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Home » Events » Master Class: How to Accelerate Early Drug Development in Oncology for Small Molecules and Biologics

Master Class: How to Accelerate Early Drug Development in Oncology for Small Molecules and Biologics

Date: March 26th, 2020
3:30 PM – 6:00 PM

Location: CLARA – Cancéropôle Lyon Auvergne Rhône-Alpes
Cité internationale,
Centre de Congrès de Lyon

Register to attend this free event.

Get an insight into what it takes to move a pre-clinical drug candidate to phase 1 clinical trial. The lectures will provide guidance on non-clinical and regulatory considerations for early drug development of oncology drugs. In addition, we will also provide expert advice into molecule developability assessment, early formulation strategies and non-clinical activities of both small molecules and biologics from lead candidate selection to phase 1.

AGENDA

TIME

LESSON PLAN

INSTRUCTORS

3:30 pm – 3:40 pm
Welcome Note

  • Introduction
  • Lecture outlines and objectives

Arnaud Bathelier
Account Director
Oral and Specialty
Delivery
Catalent

Jonathan Kearsey
Managing Director
Leads To Development
(L2D)

3:40 pm – 4:25 pm
Navigating Through the Regulatory Challenges of Early -Stage Drug Development

  • Overview of non-clinical development strategy (Pharmacology, CMC, ADME, toxicology)
  • Specificities of oncology products
  • Anticipate regulatory expectations for your clinical trial application

Julien Massiot
Project Manager
Leads To Development
(L2D)

4:25 pm – 5:00 pm
Physiologically Based Pharmacokinetic Modeling

  • Understand ADME deficiencies that can be improved through drug design or formulation
  • Set target pharmacokinetic profile and starting dose
  • Case studies

Jan Neelissen
Scientific Advisor
Catalent

5:00 pm – 5:30 pm
Formulation Development to Efficiently Complete Preclinical Studies and Transition to First-in-Human Studies (Small molecules)

  • Molecule developability assessment for oncology drugs
  • Phase-appropriate formulation: When advanced technologies are required versus simplified approaches
  • Efficient coordination of manufacturing, packaging, storage and distribution for early-stage clinical development

Stephen Tindal
Director
Science &
Technology
Catalent

5:30 pm – 6:00 pm
Challenges and Opportunities in Biopharmaceuticals Development (Biologics)

  • Overview of key process, analytical, formulation and manufacturing activities from lead candidate selection to Phase I
  • Understand why selecting the relevant cell line development technology is critical to the CMC package/IND approval
  • mAb case studies including presentation of timelines, budget estimates, clinical and commercial COGs

Christelle Dagoneau
Senior Account Director
Biologics & Biosimilars,
Drug Substance
Catalent