The pharma and biotech industry continues to thrive. In 2018 the FDA approved nearly 60 new drugs, and exciting breakthroughs in areas such as immuno-oncology and gene therapy are emerging through clinical trials. Yet the industryfaces several hurdles to its continued success. This blog post will look at what each of these trends mean for companies operating in the pharma and biotech space.
Most people new to Clinicaltrials.gov (CT.g) do not appreciate that CT.g staff undertake a review cycle to ensure that each posting is correct and fulfills the requirements of the website. They have a mistaken expectation that as soon as they hit the Submit button, the site spits out their National Clinical Trial (NCT) number. But in reality, the NCT number appears only when the study is finally accepted for registration on CT.g.
As medicines have become increasingly unique and complex, a more collaborative approach to interacting with the FDA has been undertaken by industry sponsors in recent years, displacing the dated “make them ask” approach. Trying to force the quality, pre-clinical or clinical square peg into the round hole can have devastating consequences on timing, cost, and outcome of development programs. Meetings with FDA are designed to discuss development programs during critical points in the regulatory process, helping to ensure the peg is being placed where it needs to be. In 2017, the FDA released their revised Guidance for Industry on formal meetings outlining the procedures for requesting, preparing, scheduling, conducting and documenting formal meetings.
If you’re in the business of developing drugs for the treatment or prevention of diseases, you will need the review and approval of the regional regulatory agency to market your product within its jurisdiction. These groups regulate the safety and quality of drugs prior to and after marketing approval. But regulatory bodies vary widely across the world. Knowing how the relevant agency operates could save you vast amounts of time and money and help ensure that your product reaches the market according to plan.
Cancer continues to present new challenges and opportunities for pharmacologic intervention. Accordingly, the pharmaceutical industry continues to pursue the development of cancer drugs at an unparalleled rate. Three major trends have emerged over the last several years to fuel this pursuit. In this blog post, we discuss these trends, the evolution of regulatory assessment and more.