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J&J Innovation’s The Road to the Biologic IND

February 8, 2018 @ 12:00 pm - 5:00 pm

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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

Hosted by: Johnson & Johnson Innovation, JLABS

Details

Date:
February 8, 2018
Time:
12:00 pm - 5:00 pm
Event Tags:
Event Website

Venue

LabCentral
700 Main Street, North
Cambridge, MA 02139 United States
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