Road to the Clinic for Biologic Therapeutics

 

Tuesday, April 12, 2016
12:00pm – 6:00pm
Mechanical Engineering Building, Lecture Hall 102
5 King’s College Circle Toronto, ON, M5S Canada (map)

 

Google Calendar • ICS

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 Clinical Trial Authorisation (CTA) 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 CTAs 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 CTA acceptance.

 

Join us for a series of short presentations exploring the basic requirements and considerations necessary to achieve a successful biologic CTA 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 and requirements for a CTA submission package.

 

PARTNERS:

 

This event is presented in partnership with Janssen, and the University of Toronto.

 

janssen
uot

 

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 concer
    • 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
Steven Lang | Director, Biologics Research Analytical Discovery, Cell Line Development, Janssen BioTherapeutics, Janssen R&D
Tim Coogan | Vice President and Head of Biologics Toxicology, Janssen BioTherapeutics,Janssen R&D
Hugh Davis | Vice President and Head of Biologics Clinical Pharmacology, Janssen BioTherapeutics, Janssen R&D
Bethany Paxson | Senior Director, Global Regulatory Affairs, Janssen R&D

 

FEES:

 

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

 

MORE INFO + REGISTER

 

Posted in HQP Training