Clinical-Stage Biotech Selects Collaborative Enterprise Tool

Justin Zamirowski, Edge Therapeutics’ Senior Director of Operational Excellence, and Andy Mehrotra, CEO of Boston-based cloud software developer EightSpokes, discuss howa new, collaborative approach to managing projects across the enterprise is improving time to market.

Edge Therapeutics is a is a clinical-stage biotech that discovers, develops and seeks to commercialize novel, hospital-based therapies capable of transforming treatment paradigms in the management of acute, life-threatening neurological and other conditions, based in Berkely Heights, NJ. Though a smaller biopharma, it faced the same process management challenges as many life sciences companies do today--disconnected software applications or legacy applications that result in imprecise workflows and outdated operating practices.

To avoid these problems, Edge Therapeutics took a new approach to manage its internal processes by replacing its project management tools with a cloud-based project collaboration application designed to improve the workflows of complex projects.

PharmExec: Could you tell us more about Edge Therapeutics?

Justin Zamirowski

Justin Zamirowski: Since established in 2009, Edge Therapeutics has grown dramatically, gone public and was beginning late-stage development and commercialization preparations. Moving into the Phase III clinical study of our lead investigational product EG-1962, an extended-release, micro-particle form of nimodipine administered directly to the brain being studied to show improvement in patient outcomes versus current standard of care oral nimodipine for patients experiencing ruptured brain aneurysm, we sought to establish a strong technology structure that organized workflow processes and project team structures as it moved towards its first product launch.

What was the driving force in moving to a collaborative project management platform?

JZ: Challenged with managing workflows and limited organizational resources, our company lacked sufficient technology to support operational processes and provide transparency into team interactions.  As a result, business leaders could not visualize their programs’ statuses in a timely fashion and proactively make decisions on important activities. 

With an increased focus on pricing and mounting regulatory scrutiny, today’s life sciences companies are under intense pressure to drive down costs while speeding time to market. Joining the company to lead the critical late-stage development, pre-launch preparation and commercialization planning for its drug innovations, I recognized the need to establish an agile workflow management approach for precise commercial execution, not only for a successful global product launch but for sustained long-term growth of the organization. 

While not pinned down by legacy systems and incompatible applications like many pharmaceutical organizations, Edge still needed to establish a system of record that managed its processes across the organization. I wanted a work management solution that offered visibility into work activities so team members could prioritize and make better decisions that supported corporate objectives. I also wanted a cost-effective and flexible solution that supported alignment, teamwork, and improved decision-making. An enterprise project collaboration platform provides a crucial bridge to connect stakeholders seamlessly and transparency so we can spot issues before they cause delays.

Andy Mehorta

Andy Mehorta: As life science companies face increasing pressure to reduce drug prices, effectively respond to stricter regulatory compliance, and navigate within limited timeframes to get drugs into the market to make a profit, disjointed tools is one of the greatest obstacles to success.  Much of the burden falls on project managers leading drug development programs and product launches.

What kinds of software did you evaluate?

JZ: Having previously worked at a global pharmaceutical company, I have first-hand experience with legacy project management systems such as Microsoft Project and Oracle Primavera, as well as with newer task management tools like Asana, Basecamp, Smartsheet, and Wrike. A review of these products revealed that Edge would not only be paying for unnecessary features but would need to customize applications and supplement it with additional business intelligence tools to address their specific industry requirements. Existing out-of-the-box enterprise project management tools don’t have the immediate functionality for reporting or dashboards that we would need to build ourselves, requiring additional work and consultant time. Plus, these kinds of systems are very expensive to maintain – especially for a small company like Edge. 

With limited resources, our company looked for an alternative solution rather than settle on piecing together various technology tools. We examined emerging cloud-based Enterprise Project Collaborative (EPC) software when looking to establish a technology infrastructure to support our operations. And because it runs on the cloud, we don’t have to establish a physical infrastructure or add internal resources to maintain it.

AM: Edge was ready to implement Microsoft when they discovered EightSpoke through a mutual business associate that had substantially reduced costs and work burdens using our EPC application entitled “Enligthen.” An evaluation of our work management software showed that Enlighten was a less expensive and out-of-the-box solution compared to common project management software that offered more specific capabilities to improve their workflows.

What improvements have you experience in using SaaS-based collaborative software?

JZ: Because it is configurable to meet specific requirements, the EPC provides Edge with capabilities for shared project planning, tracking of rolling NDA submissions, automated reporting on personalized dashboards, timely task reminders, and universal visibility into synchronized workflows. Operating on a single collaborative project environment, team members clearly see the impact of their work and collaborate with others to accomplish shared business objectives.

For the first time, we can visualize workflows and interdependencies that the teams are able to understand without having to duplicate work or any tedious back-and-forth conversations. We know the implications of decisions right away, which eliminate back-and-forth conversations and ambiguity between teams for very efficient decision making. And, with base plans already built into the system, we can clone and customize them for future products, saving weeks in time and effort.

EPC saves Edge about five hours per person per week just in program management. More importantly, our team does quality work under tight deadlines while reducing the need to rework deliverables that add onto costs and delays. Bottom line, we are more productive and can manage more projects simultaneously with existing resources.