Industry and regulatory agencies are collaborating at an ever accelerating pace to pave the way for faster approval and eventually accelerated launch of new therapies to address unmet needs. Understanding the differences between the various expedited approval paths, identifying which ones to pursue, and developing strategies early are all important contributors to success. Figuring out the economics of accelerated drug development is key to sustainability.
The continuous pursuit and advancement of Regulatory Information Management (RIM) systems and Submission Management Platforms is a critical component to successfully accelerating time to market. RIM is being viewed more strategically from a functional and geographical standpoint and gaining C-suite attention. There is a significant push to include local affiliates in global RIM programs. RIM imperatives and business cases have evolved from "compliance" justifications to an emphasis on realizing efficiency and productivity benefits, and the related faster approvals. Revised RIM goals include internal organizational restructuring and a growing trend towards outsourcing.
With that we also observe declining vendor satisfaction levels driven primarily by usability issues, siloed implementations, and innovation gaps, which are all challenging the current technology vendors and providing an opportunity for new players. Very capable point solutions have been implemented to support product registration, publishing, submission planning, labeling, document management, and regulatory intelligence. Yet, all of these capable solutions lack a unified platform that affords a comprehensive "bird's eye view" and "one version of the truth."
What is lacking from the RIM scene is the ability to provide each member of an organization the needed awareness and knowledge to make faster and smarter decisions, while also facilitating action in a dynamic environment of rapid change.
Advanced Business Process Management solutions are the answer to this growing need. By combining Data and Process within a unified Application Platform, Appian solves this paradox, and provides your organization with the tools to fuel accelerated time to market. Our platform facilitates building custom apps that are easy and powerful. Easy to build, easy to use, and easy to change, work on all devices, scalable & secure and always current.
Replacing the siloed approach with our integrated approach, reduces cost, increases value, and accelerates our drug development, submission, approval and launch timelines.
Watch an on-demand webinar where I discuss this topic with other Pharmaceutical industry experts called "Taking Advantage of New FDA Programs for Expediting Drug Development."
Take a look now and let me know what you think!
-Evi Cohen, Global Practice Leader ñ Pharmaceuticals, Appian
Appian is the unified platform for change. We accelerate customers’ businesses by discovering, designing, and automating their most important processes. The Appian Low-Code Platform combines the key capabilities needed to get work done faster, Process Mining + Workflow + Automation, in a unified low-code platform. Appian is open, enterprise-grade, and trusted by industry leaders.