The FDA’s Center for Drug Evaluation and Research (CDER) offers an all-encompassing bundle of information that is of interest to the pharmaceutical industry to help get their drug on the market. If you are interested in general educational resources related to this field, you should take a look at the CDER Small Business and Industry Assistance (SBIA) Learn portal that offers a series of presentations and webinars on topics such as regulatory issues, generics development, etc.
We thought the presentation provided earlier this year by the Director of CDER, Dr. Janet Woodcock, entitled the “The Future of Drug Development” was quite interesting, so we wanted to share some of the highlights.
The five main trends for future drug development are:
International regulatory convergence
Repetitive submissions in multiple regions and inspection visits throughout the world lead to errors and ultimately increases costs. The ultimate goal is for regulators to use the same submission and inspection tools, harmonize technical requirements and develop universal standards for drug development.
Advances in manufacturing automation
Advancements and use of robotics for manufacturing allows pharmaceutical companies the ability to use various platform technologies to easily and rapidly switch strengths and active pharmaceutical ingredients (APIs). This ultimately, will decrease regulatory problems significantly and cut down on costs and time.
Rise in biosimilars
Biologics are the highest price medication right now and biosimiliars are a great alternative to streamline production of effective therapeutics. In addition, there is a presently a robust program taking place at the FDA to get biologics on the market quicker and this will inevitably bring costs down.
New science and technology
With the rise of combination products, drug-device combos, innovative novel delivery systems and precision medicine – the biologic development pipeline is in a revolution phase. The vision for the future is that there may be a large number of related drugs using a “platform technology” and only small modifications will be needed to address different mutations within the same gene. So, the bottom line is that there will be an increase in the number of drugs developed but this will result in more effective therapies.
Right now, we are still in the pre-Henry Ford era of automation in drug development. We need to develop standardization and drive efficiency in the process. For example, electronic submissions and documentation will not only increase quality of patient care but also that of business processes effectiveness.
In summary, Dr. Woodcock notes that the pace of change needs to be rapid to ensure that the pharmaceutical industry will undoubtedly expand its role as major source of medical care for the world’s population. To review the full presentation, click here. Do you think Dr. Woodcock missed any important points on the future of drug development? If so, what are they? Please comment below.