PharmaBoardroom today releases its new 36-page special report, Disruptive Trends in Pharma Regulation.
While drug developers, healthcare practitioners and patients all rejoice at the advent of a golden age of scientific advancement in medicine - symbolized by recent radical breakthroughs in all manners of domains from stem cells and CAR-T generation immunotherapy to gene tech and 3D bio-printing - it is clear that regulatory science has struggled to keep pace with the sheer abundance of change.
Indeed, stewarding a new biologic to market now requires some 10 to 15 years, and the associated costs have skyrocketed to an average of more than USD 2.5 billion when out-of-pocket and opportunity costs are factored in, largely because evermore stringent regulatory requirements have increased the length, complexity and volume of clinical trials per marketing application.
Through interviews with the heads of some of the world's top regulatory bodies for medicines, as well as many top companies, this report outlines the major new trends in play as pharma regulation attempts to catch up with science. Topics covered include regulatory convergence between nations, herbal-based medicine, clinical research and much more.
Interviews
The report features in-depth interviews with:
- Tatsuya Kondo, PMDA, Japan
- Doug Clark, PMPRB, Canada
- Jarbas Barbosa Da Silva, ANVISA, Brazil
- Petra Doerr, Swissmedic
- Andrew von Eschenbach, FDA, USA
Quotes
"Right now we're on an unsustainable path, where the cost of drug development is growing enormously, as well as the costs of the new medicines. We need to do something urgently, to make the entire process less costly and more efficient. Otherwise, we won't continue to realize the practical benefits of advances in science, in the form of new and better medicines" -
Scott Gottlieb, US FDA
"Reducing regulation will not only help with drug prices, because it will induce more competition, but it would also free up the science and enable pioneering drug developers to get their product out there in an affordable and timely manner" -
Ian Read, Pfizer
"There's a pretty compelling case to say that the prevailing way that drugs are being developed and regulated is simply not fit for purpose in the contemporary age that we live in… the pharmaceutical industry is actually pretty unusual in that 95 per cent of what it does fails and for an industry that prides itself on being evidence-based, the irony is that, at the end of the day, we don't tend to really use a lot of it!"- Jackie Hunter, BenevolentAI
"At the end of the day, we do not want to spend our limited time and resources regulating highly cost-effective drugs with multiple therapeutic competitors in the market." -
Tatsuya Kondo, PMDA
Click here to register and download the report.
SOURCE PharmaBoardroom
