december, 2014

15dec8:00 am11:30 amFrom Chemical to Drug – The Path to a Small Molecule IND


Event Details

Event Details

\'JANSSENFrom Chemical to Drug – The Path to a Small Molecule IND
Best Practices When Filing Investigational New Drug Applications

Program Overview:
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. Janssen Labs, the Johnson & Johnson Innovation Centers 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


8:00 AM | Registration, Breakfast, and Networking
8:30 AM | Janssen Research & Development -Your partner of choice
9:00 AM | 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
9:30 AM | Biologics Clinical Pharmacology
– Determination of the starting dose for the First-in-Human study using MABEL, PK/PD, allometric scaling and common drug approaches
– Immunogenicity Risk Assessment and Determination: preclinical and clinical impact
10:00 AM | Clinical Pharmacology
– Designing FIH trials
– Understanding PK/PD
– Biomarkers of safety and efficacy
10:30 AM | Regulatory – Satisfy Statutory Legal Requirements for Testing in Humans
– Strategy
– Data requirements: CMC, safety, clinical plan
– eCTD
– Pre-IND meetings
11:00 AM | Discussion and Q&A
11:30 AM | Program Close


(Monday) 8:00 am - 11:30 am


Westin Copley Place

10 Huntington Ave Boston, MA 02116