PharmaCyte Biotech Inc (PMCB)

[Triple9]

Saw this on the JLabs Toronto calendar of events:

The Road to the Biologic IND
JLABS @ Toronto
Tuesday, September 19, 2017 from 12:00 PM to 5:00 PM (EDT)
Toronto, ON

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 and CTA requirements, and Pre-IND meetings

https://www.eventbrite.com/e/the-road-to-the-biologic-ind-tickets-34717748721