Biomarker Driven Drug Development

With the increase and complexity of the global supply chain, both the pharmaceutical cold chain and temperature-controlled shipping for the food and beverage industry have seen substantial growth over the last few years. It is no coincidence that the food industry is now beginning to look to the pharmaceutical supply chain for guidance on best practices, as the need for stricter standardization and controls has emerged.

This session will discuss current changes in the laboratory testing marketplace and the impact on healthcare. Major trends will be discussed specific to physician practice, reimbursement, government programs, and patient care. Opportunities for clinical laboratories and pathology groups to add value for patients, physicians, payers, and hospitals will be examined. Discuss the basic forces for change present in the national marketplace for clinical laboratory and anatomic pathology testing. Explain the ways basic forces may disrupt existing relationships between laboratories and providers. Highlight management approaches to enable clinical laboratories to deliver high-value testing services to integrated healthcare organizations.

Large-scale Production of Biologics is susceptible to microbial contamination because many manufacturing steps occur under non-sterile conditions in aqueous systems at ambient temperature or 2-8 °C under substantially neutral pH conditions. Regardless of where in the Drug Substance (DS) manufacture (manufacture of the Active Pharmaceutical Ingredient), or Drug Product (DP) manufacture (manufacture of the Final Drug, e.g. formulated mAbs filled in vials or syringes) they occur, microbial contaminations can have a significant impact on product quality and patient safety.

This series will provide you with tools to critically process and analyze medical scientific literature. You will get a good understanding of basic statistical concepts and theory that enable you to explain, understand and interpret data. These Webinars are practical and based on published articles and the analysis of these.