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

Agenda:

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