Moderator
Andra Miller, PhD

Speakers
Andra Miller, PhD
Introduction

Kimberly A. Benton, PhD
What is an IND and Why Do I Need to Know?

Ramjay Vatsan, PhD
What Type of Information Do I Need Regarding Vectors and Cell Therapy?

Traci Mondoro, PhD and Sonia Skarlatos, PhD
What Vector and Cell Resources Are Available? (PACT & GTRP)

Johannes C.M. van der Loo, PhD
Resources Offered through the Association of Academic Biologic Manufacturers (AABM)

Minako Koga
Contract Manufacturing

Andra Miller, PhD, Kimberly A. Benton, PhD, Ramjay Vatsan, PhD, Traci Mondoro, PhD, Sonia Skarlatos, PhD, Johannes C.M. van der Loo, PhD, Minako Koga
Panel Discussion and Audience Questions

Moderator
Stephanie Simek, PhD

Speakers
Stephanie Simek, PhD
Introduction

Mercedes Serabian, MS
Principles of Pharm/Tox Testing for Cell and Gene Transfer Studies

Edwin M. Horwitz, MD, PhD
Preclinical Biodistribution of Cell and Gene Transfer Vectors (with case study)

Preclinical Toxicology: Combining Novel Designs with Traditional Principles (Three 20 minute case study presentations noted below):

Jeffrey Miller, MD
Cell Therapy

John J. Rossi, PhD
Oligonucleotides

Barrie J. Carter, PhD and Katherine A. High, MD
Gene Transfer

Stephanie Simek, PhD, Jeffrey Miller, MD, Barrie J. Carter, PhD, Katherine A. High, MD
Panel Discussion and Audience Questions