Webinar: Preparing for Phase 1 - Strategies for success in advancing your drug to first-in-human trials

Companies can encounter a number of pitfalls on the path to moving a drug from preclinical to clinical trials. Understanding these hurdles—and properly preparing for them—can prevent a drug development program from stalling or, worse, stopping altogether.

Biopharma companies encounter a wide range of challenges as their molecules move towards first-in-human trials, including bioavailability issues, shortfalls in supplies of active pharmaceutical ingredients and misunderstandings during the IND process that prevent phase 1 trials from moving forward.

During this webinar, biopharma R&D professionals will review strategies for moving successfully and efficiently from preclinical studies to first-in-human trials. They will call upon their own experiences to provide advice that will help others in the industry navigate this crucial transition.

Topics include:

  • Best practices for preparing your molecule for human testing and how to ensure access to the active pharmaceutical ingredients you need
  • Recent advances in formulation technologies that can speed up your processes
  • Common mistakes companies make in filing their INDs and how to avoid them

Featured Speaker

Nathan Bennette

Director, Scientific Advisory

Catalent Pharma Solutions

Mr. Bennette is a Science and Technology Director at Catalent Pharma Solutions and is a member of the small molecule advisory team for North America. In this capacity he works directly with partners to understand the key drug delivery objectives for their specific molecule, collaborate on the target product profile and define a strategy for the development program. Mr. Bennette is particularly interested in the application of the scientific method early in the design and development process along with improving clinical outcomes by bringing a right-first-time approach to formulation and process design.

Mr. Bennette has worked in drug development for over 10 years in a range of technical and leadership roles. His area of expertise is in the development and delivery of drug candidates requiring bioavailability enhancement, with an emphasis on formulation and analysis of amorphous solid dispersions (ASD). His experience includes working across the entire drug development lifecycle from preclinical and early phase development to late phase and commercialization. Mr. Bennette has contributed to the design and development of therapies utilizing a range of oral delivery technologies including ASDs, modified/controlled release platforms, nanocrystalline formulations and multiparticulates. Mr. Bennette holds a master’s in Inorganic Chemistry from the University of Washington.

Date:  Wednesday, November 17, 2021
Time:  11am ET / 8am PT
Duration:  1 Hour

Register now for this webinar

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