The Path to a Small Molecule IND

Tuesday, May 16, 2017 | 11:00 a.m. - 2:30 p.m. Add to Calendar

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

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


11:00 AM | Registration, lunch and networking

11:30 AM | Janssen Research & Development – your partner of choice

12:00 PM | Preclinical development strategies

12:30 PM | Chemistry, manufacturing and controls strategies

1:00 PM | Clinical pharmacology

1:30 PM | Regulatory – overview

2:00 PM | Discussion and Q&A

2:30 PM | Program close

Speakers: Michael Kelley | Sr. Scientific Director, Preclinical Development & Safety, Janssen R&D

Daniel Schaufelberger | Sr. Scientific Director, Portfolio Management, Janssen R&D

Katherine Tsokas | Sr. Director, Global Regulatory Affairs, Janssen R&D




2450 Holcombe Blvd., Ste. J


Raquel Longley