The starring role it can play in driving down costs of drug development and commercialization


A shift from traditional project management practices, EPC is designed to accelerate drugs to market



Life sciences companies still operate in the dark ages in many ways when it comes to technology. Even as the industry pivots away from blockbusters to develop advanced, specialized medicines (Express Scripts says specialty meds will account for half of all drug spend in 2018), the technology supporting this ground-breaking work is anything but cutting edge. Many organizations are frustrated with this paradox, yet still rely heavily on legacy software to manage the intricacies of drug development and commercialization. Hoping to streamline processes, companies of every size continue to tack on off-the-shelf software to old ERP systems. Instead of simplifying tasks, these multiple and unrelated applications increase the burden and costs while adding confusion that reduces teams’ speed of execution. As a result, incredible inefficiency pervades, delaying the introduction of new therapies to market.

Due to the complexity of drug trials and focus on chronic and degenerative diseases, costs of developing a prescription drug averages $2.6 billion, according to Scientific America. As each drug gets only 20 years to recover costs, delays cut into profitability (see Figure 1) and inflate prices. A single day delay in taking a product to market can cost $1 million to $13 million in sales.

The use of diverse software programs throughout an enterprise causes friction with teams forced to operate in silos rather than collaboratively. With information decentralized, workers waste time searching for information stored in arbitrarily organized folders while constantly attending meetings to provide updates to other team members. Use of static slides and spreadsheets to share updates also hinders timely identification and resolution of issues. Working with outside agencies can also cause delay, as feedback is often exchanged through outdated communications channels without any automated task prioritization.

Shift to targeted therapies compounds challenges

As the industry shifts its R&D course to develop targeted therapeutics focused on serving niche markets, companies have limited patient populations and greater launch complexity to recover substantial investments. The amount of R&D and marketing effort supporting the creation of these medicines, especially in oncology, is often much greater than many mainstream medicines.

These specialty life science companies need a faster way to commercialize to ensure a return. In fact, of the 66 novel drugs approved in 2015, nearly all experienced market delay – ranging from five to 87 days. In one extreme case, a top global pharmaceutical company experienced a 233-day delay from the time product was FDA-approved and launched into the market the following year. Compounding these delays is the increasing pressure from U.S. commercial and private health plans as well as government agencies to reduce drug prices.

Companies must urgently plug the holes of leaky processes. Given the right technologies for seamless enterprise-wide project collaboration, market delays can be greatly diminished – if not eliminated – and prices can start to drop accordingly. While many are making a move to modern cloud-based technologies in other areas of the business, companies often confuse horizontal applications that address broad business functions versus specialized software focused on project management to optimize processes in making a real difference in time to market.

Other industries understand the importance of project management. In fact, many Fortune 500 companies create centralized Project Offices, equipped with enterprise software to manage their complex projects. However, enterprise project collaboration is not yet a priority for the life sciences industry, resulting in departments implementing their choice of limited project software and methodologies to manage their particular area. Without an integrated project collaboration model across the entire organization, it’s nearly impossible for commercial teams to see the full picture while missing the opportunity to respond in real time to issues that might otherwise cause delays to market.  

A holistic approach to project management

Life sciences executives recognize the need for a more holistic approach to product launches, and are starting to adopt a new type of technology called Enterprise Project Collaboration (EPC) software. EPC promises to substantially increase the productivity of cross-functional teams – by up to 40 percent – throughout the lifecycle of drug development and commercialization.

In contrast to traditional project management tools, cloud-based EPC solutions seamlessly connect stakeholders, push daily tasks, raise accountability, and provide transparency into program activities. By connecting workflows across teams, external collaborators, and business partners onto a single platform, this work management software breaks down the silos interrupting business flow to streamline communication, coordination, and collaboration.  

Workers no longer need to sift through emails, searching for relevant documents, preparing customized spreadsheets and slides for stakeholders, or attending scores of meetings, which leaves them with limited time to focus on completing actual deliverables. With everyone in sync, the EPC software moves information seamlessly across the organization, reducing friction in data exchange and ensuring everyone is working on the same page to make better decisions and achieve business objectives.

Operating more intuitively than traditional software programs, this new work management software automates the sequence of daily priorities, informing individuals of their daily priorities to stay on top of work to get more done throughout the day. By connecting every influencing action and decision on a brand’s journey, the entire team remains in the loop on project progress and status.

With shared documents and connected spreadsheets, project managers can identify issues and delays sooner and have more meaningful conversations with teams in completing tasks. The new EPC approach also provides personalized dashboards to inform team leaders about program progress, problems, and actions. Business executives can instantly drill down to understand issues and review pertinent information across all their projects in real time. With greater visibility and transparency into work processes, commercial team leaders can stay abreast of key deliverables, interact more efficiently during team meetings and make more informed decisions.  

When dealing with stakeholders outside the organization, the EPC application removes the barriers of information to continue collaboration. For example, a marketing agency partner assigned to create supporting marketing materials may inadvertently stall progress waiting for client feedback. Communicating through emails may cause long delays as communication is not prioritized or pushed to the forefront of other emails. Therefore, both the client and pharmaceutical company do not take action, often blaming each other for delays.

An EPC approach captures the attention of both parties, making deadlines a priority and ensuring everyone keeps pace with important milestones. Information is exchanged more securely than via email that travels through an open Internet. And, stakeholders only receive data relevant to their assignments, saving time and ensuring privacy in workflows. As the software maintains the status of projects in real time, traditional “catch-up” calls to exchange updates can be redirected to brainstorming and problem-solving as everyone is already current with deliverables. Relieved of project management services, both the agency and brand team can dedicate their time to more high-value work.  

Case study: Edge Therapeutics marches to market in total alignment

The New Jersey-based clinical-stage biotech company Edge Therapeutics adopted EPC software to establish an agile commercial foundation for successful global launch and sustained growth of its lead product candidate, EG-1962. Without an enterprise resource or financial planning system at the time, Edge sought an enterprise application to seamlessly build and organize workflows across the organization.

After evaluating traditional project management tools, Edge chose a cloud-based enterprise project collaboration application designed specifically for its industry. With applications integrated on a single collaborative project platform, everyone in the company can now work on the same page to easily interact, prioritize, and manage processes. As a new approach to project management focused on workflows, it also prompts real-time, data-driven decision making.

“The software’s flexibility, cost-efficiency, and scalability to grow with our organization organically – at our pace, and in sync with our changing needs – was very attractive,” says Justin Zamirowski, senior director, operational excellence at Edge. “More importantly, now we can better understand the interdependencies between functional teams and individuals, workflows, and group tasks to improve oversight. And, by removing ambiguity, EPC eliminates redundancy and the back-and-forth conversation between workers.”

According to executives, EPC saves Edge team members five hours a week per person, and thanks to improved coordination and timely communication, Edge teams are producing quality work under tight timelines. “The reduced need to rework deliverables avoids add-on costs and delays. We are more productive, with the ability to manage many more projects simultaneously,” Zamirowski says.

“For a growing biotech like Edge, going to market in total alignment is not an option. We have to get more work done with fewer resources, all without compromising quality or speed,” Zamirowski concludes. “Using an EPC application that integrates all processes onto one platform not only ensures efficiency but also that we all continue marching in lockstep together towards achieving our common corporate objectives.”