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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.
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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 |
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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 |
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~ Preclinical toxicology program objectives, endpoints, findings of concern ~ Factors to consider for biotechnology products: Species specificity, Immunogenicity, Antibody response ~ Testing considerations |
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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 |
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3:30 PM | Regulatory – Satisfy Statutory Legal Requirements for Testing in Humans | ||
– Strategy – Data requirements: CMC, safety, clinical plan – CTA Submission Package |
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4:00 PM | Q&A | ||
4:30 PM | Networking Reception | ||
6:00 PM | Program Close | ||
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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