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Henry McNamara, Senior Vice President and General Manager, Oracle Health Sciences, reviews the lessons that the industry has learned over the last year and looks at what lies ahead for pharma in 2021.
Oracle Health Sciences helps healthcare and life sciences organizations discover and develop innovative products and services to prevent and cure illness and enhance quality of life. Henry McNamara, Oracle’s Senior Vice President and General Manager, is responsible for all aspects of the global business. His career has been focused on advancing the adoption and positive impact of technology on the healthcare and life sciences industries, and he is credited with driving significant technological progress in the areas of clinical research and patient care. During his 15-plus years at Oracle, McNamara has expanded the health sciences business and continues to be instrumental in technology transformation in the world’s largest pharmaceutical companies.
Pharm Exec spoke to McNamara recently to get his thoughts on the current state of the pharma industry, the lessons that have been learned over the last year, and what lies ahead in 2021.
PharmExec: What do you think the long-term impact of the last 12 months will be on the biopharma industry?
Henry McNamara: Traditionally, the biopharma industry has been viewed as slow to adopt new technology and shift its methods. But the pandemic changed all of that. While the pandemic created many low points over the last year, one of the high points was watching the industry come together in an effort to keep clinical research moving forward.The pandemic provided a catalyst for new ways of working. It moved everyone — sponsors, sites and regulators — to embrace, use, test, and implement many new ideas, approaches, and technology in clinical trials.
Now, a year into this health crisis, it’s become clear that the industry will never turn back entirely to the old way of doing things.
For example, according to a recent survey of 252 clinical research professionals from around the globe conducted by Informa Engage on behalf of Oracle,1 76% of clinical trial teams say they have sped up the use of decentralized trials methods in the past year. It’s reasonable to expect some of these trial methods to remain.
Moving forward, sponsors will employ more and more technology for remote data collection, and adopt new eClinical platforms that make it easy to support the volume and variety of data associated with decentralized clinical trials, while also employing advanced techniques to analyze all the resulting data. And, while some new approaches and technologies will become mainstream more rapidly than others, there will be permanent changes because of the experience of the past 12 months.
While I think the adoption of these new methods and technology in clinical trials benefits the whole industry — giving us faster and richer clinical data to get new therapies to market faster – I think the real winner in this is the patient. The pandemic has forced us to figure out how to support patients involved in clinical trials from the comfort of their home, which is more convenient for the patient. If patients can participate in clinical research without having to leave their home, or with minimal site visits, I think this could really improve patient recruitment, engagement, and retention.
The shift to decentralized trials has been much heralded, but how are technological and regulatory barriers still affecting that shift among biopharma companies?
With established procedures providing a level of comfort and familiarity — and regulatory acceptance —there was no sense of urgency in making decentralized trials more mainstream prior to the pandemic. While there has been a shift over the last year, trying to incorporate new world innovations into a traditional protocol design and modify operational practices has proven to be a challenge. Some common challenges include difficulties related to technology infrastructure, personnel, and even the classic ‘status quo’ attitude.
Also, the burden of data management and analysis is becoming a more urgent problem. Whether it’s the increased volume and variety of data coming in from wearables, sensors, and other sources used in decentralized clinical trials, or the increased volume of safety cases received by pharmacovigilance teams, the amount of data is far more information than humans can process or manage and it is also much more complex.
Luckily, great advances have been made in artificial intelligence (AI) and machine learning (ML), which can be applied to automate many data-heavy processes to lessen the pressure on teams that are already spread thin. AI and ML not only process data faster than humans, they can point to patterns and trends that humans can’t see and will ideally lead to a more accurate and detailed view of how patients are responding in trials, which can lead to better outcomes in the long run.
How is Oracle working to facilitate the shift in clinical trials and the industry’s larger transformation from “the old way” to a new way of working?
Oracle Health Sciences was an early pioneer in eClinical, and over the course of two decades, we have come to intimately understand the technology needs of all trial types — from the simplest to the most complex, across all therapeutic areas. But we also learned that study teams and sites want more, with less.
In the past, sponsors and CROs may have used point solutions designed to improve specific processes in clinical trials, such as data capture and drug randomization and supplies management. But these systems weren’t built to work together, so a lot of process redundancy and data quality issues have been introduced. In fact, in the aforementioned survey2 we conducted late last year, 50% of respondents indicated that data quality was a top challenge in adopting decentralized clinical trial methods and their primary concern when it comes to remote data collection.
This is why we built Oracle Health Sciences Clinical One,3 a unified platform that can offer a streamlined, harmonized view of data. For example, with Clinical One data collection activity happens in the same environment as randomization and trial supplies management activity, so sites can randomize, dispense therapies, and collect patient data in one place, which makes their job a lot easier. Clinical One is not point solutions stitched together but rather provides a unified workflow with capabilities such as a single study build, self-service control, event-based data collection, and a single source of truth.
A major component of Clinical One is the ability to support data collection from any which allows for users to configure and monitor external data collection from any source — forms, wearable sensors, patient apps, electronic health records (EHR), labs — and harmonize it in a single place. This expanded data gives sites and study teams a more complete picture of the patient’s experience, and ultimately, the safety and efficacy of the investigative therapy, allowing them to make better decisions throughout the trial life cycle.
What are your expectations from the upcoming Oracle Health Sciences Connect events, both in the US and across the world?
I am really excited about our virtual Oracle Heath Sciences Connect event4 this year. We are bringing together leaders in the life sciences industry for in-depth discussions about what we have learned in the last year due to the pandemic and how to overcome the challenges of today’s clinical trial environment. We will hear from our customers and partners about how they are using technology to meet the demands of today’s clinical research, and how we will all adapt and prepare for the clinical trials of the future. I expect everyone will walk away from the event with new ideas and a better understand of not only what’s possible, but also how to implement these fresh approaches to conducting clinical research.