From Chemical to Drug – The Path to a Small Molecule IND

Do you have a solid plan to achieve IND acceptance? Filing an Investigational New Drug (IND) application might be the next step in advancing your company’s early-stage drug development program. Johnson & Johnson Innovation, JLABS and Janssen Discovery Sciences invite you to an in-depth look into the process of filing an IND. 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 clear blueprint for IND approval, and we want you to be ready.

The presentations will highlight the following:
– Janssen Research & Development – your partner of choice
– Preclinical Development strategies for pharmacokinetics, drug metabolism and toxicology
– Key CMC strategies to balance cost, time and quality risks
– Designing First-in-Human trials to highlight the qualities of your molecule
– Regulatory strategy, IND requirements, and Pre-IND meetings

Speakers: Janssen Pharmaceutical Companies of Johnson and Johnson

Anders Brunmark | External Innovation, Discovery Sciences, Janssen R&D

Michael Kelley | Sr. Scientific Director, Preclinical Development & Safety, Janssen R&D

Mark Krook | Head, Global Portfolio Management – Small Molecules, Janssen R&D

Kenneth Turner | Sr. Scientific Director, Quantitative Sciences
Therapeutic Area Leader, Cardiovascular & Metabolism, Janssen R&D

Stefan Ochalski | Sr. Director, Global Regulatory Leader, Janssen R&D