FDA New Drug Approval Process
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:
- Federal Food, Drug and Cosmetic Act
- Basic goals of preclinical investigations
- Code of Federal Regulations
- Responsibilities and Importance of the Institutional Review Boards
- Understand the FDA drug development requirements
- Understand the role and mission of the Center for Drug Evaluation and Research (CDER)
- Learn about the IND submission process
- Learn about the clinical phases in the drug approval process
- New Drug Application (NDA)
Who Will Benefit:
- Regulatory Affairs Personnel
- Compliance professionals
- Quality Personnel
- Clinical Personnel
- Research Personnel
- Manufacturing Personnel
- Drug Discovery Personnel
- Medical Device Personnel
- Financial Advisors and Institutional Investors
- Production Supervisors
- Clinical Development - Principal Investigators
- Legal Personnel
- Personnel who require a general understanding of the FDA drug approval process
During his prestigious career, Harold Thibodeaux’s ambition and innovation resulted in the successful clinical development of several novel drugs. As a young scientist with Genentech, his contributions to the Second Generation TPA Project were rewarded with the FDA approval of a thrombolytic drug (TNK-TPA or Tenectaplase) that was indicated for Acute Myocardial Infarction. Another notable achievement with the same project team was the approval of Activase Alterplase for Acute Ischemic Stroke Treatment.
As a scientist at Theravance, his innovative models of cardiovascular safety were instrumental in the formation of a Theravance/GlaxoSmithKline Partnership and the development of two clinical candidates for Chronic Obstructive Pulmonary Disease (COPD). Both drugs, BREO Ellipta and ANORO Ellipta, were approved by the FDA and are currently providing therapeutic benefits with patients with COPD. In his role as an investigative scientist with Stiefel, a GlaxoSmithKline Company, Mr. Thibodeaux explored new medical research paths and using his many years of experience in the industry to support project efforts for the reformulations of topical antibiotics, development of models to study acne and writing protocols psoriasis.
During his years of academia and pharmaceutical industry provided an opportunity to authored 23 published articles and discussed his work with poster presentation at major scientific meetings. Harold is proud to have been a medical researcher in both academia and the biopharmaceutical industry and continues to support projects that lead to strategic partnerships that will develop novel drug pipelines for unmet medical needs and present webinars and seminars on drug development to assist pharmaceutical companies achieve their goals.