Accelerating Clinical Entry for Poorly Soluble Molecules: A Proven and Structured Roadmap

Poorly soluble molecules face unique challenges that can slow development and limit clinical success. Early formulation decisions are critical for determining bioavailability, in vivo exposure and the speed to IND submission and first-in-human studies. This webinar will show how tailored early-phase strategies, aligned with molecule properties and clinical stage, can overcome solubility, bioavailability limitations and related formulation challenges.

The featured speaker will highlight key development risks and practical approaches to mitigate them. Case studies will demonstrate how integrating early formulation planning with DMPK insights and milligram-scale API data supports data-driven decisions and accelerates clinical entry within a structured timeline. Attendees will gain insights into how a systematic approach can streamline early development and help promising candidates to reach the clinic faster.

Register for this webinar to learn how soluble molecules can be evaluated and advanced using early formulation and DMPK strategies that support faster clinical entry.

What you will learn:

Early-phase formulation strategies tailored to the molecule stage and API properties

Key risks that may affect formulation success and timely clinical advancement

Approaches to address solubility, bioavailability limitations and related formulation challenges

A structured roadmap to advance candidates to the clinic within 6-8 months

Case studies showing integration of formulation and DMPK insights for data-driven decisions

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Speaker:

Hong Li, Ph.D.

VP of Formulation, 

BioDuro