines and regulatory pathways
  • Commercial potential and market dynamics
  • Critical risk factors and mitigation strategies

Whether you're considering early-stage assets in unfamiliar therapeutic domains or complex platform technologies outside your core expertise, we provide the comprehensive, evidence-based analysis needed to identify critical risks, optimize deal structures, and ensure your partnering investments align with strategic objectives and deliver maximum value to your organization.