Modern Pharmaceutical Development Protocols: Is Your Company Ready for the Future?

On October 15, 2018, FDA Commissioner Scott Gottlieb issued a statement about new regulatory frameworks in development for researchers and manufacturers who work in cell and gene therapies, targeted therapies and other new pharmaceutical development streams that do not as yet have a clear pathway or regulatory outline approved by the FDA.

The purpose of the new regulations is to ensure a modernization of the current regulations to support multiple pharmaceuticals, and of course, to ensure the process is competitive within the U.S. and internationally.

In the statement, Gottlieb said, “The scientific opportunities we’re seeing today demand that we make sure our policies are as sophisticated as the treatments that are being developed. As the nature of drug discovery and development has become more focused on the basic mechanisms of disease … science is bringing forward more novel opportunities to meaningfully address human disease.”

This future-focus on the part of the FDA is welcome news for many manufacturers already in the genetic therapy space, but what does the future hold for pharmaceutical development professionals?

If you are currently looking to improve your pharmaceutical product development process skills and want to ensure you get the most up-to-date information from instructors with real-world experience, our (PDCP) Pharmaceutical Development Certified Professional™ Program is designed to fit your needs. With a flexible roster of 23 courses, you can choose the topics that matter most to you and your company. Planning for the future of pharmaceutical development requires the right toolkit, and CFPIE provides it.

Per the FDA’s statement, as of October 15 this year, they had approved 45 novel drugs and biologics. In 2017, the FDA approved 46 such products in total -- and that was the most approved in the past 20 years. Pharmaceutical development is a growth-oriented and exciting career track to pursue. If you have a passion for research and developing new technologies, lean into this field with the help of CfPIE.



Sources:

http://www.pharmtech.com/fda-takes-steps-modernize-drug-development

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm623411.htm