Trends from the 2021 U.S. Pharma and Biotech Summit
The past year has been challenging for the clinical trial industry — sites were closed, patients were hesitant to visit sites, and the industry had to adapt to a remote workforce. It also created a unique opportunity to update the current methods of conducting clinical trials, gathering data, collaborating on innovations, and delivering results.
For the first time, regulators, investigators, sponsors, contract research organizations, and the pharmaceutical industry were all aligned on a singular goal: develop a Covid-19 vaccine while still continuing clinical research. This created unprecedented collaboration in the space, not only for drugs, but for solutions and initiatives to improve the overall industry. At the “Financial Times U.S. Pharma and Biotech Summit,” industry leaders came together to discuss key trends that are moving the life sciences industry forward after the pandemic.
Technology Innovations for Better Outcomes
“We believe that the pandemic accelerated digital adoption by at least five years and that these new ways of working are here to stay.”—Lidia Fonseca, EVP, Chief Digital and Technology Officer, Pfizer
During the pandemic, the life sciences industry had to innovate at unprecedented speeds, finding solutions to keep drug development on track while looking ahead at Covid-19 vaccines. For once, technological tools and digital transformation became a necessity in order to continue to facilitate trials. John Reites, CEO, THREAD Research, said that they “used to get a lot of questions about why the industry should adopt a decentralized approach. Now, we’re getting questions about how to shift to decentralized trials.” For a highly regulated industry that struggles to change, pharmaceuticals needed a push to innovate which the pandemic delivered.
At the same time, clinical trials are contending with an increased number of data sources, which is creating immense amounts of data. By improving data management strategies to enable real-time analysis, the industry can use this proliferation of data to harness artificial intelligence, machine learning, and advanced analytics. Pfizer credits the success of their Covid-19 clinical trials to the speed at which they could drive data analysis. “It got to the point where we were able to look at data every hour and make decisions based on that,” said Fonseca. With a strong foundational data structure, clinical trials are able to use advanced analytics to enable better trial outcomes.
Decentralizing Trials for Patient Centricity
Although decentralized and hybrid trial approaches have existed for years, the pandemic forced the industry to rapidly adapt to continue trials. With remote and virtual monitoring being used alongside wearables and medical devices, trials were successfully completed while enabling further access to trials. Decentralized trials have also fostered patient-centric environments as the industry is able to work with patients at home or in diverse settings, in tandem with monitoring methods that make participation easier. Many professionals are hoping that these methods will also help diversify patient populations, as they can access individuals located in remote communities. This democratization of trials will promote the creation of drugs and therapies that work for diverse populations.
Although many understand the need for decentralized and hybrid trials, there are still difficulties in implementing these solutions, including a workforce that can support these tools. The life sciences industry is focused on upskilling their workforce to ensure that they understand the new tools and can draw advanced analytics from new data sources. Many experts have also emphasized the need to create standardized processes throughout the industry. Organizations like the Decentralized Trials and Research Alliance are helping the industry accelerate the adoption of patient-focused, decentralized trials by creating standards. Currently, decentralized trials are used “to enable trials to be completed at the best way possible and to enable patient centricity,” says Anne Heatherington, SVP, Head of Data Sciences Institute, Takeda. In the future, decentralized trials will be optimized to become more cost-effective and efficient.
Industry Collaboration for Speed to Market
“We have seen an unprecedented amount of collaboration between government, industry, and academia to develop vaccines in record time and understand patient populations.”—Dr Niven R. Narain, Co-Founder, President & CEO, BERG
Throughout this past year, universities and key stakeholders have collaborated on research in order to accelerate the Covid-19 trials. This was critical for creating agile clinical trials, where pharmaceutical companies could begin trial phases in conjunction, without waiting for results. It also improved the drug manufacturing process — vaccine developers were able to partner with drug manufacturers to hasten the speed to market once the vaccines were approved. With government support, organizations working toward a vaccine were also able to receive funding to improve processes and tools.
Emerging from the pandemic, there has been significant interest in data sharing and collaboration. In order to accelerate promising drugs and therapies, industry leaders are focusing on pooling available resources. Sharing knowledge can also be used to assemble more heterogeneous data sets, as organizations can access diverse populations.
Unfortunately, there are still many hurdles for secure data sharing. For one, data standards differ between companies, which makes preparing data to export burdensome. Another problem is access — there are contrasting ideas about who should be able to access shared data and how to do this securely. With a renewed focus on patient centric trials, data sharing will be an important next step for the industry.
Remaining Focused on the Future
“Is there a danger that some of the old ways of working reassert themselves when there’s no longer a sense of urgency?”—Sarah Neville, Global Health Editor, Financial Times
The trends emerging from the life sciences industry follow a common goal: improving speed to market for drugs and therapies. Collaboration, digitization, and decentralized trials — along with interest and support from industries and the public — allowed Covid-19 vaccines to be developed at unprecedented speed. As Dan DiVito, Head of Respiratory Portfolio, Sanofi, said in the session Pharmaceutical portfolio management strategy, “After the pandemic, what will the new normal be? Clinical trial timelines will not be as quick as 8 to 10 months, but they can no longer take 8 to 10 years.”
What we’ve echoed in our company — and what we’ve seen at the event — is the importance of advancing the life sciences industry. We have all made great strides to improve clinical trial development. The challenge becomes how to continue building on these advancements to achieve great outcomes in the future. As an industry, we need to collaborate to continue developing efficient, patient-centric clinical trials to bring lifesaving drugs and therapies to market quickly.