The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. Contract Research and Development Organizations: Their Role in Global Product Development has been crafted by these authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also covered are the contract synthesis of drug substances and corresponding manufacture of biologics and manufacture of products, formulation development, clinical evaluation, regulatory and document preparation support, and use of consultants.
Included in the volume are an exhaustive listing of those CROs in the (drug and device) safety evaluation sector and their contact information and capabilities, and extensive similar listing for the other types of contract service providers. Also included are guidances on how to monitor ongoing work at contract facilities and audit check lists for GLP, GMP and GCP facilities. These listings are international in scope, and a specific chapter addresses working with some of the newer international CROs.
Cuprins
Introduction.- The pharmaceutical Development Process & Testing Requirements.- The Medical Device Development Process & Testing Requirements.- Functions and Types of CROs (referencing function listings in appendices).- Selection of CROs.- Labs in China and India.- Contracting, Pricing, and Cost of Works Performed by CROs.- Monitoring Ongoing Studies and Work.- Common Problems and their Solutions.- Appendix.
Despre autor
Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1970) and Ph.D. in Pharmacology/Toxicology (Texas, 1977) DABT, ATS, is the principal of Gad Consulting Services, an eighteen year old consulting firm with six employees and more than 450 clients (including 120 pharmaceutical companies in the US and 50 overseas). Prior to this, he served in director-level and above positions at Searle, Synergen and Becton Dickinson. He has published 41 books and more than 350 chapters, articles and abstracts in the fields of toxicology, statistics, pharmacology, drug development and safety assessment. He has more than 34 years of broad based experience in toxicology, drug and device development, statistics and risk assessment. He has specific expertise in neurotoxicology, in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology, and genotoxicology. Past President of the American College of Toxicology, the Roundtable of Toxicology Consultants and three of SOT’s specialty sections, and recipient of the American College of Toxicology Lifetime Contribution Award. He has direct involvement in the preparation of INDs (92 successfully to date), NDA, PLA, ANDA, 510(k), IDE, CTD, clinical data bases for phase 1 and 2 studies, and PMAs. He has consulted for FDA, EPA and NIH, and has trained reviewers and been an expert witness for FDA. He has also conducted the triennial toxicology salary survey as a service to the profession for the last 19 years.
Charles ‘Bart’ Spainhour, V.M.D., Ph.D., DABT, DABFS, DABFM received his B.S. from Michigan State University, veterinary degree from the University of Pennsylvania and doctoral degree from Texas A&M University. Dr. Spainhour has over forty-two years experience in the pharmaceutical industry and with various aspects of drug development. Currently, Dr. Spainhour is the Chief Scientific Officer for Calvert Holdings and is also the President and Chief Scientific Officer for Calvert Laboratories, where he works with clients in the design, conduct and management of safety assessment programs. He has played a significant leadership role in the development of Calvert Laboratories into the highly respected CRO that it is today. Previously, he has worked in the areas of pharmacokinetics & metabolism, biochemical pharmacology and process chemistry. His employment history includes MDS Pharma Services, Phoenix International Life Sciences, Chrysalis International, Pharmakon and Smith Kline Corporation (presently GSK). Dr. Spainhour has also worked as a veterinarian in private practice and as a forensic toxicologist and independent consultant, founding The Summit Group, which has provided services in the areas of safety pharmacology, toxicology and drug development. Dr. Spainhour is a Diplomate of the American Board of Toxicology, American Board of Forensic Science, American Board of Forensic Medicine and is a memberof numerous scientific and professional organizations, including the American College of Toxicology, Society of Toxicology, Roundtable of Toxicology Consultants, Society of Toxicologic Pathology, Drug Information Association, American Chemical Society and the Regulatory Affairs Professionals Society.
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