september, 2014

11sep8:00 am11:00 amThe Road to the Biologic IND


Event Details

The Road to the Biologic IND
Best Practices When Filing Biologic Investigational New Drug Applications 

Program Overview:
Janssen Labs, the Johnson & Johnson Innovation Centers and the Janssen Biotechnology Center of Excellence 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 biologics – your partner of choice
– 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


8:00 AM | Registration, Breakfast, and Networking
8:30 AM | Development of a Process Suitable for Manufacturing a Biologic Drug
– Cell culture
– Protein purification
– Product characterization
– Formulation & stability
– Fill/Finish
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 | 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
10:00 AM | Regulatory – Satisfy Statutory Legal Requirements for Testing in Humans
– Strategy
– Data requirements: CMC, safety, clinical plan
– eCTD
– Pre-IND meetings
10:30 AM | Discussion and Q&A
11:00 AM | Program Close


(Thursday) 8:00 am - 11:00 am


Janssen Labs