Contract Research and Development Organizations-Their History, Selection, and Utilization

Dr. Shayne Gad has over 43 years experience as a toxicologist, statistical consultant, manager and consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. He is experienced in occupational and industrial toxicology, development programs (both preclinical and clinical) and study design, conduct and reporting, in evaluating clinical and product safety data, in training and managing staff; in dealing with a wide range of U.S. and foreign regulatory bodies, commercial concerns, and contract research organizations; in labeling and other FDA and EMA compliance issues for drugs, devices and dietary supplements; identifying, developing and putting into everyday use new technology; in writing reports, position papers, Safety Data Sheets, MAA/PLA/IND/NDA/PNA toxicology and pharmacokinetic summaries and package inserts; in preparing and maintaining INDs, MMFs, NDAs , DMFs, IDEs and 510(k)s; in preparing labels and package inserts for drugs, devices, combination products and consumer products; in presentations to FDA and in designing experiments, designing and executing surveys; in the pharmacokinetic and statistical analysis of both experimental and clinical data; in risk assessment; in Proposition 65 assessments and labeling; in the registration of OTC, dietary supplement, nutraceutical, and sterilant products with FDA; and in the development and production of biologic products. This is his 52 nd published book. Dr. Spainhour has amassed approximately fifty years of experience in the pharmaceutical industry. For his first fifteen years Bart worked at a company known then as Smith Kline & French Laboratories and now as GlaxoSmithKline Corp., where he held positions in both the discovery and the development segments of the drug development process. Specifically, on the research side Dr. Spainhour's activities involved the areas of phosphodiesterase inhibition, anti-diuretic hormone agonism and antagonism, dopamine agonism and antagonism, neuroleptic biochemistry, anti-infective mechanisms and structure-activity-relationships. On the development side, Bart worked in pharmacokinetics & metabolism, radiosynthesis, process chemistry and drug safety evaluation. Specific areas of drug development included H 2 -antagonists, leukotrienes, anti-infectives, anti-hypertensives, anti-hyperglycemic agents and anti-arrhythmics. Dr. Spainhour has a great interest and copious amount of experience in the discovery and development of natural products. Bart has also worked as an independent consultant in the areas of safety assessment and forensic toxicology, held a position on the faculty at the school of veterinary medicine at Texas A & M University and worked as a toxicologist in the CRO Industry for Pharmakon Research International, Chrysalis International, Phoenix International Life Sciences, MDS Pharma Services and Calvert Laboratories. Currently Dr. Spainhour serves as the Executive Vice President and Chief Scientific Officer for Calvert Laboratories, a company which grew and flourished under Bart's leadership into the highly-respected CRO that Calvert is today. Bart is also the Chief Scientific Officer for Calvert Holdings and is the President and Chief Scientist of Spainhour & Associates, LLC. Dr. Spainhour has designed and overseen the execution of many hundreds of safety assessment programs (IND, NDA,505(b)2, PLA, ANDA, IDE, 510(k)) for virtually every indication in the Physician's Desk Reference, with none of the programs ever encountering any negative feedback from any world-wide regulatory agency, with regard to design or execution. Dr. Spainhour's experience encompasses small molecules, peptides, proteins, chiral chemicals, biotechnology products, nanoparticles, liposomal formulations, combination products, nutraceuticals, OTC products, and medical devices. Dr. Spainhour holds a veterinary degree f

Introduction.- History of CROs: Including CRO Snapshots and a CRO Genealogy Chart.- The Pharmaceutical Development Process & Testing Requirements.- The Medical Device Development Process & Testing Requirements.- Functions and Types of CROs.- Labs in China and India.-  Selection of CROs.- Study Directors and PIs.- Nuts and Bolts of Study Performance SCG/CBS.- Electronic Reporting Requirements (SEND & eCTD).- Study and Project Monitoring.- Contracting, Pricing, and Cost of Works Performed by CROs.- Consultants and their Role.- Building Relationships: Maximizing your return on Expectations with a CRO.- Common Problems and their Solutions.- Appendices: A Toxicology Labs B  Medical Device Labs C  Phase I Labs D Analytical Labs E  GMP Contract Facilities F  Formulation G  Dosage Forms H Clinical Testing I  Regulatory Services J Forms and Checklists.- K  Specialized Services.- L  Consultants Known to be In-Practice.- Index.