Charles River Biotech Symposium| Biotechnology-Derived Therapeutics Perspectives on Nonclinical Development

Sunday, September 8th

Demystifying the Late Stages of Nonclinical Development of Biotherapeutics

 

Session 1: Late Stage Development Considerations

8:00 – 8:15 a.m.
Introduction
Ursula Jeffry, MD, PhD - NGM Biopharmaceuticals

8:15 – 9:00 a.m.
DART Strategies for Biotherapeutics
Christopher J. Bowman, PhD, DABT - Pfizer

9:00 – 9:45 a.m.
Practical Aspects and Challenges of Running DART Studies in NHPs
Kristina York, MS - Charles River

9:45 – 10:00 Break

10:00 – 10:45 a.m.

Carcinogenicity and Tumorgenicity
John Vahle, DVM, PhD, DACVP - Eli Lilly

10:45 – 11:30 a.m.
Comparability/Excipients/Impurities
Tom Gelzleichter, PhD, DABT – Genentech

11:30 – 12:00 noon Q&A

12:00 noon – 1:00 p.m. Lunch

Session 2: Nonclinical Aspects of the BLA, All Those Other Documents, and Beyond

1:00 – 1:30 p.m. 
Mind the Gap! How to Identify and Rectify Program Gaps Before Registration
Vince Torti, PhD – Pfizer

1:30 – 2:15 p.m.
eCTD Basics: Where is Nonclinical Involved
Marque Todd, DVM, MS, DABT - Renaissance Consulting, Inc.

2:15 – 2:25 p.m. Break

2:25 – 3:10 p.m.
Communication Tools, Labeling, 
and Documents
Mary Ellen Cosenza, PhD, DABT, ATS, RAC - MEC Regulatory & Toxicology Consulting

3:10 – 3:55 p.m.
A Peak into the Black Box – Insight from Former FDA reviewers on the BLA Review Process
Janice Lansita, PhD, DABT – ToxStrategies and Shawna Weis, PhD - Wave Life Sciences

3:55 – 4:20 p.m. Refreshment Break

4:15 – 4:45 p.m.
World-Wide eCTD Review
Mary Ellen Cosenza, PhD, DABT, ATS, RAC - MEC Regulatory & Toxicology Consulting

Abstract

The workshop will focus on late stage nonclinical scientific and regulatory strategies necessary for a successful BLA filing and marketing authorization. How to plan for and execute a US and worldwide nonclinical toxicology registration strategy based on specific requirements for biologics and share insight around regulatory procedures and the FDA review processes will be discussed. The different late-stage studies and sections of a BLA including reproductive toxicity, juvenile toxicity, carcinogenicity, and comparability assessment will be discussed in more detail also. The use of a gap analysis to assess for potential scientific and regulatory issues mid-development as well as tips for drafting appropriate supportive late-stage program documents (e.g. briefing documents, annual updates, PPSR/PIP, labels, RMP) will be shared.

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