For companies in the life science industry, managing their processes in house on their own platforms proved beneficial.
For many growing biotechs, it can be difficult to choose a safety or pharmacovigilance (PV) operating model that works for their organization’s size, budget, and case volume. Some biotechs see owning their safety system as their end goal. Others who rely on outside partners for most or all their PV activities may believe that bringing safety in-house isn’t an option. But, with a modern, cloud-based safety system, companies can maintain operational oversight and own their safety data regardless of their outsourcing model.
Dealing with fragmented processes and data quality issues led Hanssar Chacon, senior director of global pharmacovigilance and risk management operations at Swiss-American biotech CRISPR Therapeutics, to move from outsourcing to a contract research organization (CRO) to bringing safety operations in-house. “We wanted to improve the quality of our cases and manage the entire process from intake to reports and submissions,” says Chacon.
Similar challenges led Amylyx Pharmaceuticals, whose first commercial product was launched in 2022, to make the same change. However, the company also wanted to continue working with a vendor for specific PV activities. Now, Amylyx employs a hybrid model where the company owns its safety system and data and invites a CRO to process cases in its database.
“Since migrating our database in-house, we have better oversight of our data and vendor compliance. We also have quicker response times when pulling our data,” says Joseph Wong, head of pharmacovigilance operations and alliance management at Amylyx.
Biotechs often start by outsourcing their safety database and activities to a CRO. As safety cases increase, they may decide to move their safety system in-house. But, Chacon advises companies to do the opposite. “Anybody who’s dealt with a migration understands that the best time to do it is when you have a low volume of cases. As the volume increases, it only gets harder,” he explains. “At CRISPR, the time was right because our case volume was still low, but we knew that the company would continue to grow. We wanted to build out our structure and processes before it became unmanageable.”
For Amylyx, they decided to make a change in anticipation of a global trial and drug approval, which they received in September 2022. The move to an in-house safety solution became even more critical with a significant increase in case volume. “We went from having about 20 cases a month to over 1,000 in a very short amount of time,” says Wong.
Amylyx needed a robust safety solution that could handle the increased data volume.
The first step to bringing safety in-house is building a strong business case to get company executives on board. Chacon started by establishing strategic internal partnerships, especially with CRISPR’s compliance and quality assurance teams. “Nobody thinks about safety until something goes wrong and you must provide answers to a regulator. In those situations, you start to see that safety can really make or break a company,” says Chacon. “Taking the time to build close relationships with key partners and explain the value of owning your safety system will go a long way.”
For Chacon, the greatest benefit of CRISPR owning its data is being able to pick up on signals before regulators do. “Owning the data means we can manage it, analyze it, and better understand it. It helps us figure out the best way to move forward and minimize potential risks,” he says. Reports and dashboards can also help PV teams to track processes and provide operational oversight. “It created a lot of efficiencies for us. We can see where cases are getting stuck or if there’s a backlog,” says Wong.
Deciding whether to go with a customized or out-of-the-box solution depends on your organization’s goals. For CRISPR, Chacon chose an out-of-the-box solution because it was faster to implement. “We’re a small company, so our resources are limited. It was important to us to have a partner we can count on for resources and expertise,” Chacon explains. “Selecting a pre-validated system helped us speed up our implementation.”
Amylyx took a slightly different approach. Wong configured the safety system to align with their CRO’s processes while still maintaining the leanest case workflow. Wong advises companies to involve their external partners as early as possible when beginning a migration. “You don’t want to be in a situation where you’re going back and fixing things,” says Wong. “We also took on SOP writing, authoring work instructions, and business continuity planning.”
Managing new releases can be overwhelming, especially for biotechs with limited resources. Sometimes sponsors are given only a release note to understand how an update affects them. To improve the validation process, request partners to provide a risk impact assessment document. Chacon works closely with managed services consultants and IT personnel to understand software upgrades before they happen. “Our partners walk us through each release, including new features and how our team will be impacted.”
Amylyx and CRISPR also appreciate flexibility in release management. Chacon and Wong both test out new releases in a sandbox before choosing which to implement or defer. “We meet with our partner before making any decisions. Then, we make sure that we communicate the impact of a new release with our internal stakeholders and our CRO,” says Wong.
For Chacon, the greatest benefit of Vault Safety’s frequent updates is that they help CRISPR remain compliant while navigating constantly changing regulations. “The world of PV doesn't stay still. There are always new regulatory changes to navigate, so it’s important to stay up-to-date,” he says.
No department can do its job alone. Clinical feeds data, like study information and serious adverse events, to safety teams. And, safety provides data and documents, like Medwatch forms and aggregate reports, to regulatory teams for submission of investigational new drug (IND) applications. Integrating systems across functions allows for seamless safety processes, automated document and data exchange, and improved visibility. Now that both companies have successfully migrated their safety systems in-house, Amylyx and CRISPR are looking beyond drug safety.
“We want to be able to reconcile safety data with our clinical adverse events and quality product complaints,” says Wong.
“I have a long wishlist of additional systems that I’d like to implement, especially on the clinical side,” he says. “We’re looking at ways to avoid or eliminate reconciliation. That will be a huge step forward.”
Christina Kim is senior director at Veeva Vault Safety.