JLABS: The Road to the Biologic IND

JLABS, the Johnson & Johnson Innovation Centers and Janssen BioTherapeutics invite you to an in-depth look into the process of filing a biologic Investigational New Drug (IND) application and the procedures necessary for advancing your company's early-stage drug development program. 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 solid plan for achieving IND acceptance.

Join us for a series of short presentations exploring the basic requirements and considerations necessary to achieve a successful biologic IND submission. The presentation will highlight the following:

• Janssen BioTherapeutics - overview of biologics
• Key CMC strategies to balance cost, time and comparability risks
• Non-Clinical safety assessment strategies for biologics
• Determining and understanding PK/PD and immunogenicity
• Regulatory strategy, IND requirements, and Pre-IND meetings

Agenda:

8:00 AM | Registration and Welcome8:30 AM | Opening Remarks
- Background on Johnson & Johnson and Janssen
- Opportunities to partner

8:30 AM | Discovery of a Biologic Drug
- Choosing a target
- Different platforms and implications
- Product characterization
- Critical attributes of the molecule that increase the probability for success

9:00 AM | Toxicology of Biotechnological Products
- Goals of preclinical toxicology evaluations
- Why biopharmaceuticals are different from small molecule drugs - a toxicology perspective
- Unique considerations for biologics Typical First-in-Human Program ~ Preclinical toxicology program objectives, endpoints, findings of concern
~ Factors to consider for biotechnology products: Species specificity, Immunogenicity, Antibody response
~ Testing considerations

9:30 AM | Q&A10:00 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

10:30 AM | Regulatory - Satisfy Statutory Legal Requirements for Testing in Humans
- Regulatory Strategy Considerations
- IND Requirements
- IND Review and FDA Actions
- Pre-IND meetings

11:00 AM | Q&A11:30 AM | Program Close

Speakers
Barry Springer | Vice President and Head of Strategy, Technology and External Innovation, Janssen BioTherapeutics, Janssen R&D read bio»
Tim Coogan | Vice President and Head of Biologics Toxicology, Janssen BioTherapeutics,Janssen R&D read bio»
Hugh Davis | Vice President and Head of Biologics Clinical Pharmacology, Janssen BioTherapeutics, Janssen R&D read bio»
Bethany Paxson | Senior Director, Global Regulatory Affairs, Janssen R&D read bio»


About Janssen BioTherapeutics:
Janssen BioTherapeutics (JBIO) is a family of scientists, innovators and committed partners that are changing the way molecules become medicines by asking and answering the simple, liberating question "what if?"
We are the biotherapeutics innovation engine of Janssen R&D, with the spirit and energy of a biotech start up and the proven track record of delivering therapies that treat millions. We are Janssen. We collaborate with the world for the health of everyone in it.
Click to connect: janssenbiotherapeutics.