Current Topics in Nonclinical Drug Development Volume 1 Current Topics in Nonclinical Drug Development Series

The inaugural volume in the Current Topics in Nonclinical Drug Development Series explores the critical issues and current topics in nonclinical drug development. This first volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed.

Additional features include:

• Deals with day-to-day issues in study design, evaluation of findings, and presentation of data.
• Explains new approaches in the development of medical devices.
• Includes dedicated chapters on the use of bioinformatics in drug development.
• Addresses strategies for photosafety testing of drugs.

Current Topics in Nonclinical Drug Development, Volume I will aid toxicologists, toxicologic pathologists, consultants, regulators, Study Directors, and nonclinical scientists dealing with day-to-day issues in study design, evaluation of findings, and presentation of data. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development.

Contents

PREFACE VII

ACKNOWLEDGMENTS IX

EDITORS XI

CONTRIBUTORS XV

1 Bioinformatics/Impact of Computational Biology

for Molecular Safety Assessment during Drug

Development 1

JULIANE PERNER, MEGUMI ONISHI-SEEBACHER,

ALBERTO DEL RIO ESPINOLA, ELAINE TRITTO, PHILIPPE COUTTET,

RÉMI TERRANOVA, AND JONATHAN MOGGS

2 Integrating Toxicogenomics Data into Risk

Assessment 23

ARUN R. PANDIRI, WARREN CASEY, AND SCOTT S. AUERBACH

3 New Approaches in Development

of Medical Devices 53

SHANNON M. WALLACE, PEGGY A. LALOR,

AND KATHLEEN A. FUNK

4 Recent Advances in the Development

of Novel Biomarkers of Toxicity 81

DOMINIQUE BREES, DANA WALKER, DAVID LEDIEU,

DAVID BROTT MICHAEL MERZ, AND JACQUELINE TARRANT

5 Preclinical Evaluation and Translational

Development of Cell and Gene Therapies 121

SHON GREEN, TIMOTHY K. MACLACHLAN, JENNIFER L.

MARLOWE, AND PRASHANT NAMBIAR

6 Value of Juvenile Toxicity Studies 185

PAUL BALDRICK

7 Photosafety Testing of Drugs 223

ANTHONY M. LYNCH AND DANIEL BAUER

8 Combination Safety Assessment During Drug

Development 275

JOANNE BIRKEBAK, SHERRY L. RALSTON,

AND LEIGH ANN BURNS-NAAS

INDEX 307

Pritam S. Sahota, Global ToxPath LLC, Kennewick, Washington, USA,

has extensive experience in toxicologic pathology and drug development

within the framework of nonclinical safety assessment of pharmaceuticals.

Dr. Sahota was previously Executive Director and Head of Pathology,

Preclinical Safety, at Novartis Pharmaceuticals, East Hanover, New Jersey.

He obtained his veterinary medicine (BVSc) and veterinary pathology

degrees (MSc and PhD) from Punjab Agricultural University, India. He

is a diplomate of the American Board of Toxicology. After receiving his

PhD in 1976, he started working as a toxicologic pathologist at Dawson

Research Corporation (DRC), Orlando, Florida, a contract research organization

involved in the preclinical safety evaluation of drugs and chemicals.

At DRC, he received increasing responsibility over the next 10 years

(toxicologic pathologist, senior toxicologic pathologist, and scientific director).

As a scientific director, he was responsible for the scientific aspects of

pathology as well as toxicology at DRC. While working briefly for Dynamac

Corporation, Research Triangle Park, North Carolina (1986–1987), he conducted

retrospective scientific audits of 23 NTP carcinogenicity studies and

participated in discussions with the representatives of NTP, FDA, and EPA

to review the results of scientific audits of over 200 NTP carcinogenicity

studies. In 1987, he joined Ciba-Geigy Pharmaceuticals in New Jersey as

Head/Manager of pathologists in preclinical safety and was also responsible

for establishing pathology peer review, quality control, and scheduling

systems. He continued to work primarily in this position with increasing

responsibilities at Ciba-Geigy and then Novartis Pharmaceuticals (after

Ciba-Sandoz merger in 1997) to become director and eventually Executive

Director and Head of pathol