Tyson Bertmaring, Thought Leader

Tyson Bertmaring, Thought Leader

A Tale of Two Launches

By: TYSON BERTMARING
Associate Director, Project Management - Global Drug Development, Merck & Co.

Background:

Cubist Pharmaceuticals was a company founded to address the threat of MRSA ravaging our hospitals, and grew to a multi-product acute care focused company prior to our acquisition by Merck & Co.

The Global Medical Affairs department at Cubist Pharmaceuticals was uniquely diverse: field liaisons, health economics, medical information, investigator research, scientific communications, and microbiology. We all collaborated to pull through Phase 3 clinical candidates as successful products. 

The Company was growing rapidly after two separate acquisitions; the fabric of our culture, and our ability to scale to meet the challenges in delivering lifesaving products to the acute care environment, demanded an innovative approach to product launch management.    

Challenge:

We had not attempted a product launch since CUBICIN®, over 10 years prior. Our institutional knowledge had diluted over the years, and meanwhile the global regulatory and market expectations for product launches had changed significantly. There was now an even greater need for collaboration and coordination to execute successful launches. Coupled with that we had to launch two separate antibiotic products in six months.

Experience:

For our first new product, SIVEXTRO®, we used existing technologies to manage the launch: Microsoft Excel, SharePoint, Outlook, and PowerPoint. We experienced confusion which led to more meetings, lack of timely reporting which led to poor decisions, and lack of coordination which led to redundant deliverables. 

Lessons learnt during the SIVEXTRO® launch made us realize that we needed to do things differently for our upcoming ZERBAXA™ launch. We needed a way to manage product launches that mirrored the collaborative, innovative, and entrepreneurial spirit of our culture. 

A way to organize product launch strategy to enable distributed tactical decision making at the deliverable level. A way that moved meetings from updates to decision making, and a team of individuals to a team that operated as one. We needed to be enlightened.

Search:

We needed a capability which provided a true single collaborative project environment, which was simple to understand and intuitive to use.  As a result we ruled out everything out there, MS Project - Server and Online, Asana, Basecamp, SmartSheet, you name it.

Even though I believe Enlighten can be used for any project, in any industry, the icing on the cake was the fact that Enlighten was built specifically for supporting pharmaceutical product launches. And that, coupled with the no obligation pilot phase offer, made going with Enlighten practically a no brainer for us.

Implementation:

From Day 1 we had all the training and implementation support we could have asked for, and within the first week - our ZERBAXA™ project plan was migrated into Enlighten, our team was trained and truly accountable for their project scope. It doesn’t get easier than that!

Results:

We approached launches differently with the help of EightSpokes, while leveraging our greatest asset, our culture.  They consulted with us to establish a core personnel framework for product launches, trained us on how to use Enlighten, shared with us best practices for global launches, and stayed with us during the entire launch process. 

Accountability remained with the team leadership, but now we could clearly feel the effects of distributed responsibility for every critical launch deliverable.

Our post-launch lessons learned reviews clearly showed a difference between the SIVEXTRO® and ZERBAXA™ launches: timelines were met, risks identified before turning into issues, launch status was known in real-time by the entire team, the opportunity for clear decision making was not clouded by the confusion of what was going on, and most importantly the team had more fun!   

 


 
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Justin Zamirowski, Thought Leader

Justin Zamirowski, Thought Leader

Going To Market in Total Alignment

By: JUSTIN ZAMIROWSKI
Senior Director, Operational Excellence, Edge Therapeutics

Background:

Edge Therapeutics is a clinical-stage biotechnology company founded in 2009 and based in New Jersey. The company’s lead product candidate is in Phase 3 clinical study and has the potential to improve patient outcomes over the current standard of care for 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,  pre-launch preparation and commercialization planning for our pipeline product candidates.

We had just 15 employees, very little technology infrastructure, and no formal project team organizational structures. Yet, less than two years later, the company has doubled in size, gone public, and is conducting its Phase 3 pivotal trial to get EG-1962 onto market .

My goal was – and still is – to establish an agile commercial foundation for a successful global product launch and sustained ongoing growth.

Shifting from a “Big Pharma” 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 we make 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.

Luckily, this need for more detailed supplier scrutiny is what led me to EightSpokes.    

Challenge:

When I started at Edge, our corporate objectives and functional goals were not as well integrated as they needed to be, nor was there technology in place to help manage the work and visualize the interdependencies between teams and individuals. This also made it difficult to ensure organizational resources were prioritized appropriately. As a result, it became difficult to understand where we were and what obstacles were in the way of achieving our objectives. Nevertheless, we were getting much closer to starting our phase 3 study of our lead product, EG-1962. I was determined to proactively address this challenge that so commonly impacts growing biotech companies. I wanted to avoid misalignment from affecting Edge as we headed towards our first product launch. We needed to begin establishing processes, more structure and organized workflows that would lay the foundation for our company now and in the coming years.

Experience:

Edge did not have any enterprise resource or financial planning (ERP) systems in place, so I had the benefit of establishing a system of record that would help manage Edge’s work across the entire organization. It was a fresh start, and opportunity to try something new.

At Otsuka, I had personally worked with a number of standard project management systems and supporting tools and so considered all options – from Microsoft Project and Oracle Primavera, to Asana, Basecamp and SmartSheet.

I was prepared to invest in Microsoft Project Online. However, I knew that it was expensive as I would have to pay for additional consulting support to customize the system for my specific needs. This option would have forced Edge up to go down the pathway of investing in add-ons like business intelligence software just to get appropriate reporting. Out-of-the-box enterprise project management tools have very little simple reporting tools that executives can utilize. Plus, these kind of systems are very expensive to maintain – especially for a small company like Edge. 

Fortunately, I received an unexpected call from EightSpokes and then was subsequently given a demo of their Enterprise Project Collaboration (EPC) solution, Enlighten.

From day one, you get much more out of Enlighten than you ever put into it.
— Justin Zamirowski

Since Enlighten 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 Enlighten 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 Enlighten.

Solution:

At Edge, the single most important benefit we searched for in a work management solution was the ability to make better day-to-day decisions that everyone could see and understand, so that they could prioritize their own work for meeting overall corporate objectives. We wanted alignment, teamwork, and improved decision-making. Enlighten provided a single collaborative project 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 as a whole much more effective at executing the corporate strategy.

As important, Enlighten is simple and intuitive, which means the entire organization wants to – and will – use the system. No special project management degree is needed to use it.

Implementation:

EightSpokes provided all the training and implementation support we needed so that we were up and running in just one week. I really appreciate how closely connected the EightSpokes team is with our group – any questions or requests are handled swiftly. They also take our recommendations into consideration as they innovate future releases. I have seen several of these recommendations put into practice and it’s often covered in the cost of our subscription.

Results:

For the first time at Edge, we can each see the consequences of our decisions right away in Enlighten. We understand the interdependencies between functional teams and individuals, how the work flows, and who is doing what, when. We know the implications of decisions right away, which eliminates all the back-and-forth conversation between teams for very 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, but using Enlighten, we now 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 alone has saved us weeks’ worth of time and effort.

Enlighten was built with the end in mind – to make information easy to understand, reportable, and actionable without extra manipulation. For example, 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 uses their personalized dashboards to stay updated about work important to them. And, if they still need slides for offline use, Enlighten can print them a custom slide deck with multiple reports, at the click of a button.

Bottom line, Enlighten saves team members about five hours a week, but more importantly – thanks to improved coordination and timely communication – it helps our teams do quality work under tight timelines. Plus the reduced need to rework deliverables avoids add-on costs and delays. With Enlighten, our team members are more productive and can manage many more projects simultaneously.

For a growing biotech like Edge, going to market without total alignment is not an option. We have to get more work done with fewer resources, all without compromising quality or speed. Enlighten 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 collaboratively in a timely manner, and we will all keep marching in lockstep towards achieving our common corporate objectives.