Trends at the FDA in Drug Approvals

Dr. Thomas Stephens delivered a speech at the LifeSciences BC McCarthy Spotlight Speaking Series event in Vancouver, BC on November 17, 2016. The speech was focused on the trends at the Food and Drug Administration regarding drug approvals.   View and download the full presentation View and download the full presentation   About the Author Thomas W. Stephens, Ph.D. has 28 years of pharmaceutical development preceded by 12 years of in vitro diagnostic experience with emphasis in research, regulatory, project management and administration. In his spare time Tom pursue various interests including astrophotography, underwater photography, swimming, gardening and...

How Do We Create the Most Value With Limited Resources?

Questions to Consider From the Beginning: Drug development is a time and resource expensive proposition and most if not all companies pursuing such a path must find ways to make the greatest progress as fast as possible within their resource limitations. This article intends to help the reader understand some of the necessary considerations to achieve this efficiency by providing answers to these questions: How do we utilize limited time, money and talent to achieve the most value the most efficiently? How do we focus these resources on the critical questions and risks or opportunities? How do we assure that expended resources are delivering the intended product? How do we prepare for our final or intermediate submissions as the work are being conducted minimizing the turnaround time? How do we organize, manage, store and maintain the integrity of our data? Keeping the End in Mind From the Beginning: What are the attributes of a therapeutic product that are needed to achieve a successful launch and commercialization? How do the current marketed products stand up? What are the products in the development pipeline and how will they differ in hurdles and potential? Keeping the end in mind from the beginning is a fundamental requirement to achieving the ultimate goal effectively. Of course at first there are goals that must be met on the way to keep the ball rolling and the funds coming. How do these intermediate goals impact the ultimate success or failure of the intended product? There are many approaches to creating a map for the final product profile. The FDA and industry have worked together to provide...

The Evolving Biotechnology Regulatory Landscape

From blood products and vaccines to gene markers, gene therapy and RNA interference, the technology of biological based therapeutics is changing at an exponential rate. Challenges for the efficacy and safety of these stem from characterization of a therapy, manufacture, quality control, distribution and use. Regulatory authorities in the USA and around the globe are working to keep up with technology which results in a rapidly changing regulatory landscape. This document is intended to summarize some of the key changes that have occurred over the last several decades. Contents: Primary Regulatory Institutions The Transition from Small Drugs to Biologics Humanization and Engineering of Biologics Biosimilars Elucidation of the Human Genome Companion Diagnostics Gene Therapy and RNA Interference Monoclonal Antibodies Lead New Biotechnology Development Medical Devices and Diagnostics Primary Regulatory Institutions In the USA, federal regulation of drugs and devices including diagnostics begins with the Food, Drug and Cosmetic Act approved by Congress in 1938 and is supported by the US Constitution’s requirement for the Federal Government to regulate interstate commerce. The intent is to protect the American public from products that have limited or no efficacy or significant safety concerns when used as recommended by a manufacture either for the treatment of a medical condition or to aid physicians in making decisions about medical treatment. The FDA is currently structured in several divisions: Center Drug Evaluation and Research (CDER) for drugs, Center for Biologics Evaluation and Research (CBER) biologics, and Center for Devices and Radiological Health (CDRH) for devices including diagnostics. In Europe and internationally, centralized regulation of drugs and devices originated with the formation of the European Agency...