Footnotes

• Article, publication date, and citation information can be found at http://dmd.aspetjournals.org.

• doi:10.1124/dmd.106.012419.

• ABBREVIATIONS: PEG, polyethylene glycol; ADME, absorption, distribution, metabolism, and excretion; EPAR, European Public Assessment Report; AUC, area under the curve.

• Eric Didier is a Docteur en Pharmacie, graduating from the University of Auvergne, France in 1995. He worked for the Institut de Recherche Pierre Fabre (Castres and Toulouse, France) as a Clinical Pharmacokineticist (1996–2001), before joining the Clinical Pharmacology Department of Pharmacia, High Wycombe, UK, in 2001. He is currently Associate Director in the Clinical Pharmacology Department of Pfizer Global R&D in Sandwich, UK.

• Dr. Philip Harris trained as an adult endocrinologist. He has written numerous publications in neuroendocrinology, endocrine oncology, and thyroid disease. Currently he is Senior Director in Clinical Development, Pfizer, Sandwich, UK, and is an Honorary Consultant Endocrinologist at St Bartholomew's Hospital, London, UK.

• Ned Siegel received B.S. and M.S. degrees in Biology and Botany, respectively, from the University of Illinois in 1972–1973. He began his professional career with the Monsanto Company in 1974, where he worked in the Agricultural Research department, before subsequently assuming basic research activities for the former G.D. Searle and Pharmacia Corporations, with responsibilities involving the analytical characterization of proteins and peptides. His work has included preformulation development support for the clinical development of protein therapeutics and, more recently, project leadership responsibilities for Pfizer Inc. in the area of novel formulation and delivery strategies, including expertise in the area of protein and peptide PEGylation. He retired in 2006 from Pfizer Global Research and Development as a Research Fellow at the Chesterfield, MO facility.

• Dr. Dennis Smith has worked in the pharmaceutical industry for the past 30 years since gaining his Ph.D. from the University of Manchester. For the last 18 years he has been at Pfizer Global Research and Development, Sandwich, UK, where he is Vice President-Pharmacokinetics, Dynamics and Metabolism. His research interests and publications span all aspects of drug discovery and development, particularly where drug metabolism knowledge can have an impact on the design of more efficacious and safer drugs. During this 30-year span he has directly helped in the discovery and development of eight marketed new clinical entities (NCEs) with, hopefully, several more to come. He has authored over 100 publications including two textbooks. He is active in a teaching role, holding appointments as Visiting Professor at the University of Liverpool and Honorary Senior Lecturer at the University of Aberdeen, and lectures widely to students at several other universities.

• His wish in much of his work now is “to inspire another generation to take up the cudgel against disease”.

• Jeanne Stadler received a degree in Pharmacy from the Faculté de Pharmacie, Université de Paris, in 1972. She joined Pfizer the same year and, as a toxicologist, became a specialist in reproduction and developmental toxicology.

• She is a member of the Teratology Society and the European Teratology Society, and is a Council Member of the AFARED (Francophone Association for Research in Reproduction and Development). After a more than 30-year career in preclinical research, she is currently an independent consultant in toxicology.

• Dr. Lorraine Tilbury joined Pfizer Global Research and Development in April 2005 as an Associate Research Fellow in their Regulatory Submissions department, and leads the Regulatory Submissions team. Prior to joining Pfizer, she devoted 15 years to the E.I. DuPont de Nemours Europe/Middle East/Africa business, as a toxicologist specializing in human health risk assessment of chemicals and, subsequently, as leader of the French and European Registration and Regulatory Affairs group. Dr. Tilbury's background is in veterinary medicine with postdoctoral work in toxicology carried out at New Mexico State University and Research Triangle Park (NC), and working with CIIT, a toxicology research institute.

• Rob Webster joined Pfizer Global Research and Development in 1989 in their Pharmacokinetics, Dynamics and Metabolism department Currently, Rob is a Director in this department, with responsibilities for providing guidance and direction on drug metabolism questions/issues, from lead discovery through to and beyond filing. Prior to joining Pfizer, Rob studied Biochemistry at Liverpool Polytechnic.

• • Received August 9, 2006.
  • Accepted September 29, 2006.