Case Study: Strategic Collaboration from Hit Identification to IND Filing

Tue, 13 Feb 2024 21:23:12 GMT

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.