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Setting Up Your Small Molecules and Biologics for Success: Development Consideration from Candidate Selection to Phase 1

Date: March 5th, 2020
9:30 AM – 4:00 PM

Location: Hilton Tel Aviv
205 Hayarkon St.
Independence Park
Tel Aviv 6340506
Israel

Register to attend this free event.

This workshop will bring together industry experts in formulation and manufacturing sciences in both small molecule and biologics, preclinical safety and toxicology as well as clinical development. Experts will share insights into key processes in formulation, analytical and manufacturing activities for oral solids, sterile and biologics products and discuss key considerations for transitioning small molecules and biologics into the clinic.

AGENDA

TIME

TOPIC

SPEAKER

9:30 am – 10:00 am
Registration
10:00 am – 10:30 am
Welcome & Introduction

Leah Klapper
Chief Technology Officer
FutuRx

Arnaud Bathelier
Account Director, Oral and Specialty Delivery
Catalent

10:15 am – 11:00 am
Formulation Development to Efficiently Complete Preclinical Studies and Transition to First in Human Studies

  • Phase-appropriate formulation: When advanced technologies are required versus simplified approaches
  • Integrating PK modelling during molecule developability assessment
  • Efficient coordination of manufacturing, packaging, storage and distribution for early-stage clinical development

Stephen Tindal
Director, Science & Technology
Catalent

11:00 am – 11:45 am
Challenges and Opportunities in Biopharmaceuticals Development

  • 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, PhD
Senior Account Director
Biologics & Biosimilars, Drug Substance
Catalent

11:45 am – 12:00 pm
Q&A Session
12:00 pm – 1:30 pm
Networking Lunch & Meet the Experts
1:30 am – 2:15 pm
Overview of the Nonclinical Development Strategies for Large Molecules and Comparison with Small Molecules

  • Properties of large and small molecule drug candidates
  • Nonclinical species for toxicology testing
  • Principles of toxicology evaluation for large and small molecules

Philippe Ancian
Senior Director, Biomarkers
Charles River

2:15 pm – 3:00 pm
Clinical Development of Biopharmaceuticals Based on Nonclinical Data

  • Pharmacokinetics and pharmacodynamics of biopharmaceuticals
  • Mechanism-based translation and scaling of in vitro and preclinical data
  • Design of first-in-human clinical studies
  • Choice of analytes and assays in clinical development of biopharmaceuticals

David Stepensky
Associate Professor
Ben-Gurion University of the Negev

3:00 pm – 3:15 pm
Q&A Session and Concluding Remarks
3:15 pm – 4:00 pm
Networking Coffee Break