\nWith several innovative therapies in the pipeline, one CAR T-cell therapy company is at a pivotal point in its regulatory journey. Having achieved FDA approval for one of its products in the US, the company also has several pipeline assets.\n<\/p>\n
\nManaging regulatory information across multiple markets demands perfect alignment of speed and transparency \u2014 a challenge for many biotechs. \u201cEveryone wants to go as fast as possible,\u201d says a regulatory operations lead at the company. \u201cBut being in several regions makes speed sometimes a challenge.\u201d\n<\/p>\n
\nBy unifying its regulatory information management (RIM) systems with ³Ô¹Ï±¬ÁÏ RIM, the biotech company streamlined its submissions approach across multiple regions. A key piece of the puzzle was introducing continuous publishing: \u201cWe always aimed to manage the BLA submission in-house. Having a tool in place gave us time to publish submissions ahead of the BLA,\u201d explains the regulatory operations lead. \u201cFor the BLA submission specifically, it enabled us to file faster. It\u2019s very important for the company to have that speed,\u201d they add.\n<\/p>\n
\nBiotech companies that begin the publishing process early can initiate validation at the same time, streamlining and accelerating the submission process.\n<\/p>\n
\nWith ³Ô¹Ï±¬ÁÏ Submissions and Submissions Archive already in place, the regulatory operations team increased the value of the unified ³Ô¹Ï±¬ÁÏ RIM solution by implementing ³Ô¹Ï±¬ÁÏ Submissions Publishing. Switching to in-house continuous publishing, within a rapid three-month timeline, the team optimized preparation for the Biologics License Application (BLA) submission. \u201cFiling for our first drug was our driving force,\u201d recalls the regulatory operations lead. \u201cAs soon as a company comes to file for a drug, there\u2019s a keen focus on everyone following one process.\u201d\n<\/p>\n
\nContinuous publishing and validation, in parallel with the submission document authoring process, enabled publishers to move their tasks upstream. This has reduced late manual rework, validation errors, and bottlenecks. \u201cI knew for a company of our size, ³Ô¹Ï±¬ÁÏ Submissions Publishing would be valuable because we want to go so fast,\u201d explains the regulatory operations lead.\n<\/p>\n
\n\u201cI knew for a company of our size ³Ô¹Ï±¬ÁÏ RIM would be valuable, because we want to go so fast.\u201d
\n– Regulatory Operations Lead, emerging biotech company<\/span>\n<\/p><\/blockquote>\nBetter collaboration, shorter submission timelines<\/h2>\n
\nPreviously dependent on fragmented regulatory systems and processes, another key goal was to accelerate submissions by improving collaboration and transparency among regional functions. Teams began reviewing and approving documents within a single trusted platform rather than using various other channels including email, disparate spreadsheets, and storage drives. \u201cHaving a single source of truth is every company\u2019s ambition,\u201d says the regulatory operations lead.\n<\/p>\n
\nA clear and simple onboarding experience facilitated the rapid adoption and use of ³Ô¹Ï±¬ÁÏ Submissions Publishing. \u201cWith any other tool, it would be impossible to jump straight into publishing without a lot of training,\u201d the regulatory operations lead notes, adding: \u201cBecause of my experience with Submission Content Plans, I could use ³Ô¹Ï±¬ÁÏ Submissions Publishing right away. This is great for resourcing a lean team.\u201d\n<\/p>\n
\n\u201cHaving a single source of truth, that\u2019s every company\u2019s ambition\u201d
\n– Regulatory Operations Lead, emerging biotech company<\/span>\n<\/p><\/blockquote>\n\nWith real-time visibility and traceability through submission content plans, end-users can see outstanding items and swiftly make document updates to meet tight deadlines. Using continuous publishing in ³Ô¹Ï±¬ÁÏ RIM, the emerging biotech company filed its BLA submission ahead of schedule. \u201cWe can get the last document for the FDA at midday and submit it within an hour,\u201d the regulatory operations lead says.\n<\/p>\n
An advanced RIM environment<\/h2>\n
\nThe company now leverages the Vault crosslinking between ³Ô¹Ï±¬ÁÏ RIM and ³Ô¹Ï±¬ÁÏ Quality, enhancing agility and control. \u201cIt means we can answer queries straight away without having to download and re-upload documents,\u201d the regulatory operations lead explains.\n<\/p>\n
\nThe company implemented ³Ô¹Ï±¬ÁÏ Registrations in August 2024 and intends to use this application to scale its management of ever-increasing volumes of xEVMPD and IDMP registration data.\n<\/p>\n
Future of RIM transformation<\/h3>\n
\nA unified RIM solution that includes continuous publishing has increased the biotech company\u2019s regional drug application submission speed and efficiency.\n<\/p>\n
\n³Ô¹Ï±¬ÁÏ RIM\u2019s feature releases three times a year adds continuous value to the regulatory operations team: \u201cOne thing I like about [the platform] is that it continues to develop. The applications don\u2019t ever just sit there. They evolve with industry standards, but also based on customer feedback,\u201d the regulatory operations lead concludes.\n<\/p>\n
\n\u201cI don\u2019t think we could do without [³Ô¹Ï±¬ÁÏ RIM]. For the BLA submission specifically, it helped us file our submission faster. It\u2019s very important to the company to have that speed.\u201d
\n– Regulatory Operations Lead, emerging biotech company<\/span>\n<\/p><\/blockquote>\n\nThis culture of feedback and improvement will support the company in remaining agile in the face of continuous regulatory change.\n<\/p>\n