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
• Modernizing phase one and using AI to develop better translational models

Featured Speakers

Borje Darpo, MD, PhD is the Chief Scientific Officer at Clario, the combined organization that brings together the best of ERT and Bioclinica.

Dr. Darpo oversees Clario’s cardiology services and consults with external customers to ensure the cardiac safety of their compounds in development. He is board-certified in cardiology and internal medicine and has 20 years of experience overseeing projects across all phases of clinical development.

Greg joined Exscientia through the acquisition of Allcyte, a pioneer in the field of AI-first functional precision oncology and translational cancer research, where he was a Scientific Co-Founder and the Chief Scientific Officer. At Allcyte, he and his team pushed the boundaries of translational cancer research through the use of disease relevant primary human cancer samples, high content imaging, custom AI-powered computer vision, and scalable cloud computing. Greg has a PhD from University of Massachusetts Medical School in Immunology, after which he moved to Vienna as an EMBO-supported Postdoctoral Fellow at CeMM where he and a colleague invented the first-generation platform used for the translational work, and spearheaded the first ever prospective interventional clinical trial showing that drugs prioritised using a functional precision medicine tool had clinical benefit for late stage blood cancer patients.

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.