The Road to the Biologic IND: Best Practices When Filing Biologic Investigational New Drug Applications

Janssen Labs, the Johnson & Johnson California Innovation Center and the Janssen Biotechnology Center of Excellence invite you to an in-depth look into the process of filing a biologic Investigational New Drug (IND) application and the procedures necessary for advancing your company’s early-stage drug development program. Whether your goal is to develop a pipeline through commercial launch, or partner as early as possible, submitting an IND is a critical early milestone for every biotech company. With big Pharma and VC firms competing for the most promising compounds, startups are expected to demonstrate a solid plan for achieving IND acceptance. Join us for a series of short presentations exploring the basic requirements and considerations necessary to achieve a successful biologic IND submission. The presentation will highlight the following: Key components of the Chemistry/Manufacturing/Controls section; Expression, Purification, Analytics, Formulation, Fill/Finish; Preclinical study design, species selection, material requirements, and timelines; Regulatory requirements, strategies to minimize costs and timelines while balancing risk.

Speakers: Barry Springer, PhD, VP of Technology, Strategy & Operations, Biotechnology Center of Excellence, Janssen R&D | Steven Lang, PhD, MBA, Director, Biologics Research Analytical Discovery, Cell Line Development, Biotechnology Center of Excellence, Janssen R&D | Pauline Martin, PhD, Senior Scientific Director, Biologics Toxicology, Biotechnology Center of Excellence, Janssen R&D | Hugh Davis, PhD, VP and Head of Biologics Clinical Pharmacology, Biotechnology Center of Excellence, Janssen R&D | Salvatore Morello, Director, Global Regulatory Affairs, Janssen R&D

Information and registration here.