In the calendar year 2015, the pharmaceutical industry witnessed the largest number of Food and Drug Administration (FDA) prescription drug approvals in the past decade. The FDA's Center for Drug Evaluation and Research played a valuable and key role in bringing these drugs to market.
With the growth of the pharmaceutical industry, technological advances with the drug screening process and innovative engineering of the drug discovery process, the need to educate research scientist of the regulatory process has become an important part of the entire drug discovery process. Although the definition of "drug development" is simplistic the process of drug development is a challenging undertaking, which may take 10 to 15 years to get a drug to market. Therefore after target identification and validation, drug discovery, early safety evaluation and optimization of the lead molecules, the project leaders embark on the path of the drug development process. The successful completion of this process leads to the drug approval for therapeutic benefits for patients with unmet medical needs.
The drug approval process can be perceived as a clinical trial continuum, which is initiated with the preclinical laboratory screening process to identify a drug product candidate. The chosen drug candidate enters the clinical development phases as witnessed in pre-market clinical trial studies. If successful the drug product candidate progresses to optimum regiment and then to treatment strategies in the real world setting of providing patients with the therapeutic benefits they need to improve their quality of life. During the Phase IV post-marketing period, a drug sponsor or company may decide to pursue another therapeutic indication for the approved drug product which would begin the clinical trial continuum and the drug development process from the beginning.
Why should you Attend:
By definition, drug development is the process of bringing a new pharmaceutical drug product to market once a lead compound has been identified through the process of drug discovery. Although the drug approval process has its rewards, sponsors, clinical investigators and regulatory professional need to understand the complete process, resources and guideline available to assist them in all phases of clinical development.
This presentation on "FDA New Drug Approval Process" will provide those resources and guidelines as well as the regulatory requirements to be compliant with all regulatory agencies. This webinar will highlight the preclinical and clinical investigations, responsibilities of the clinical investigators and the sponsors. Above all it will provide details into the entire New Drug Application (NDA) process and discuss the drug safety and efficacy data that is required to submit the NDA. Additionally the monitoring and reporting that is required during the clinical trials will be discussed.
The post-drug approval period will be discussed to illustrate that safety and efficacy monitoring does not end with FDA drug approval but is continuous throughout the life of the drug. Participants will learn that the approval process is one continuous process during the post-marketing phase as the drug sponsor/company may decide to seek another target indication of the drug product and therefore the process will start all over once again. There is so much to learn from this webinar and will provide the information and resources to successfully conduct a clinical research program, one that is rewarded with FDA Drug Approval.
Areas Covered in the Session:
Who Will Benefit:
Harold Thibodeaux is a medical research scientist with in vivo pharmacological experiences in both academia and biopharmaceutical industry. During his prestigious career the focus of Mr. Thibodeaux’s research efforts has been on the efficacy of cardiovascular drugs most notably Hypertension, Myocardial Infarction, Focal Ischemia (Stroke), Beyond Advair Pulmonary Research and topical antibiotics. Optimal therapeutic benefits were the goal in all of these projects but cardiovascular safety to provide safer medicines to patients was a priority. Mr. Thibodeaux transitioned into the pharmaceutical industry when he joined the Cardiovascular Department of Genentech in 1990, as a technical lead with the Second Generation TPA Project Team. Mr. Thibodeaux is a graduate from the College of Charleston with a Bachelor of Science Degree in biology and is a member of The Safety Pharmacology Society.