december, 2014
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Event Details
Event Details
From 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
Agenda:
| 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 |
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| 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 |
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| 10:00 AM | | Clinical Pharmacology |
| – Designing FIH trials – Understanding PK/PD – Biomarkers of safety and efficacy |
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| 10:30 AM | | Regulatory – Satisfy Statutory Legal Requirements for Testing in Humans |
| – Strategy – Data requirements: CMC, safety, clinical plan – eCTD – Pre-IND meetings |
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| 11:00 AM | | Discussion and Q&A |
| 11:30 AM | | Program Close |