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Road to the Clinic for Biologic Therapeutics

April 12, 2016 @ 12:00 pm - 6:00 pm

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

Register Today!
Partners:
This event is presented in partnership with Janssen, and the University of Toronto.

Agenda:

12:00 PM | Lunch
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 / Coffee Break
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
– CTA Submission Package
4:00 PM | Q&A
4:30 PM | Networking Reception
6:00 PM | Program Close

Speakers:
Barry Springer | Vice President and Head of Strategy, Technology and External Innovation, Janssen BioTherapeutics, Janssen R&D read bio»
Steven Lang | Director, Biologics Research Analytical Discovery, Cell Line Development, Janssen BioTherapeutics, Janssen R&D read bio»
Tim Coogan | Vice President and Head of Biologics Toxicology, Janssen BioTherapeutics,Janssen R&D read bio»
Hugh Davis | Vice President and Head of Biologics Clinical Pharmacology, Janssen BioTherapeutics, Janssen R&D read bio»
Bethany Paxson | Senior Director, Global Regulatory Affairs, Janssen R&D read bio»

Fees:
FREE | UofT Employees, Students, and Faculty
CA$ 40  | General Public
CA$ 30  | Student/Academic
CA$ 55  | At the door

Locations:
Presentation
University of Toronto
Mechanical Engineering Building
Lecture Hall 102
5 King’s College Circle
Toronto, Ontario
CANADA

Networking Reception
University of Toronto
Lobby
1 King’s College Circle
Toronto, Ontario
CANADA

Register Today!

Details

Date:
April 12, 2016
Time:
12:00 pm - 6:00 pm
Event Categories:
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