Driving Down Launch Costs with EPC

Driving Down Launch Costs and Timing with EPC Edge Therapeutics, a young biotech, finds a better way to get ready for launch

By Justin Zamirowski, Senior Director, Operational Excellence, Edge Therapeutics

In 2015, 29 new drugs were launched in the U.S. and all of them experienced some delay, ranging from 5 to 87 days with the average at 45 days delay. The price of such massive delays in today’s competitive marketplace can be, on average, $1 million per day, which is unacceptable. Now, with more pressure to bring down drug prices, life sciences companies need to plug the holes of leaky processes. Many are turning to modern cloud-based technologies but few are considering the role that improved project management can play in making a real difference in time to market.

Project management plays a much bigger role in other industries, with many Fortune 500 companies creating entire centralized Project Offices equipped with enterprise software to run nearly every complex project at the company. However, there is not as much emphasis in the life sciences industry, for a range of reasons. Yet, there’s no more time left to be inefficient or rest on old processes. Real change is needed, and it’s coming in the form of enterprise project collaboration (EPC) software. EPC software can improve visibility and increase the efficiency of decision-making so life sciences companies can finally eliminate their delays to market. -Editor Edge Therapeutics is a clinical-stage biotechnology company founded in 2009 and based in New Jersey. The company’s lead product candidate, EG-1962, is in Phase 3 clinical study and has the potential to improve clinical outcomes over the current standard of care for patients experiencing a ruptured brain aneurysm. The product utilizes Edge’s proprietary delivery system that seeks to enable targeted and sustained drug exposure at the site of injury while potentially avoiding off-target side effects. While still the Senior Director of Commercial Operations at Otsuka, I was invited to join this very exciting and fast growing organization to lead the crucial stages of late stage development, portfolio management,

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and the pre-launch preparation and commercialization planning for EG-1962. Edge had just 15 employees, very little technology infrastructure, and no formal project team structures in place. Fast forward to present. In under two years, the company has doubled in size and gone public. My goal was—and still is—to establish an agile commercial foundation for a successful global product launch and sustained ongoing portfolio growth. Be successful with our first commercial product and enable continued advancement of our pipeline candidates.

In under two years, the company has doubled in size and gone public. My goal was—and still is—to establish an agile commercial foundation for a successful global product launch and sustained ongoing portfolio growth.

Shifting from a “larger company culture” to an emerging biotech has provided me with tremendous opportunity, and equally important responsibility to build a strong commercial foundation from the ground up. With limited resources, every purchase decision requires a close look as opposed to merely selecting the most expensive or well-known technology on the market—a.k.a. the “safe” choice. A ligning the O bjectives A t a small company, things are constantly in motion, and you don’t have a lot of staff or layers of expertise to manage them all comfortably. In launch planning, you have to work out different scenarios for various timelines and departments—clinical, regulatory, marketing and more. When I started at Edge, our corporate objectives were not closely aligned with either our processes or technology, so there was no way to visualize the integration across functions, the interdependencies between teams and individuals. This also made it more challenging to focus organizational resources around common key goals. Nevertheless, we were getting much closer to starting our Phase 3 and ultimately launching our first product. Being well aware of this common challenge in growth oriented biopharmaceutical companies, I was determined to avoid misalignment from affecting us and wanted to establish processes and organized workflows that would enable company-wide collaboration and execution against our shared objectives.

G etting Up to S peed Edge did not have any enterprise resource or financial planning (ERP) system in place so I had the benefit of establishing a system of record that would help project management across the entire organization. It was a fresh start, and opportunity to avoid developing bad habits. I had personally worked with a number of standard project management systems and supporting tools and so considered all options—including Microsoft Project as well as other enterprise project and resource management systems. I was prepared to invest in Microsoft Project Online but was concerned it was solving our issues with a sledge hammer. We needed a solution that was agile and flexible and had the reporting and capabilities we would use in the real world. Edge couldn’t afford to invest in functionality that we didn’t need, and then be required to additionally invest in add-ons like reporting tools to just get the basics done. Plus, we couldn’t afford to invest our people in maintaining the upkeep of a system like Project Online. I knew, once we started, the consulting and maintenance fees would only go up. During this process I was introduced by my industry peers to Eightspokes, the makers of a new generation of EPC, and we made the decision to utilize Enlighten.

EPC—T he N ext G eneration Previous EPC software I had used made it difficult to translate inputs and outputs in a meaningful way so that team members could collaborate. Charts were hard to understand. We weren’t all clear on input-in-results-out parameters. EPC needs to do a few things capably. It has to give everyone an immediate and understandable view of what’s happening across

the enterprise. What is the data telling us? How do various inputs inter-relate? Are visualizations easily digestible and usable by team members? So I’m happy to say that the new generation of EPC has overcome those hurdles. The whole team now has a comprehensive picture of what’s happening. We can clone a project and put together different scenarios—in minutes, not days. Outputs are quickly available for executive level conversations— they don’t have to be translated to be digested and understood. Since this new version is an industry-specific cloud platform, we wouldn’t have to invest in any physical infrastructure or pay for ongoing maintenance or upgrades. And, with built-in features designed to suit our industry’s complex operating environment, we didn’t need to build or integrate a lot of additional applications yet could easily custom-configure it to meet our needs. The product’s flexibility, cost-efficiency, and scalability to grow with our organization organically (at our pace, and in sync with our changing needs) were other aspects that attracted us to it. At Edge, the single most important benefit we searched for in a work management solution was the ability, through visualization of the work, to make better day-to-day prioritization decisions that everyone could see and understand to meet our corporate objectives. We wanted alignment, teamwork, and improved decision-making. The new EPC generation provided a single collaborative work environment that allows every team member to clearly see how their work impacts each other. It allows everyone to collaborate together to accomplish a single mission and execute confidently. It makes the organization more effective at executing the corporate strategy. It’s simple and intuitive, which means the entire organization uses the system. It reduces administrative effort and helps us stay in alignment. It includes all the training and implementation support we needed so that we were up and running in just one week. Any questions or requests are handled swiftly. Since we also deal with a lot of vendors—consultants, agencies— they need to get into the system and integrate their content with ours. This avoids us having to double-track activities, keep standalone spreadsheets, and one-off plans that go out of date. From an IT security standpoint, they don’t have to be on our email system to offer detailed and sophisticated timelines or use the system. The IT structure provides its own individual based security. There also doesn’t have to be duplication of information. We don’t have to re-do data entry, vendor info, visualization. We can seamlessly export info into slides. Most important, this works with a multi-generational workforce: from senior executives still getting used to current digital platforms to Gen-X and Millennials. Information can be printed, downloaded to slides or viewed on the web or mobile devices.

R es ults For the first time at Edge, we can each see the consequences of our decisions right away. We understand the interdependencies between functional teams and individuals, how the work flows, and who is doing what, and when. We know the implications of decisions right away that eliminates all the back-and-forth conversation between teams—it’s efficient decision-making. This also removes ambiguity. The less ambiguity, the better, as it prompts faster, smarter decisions that avoid repeat work. For example, we used to spend a considerable amount of time to pull together the stages and steps needed to develop different compounds and build individual plans. Now we use one plan and then clone it for six products, customize it and see if the plans were optimal from an operations standpoint. Just this capability has saved us weeks’ worth of time and effort.

It saves team members hours of creating PowerPoint slides. The project charts look better than what PPT consultants can make.

It’s built to make information easy to input, understand, report, and take action upon without extra manipulation. It used to require several hours to create custom PowerPoint presentations for various stakeholders who needed to stay abreast of progress and problems relevant to their work streams. Now, everyone from middle management to senior executives use their personalized dashboards to stay updated about work important to them. And if they still need slides for offline use, they can print a custom slide deck with multiple reports, at the flick of a button - it’s like magic! Bottom line, helps our teams do quality work under tight timelines at fractions of the cost. Plus the reduced need to rework deliverables avoids add-on costs and delays. Our project managers are even more productive and can focus on managing issues versus making slides.

T he P rime D irective What’s the first commandment at an emerging company? Thou shalt save money. This new EPC generation gives us three big ways to do that. One, we don’t have to re-do, translate and manipulate. Everything input is automatically available in easy-to-understand formats. Two, there are no onerous consulting fees for activities that the software doesn’t handle. This can add up to hundreds of thousands or even millions in extra expenses. It’s a major cash cow for consultants. With the new EPC, the license covers not just the product we initially installed, but ongoing upgrades that obviate ongoing consulting fees. And three, it’s a time saver. By the second day after installation we were using it across the company without the need for constant need for customization. For a growing biotech like Edge, going to market in total alignment is not optional. We have to get more work done, with less time and resources, without compromising on the quality or timeliness of our deliverables. The new EPC generation gives me the peace of mind that our teams will continue to be on the same page, our business leaders will be able to make more informed decisions in a timely manner and together, and we will all keep marching in lockstep towards achieving our common corporate objectives.

B eyond Our Own Benefits Every company has its own point of view and its own goals. But I have to say that this new generation actually provides industry benefits that help others. What is learned from our experience informs the software that the next company will license, in a confidential and compliant way. • Justin Zamirowski Senior Director Operational Excellence, Edge Therapeutics

Justin has over 18 years of life science experience across diagnostics, pharmaceutical, biotechnology and healthcare technologies industries.. He has held leadership roles in sales, market access, commercial operations, project and portfolio management, business development and alliance management. He currently heads Product Planning and Commercialization at Edge Therapeutics, Inc.

Edge Therapeutics, Inc. is a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies capable of transforming treatment paradigms in the management of acute, lifethreatening neurological and other conditions.