One silver lining of the COVID-19 pandemic is that it has accelerated the rate of change for pharma and life sciences fields in general.
The pandemic has forced a rethink of how to manage clinical trials and treat patients in hospitals and their homes. And the breakneck speed of vaccine development in 2020 could potentially lead to accelerated timelines for other therapeutics in the future.
The coming year of 2021 will likely be another pivotal year for the life sciences field at large, and drug developers in particular. Here, we asked several experts to predict the trends that will be most relevant in the coming year.
1. Pressure will mount to unblock clinical trial bottlenecks
The COVID-19 pandemic has underscored the need to optimize clinical trial processes. While the public-private initiative Operation Warp Speed has won public attention for its ability to speed vaccine development and distribution, “it has also focused new attention on common bottlenecks in the clinical trial process,” said C.J. Anderson, president of CCT Research, a clinical research network. “Now, the industry is looking at steps the life sciences industry could take to reduce those bottlenecks and speed up the process for other drug candidates.” Anderson cites several strategies to optimize clinical trials, including exploring new access points for patients, using AI to compress the screening process, generating public awareness of the benefits of participation, encouraging physician participation and expanding patient diversity.
2. Global decentralized studies will become a standard clinical trial design approach
After a year of unprecedented disruption in the clinical research industry, 2021 is set to be another transformative year for sponsors and contract research organizations (CROs), according to John Reites, president of Thread, a technology and service provider focusing on decentralized clinical research. “Studies will embrace decentralized trial approaches as design options earlier in the clinical trial planning process,” Reites said. This decentralized approach will support ongoing studies affected by COVID-19 lockdowns and studies that launch in 2021. “Sponsors and CROs will continue to be eager to bounce back and accelerate the drug development process after significant delays caused by the pandemic,” Reites said.
Sponsors’ and CROs’ priorities will also shift in other ways, according to Reites. There will be “greater focus on participant and research site inclusiveness,” he said. As the industry strives to improve recruitment, data collection and retention, it will seek to enhance flexibility and visit options for patients. “These focus areas will materialize in study designs as hybrid decentralized approaches that support global programs,” Reites said. “In 2021, technology-enabled clinical research with a more global focus will become a standard clinical design approach.”
3. Radiomics will gain ground in drug development and clinical trials
Precision imaging analytics technology known as radiomics will see increased adoption in 2021 and will be incorporated into drug development strategies and clinical trials management, according to Rose Higgins, CEO of HealthMyne. “These AI-powered analytics will enable drug developers to gain deeper insights from medical images than previously capable, driving accelerated therapy development, greater personalization of treatment and the discovery of new biomarkers that will enhance clinical decision-making and treatment,” said Higgins.
4. Life science companies will turn to NLP to process mountains of text-based data
Natural language processing (NLP) has long held potential for the life sciences field, given the industry’s reliance on text-based data in the form of clinical records, scientific papers, pharmaceutical companies’ call center transcriptions and so forth. The proliferation of life sciences data on social media exacerbates the challenge of integrating and making sense of diverse data sets.
The data proliferation has “created a wealth of opportunities for life science companies seeking to advance drug development and gain deep insight at all stages — from discovery to development and the delivery of therapeutics in the clinic,” said Jane Z. Reed, director of life sciences at Linguamatics, an IQVIA company. “To effectively leverage value from massive data sets – and also efficiently manage compliance and safety initiatives – life science companies will need advanced AI-based technologies such as natural language NLP to advance their digital transformation efforts, enable a deeper understanding of data, and help boost organizational productivity,” she explained.
Reed also expects growing traction for AI and machine learning tools and digital health initiatives in the coming year. One trend driving this shift is the rise of remote healthcare and telehealth during the pandemic, which heightened the need for “more innovative data capture at the patient end but also data reuse at the healthcare end,” Reed added. Furthermore, a branch of AI known as robotic process automation that has gained traction in other sectors will continue making inroads in healthcare to reduce the need for tedious routine tasks.
5. Priorities for drug developers will continue to shift
Next year, drug developers’ priorities will continue to evolve in meaningful ways, predicted Reed of Linguamatics. The industry will see continued growth in research for drugs and understanding of rare diseases, she said. Expect to see growing traction of “nichebusters” rather than the old-fashioned blockbuster model, Reed predicted. “The life sciences industry is looking at unmet needs and developing drugs to address this,” she added. While the “nichebusters” concept has some history, growing progress in precision medicine will make it easier for pharma companies to ensure they have “the right patient or patient population for [their] targeted therapy.”
As the number of drugs entering the market increases along with pricing and market-access pressures, Reed expects to see progress in pharmaceutical companies’ ability to make value-based assessments based on “real-world data to support drug access, product brands and so forth.”
6. Digital therapeutics will increasingly complement drugs
After smartphones had been around several years, a handful of influential digital-savvy physicians began to boast that they prescribed more apps than drugs. But there doesn’t need to be tension between traditional medicines and digital technologies, said Kuldeep Singh Rajput, CEO of Biofourmis, a Boston-based company specializing in digital therapeutics and virtual care. “In 2021, we will see an increasing number of drugs developed in conjunction with digital therapeutics (DTx) solutions,” Rajput predicted. “Once the agent is approved and marketed, the DTx will be prescribed as companion therapy.”
When patients are prescribed a drug, their doctor will explain “that it comes with a companion biosensor such as an armband wearable to collect physiological data 24/7 and a smartphone app,” Rajput said. From there, the IoT-enabled sensor will enable the physician to track relevant health changes. Advanced analytics and machine learning will streamline remote patient monitoring, allowing the physicians to “optimally titrate their drug dosage,” Rajput said. “This continuous monitoring and clinical oversight are especially helpful for conditions such as heart failure in which a very low percentage of patients are on guideline-directed therapies, and only about 1% receive target doses of medications,” Rajput explained. The use of analytics-driven patient monitoring also supports “alerting clinicians to any clinical decompensation that could signal an issue with the drug or another health problem that needs to be addressed,” Rajput added. “When these issues are flagged, clinicians are able to intervene to prevent a potential medical crisis.”
7. Visibility grows across the life sciences value chain
The Pfizer-BioNTech SARS-CoV-2 vaccine’s requirement to be stored at –70 °C has highlighted the cold-temperature-controlled supply chain’s importance. Mandar Paralkar, head of life sciences industry at enterprise software giant SAP, sees a growing number of organizations becoming aware of the need for more stringent traceability of supply chains extending beyond COVID-19 vaccines. “Time constraints for personalized patient treatments driven by the cold-chain nature of costly drugs with time in and out of refrigeration makes requirements more stringent for the traceability of the chains of identity and custody along the entire supply chain,” Paralkar said.
Another factor driving improved visibility of the supply chain in life sciences is the growing adoption of Industry 4.0, the German smart manufacturing concept. In Industry 4.0, “sensors, devices, machines and other equipment are all interconnected,” Paralkar said. Similar interconnection is coming to the life sciences field at large. “We’re gaining full transparency and visibility across the Life Sciences value chain,” Paralkar explained.
8. Uptick in M&A and more precise inventory management
Earlier this year, there was a surge in large pharmaceutical companies acquiring biologics and therapy companies. Paralkar of SAP expects this trend to continue in 2021. “In the coming year, we’re going to see a lot of business activity in the field,” he said. “Because of the growing interest in personalized medicine — not to mention the high-profit margins on costly drugs — we will probably see even more acquisitions as the pharmaceutical sector continues to diversify and grow its portfolios.”
Given the increased transparency stemming from the digitized supply chain mentioned in the prior prediction, “inventory management will become more tightly focused,” Paralkar said. “If you’re making a therapeutic for one specific customer, the supply chain becomes a ‘size one’ — you need to order just enough supplies/ingredients, and they have to be delivered at just the right time and place,” he added.
In the long run, Paralkar expects that drug companies will shift toward making personalized treatments rather than produce assembly-line-driven “make-to-stock” inventories. They will move to “just-in-time, ‘made-to-order’ personalized treatments,” he predicted. Underpinning that model, drug makers will rely on “automation and AI- and blockchain-centric platforms that can link up with hospital systems to quickly get data about patients,” Paralkar said. “There will be faster time-to-market for targeted therapies.”
9. Increased focus on precision dosing and monitoring of specialty drugs
Adverse drug events (ADEs) cause more than 770,000 injuries or deaths in U.S. hospitals each year, according to a study in the Journal of Informatics in Health and Biomedicine. Such adverse events “prolong hospital stays by up to 4.6 days and adding a cost burden of more than $30 billion annually to the U.S. healthcare system,” said Sirj Goswami, CEO of InsightRX, a cloud-based clinical decision support platform. “As the focus continues on reducing harm from ADEs, we will start to see an increase in precision dosing and monitoring of specialty drugs, especially for those with narrow therapeutic indexes and wide variations in drug response,” Goswami added.
Goswami also anticipates that pharmaceutical companies will place an early emphasis on precision dosing during clinical trials related to drug development. “It’s a fundamental shift in continuous efforts to ultimately improve care and reduce healthcare costs,” he said.
10. COVID-19 will continue to surprise
For all of the brainpower and data models researchers have used to model the COVID-19, the pandemic continues to surprise experts. The unprecedented nature of the pandemic makes it challenging to anticipate what impact the virus will have next year. “I don’t think there is enough information at this point to do long term estimates,” said Kasey Fu, director of epidemiology at GlobalData. “There are so many unknowns.”
There are known unknowns and unknown unknowns at work, to paraphrase former U.S. Secretary of Defense Donald Rumsfeld. When it comes to the former, it is difficult to anticipate the rate of transmission months in advance or to foretell the logistics issues at play when distributing two doses of vaccine to hundreds of millions of people in the U.S. Production hiccups and vaccine hesitancy are other factors to consider. But there will also be surprises, Fu said, just as there was with the pandemic in 2020. “When the pandemic started, nobody expected the U.S. to mess up testing,” she said. “Nobody expected so much push back about wearing a mask. It’s what we don’t know that’s scary at this point.”
Fu counsels that healthcare leaders act if a vaccine won’t be available for at least six months. “Vaccines are not going to be widely available for months. “Worldwide vaccine distribution coverage is going to be even slower and with much bigger gaps,” Fu said. “COVID-19 anywhere is COVID-19 everywhere. Resurgence due to travel-related cases has been a big problem in countries that have controlled the domestic spread of the virus well, like China, South Korea and Japan.”
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease