By Ed Miseta, Chief Editor, Clinical Leader
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As a sponsor company, your outsourcing strategy is one of the most important decisions you will make. Deciding what capabilities to keep in house and which ones to outsource is difficult. Beyond that, the CRO selection process can be both challenging and time consuming. Once all the decisions are made and the partners are in place, sponsors hope their operations will run smoothly.
Unfortunately, a host of unforeseen issues can cause this well-planned strategy to veer off the rails. Clinical trials with a global footprint can encounter unpredictable events such as natural disasters or political unrest that can disrupt trials. Accent Therapeutics, however, had the foresight to implement an outsourcing model that allows it to avoid these unforeseen operational pitfalls. In fact, this strategy even enabled the company to minimize disruptions from the COVID-19 pandemic.
Accent Therapeutics was founded in September 2017. The company and its 25 employees are focused on oncology therapies targeting a new and emerging area of biology known as RNA modification. Accent hopes to identify and target RNA modifying enzymes that are critical for specific cancers.
A Diversified Strategy
Two executives founded the company and were soon joined by two others. Their core operations approach used a blended model of internal capabilities and external leveraging. Accent has a global footprint, with the ability to conduct preclinical research in China, India, Western Europe, the UK, and North America.
Robert Copeland, co-founder, president, and CSO, Accent Therapeutics
From the start, Accent strove for a CRO strategy that involved distributing its trial work and operations across multiple CROs. It wanted the flexibility to identify the best CROs for specific scientific disciplines and tactical (case-by-case) needs. It also did not want that expertise to reside in a single country. Robert Copeland, co-founder, president, and chief scientific officer for Accent Therapeutics, notes his experience has taught him that the capabilities and expertise of CROs can vary greatly based on geographic location. Capabilities are always important, but Copeland notes another key element of the strategy was risk mitigation.
“Having served in other pharmaceutical companies, I've experienced situations where geopolitical tensions or natural disasters have created bottlenecks for companies with operations in one particular country or region,” notes Copeland. “We thought having a global footprint would allow us to shift resources from one region to another when a risky situation arose. Many things can go wrong with your outsourcing model when conducting research, and a pandemic is certainly something that falls into that category.”
Face-To-Face Meetings Prove Valuable
Once the decision was made to have geographically dispersed CRO partners, Copeland and the other executives still had to select its CROs. When starting with a large pool of potential partners, it can be difficult to narrow that number down to a handful of lead candidates. Copeland believes having a seasoned and experienced executive team helped with the winnowing process.
There were CROs the executive team had good and bad experiences with in the past. That enabled them to fast track a few companies to the short list while quickly disqualifying others. The company also knew what capabilities it required, and was able to weed out other providers via a telephone call or video interview. Still, it faced a daunting task of finding the best CRO for particular outsourcing needs.
Copeland values the insights that can be gleaned from face-to-face meetings. To facilitate those meetings with CRO candidates, Accent took the additional step of budgeting extensive travel costs into its CRO selection process.
Copeland says the goal of that budget was to enable Accent’s scientists to travel to prospective CRO partners. He felt it was important for them to be able to meet with the CRO’s staff, perform onsite interviews, and inspect their laboratories. He believes there is no good substitute for being able to visit an organization and kick its tires. Although this is an ongoing process, he notes his team evaluated more than 10 CROs in the first year alone, and had relationships in place that allowed Accent to begin work with them.
“Our scientists have the ability to stand shoulder-to-shoulder with their colleagues,” explains Copeland. “They have the ability to assess the scientific acumen of those service providers. That allows us to better gauge their ability to deliver and execute on a strategy, and analyze their quality control process to understand their abilities and limitations. You can also assess more subtle things such as laboratory notebooks and experiment documentation. Those are things you really can’t evaluate on a phone call or video conference.”
One additional benefit is harder to measure and evaluate, and was not immediately obvious to Copeland. He found that the more time you spend interacting with scientists at a CRO, the more those individuals are made to feel a part of your team. He believes those interactions help drive rapport and great collaborations that allow teams to discuss potential problems before they materialize. The resulting brainstorming sessions help the teams produce powerful solutions to the anticipated challenges.
Copeland does not have a size preference when it comes to CRO partners. “If you looked over our network of CROs, you would find a mixture of small and large companies,” he says. “We look for CROs that have the expertise to meet our needs and have the capacity to scale as we grow. In some cases that is a large CRO, and at other times it’s a smaller one that is specialized in a particular scientific discipline like structural biology or animal models.”
It is not always easy to determine if a CRO has the capacity to scale. However, Copeland notes the team has ongoing discussions with the CRO to discuss future plans and potential for growth. By sharing these goals with each partner, both sides can discuss scaling needs and opportunities. During those discussions, full time equivalent (FTE) availability is a key topic. While it’s impossible to guarantee the future capabilities of a CRO, the team will leave those meetings with a much better understanding of resource availability.
Surviving A Pandemic
The idea for the geographically dispersed CRO model came about from experiences the executives had at prior companies. A few years ago Copeland was working for a small biotech that experienced supply chain disruptions due to a volcanic eruption in Iceland. That situation resulted in his organization being unable to move supplies among certain countries. In recent years he has seen tariffs and political differences threaten to disrupt operations. Although a global footprint would not eliminate all threats, Copeland felt it could mitigate them. “Having all of your operations situated in one country is never a good strategy,” he advises.
Although preparing to conduct research during a global pandemic was not on the minds of the executives when they decided on the outsourcing strategy, that model ended up being beneficial when the COVID-19 pandemic hit. It certainly helped his company weather the uncertain climate.
“I don't think anybody anticipated COVID-19, but infectious disease experts have been talking for years about the potential for a pandemic,” says Copeland. “Having that global CRO footprint and our own internal laboratories turned out to be a great risk-mitigation factor.”
As the virus took hold in China, Copeland knew some Chinese CROs would be shutting down. As a result, he was able to shift a lot of the work to European and North American CROs. Accent also pulled some experiments back into its own laboratory. When the virus began to hit North America, some of its Chinese CROs were already emerging from their quarantine period. In anticipation of that, the company was able to shift work away from its home laboratories and European CROs back into the China market. As a result, Accent never completely shut down its research operations.
Even without a natural disaster or global pandemic, the model still has built-in benefits. Copeland notes during normal times the model allows Accent to seamlessly scale resources up and down or from country-to-country, as needed, on a project-by-project basis. He does not expect this model to change as the company makes the shift from preclinical to clinical testing in humans.
“The principles we're applying in our preclinical studies are equally applicable to clinical CROs,” he says. “The goal is to have a broader global footprint. Even if we were to perform our trials exclusively within the U.S., having a broad geographic distribution of CROs can still be helpful. It’s also important to have an executive team that pays close attention to the news and can anticipate the ramifications of what is happening on your business, research and ultimately to your clinical trials.”