The Road to the Biologic IND: Best Practices When Filing Biologic Investigational New Drug Applications
When:
Wed, March 18, 11am – 4pm
Where:
Texas Medical Center - John P. McGovern Campus - 2450 Holcombe Blvd, Suite X - Houston, TX 77021
Description:
Wednesday, March 18, 2015 11:00 AM-4:00 PM (UTC-08:00) Pacific Time (US & Canada).
Where: Texas Medical Center - John P. McGovern Campus - 2450 Holcombe Blvd, Suite X - Houston, TX 77021
Note: The GMT offset above does not reflect daylight saving time adjustments.
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The Road to the Biologic IND
Best Practices When Filing Biologic Investigational New Drug Applications
Program Overview:
JLABS, 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 Biotech, Inc. - 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:
1:00 PM | Registration and Welcome
1:30 PM | Development of a Process Suitable for Manufacturing a Biologic Drug
- Cell culture
- Protein purification
- Product characterization
- Formulation & stability
- Fill/Finish
2:00 PM | 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
2:30 PM | Q&A
3:00 PM | 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
3:30 PM | Regulatory - Satisfy Statutory Legal Requirements for Testing in Humans
- Strategy
- Data requirements: CMC, safety, clinical plan
- eCTD
- Pre-IND meetings
4:00 PM | Q&A
4:30 PM | Networking Reception
6:00 PM | Program Close
Speakers: Janssen Pharmaceutical Companies of Johnson and Johnson
Barry Springer, Ph.D. | VP of Technology, Strategy & Operations, Biotechnology Center of Excellence, Janssen R&D read bio»
Steven Lang, Ph.D., MBA | Director, Biologics Research Analytical Discovery, Cell Line Development, Biotechnology Center of Excellence, Janssen R&D read bio»
Tim Coogan Ph.D., DABT | VP and Head of Biologics Toxicology, Biotechnology Center of Excellence, Janssen R&D read bio»
Hugh Davis, Ph.D. | VP and Head of Biologics Clinical Pharmacology, Biotechnology Center of Excellence, Janssen R&D read bio»
Bethany Paxson | Senior Director, Global Regulatory Affairs, Janssen R&D read bio»
Fees:
$35 General Public
$20 Student/Academic
$45 Onsite
Location:
Texas Medical Center
John P. McGovern Campus
2450 Holcombe Blvd, Suite X
Houston, TX 77021
