Don Tracy

When it comes to selecting Digital Health Technologies (DHT) providers, there are numerous factors that need to be considered when deciding.

In the discussion, “Key Considerations for Evaluating and Selecting Technology Suppliers for Digital Health Technologies,’ held at the 14th Annual Summit for Clinical Ops Executives (SCOPE) meeting in Orlando, Sonali Bhatnagar, associate director of clinical innovation & digital health, R&D, sourcing & procurement for Merck, examined the trials associated with evaluating, selecting, and onboarding new suppliers and the questions that should be considered.

Bhatnagar explained the need to include enough time for negotiating, or it could lead to a frustrating experience. “We need to make sure we build enough time to build a relationship with the supplier and deliver good things for our patients,” she said.

She also stressed the importance of understanding the role of subcontractors, and the extent that they impact the project. “If they were to be acquired, we would need to have a backup plan. Ultimately, we’re responsible for getting data back. We need to make sure we’re having those conversations with subcontractors beforehand.”

Communication is vital to selecting the correct vendor…companies need to make expectations clear prior to any agreement. “Responsibilities need to be clear in regard to what we are doing, what they are doing,” explained Bhatnagar. “Tie-in your milestones to payments.”

At each stage of negotiations, Bhatnagar believes that an appropriate assessment should be conducted.

“We want to build fast, but we also want to follow our policies and keep going,” she said. “Have a conversation at each stage to see how things are going.”

Key performance indicators (KPI) were also recommended as something important to the negotiation process, especially for newer vendors. According to Bhatnagar, KPIs can be helpful based on the scope of the project, and where they make sense.

Bhatnagar wrapped up her presentation with some final thoughts to consider. These include:
•	Does it work the way we expect it to?
•	What are the regulatory implications?
•	What markets are we thinking?
•	What would the cost of clinical trials look like?

Reference
Bhatnagar, Sonali. Key Considerations for Evaluating and Selecting Technology Suppliers for Digital Health Technologies. Presented at : SCOPE; Feb. 6-8, 2022; Orlando, Fla.


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SCOPE session discusses key challenges of evaluating potential providers. 


Tips for Selecting Digital Health Technology Suppliers

In the discussion: “Novel Evidence for Regulatory Decisions: The Key Factors for Success,” held at the 14th Annual Summit for Clinical Ops Executives (SCOPE) meeting in Orlando, panel members offered suggestions on how to successfully implement novel evidence—defined as RWE, digital biomarkers and novel digital endpoints—in the life cycle of drug development. The panel, moderated by Michelle Crouthamel, D.BA, head of digital sciences for AbbVie Inc., consisted of Jennifer Goldsack, CEO of Digital Medicine Society (DiMe); Christopher Boone, VP, global head of health economics of AbbVie Inc., and Amy Abernethy, president of Verily Life Sciences.

Boone kicked off the discussion, explaining what he’s noticed across the industry and suggested preliminary steps to take. “We’re seeing an awakening in the pharmaceutical industry,” he said. “It’s not just about R&D and regulatory approval but thinking about our evidence plans and the continuous evidence generation across the life cycle of an asset is very important.”

Boone also noted Crouthamel leads AbbVie’s digital science team, which “accesses the landscape of these novel technologies and certifies their usefulness before we put our hands on them.”

Abernethy described her own experiences using novel evidence through Project Baseline, a study that enrolled 2,500 individuals in order to create a 360-degree view of health.

“Reflected across time, this view of health included clinical data, echocardiograms, and visits with clinicians,” she said. “It also included wearing sensors on the wrist in order to understand movement and sleep across time. The sensor was also able to alert participants to answer questions, helping understand their story over time.”

Abernethy stressed that in the end, the science matters. “We have to do the hard work of understanding performance, reliability, and the correct context for intended use.”

Goldsack agreed: “When we think about a digital health model, we aren’t thinking about a single proprietary product, but about a high performing sensor technology, coupled with a trustworthy algorithm that works in every single person,” she explained.

Crouthamel asked the panelists for key takeaways.
“The number one thing to think about is building scalable infrastructure at which we can do this science,” said Abernethy. “Longitudinal infrastructure that sets up the mechanism to continuously validate all of the endpoints that we are talking about. We need to set a scale so that we don’t have to do this over 40 years, but only a few.”

Boone continued by stating, “The data infrastructure piece is very important. The upscaling and rescaling in addition to building longitudinal data points is key.”

Goldsack agreed. “I think that what the infrastructure affords us to do is have a more thoughtful digital strategy that transcends these individual slings shots. That allows us to think about how we capture return on investment for our business and for the patients through the development of these new tools. We need appropriately trained colleagues to make this happen. Pathways to ROI need to exist.”

Reference
Crouthamel M, Goldsack J, Boone C, Abernethy A. Novel Evidence for Regulatory Decisions: The Key Factors for Success. Presented at: SCOPE; Feb. 6-8, 2022; Orlando, Fla.

Panel at SCOPE discusses applying novel evidence in regulatory decision-making. 






Expert Insights into Novel Evidence 

Despite ongoing challenges following the COVID-19 pandemic, there is a lot of optimism about the future of drug research.

In the discussion: “Navigating a Global Crisis: Pandemic, War, Hyperinflation, Supply Chain Disruptions…You Name It,” held at the 14th Annual Summit for Clinical Ops Executives (SCOPE) meeting in Orlando, members of a panel noted the challenges imposed on clinical trials because of the COVID-10 pandemic. The panel, moderated by Balazs Flink, senior director of clinical development operations at Daiichi Sankyo, included:
Gaurav Sawhney, VP, head, clinical partner management, Takeda Pharmaceuticals Inc.; Deborah Profit, PhD, VP of clinical management & applied innovation, Otsuka America Pharmaceutical, Inc.; Ken Getz, MBA, founder of CISCRP; deputy director of the Center for the Study of Drug Development, Tufts University School of Medicine, and Bryan O’Neill, global head of clinical supply operations at Daiichi Sankyo, Inc.

Profit said that Otsuka leveraged quantitative and qualitiative data during the pandemic to respond to the pandemic, shifting resources when necessary from more impacted areas to less. She said they also gathered data on how their employees were impacted, as well as site trial areas to make decisions about research.

“This is our moment, quite honestly,” said Profit. “This is our opportunity to take what we’ve learned through the pandemic to do better.”

Getz noted that while there are opportunities for improvement, “the long-term outlook is remarkably positive and optimistic.”

He noted that pipelines are growing by three to four percent a year, with major areas of focus centering on rare diseases and personalized medicines. “Sixty percent of all drugs approved are relying on biomarker or genetic information to really target a therapy and there’s huge promise there.”

While there is no shortage of optimism for the future, the experts agreed that there is still room to grow.

“What we still need to understand are the intangible ways that we collaborated as a team,” said Getz. “We are often trying to draw lessons from how we handled and succeeded in addressing a global pandemic.”

In addition to the challenges that Getz spoke about, O’Neill also discussed ongoing supply chain issues.

“When supply chain staff are stricken with COVID-19 protocols, we all of the sudden have a very high touch process that is not very vendor friendly, especially when they are trying to deal with personnel challenges,” said O’Neill. “For me, there was a great deal of learning during the pandemic and figuring out what would work to keep the supply chain flowing.”

Flink B, Profit D, Sawhney G, O'Neill. Navigating a Global Crisis: Pandemic, War, Hyperinflation, Supply Chain Disruptions…You Name It . Presented at: SCOPE; Feb. 6-8, 2022; Orlando, Fla.

Panel at SCOPE discusses the possibilities of research in a post-COVID world.






Don Tracy

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Tips for Selecting Digital Health Technology Suppliers

Expert Insights into Novel Evidence

Global Health Crisis Provides Learning Opportunities Moving Forward