Phase‑Gated Formulation Design for Poorly Soluble Active Pharmaceutical Ingredients: End‑to‑End Contract Research, Development and Manufacturing Organization from Screening to Scale‑Up

Tuesday, November 11, 2025

9:00 AM - 10:00 AM CT

Location:360 Stage #1, Exhibit Hall

Sponsored By

Partner Presentation Speaker(s)

HT

Hibreniguss Terefe, n/a

Director, Research and Development • Product Development
Ardena
Somerset, New Jersey

Description: This presentation showcases a novel, end‑to‑end phase‑gated formulation design framework for poorly soluble active pharmaceutical ingredients, implemented within a contract research, development and manufacturing organization. By leveraging the expertise of the contract research organization function, early‑stage studies are designed to maximize data quality, conserve API, and de‑risk candidate selection. API‑sparing screening is combined with scalable formulation technologies and integrated chemistry, manufacturing and controls strategies to ensure seamless progression from discovery‑driven research through commercial scale‑up. Together, these capabilities accelerate oral drug development while reducing technical uncertainty and regulatory risk.

Learning Objectives:

Upon completion, participant will be able to describe an end‑to‑end, phase‑gated formulation design framework for poorly soluble active pharmaceutical ingredients within a contract research, development and manufacturing organization.
Upon completion, participant will be able to explain how API‑sparing screening, scalable formulation technologies, and integrated chemistry, manufacturing and controls strategies accelerate oral drug development.
Upon completion, participant will be able to assess the contract research organization's role in enhancing data quality, conserving API, and de‑risking candidate progression from screening through commercial scale‑up.