Road To Success: Mapping drug development from preclinical to commercialization

A phase appropriate development roadmap for biologics, covering formulation, analytical characterisation and derisking from preclinical to market.

February 21st, 2024

4pm (CET) / 10am (ET)

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OVERVIEW

There is vast knowledge on studies needed for development of a drug product, but so far, NO specific guidance set out in a phase dependent manner explaining what studies should be completed with the different phases of clinical development from pre-clinical through to commercialization.

Bruce Kerwin, Scientific Advisor at Coriolis Pharma together with leading scientific experts from Coriolis have assembled a high-level drug product development and manufacturing roadmap. The roadmap is applicable across the different modalities providing a unified framework from early phase development to commercialization of biologics drug products.

In this webinar Bruce Kerwin, PhD – Scientific advisor and Dr. Eva Keilhauer – Scientist at Coriolis Pharma will be discussing common issues during the development for different biologics drug product presentations. The experts will be highlighting how DP and Clinical Development are linked, going into detail about phase-appropriate actions taken as part of the roadmap.

Addressed Challenges

01Ignoring early drug product issues such as colour, reconstitution time, or colloidal instability leads to costly and time-consuming late-stage problems.

02Defining phase-appropriate drug product design that balances the speed and cost needs of early development with the rigour required for late-stage trials.

03Derisking late-phase development by identifying molecular vulnerabilities early and incorporating mitigation strategies throughout the development programme.

WHAT YOU WILL LEARN

01Understand why a quality target product profile is essential and how it shapes formulation and analytical decisions across all development phases.

02Learn which formulation studies are required at each stage of drug product development and how phase-appropriate design reduces risk and rework.

03Gain clarity on the appropriate level of characterisation needed to ensure safety, quality, and potency in relation to each phase of human clinical trials.

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SPEAKERS

Bruce Kerwin - PhD

Scientific Advisor at Coriolis Pharma and President of Kerwin Biopharma Consulting LLC.

Bruce Kerwin - PhD, is a recognized expert in protein formulation and drug product development. He worked for multiple companies including Baxter Hemoglobin Therapeutics, Amgen, Just-Evotec Biologics and Umoja Biopharma before joining the Scientific Advisory Board of Coriolis Pharma. Bruce Kerwin led numerous scientific research and project teams developing novel solutions to formulation problems such as high viscosity, high concentration, and protein co-formulation while successfully bringing drug candidates through development from pre-IND to commercialization. He was also intimately involved with alternative drug delivery systems such as slow release and nanoparticle formulations. His research has yielded over 60 research publications and book chapters in a wide array of areas relating to protein science and formulation development, including protein stabilization, polysorbate degradation, photodegradation, protein phosphorescence, and high throughput biophysical screening. Dr. Kerwin is an inventor on multiple patents and is a member of the editorial advisory board for the Journal of Pharmaceutical Science.

Dr. Eva Keilhauer

Scientist at Coriolis Pharma

Dr. Eva Keilhauer - Scientist at Coriolis Pharma, with a special focus on liquid formulation development projects. Dr. Keilhauer joined Coriolis in 2017 as a scientist, working in the operative team for several years, supporting and leading various formulation development projects. Since 2022, Dr. Keilhauer is a member of the business development team, where she continues to apply her knowledge in formulation development to help clients tackle their specific challenges.

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