Even as new drug development focuses more on precision medicines, disconnected software applications force life science companies to continue struggling with imprecise workflows and outdated operating practices…reminiscent of the dark ages

By Andy Mehrotra, CEO, EightSpokes

Life sciences companies spend millions of dollars to bring the next generation of critical medicines to patients. Forbes reports that the cost of creating a drug is around $5 billion.In addition to the monetary investment, talented cross-functional teams spend endless days in drug development and launch activities in hopes of creating the next blockbuster among the legends of pharmaceutical commercial successes. Typically, the journey from initial drug discovery to market introduction of a new medicine takes ten years.2

Even with so much time, effort, and money on the line, many companies still rely on outdated technologies to support internal processes. It’s the biggest risk to the success of even the best-planned product launches. These legacy applications create information silos, causing friction in data exchange and gaps in knowledge that ultimately restrict collaboration. And as the number of stakeholders and outsourced partners increase throughout the drug development life cycle, companies cannot afford information bottlenecks that slow activity, or worse, jeopardize outcomes. A single day’s delay in taking a product to market can cost $1 to $13 million in sales, a huge, unrecoverable loss when considering the short timeline to recoup investments in R&D.3

Without the right collaborative technologies, sharing information becomes a weekly chore of creating static status slides that quickly become outdated. Lack of visibility and insufficient clarity of accountability leads to frequent rework, which adds cycles of reiteration for deliverables. Without efficient mechanisms to capture and analyze data, many companies reinvent the wheel for each new drug candidate, unable to capitalize on the knowledge gained through past experiences.

As sharply as the life sciences industry has pivoted in recent years, so have the requirements of project managers leading drug development programs and product launches. In the past, these project managers were expected to oversee a small team of functional leads but today they must lead large internal teams, integrate multiple external vendors, and inspire to get full engagement from cross-functional teams. And while the expectations of project managers have matured, the technology being used to support them has not.

Pharmaceutical companies continue to limp to the finish line in bringing their innovations to light, draining the last from their current enterprise technology. As businesses invest time and talent into novel, specialized therapeutics, they must let go of their legacy systems and invest, too, in modern workflow management solutions that keep pace with their own science. This is the low-hanging fruit. New, cloud-based enterprise project collaboration (EPC) software developed specifically for life sciences provides today’s project managers with the tools they need to insure operational excellence… as one growing biotech has discovered on its way to its first product launch.

Growing Biotech Company Investigates the Merits of EPC

Instead of settling for limited technology implemented by enterprises in other industries, clinical-stage biotechnology company Edge Therapeutics examined emerging EPC software when looking to establish a technology infrastructure to support its operations.

Challenged with managing workflows and limited organizational resources, the New Jersey-based 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.

Moving into the phase III clinical study of its 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 the current standard of care oral nimodipine for patients experiencing ruptured brain aneurysm, the biotech company sought to establish a strong technology structure that organized workflow processes and project team structures as it moved towards its first product launch. Since established in 2009, Edge Therapeutics has grown dramatically, gone public and was now beginning late-stage development and commercialization preparations.

Joining the company to lead the critical late-stage development, pre-launch preparation and commercialization planning for its drug innovations, Justin Zamirowski, senior director, Operational Excellence at Edge, 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,” noted Zamirowski. “I wanted a cost-effective and flexible solution that supported alignment, teamwork, and improved decision-making.”

Having previously worked at a global pharmaceutical company, Zamirowski had 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. With limited resources, Edge looked for an alternative solution rather than settle on piecing together various technology tools.

“Existing enterprise project management tools don’t have the immediate functionality for reporting or dashboards.  We would have to build them ourselves, requiring months of work and consultant time,” explained Zamirowski. “Then, we discovered a new category of enterprise project collaboration (EPC) software designed specifically for our industry that works out-of-the- box to support everyone on our team. And because it runs on the cloud, we don’t have to establish a physical infrastructure or add internal resources to maintain it.”

EPC Functionality Focuses on Life Science Activities

With specialized functionality for drug development, product launches and life cycle management of in-market products, this new generation of software for the life sciences industry eliminates the need to build or integrate additional, supplementary applications. Easily configured to meet specific requirements, the cloud-based EPC solution 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. Additionally, EPC gives Edge the ability to maintain alignment among its multiple internal and external stakeholders simultaneously. By promoting streamlined communication, coordination, and collaboration among Edge’s partners and agencies, EPC ensures that progress and problems are shared in real-time, and potential risks assessed and acted upon early.

“For the first time, we can visualize workflows and inter-dependencies that the teams are able to understand without having to duplicate work or any tedious back-and-forth conversations,” Zamirowski pointed out. “And, with base plans already built into the system, we can clone and customize them for future products, saving weeks in time and effort.”

Personalized dashboards and automatic daily updates prompt team members about work deadlines while pushing relevant information to authorized users who need to stay abreast of progress and problems related to their work streams. By reducing data re-entry, opening/closing various programs, and back and forth conversations, 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.

As life science companies face increasing pressure from commercial and private health plans4 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 that keep life sciences companies operating in the past is one of the greatest obstacles to success. Modern, cloud-based EPC software designed specifically for processes and stakeholders within biotech and pharmaceutical companies can increase efficiency, transparency, and visibility across the full life cycle of drug development and commercialization to bring novel medicines to market quicker while building a stronger, more connected organization for sustained growth.

Sources:

  1. Herper, Matthew. (2013, August 11). The Cost Of Creating A New Drug Now $5 Billion, Pushing Big Pharma To Change. Forbes Magazine. Go to: https://www.forbes.com/sites/matthewherper/2013/08/11/how-the-staggering-cost-of-inventing-new-drugs-is-shaping-the-future-of-medicine/#4894029713c3
  2. PhRMA, Biopharmaceutical Research & Development. Go to: http://phrma-docs.phrma.org/sites/default/files/pdf/rd_brochure_022307.pdf
  3. The Pharma Letter, “$1-$13 million a day at risk from product launch delays”. See more at: https://www.thepharmaletter.com/article/1-13-million-a-day-at-risk-from-product-launch-delays
  4. Deloitte, “2016 Global life sciences outlook”. See more at: https://www2.deloitte.com/content/dam/Deloitte/global/Documents/Life-Sciences-Health-Care/gx-lshc-2017-life-sciences-outlook.pdf