The Road To Success:Mapping drug product development from preclinicalto commercialization

The Road To Success: Mapping drug product development from preclinical to commercialization

February 21st, 2024 - 4pm (CET) / 10am (ET)

The Road To Success: Mapping drug product development from preclinical to commercialization

February 21st, 2024 - 4pm (CET) / 10am (ET)

Valuable insights for a successful transition from early development to market approval

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

Developmental Pitfalls: Ignoring problems such as DP color, reconstitution time, or colloidal instability can lead to problems during development such as storage and delivery. Tackling these issues early can lead to significant savings in time and cost when approaching pivotal and commercial DP design.
Defining Phase Appropriate Drug Product Design: The needs of early development, speed to clinic and cost, are very different than late stage development, pivotal clinical studies and commercialization, leading to different formulation and analytical needs appropriate to the phase of development.
Derisking Late Phase Development: Taking steps early to fully understand a molecules vulnerabilities can lead to incorporation of strategies during development for reducing or eliminating their impact. Examples include molecular level understanding of post-translational modifications, developing protein aggregate profiles, and characterizing attributes such as viscosity and room temperature stability.

Learning Objectives

Why do you need a quality target product profile?
What type of formulation studies are required for which stage of development?
What is the appropriate level of characterization ensuring safety, quality, and potency in relation to the phase of the Human Clinical Trials?

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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