From Chemical to Drug – The Path to a Small Molecule IND
When:
Wed, April 15, 8:00am – 11:30am
Where:
UCSF - Byers Auditorium, Genentech Hall - 600 16th St - San Francisco, CA 94158
Description:
When: Wednesday, April 15, 2015 8:00 AM-11:30 AM (UTC-08:00) Pacific Time (US & Canada).
Where: UCSF - Byers Auditorium, Genentech Hall - 600 16th St - San Francisco, CA 94158
Note: The GMT offset above does not reflect daylight saving time adjustments.
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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. 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:
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 | Chemistry, Manufacturing and Controls Strategies
- Optimizing manufacture of your Active Pharmaceutical Ingredient (API)
- Drug product formulations for FIH
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
- Regulatory Strategy
- Data requirements: CMC, safety, clinical plan
- eCTD
- Pre-IND meetings
11:00 AM | Discussion and Q&A
11:30 AM | Program Close
Speakers: Janssen Pharmaceutical Companies of Johnson and Johnson
Christopher Flores, Ph.D. | Janssen R&D read bio»
Michael Kelley, VMD, Ph.D. | Janssen R&D read bio»
Mark Krook, Ph.D. | Janssen R&D read bio»
Donald Heald, Ph.D. | Janssen R&D read bio»
Katherine Tsokas, J.D. | Janssen R&D read bio»
Fees:
$35 General Public
$20 Student/Academic
$45 Onsite
Location:
UCSF - Byers Auditorium, Genentech Hall
600 16th St
San Francisco, CA 94158
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