Protocol Networks Guides Biopharma Company Through FDA Process

FDA Approved

FDA ApprovedSarepta Therapeutics, a biopharmaceutical company in Cambridge, Mass., develops genetic medicines to treat rare neuromuscular diseases which currently lack therapies to help the lives of patients with the debilitating diseases. As Sarepta focuses on transforming the treatment of serious, life-threatening diseases through RNA-based technologies, it relies upon good partners to assist with major projects that fall outside of their core competencies.

Since 2014, Sarepta Therapeutics has trusted Protocol Networks to manage key technology projects during growth and transition periods.

The Challenge

Protocol Networks initially completed two projects for Sarepta — a data center relocation and an office consolidation project. The scope of these projects included relocating Sarepta’s data center from Colorado to Massachusetts along with designing and installing telecommunications and computer networking infrastructure for Sarepta’s new headquarters in Cambridge. Because Sarepta Chief Information and Privacy Officer Steve Aschettino was so pleased with Protocol’s work on these projects, he called them in when Sarepta faced their next growth point.

When Douglas Ingram came on board as Sarepta’s President and Chief Executive Officer in 2017, he brought along years of experience in biopharmaceutical management and corporate affairs. He also brought his vision for taking Sarepta into pharmaceutical marketing which includes going through the Food and Drug Administration approval process for drugs.

With an already high reliance on computing assets, the biotechnology firm needed to bolster its technology assets – from infrastructure to user education – to be prepared for the long, challenging process of bringing a drug to market.

The Solution

As Sarepta approached its first FDA Investigational New Drug (IND) application, Protocol knew there was no time to spare in putting a winning plan into place. Because there is only a short window for companies to be profitable on a newly approved drug, Protocol’s Philip Rogers, Chief Information Officer, put together a three-phase plan to ensure Sarepta would be ready to optimize their investment in the drug development and application process.

Phase 1 – Protocol built up the infrastructure to include on-site and remote help desks, network monitoring and managed services to position Sarepta to scale up for phases 2 and 3. Protocol developed “office kits” so Sarepta’s upcoming physical expansion could be implemented easily.

Phase 2 – Sarepta was using larger labs and needed more staff members to support the FDA approval process so internal needs increased. International office locations were added resulting in even more users. Because the technology foundation had been laid in Phase 1, Protocol efficiently brought new employees and facilities online quickly.

Phase 3 – The clock starts ticking on marketing a new drug once the FDA approves it. Sarepta was ready and waiting with its IT infrastructure in place and its employees up-to-speed on the technology.

The Benefit

Bringing in Protocol Networks as project manager instead of hiring more staff to prepare Sarepta for its new line of business was a strategic decision that was cost effective as Sarepta only paid for what it needed. Sarepta’s internal IT staff was just one person at the time. As a strong, trusted partner Protocol operated as though they are part of the Sarepta team, attending team meetings and trainings to better understand Sarepta’s objectives and mission. Protocol Networks allowed the CIO of Sarepta to fill out his Organizational Chart as if he had all the resources the strategy required.

Sarepta’s first IND was eventually approved by the FDA, so they didn’t have to invest in internal infrastructure and then figure out what to do with it if the drug wasn’t approved. Protocol advised them on how to handle this situation as well. Protocol Networks converted two of its system administrators to Sarepta’s full-time employees.

Protocol Networks specializes in change for companies going through transition. If you need help with short- or long-term technology projects, give us a call at 877.676.0146 or get in touch online here.

You Don’t Have To Go It Alone

As businesses evolve, they often face challenges they aren’t fully equipped to handle. If your business is relocating to a larger facility, is migrating from a physical IT environment to a virtual IT environment, or you have a product entering the drug approval stage, you may not have the expertise on staff to navigate the implementation – and completion – of these changes.

It’s tempting to put transitional events onto the plates of existing staff. But, let’s face it, most departments are already understaffed. For example, your internal IT team handles core business processes like onboarding new employees, data security, compliance and day-to-day help desk issues. They generally do not have enough capacity to implement and manage the additional challenges presented by large or specialized projects.

Information technology is an area often reinforced during transitions that require senior IT professionals that companies commonly don’t possess. They also hesitate to bring on board permanent staff for projects since the hiring process can take months to complete. Pharmaceutical companies instead often hire an IT partner to guide them through transitional events like the drug approval process, since they have the necessary expertise and experience required to make the project a success.

It takes an average of 12 years and expenses of over $350 million per drug to research, develop and get to market. This means pharmaceutical companies make huge investments in each drug they develop. Only 1 in 1,000 drugs developed actually make it to trial testing, let alone to the pharmacy shelf. This low success rate makes it extremely important for companies to support the drug at every step of the process to give it the best chance for FDA approval. This means bringing on more expertise during the drug trial process to further strengthen chances of approval.

Logically, pharma IT leaders hire a third-party IT partner with the experience and expertise to guide them through transitions. The IT partner must be trusted, cost effective and have the ability to meet stringent deadlines.

Protocol Networks specializes in helping companies through unique events like an FDA drug approval, facilities expansions and other growth activities. As a change agent, Protocol has encountered and facilitated these kinds of situations many times.

Selecting the right IT provider is critical to successfully making these transitions. Here are the top 4 considerations when hiring an IT partner:

  1. Cost effectiveness – Whether you’re deciding where to go to dinner or which car to buy, the first consideration is cost. Hiring senior IT professionals temporarily for the life of the project provides you with the expertise and experience needed without long-term expense.
  2. Strategic direction – Your IT partner should go beyond tactical solutions to identifying strategies to propel the project (and your organization) forward. A good partner won’t just make sure your infrastructure is up to date; they will also ensure that it is capable of supporting your organization through upgrades, physical to virtual migrations, and even global expansion.
  3. Experience – Your expertise is biopharma technology; your IT partner’s strengths need to complement yours. Let’s say your active directory needs updating, and you’ve never done it before. You need an IT partner who has upgraded directories many times. More to the point – you have one shot to get this drug approved so a partner who has been through the process many times is who you need on your team.
  4. Working relationship – Speaking of teams, you need to know who you’re in the foxhole with. Hiring a trusted, third-party to come in and help your company get through an important transition is essential for a smooth process. Protocol listens to your needs and works with you to identify the best solutions for your situation instead of just applying a standard template.

Protocol Networks is a true partner who will expertly guide you through transition events like moving or getting new products approved and will coach you about how to effectively convey information to the C-suite. Let us know if you are interested in drawing upon Protocol’s extensive resources: online or call 877.676.0146