The TrialSite News research team recently conducted research to understand trends in drug development timelines—from initial Investigatory New Drug (IND) filling to New Drug Application (NDA) approval. We encountered some surprises. First, we found that that the FDA doesn’t allow the public to access IND data—not even the date when the submission was filed. Second, for those drugs where we found IND application dates, we uncovered that the average time from IND filing to NDA approval was not what many might assume—under 6 years.
TrialSite News research analyzed drug approvals to date for 2019. Out of 48 approvals, we were able to secure Investigatory New Drug (IND) approval data for 22 new approved products. What follows is a brief summary of our findings as well as an overview of some other trends.
The FDA Doesn’t Share IND Submission Data (not even dates)
As declared on the public website, “The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.”
Among many other activities, the FDA reviews and approves drug developers Investigatory New Drug Application (IND). The FDA tracks information such as “IND Receipts” but only at a high level. During our effort, the TrialSite News research team couldn’t find IND submission and approval dates for over half of the approved drugs. Consequently, we reached out to the FDA to secure information about certain IND submissions. We simply sought dates of receipt for each approached IND in 2019.
We reprint the email the agency sent to our team:
“FDA cannot provide information on IND submission dates, as this information is confidential and belongs to the manufacturer/sponsor developing the drug, so we cannot provide it to the public. You may contact the drug sponsor for additional information.”
We note also for new IND’s for already approved drugs with new indications this is also the case—the filing dates are not available. The same goes for new formulations of already approved drugs.
This communication from the FDA didn’t seem right. Firstly, drug sponsors base their submissions on patented intellectual property (IP). Once they file a patent that proprietary information is essentially available for generic drug producers for example. Why on earth would an IND filing date be considered proprietary? We will continue to investigator this suspicious claim.
FDA does Seek more Transparency with BMIS Data
The FDA does seek to foster transparency and encourage information sharing within the clinical research community as FDA’s Center for Drug Evaluation and Research (CDER) maintains a bioresearch monitoring web site that makes clinical research information available to the public. The web site contains information that identifies the clinical investigators, contract research organizations, and institutional review boards involved in the conduct of Investigational New Drug (IND) studies with investigational drugs and therapeutic biologics. The FDA reports that the information is extracted from IND-related documents submitted to the agency and available to the public as the Bioresearch Monitoring Information System (BMIS).
Back in 2012, the FDA’s CDER acknowledged that the BMIS data set was not complete-e.g. it didn’t contain clinical investigator information from all IND studies reviewed by CDER. They note on their website that data form submissions received in electronic format were not included in the publicly searchable information. Consequently, BMIS, the FDA notes, represents only a sampling of the information CDER received from sponsors regarding clinical investigators participating in clinical trials. In the spirit of supporting public interest in clinical research CDER did change the process of the BMIS data entry procedures to include documents submitted in electronic format and instituted a plan for entry of the electronic format data received since September 2008—they note on the website that all of the data backlogs is complete.
Drug Development Timelines Condensed
According to industry association Pharmaceutical Research and Manufacturers Association (PhRMA) the average drug development timeline are 10 years and $2.6 billion. However, TrialSite News data reveals a somewhat different reality. Based on our preliminary data run (again for IND dates that we could secure) the average duration is about 5.75 year. In a number of cases, the duration from IND filing to NDA approval is under 5 years.
Growing Number of Breakthrough & Orphan Designated Products May Accelerate Timelines and Lower Cost
We note that a growing number of therapeutic targets center on cancers and rare diseases, and out of 49 new approvals 12 received Breakthrough Designation.
Moreover, we have reported on the growing influence of the rare disease targeting strategy. About 33% of all drugs inactive R&D pipelines are now included in the rare disease category according to multiple reports including an IQVIA survey and a report by Tufts Center for the Study of Drug Development. This study revealed that material changes will ripple through the drug development ecosystem. The share of new drug approvals worldwide for rare diseases doubled from 29% of all approvals in 2010 to 50% in 2018.
TrialSite News Research Ongoing
In addition to pouring through 2018 and 2019 numbers for actual drug development timelines—e.g. IND submission through NDA final approval—we are looking at select drugs to identify the actual estimated cost of development. This type of analysis represents an incredibly complex series of calculations made with many assumptions with imperfect data—in many cases, the costs are proprietary and only rational estimates can be inferred factoring in a number of assumptions. Stay tuned for more drug development timeline and cost research.
Call to Action: Are you interested in specific drug development timelines? For a competitor or a partner? It could be that our research could overlap with yours so feel free to reach out.
Tracy Lawton with the TrialSite News research team contributed to this project.Source: