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.
Speaker
Hong Li, PhD, VP of Formulation, BioDuro
Dr. Hong Li brings over 20 years of expertise to the pharmaceutical industry, specializing in the formulation and process development of new and generic drugs. As the leader of a dynamic formulation development team, she guides projects from initial assessment through clinical development to product launch and lifecycle management. Dr. Hong Li is renowned for her deep expertise in both FDA and NMPA regulations and her proven proficiency in managing global regulatory submissions. Her strategic insight and commitment to innovation make her a distinguished figure in the ever-evolving landscape of pharma services.
Message Presenter
Who Should Attend?
This webinar is designed for R&D professionals from pharmaceutical and biotech companies who are involved in early-phase drug formulation, drug development strategy, regulatory affairs and CMC program management. Academic researchers focused on formulation or drug delivery are also welcome.
Relevant roles include, but are not limited to:
- Formulation, Pharmaceutical and Biopharmaceutics Scientists
- Early-Phase Drug Development Project Managers and CMC Leads
- R&D Directors and Team Leads
- Academic researchers focused on drug formulation and delivery
- Consultants
What You Will Learn
Attendees will gain insight into:
- 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
Xtalks Partner
BioDuro
BioDuro, an Advent portfolio company, is a CRDMO with a 30-year proven track record. Headquartered in Irvine, California, BioDuro employs more than 2,000 scientists with deep expertise in small- and large-molecule discovery, development, and manufacturing. We provide fully integrated drug discovery services spanning chemistry, biology, and pharmacokinetics (DMPK), along with comprehensive IND-enabling capabilities, including both drug substance and drug product development.
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