Therapeutic Delivery Solutions

Therapeutic Delivery Solutions presents a comprehensive review of the full range of potential medical therapeutic development solutions. The book discusses three therapeutic delivery platforms (Conventional Therapeutic Delivery System, Medical Device Therapeutic Delivery System, and Cellular Therapeutic Delivery) and their associated regulatory requirements. There is currently no other resource examining these three areas in one textbook. It allows development scientists, engineers and medical professionals more options to develop a therapeutic agent to its fullest potential and creates better and more creative therapeutic solutions. The book is divided into 5 sections. Section 1 describes the regulatory requirements and issues encountered in pharmaceutical and medical device submissions. Section 2 gives a detail treatment of traditional and latest innovations in oral drug product development. Section 3 outlines current trends and strategies of combination medical devices therapy development including bone graft delivery systems, pulmonary delivery systems, and powder inhalation technology. Section 4 introduces the reader to the latest advances and innovations in cellular and stem cell therapeutic delivery such as cancer cell therapeutic delivery and stem cell therapeutic delivery. Section 5 provides information on how the developments in sections 1–4 are supported.

Preface Section 1 – Requirements and Issues encountered in Regulatory Submissions in the Pharmaceutical, Cell Therapy and Medical Device Industries Chapter 1 Challenges to Quality and Regulatory Requirement in the United States – Drugs, Medical Device and Cell Therapy Section 2 – Traditional Pharmaceutical Drug Therapy Development Chapter 2 Development of Tablets Chapter 3 Formulation of Poorly Soluble Drugs for Oral Administration Section 3 – Overview, Current Trends and Strategies of Special Medical Device Development Chapter 4 Overview of Drug Delivery Devices Chapter 5 Bone Growth Factors – Applications for Local Delivery of Bone Growth Factors Chapter 6 Delivery of Insulin – From Glass Syringes to Feedback Controlled Patch Pumps Section 4 – Advances and Innovations in Cellular and Stem Cell Therapeutic Delivery Chapter 7 Endocrine Therapeutic Delivery – Pancreatic Cell Transplant and Growth Chapter 8 Cellular–Based Biologic Therapy for the Treatment of Medical Diseases Chapter 9 Development of Stem Cell Therapy for Medical Uses Section 5 – Analytical Support Needed For the Research and Development Chapter 10 Specification Setting and Stability Studies in the Development of Therapeutic Delivery Solution Chapter 11 LC–MS for Pharmaceutical Analysis Chapter 12 Biorelevant Dissolution Testing Chapter 13 ICH Quality Guidelines: Their Global Impact Chapter 14 Out of Specification/Atypical Investigation

Chung Chow Chan is currently with CCC Consulting/Covar Inc and provides services for analytical method development and validation, pre–formulation, formulation development, and CMC strategy building. He was Senior Director with Azopharma and had managed the drug developments programs for Phase 1 Express projects and analytical development laboratory. Kwok Chow was the Senior Director of Global PDS Technology and Alliances at Patheon Inc. with the responsibility of developing/introducing new technologies, establishing strategic technical alliances and providing scientific input in the pharmaceutical development of challenging molecules.  Currently he is the Director of Covar Inc. responsible for pharmaceutical consulting and formulation development services. Bill McKay has over 30 years of product development experience in the Orthopaedic device business developing orthopaedic implants and combination drug/device products. He is currently Vice President of Biologics Research and Development at Medtronic Spinal and Biologics where he has developed and launched several unique bone grafting technologies and is developing novel locally delivered pain therapies.  He has more than 100 patents and applications. Michelle Fung is currently a Clinical Associate Professor in the Division of Endocrinology & Metabolism, Department of Medicine, at the University of British Columbia.