International Psoriasis Council

Chapters

Opening
Introduction
Chapter 1
The Evolution of the Clinical Trials Process - A Brief History Lesson
Chapter 2
It Takes a Village to Conduct a Clinical Trial
Chapter 3
Not All Clinical Trials are Created Equal - Understanding the Different Phases
Chapter 4
There's No Going Outside the Lines - Ethical Considerations in the Conduct of Clinical Trials
Chapter 5
What You Need to Know to Live in Harmony with Your Institutional Review Board and Research Ethics Committee
Chapter 6
Be Informed About Informed Consent
Chapter 7
Practical Advice for Following Good Clinical Practice
Chapter 8
Living in a Material World - What is Needed to Run a Successful Clinical Trial
Chapter 9
Clinical Trial Coordinators - A Vital Sign of a Good Clinical Trial
Chapter 10
The Subject of Recruitment and Retention
Chapter 11
The Investigational Compound - Like Handling Kryptonite

Chapter 12
Budgets and Contracts - Show Me the Money
Chapter 13
Everything You Write Can Be Used Against You in a Court of Law - Understanding Proper Documentation
Chapter 14
Audits/Inspections - Be Prepared for Anything
Chapter 15
Conducting Clinical Trials Without Ending Up on Trial

Investigational Compound Bios

Craig L. Leonardi, MD, FAAD

Craig L. Leonardi, MD, is Associate Clinical Professor of Dermatology at St. Louis University Medical School in St. Louis, Missouri, where he also has a private practice, Central Dermatology. He received his medical degree from the University of Miami School of Medicine in Miami, Florida, and completed an internship in pediatrics and residency in dermatology at the University of Miami/Jackson Memorial Hospital. Dr. Leonardi is certified by the American Board of Dermatology. He is a Fellow of the American Academy of Dermatology and a member of the Noah Worcester Dermatological Society. He serves as a member of the Medical Advisory Board of the National Psoriasis Foundation. Dr. Leonardi has extensive experience using the new biologics in the treatment of psoriasis. He has been an invited speaker at national, regional, and state venues and serves on the advisory boards of several pharmaceutical companies. Dr. Leonardi has been involved in more than 150 clinical trials and has published more than 150 original articles and abstracts in such journals as the Journal of the American Academy of Dermatology, the British Journal of Dermatology, Archives of Dermatology, the Journal of the American Medical Association, and the New England Journal of Medicine.

Kim Alexander Papp, MD, PhD, FRCPC

Canadian Dermatologist, Kim Alexander Papp, M.D., Ph.D., F.R.C.P.C. is the founder and President of Probity Medical Research, an organization that guides research physicians in the conduct of clinical research studies. Over the past 15 years Dr. Papp has conducted more than 170 clinical trials and followed over 2700 subjects in these studies. Dr. Papp has authored or co-authored more than 190 publications and abstracts on the results of his work. Dr. Papp has been an investigator in research studies on over 45 unique compounds in development for the treatment of Psoriasis. In addition to his passionate dedication to clinical research, Dr. Papp maintains a large, private medical dermatology practice where he follows thousands of psoriasis patients. Prior to his current positions, Dr. Papp taught at York University as well as the University of Waterloo. In his spare time, Dr. Papp trains and conducts seminars for other dermatologists around the world on new and developing therapies for dermatology. Dr. Papp is a Fellow of the Royal College of Physicians and Surgeons of Canada and a specialist in Dermatology. He received his Doctor of Medicine degree from the University of Calgary Medical School and survived his residency in Internal Medicine and Dermatology at the University of Toronto. Dr. Papp holds positions in both public and professional organizations including, Councilor for the International Psoriasis Council and Committee Representative for Dermatology at the Ontario Medical Association. He is also a member of several international organizations including the Canadian Dermatology Association, the European Academy of Dermatology and Venereology, the American Academy of Dermatology and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). He serves on numerous advisory boards and is a consultant for several pharmaceutical and biotech corporations.