The pharma industry has been slower to embrace technologies such as AI and digital technology than many less-regulated sectors. The COVID-19 pandemic has changed the equation, forcing pharma companies to become more agile and open-minded in approaching drug discovery and development, including managing evolving clinical trials.
In this article, several experts offered their predictions of the trends that will be most meaningful in 2022.
1. Digital components drive new pharma value
In 2022, a growing number of pharmaceutical companies will recognize how their products could deliver significantly improved outcomes with a digital component, predicted Jaydev Thakkar, chief operating officer of Biofourmis, which offers digital therapeutics and care-at-home solutions powered by AI. “This digital component could be either a regulatory-cleared therapeutic, combined with a drug that helps treat or manage a disease, or a virtual care element to improve patient engagement and experience across the disease management journey,” Thakkar said.
Digital companion tools can capture meaningful real-world data on drugs’ efficacy, safety, adherence and engagement. As more pharma companies realize this fact, such “tools also will become essential in developing value-based contracts with payers,” Thakkar said. “We expect more pharmaceutical companies to release new drugs along with such evidence-based digital therapeutics or to introduce a virtual care element to accompany a previously released drug they still control under patent.”
2. Dynamic clinical trial designs dawn
The pandemic has disrupted how biopharma meets the complex needs of patients in clinical research. “Thanks to these changes, patients who wish to participate in many clinical trials are no longer tied to single locations,” said Tom Lemberg, founder and CEO of Curebase, which has created a decentralized clinical trial software platform. “Patients have unique lifestyles, and study designs that cannot accommodate a patient’s needs fail to recruit participants effectively.”
Traditional clinical trials can often be burdensome for patients. “It’s not uncommon to see a trial requiring a patient to visit the same clinical trial site repeatedly, and those trials sometimes only secure a single patient for common conditions,” Lemberg said.
A growing number of studies now allow more flexibility in how patients choose to participate. “When participation can be handled virtually — at home, at local pharmacies, or with their own doctor — options are an effective way to engage patients successfully,” Lemberg said. “As we move into 2022, I expect we will see dynamic trial designs that give patients an ever-growing number of methods to participate in studies from home or amidst their busy lifestyle traveling the globe,” he added. “Biopharma must meet the needs of these people to accelerate studies and engage target patients.”
3. Data science in drug discovery and development evolves
2021 proved to be a pivotal year for the adoption of data science in the pharmaceutical industry for drug discovery and development. Jane Z. Reed, director, life sciences at Linguamatics, an IQVIA company, expects this trend to continue. “Companies risk missing market opportunities if they wait for the development of enterprise solutions, so data scientists are asking for cloud-first tools that can be plugged quickly and easily into existing workflows — without requiring the implementation of an enterprise solution,” Reed said. “Agile tools are needed that can be leveraged with existing processes to surface the appropriate answers.”
The uptick in interest in data science in pharma encompasses natural language processing (NLP), which can help “data scientists automate and accelerate workflows for unstructured text more quickly and efficiently to surface insights that inform the drug development process,” Reed said.
4. Pharma invests in pharmacogenomics
Genetic mutations play an important role in many diseases, yet fewer than 200 of the 20,000 FDA-approved drugs have labeled indications and usage that include genetic mutations. “In 2022, life science researchers will increase their investment in pharmacogenomics,” said Jim Robbins, senior vice president of life sciences at Arcadia, a healthcare data and software company.
“This investment will focus on two key areas: the collection of genetically diverse population genomic data and the linkage of these data to deep phenomic data that includes claims, structured EHR, NLP-extracted unstructured EHR, lab results and wearable device data,” he said. Robbins anticipates that the resultant genomic-phenomic data will accelerate pharmacogenomic discovery. As a result, pharmacogenetics will “reshape the current paradigm of disease-specific drug approvals into mutation-specific indication and usage approvals,” he said.
5. Digital therapeutics step up
The use of digital therapeutics (DTx) is poised for high-need conditions, including neurodegenerative diseases such as Alzheimer’s disease, will accelerate in 2022, said Aniket Singh Rajput, CEO and founder of Neuroglee Therapeutics. “While there are more than 100 drugs in the drug development pipeline for Alzheimer’s disease, not all patients are candidates for every drug; many have only a modest effect on patients’ cognitive functioning, behavior and other symptoms; and it can be difficult to objectively measure any improvement on an ongoing basis,” said Aniket Singh Rajput, CEO and founder of Neuroglee Therapeutics, which builds personalized prescription digital therapeutics and virtual care solutions for neurodegenerative diseases. “This means there’s an urgent need to slow dementia-related cognitive decline via digital therapies, either adjunctive therapy or monotherapy,” Rajput said.
Rajput is optimistic about the prospect of emerging technology that can employ gamification and cognitive tasks on a digital tablet, and machine learning algorithms will customize the tasks for each patient based on their personal baseline. “In addition, the platform will continuously track the patient’s cognition, enabling the clinical team to perform clinical monitoring, ongoing assessments and interventions — all virtually,” Rajput. “Given the enormous unmet need in this area, this may be one of the biggest game-changers yet in the DTx space.”
6. Radiomics adoption continues gaining steam in drug development
Drug developers will increase their use of radiomics, or advanced imaging analytics, to help guide clinical trials strategies, predicted Rose Higgins, CEO of HealthMyne. “For example, life sciences companies can develop more robust inclusion-exclusion criteria for clinical trials and more precisely predict patient outcomes by leveraging radiomics, which creates new insights into the biology of tumors through artificial intelligence algorithms that analyze traditional images like CT and PET scans,” Higgins said. “By enabling researchers to obtain real-world data that objectively quantifies the characteristics of cancer patients’ tumors, radiomics allows clinicians to make personalized, data-driven predictions about how a patient’s disease is likely to progress.”
7. The pharma industry’s use of AI continues to mature
The pharma industry’s adoption of AI remains a nascent stage. But next year, the pharmaceutical industry will benefit from new insights in understanding patients and diseases thanks to advances in artificial intelligence, according to Sujay Jadhav, CEO of Verana Health. “Specifically, natural language processing, machine learning and computer vision will unlock more profound insights into disease progression, clinical characteristics and outcomes that inform the drug lifecycle,” Jadhav said. “There is valuable real-world, unstructured data stored in electronic health records,” he added. “Using natural language processing to make sense of the free-form text and derive meaningful insights from millions of doctors’ notes will allow life sciences companies to advance research and develop more targeted and effective therapies for patients.”
8. Precision dosing grows more common
Preventable adverse drug events are all too common, leading to approximately hundreds of thousands of hospital admissions every year. The increase in precision dosing and the monitoring of specialty drugs, especially those with narrow therapeutic indexes and wide variations in drug response, can help tackle the problem, said Sirj Goswami, CEO and co-founder of InsightRX.
“In 2022, many pharmaceutical companies will begin to incorporate precision dosing early on in the drug development process for specialty drugs to close the real-world data gap and help develop more precise dosing recommendations for novel therapeutics,” Goswami said.
9. Virtual healthcare catalyzes more change in health IT
Patients’ expanded appetite for healthcare at home will have a domino effect on health IT, including driving digital tech that enables virtual care at scale, predicted Andrew Burns, chief growth officer at DrFirst. “This tech will go beyond telehealth visits to include new ways to support the patient at home throughout the patient journey,” Burns said. “Expanded opportunities for remote care will, in turn, drive the need for better communication and connection between patients and their entire care team.”
The demand for virtual healthcare is poised to grow as the populations in many parts of the world age. “We can strengthen patient connection and engagement with secure access to their health data, seamlessly integrated with personalized and relevant clinical and educational resources that meet their specific needs,” Burns said. “Patients will expect more and easier access to their medical records and want trusted health information to take a more active role in their treatment decisions.”
Filed Under: clinical trials, Drug Discovery