Veranstaltungen

Road to the Clinic for Biologic Therapeutics

BioM in cooperation with Johnson & Johnson Innovation, JLABS, invites you to an in-depth look into the process of filing biologic Clinical Trial Authorisation (CTA) applications and the procedures necessary for advancing your company's early-stage drug development program.

The event is fully booked. A registration on site is not possible anymore.


BioM in cooperation with Johnson & Johnson Innovation, JLABS  

Time and Place:

Wednesday, 25 October 2017, from 12:30 to 18:00
BioM Biotech Cluster Development GmbH, Am Klopferspitz 19 a (IZB West II BioM Conference Room, 3. floor), 82152 Martinsried

Event Details:

Johnson & Johnson Innovation, JLABS and Janssen BioTherapeutics invite you to an in-depth look into the process of filing biologic Clinical Trial Authorisation (CTA) applications 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 BioTherapeutics - 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

Agenda:

12:30 |     Registration and Networking
13:00 |     Welcome
13:30 |     Development of a Process Suitable for Manufacturing a Biologic Drug

                    - Cell culture
                    - Protein purification
                    - Product characterization
                    - Formulation & stability
                    - Fill/Finish
14:15 |     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
15:00 |     Coffee Break
15:15 |     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
16:00 |     Regulatory - Satisfy Statutory Legal Requirements for Testing in Humans
                    - Strategy
                    - Data requirements: CMC, safety, clinical plan
                    - CTA Submission Package
16:45 |     Networking Reception
18:00 |     Programme Close

Speakers:

Barry Springer, Ph.D. | Vice President and Head of Strategy, Technology and External Innovation, Janssen BioTherapeutics, Janssen R&D
Tim Coogan Ph.D., DABT | Vice President and Head of Biologics Toxicology, Janssen BioTherapeutics, Janssen R&D
Hugh Davis, Ph.D. | Vice President and Head of Biologics Clinical Pharmacology, Janssen BioTherapeutics, Janssen R&D
Birge Berns, M.D., MRCP, FFPM | Senior Director, Global Regulatory Affairs Immunology, Janssen R&D

Fees:
€25 | General Public
€15 | Student/Academic
€30 | Onsite

Registration:

please register via this link: https://www.eventbrite.co.uk/e/road-to-the-clinic-for-biologic-therapeutics-tickets-34892655873?aff=weekly