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
Agenda:
11:00 AM |Registration, Lunch, and Networking
11:30 AM |Janssen Research & Development -Your partner of choice
12:00 PM |Preclinical Development Strategies
– Designing drugable molecules with appropriate kinetics and metabolism
– Preclinical toxicology evaluations before and during GLP toxicology
– Considerations for typical First-in-Human (FIH) Program
12:30 PM |Chemistry, Manufacturing and Controls Strategies
– Optimizing manufacture of your Active Pharmaceutical Ingredient (API)
– Drug product formulations for FIH
1:00 PM |Clinical Pharmacology
– Designing FIH trials
– Understanding PK/PD
– Biomarkers of safety and efficacy
1:30 PM |Regulatory – Overview
– Data requirements: CMC, safety, clinical plan FIH trials
– eCTD
– Pre-IND meetings
– Regulatory Strategy
2:00 PM |Discussion and Q&A2:30 PM |Program Close
Speakers:
Michael Kelley, PhD | Sr. Scientific Director, Preclinical Development & Safety, Janssen R&Dread bio»
Mark Krook, PhD | Head, Global Portfolio Management- Small Moledules, Janssen R&D read bio»
Katherine Tsokas, JD | Sr. Director, Global Regulatory Affairs, Janssen R&D read bio»
Jan de Jong, PhD | Scientific Director Clinical Pharmacology, Janssen R&D read bio»