Case Study: Strategic Collaboration from Hit Identification to IND Filing

Read our dug discovery case study involving a collaboration with an emerging biotechnology company.

Overview

Affinity initiated a strategic collaboration with an emerging biotechnology company in Q1 2019. The partnership evolved through multiple stages—Hit Identification, Hit-to-Lead, Lead Optimization, and Process Development—culminating in a successful IND submission to the FDA in Q1 2021.


Hit Identification (Q1 2019)

The collaboration began under a Fee-for-Service (FFS) model. Within the first quarter, Affinity delivered rapid progress:

  • Synthesized a series of tool and reference compounds (10–25 steps each) to support assay development.
  • Designed and prepared a focused compound library (20–30 compounds, each requiring 15–25 steps), guided by molecular modeling.
  • Enabled the customer to identify initial hit compounds within just three months.


Hit-to-Lead Exploration (Q1–Q2 2019)

Following early success, the project transitioned to a Full-Time Equivalent (FTE) model:

  • Initiated with two FTEs, quickly expanding to six.
  • Delivered approximately 180 new compounds.
  • Resulted in the discovery of the first lead compound.


Lead Optimization (Q3 2019 – Q1 2020)

The collaboration continued in FTE format, accelerating compound optimization efforts:

  • Deployed 8 FTEs throughout the period.
  • Synthesized approximately 600–700 compounds at the milligram scale.
  • Scaled up 10–15 compounds to the gram scale to support PK/PD studies.
  • Identified a development candidate for IND-enabling studies.


Process Development Services (Q2 – Q4 2020)

The project transitioned back to a Fee-for-Service model to support process development and preclinical manufacturing:

  • Developed a scalable, 35-step synthetic route from commercially available raw materials.
  • Produced 30 kg of cGMP starting materials.
  • Prepared GLP tox batches.
  • Performed salt screening and polymorph studies.


Regulatory Milestone (Q1 2021)

  • The customer successfully filed an Investigational New Drug (IND) application with the U.S. FDA, marking a major milestone in the collaboration.