Why Seamless Submissions and Good Compliance Envelopes Matter
Are you finding it increasingly challenging to manage your organization’s regulatory submission process? The entire process of developing a drug from preclinical research to marketing takes approximately 12 to 18 years and can cost billions of dollars before a drug is even approved. I recently had a pharmaceutical R&D executive tell me their organization’s most recently FDA-approved drug submission was over 950,000 pages; stacked up, that’s the equivalent of 310 feet or the height of the Statue of Liberty.
Take that in. Think about how much valuable and critical data resides in that stack of paper.
Whether you’re in pre-IND or entering Phase II, there is a good chance the process is monopolizing a good portion of your resources and eroding your budget. This is true not just for pharmaceutical, but, also for other industries such as healthcare, financial services and automotive. The advantages of a good ‘compliance envelope’ can far outweigh its costs by making companies operationally more effective, with a positive impact on the top line.
Romancing the Milestone
All aspects of the drug discovery, development and submission processes are extremely complex – we know that, for sure. They require highly-skilled scientific staff, experienced project managers and heaps of funding among the laundry list of necessities.
Unfortunately, a company might have an abundance of research capabilities and funding, but still suffer from delayed submissions and time to market. This is a result of extremely complex paperwork and poorly managed data and dossier submissions. The dossier submission, or the selection of documents and data that encapsulates the entire story of how a company’s product developed and evolved, is the cornerstone of a product gaining (or not gaining) marketing approval.
Additionally, there are several different parts to any given submission as well as many specific components that need to be structured, including metadata: the unsung hero of drug development. To pile on to the complexity of data and dossier submissions, a milestone payment or a predetermined fee biotech companies receive from larger partners after their collaboration project passes a specific goal, tends to substantially increase if a candidate earns regulatory approval. While all this seems straightforward, milestone payments not only provide important insights for savvy biotech investors; but, they can also be made or broken based on the integrity of data and submissions.
Research tells us that the probability of a new drug candidate earning an FDA approval is only 9.6% after success in a Phase 1 clinical trial. When a well-heeled drug-maker willingly pays upfront for the rights to co-develop early-stage drugs, it speaks volumes about the larger company's confidence in its partner.
For example, Celgene’s upfront payment of $150 million and an equity stake in Juno Therapeutics for an initial payment of roughly $1 billion, affirmed certainty in Juno's ability to succeed.
Mission not impossible
Once the dossier is submitted, there are some required follow-up steps such as responding to queries from the regulatory agency, such as providing additional data or attending meetings, etc. If a company misses a meeting or a certain follow-up submission, regulatory agencies in some cases can, and will, put the company’s submission at the bottom of the queue or stop the clock running on their review cycle. We can decode this as possibly missing the approval date they’ve been promised or having to wait until the next set of meetings, which ultimately can affect the timing of a product launch and cost the company a lot of money.
In my view, mastering the submission process is one of the most important steps in establishing a cognitive business. A solid compliance envelope encompasses the quality, sources and presentation of submission data. To do it requires adopting advanced analytics and solutions that enable an organization to better understand and control its data and submissions to ultimately improve performance and drive revenue. So, how can a company find an opportunity to help make the process air tight?
Data that is loved, survives
For Egnyte, the essentials of centralized data solutions include comprehensive data management practices that provide data integrity, quality, security, usability and availability. Our belief is that when done properly, data that is loved will enable successful results, specifically in the drug submission process.
Our central repository solution that’s validated specifically for your business units enables cross-functional, internal stakeholders (clinical, quality, CMC, etc.) to apply metadata in a configurable, credible and easy-to-use way. By way of example, trial master files leverage metadata to annotate and add context to a clinical trial procedures and results. That said, it’s clear that metadata is paramount in distinguishing data from program-to-program, measurement-to-measurement and stage-to-stage.
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