Events

Time: 12:00PM – 3:30PM
Location: Lobby

RSVP after requesting the LabCentral code for free entry from Clancy

Best Practices When Filing Small Molecule 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. 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: 
12:00 PM | Registration, Lunch, and Networking
12:30 PM | Janssen Research & Development -Your partner of choice
1:00 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
1:30 PM | Chemistry, Manufacturing and Controls Strategies
- Optimizing manufacture of your Active Pharmaceutical Ingredient (API) 
- Drug product formulations for FIH
2:00 PM | Clinical Pharmacology
- Designing FIH trials 
- Understanding PK/PD 
- Biomarkers of safety and efficacy
2:30 PM | Regulatory Overview
- Data requirements: CMC, safety, clinical plan 
- eCTD 
- Pre-IND meetings
- Regulatory Strategy
3:00 PM | Discussion and Q&A
3:30 PM | Program Close

Speakers
Eric Schaeffer | Sr. Director, Neuroscience External Innovation, Janssen R&D 
Daniel Schaufelberger | Sr. Scientific Director, Portfolio Management, Janssen R&D 
Liping Zhang | Sr. Scientific Director, Global Clinical Pharmacology, Janssen R&D
Katherine Tsokas | Sr. Director, Global Regulatory Affairs, Janssen R&D 
Mark Kao | Scientific Director, Janssen R&D