1. 2023 could be ‘massive showcase’ for ML in pharma
Drug developers are sharpening their focus on machine learning (ML) — exploring the use of algorithms to sift through massive volumes of molecular, biochemical and genomic data. “AI is contributing to the acceleration of the discovery and development of new drugs and will continue to have a significant impact in 2023,” said Sigma Mostafa, senior vice president and site head at KBI Biopharma.
“As ML continues to become more accessible, more research teams can meaningfully collect, process and analyze massive data sets,” said Chris Fisher, scientific affairs manager at Provectus Algae. “This allows researchers to better mine life’s biochemical diversity, evaluate candidate drug performance, improve bioprocesses, and much more.”
Many life science companies are integrating ML into their work, including “startups built on a foundation of these technologies,” Fisher said. “I think 2023 will be a massive showcase for those efforts.”
2. Omics plus AI will be a ‘game changer’
One factor driving the adoption of AI in drug discovery and development is the combination of omics data with AI. Mostafa predicts the marriage of the two “will be a game changer” in 2023. “The availability of novel Cas nucleases and non-nuclease gene editing tools with better specificity than CRISPR will have a significant impact on gene therapy and on disease model development for drug discovery,” Mostafa said.
3. Plant-based platform adoption will accelerate
The pandemic has inspired the exploration of new platforms beyond mammalian cell drug development. Plant-based platforms are a benefactor of this thirst for innovation. “Plants as bioreactors have been in the clinical space shadow for years,” said Bill Brydges, CEO of Phylloceuticals. “However, they will now explode due to the incredibly fast turnaround from target protein to product production and fast ‘switching ability.’
Given the behemoth stainless steel infrastructure they require, mammalian cell platforms have traditionally struggled to switch to a new target product. “With plant-based platforms, scientists just grow a new set of plants to produce the next needed product,” Brydges said.
The CEO expects his company to win growing traction in 2023 — pointing to companies such as Provectus Algae, Angany and Medicago as further examples of companies that will see growth.
Medicago and its partner GSK won approval from Health Canada for an adjuvanted plant-based COVID-19 vaccine in February 2022. Medical recently cut 62 jobs at a site in Durham, North Carolina.
4. Pharma industry will redouble its focus on sustainability
In recent years, many life science companies — including drug developers — have announced environmental initiatives. Many pharma companies have pledged to go carbon neutral within the next decade. “In 2023, the life science community and the pharmaceutical industry need to redouble their commitments to long-term sustainability,” said Chris Fisher of Provectus Algae. “Today’s innovations can only provide their anticipated impact if we protect them from the consequences of environmental damage.”
Fisher notes that the pharmaceutical industry has an opportunity to lead by example by being climate-conscious. “We have the scientific chops needed to make it a reality,” he said. “We need to go beyond carbon offset programs by developing new technologies that significantly improve the sustainability of research workflows and bioprocesses.”
5. The success of mRNA vaccines will provide a template for collaboration
The pandemic helped catapult mRNA vaccines into the mainstream. The success of mRNA vaccines will provide a “template for collaboration across industry, academia and government sectors to propel new therapeutic innovations forward,” said Sigma Mostafa of KBI Biopharma. In addition, the pandemic helped the industry “take a critical look at all aspects of drug discovery, development, manufacturing, and regulatory review to determine the fastest pathway to get the vaccines approved,” Mostafa continued. “The cross-sector collaboration and the streamlining of the drug development paradigm are critical to accelerating therapeutic innovation in 2023.”
6. Digital biomarkers are poised for a breakout year in 2023
With renewed interest in Alzheimer’s Disease therapeutics from lecanemab, to CMS final rule issuance on Remote Therapeutic Monitoring (RTM) services, there has never been a greater need for biomarkers that can precisely track or even predict an individual’s disease trajectory, according to Dr. Sunny Kumar, a partner at GSR Ventures, which invests in early-stage digital health companies. “Although the industry is still in relative infancy, the significant tailwinds being generated around the sector will create strong set of aligned incentives that will drive a robust wave of adoption in the upcoming year and beyond,” Kumar said.
7. Omics will lead to an explosion of new diagnostics, candidates and drug targets
The level of investment in omics for drug discovery is increasing, noted Sigma Mostafa of KBI Biopharma in his drug discovery predictions. “Multi-omics technology elucidates the exact cause of a disease and its effect on a specific biological pathway,” she said. “These technologies can accelerate hypothesis generation, target selection, and biomarker prioritization.”
Biological systems rely on an intricate interplay of countless biomolecules, noted Chris Fisher of Provectus Algae. Sophisticated multi-omics technologies help researchers deconvolute this interplay to the role of biomolecule dysregulation and disease. “As more omics technologies are clinically explored in 2023, we will see an explosion of new diagnostics, candidates and drug targets,” Fisher predicted. “For example, the pharmaceutical industry has hardly scratched the surface of glycobiology. With better glycomics technologies, researchers can unlock this untapped class of biomolecules as drugs and targets.”
Another one of Fisher’s drug discovery predictions is that there will be more efforts merging omics technologies with machine learning for biodiscovery.
Mostafa said omics data would lead to the enrollment of high-risk patients most likely to benefit from a new drug. Such data can reduce clinical trial size and increase the probability of clinical trial success. “The current challenges with omics data are data quality, computational tools, and end-user training,” she said. “In 2023, we will see further adoption of omics technologies by large pharma and more startups offering solutions for omics data processing.”
8. DCT industry will fuel patient-centricity
In 2023, the decentralized clinical trial (DCT) industry will accelerate the adoption of patient-centric technology and approaches, according to Sean Lynch, VP of clinical operations at Curebase, a U.S.-based DCT technology and services provider. “As regulators continue to engage more deeply with the industry on the understanding of what DCT actually means, better guidance and guardrails will continue to be put forth,” he said. As a result, major players in commercial pharmaceuticals and clinics will increase their focus on the DCT space. “Not only will this expand the DCT industry, but more importantly, patients will have better access to care options and opportunities to participate in trials,” Lynch said.
9. Deep learning will extend role of EEG in clinical trials
Jacob Donoghue, CEO and co-founder of Beacon Biosignals, expects researchers to identify endpoints in clinical trials that haven’t been seen before by applying deep learning models to full EEG recordings. “For example, novel neurobiomarker endpoints such as 24-hour spike burden, spike counts or spike amplitude could be established as primary or secondary endpoints in pivotal clinical trials,” Donoghue said. “These endpoints will help study sponsors assess the effectiveness of specific targeted therapies and doses,” he explained. “We expect this to accelerate as more life sciences companies incorporate EEG into their trial design.”
10. Role of AI in safety will be a priority
The evolving growth of precision medicine, patient-centered drug development and real-world data will sharpen the focus on delivering safer drugs and the right drug to the right patient at the right time, according to Jane Reed, director life science strategy at Linguamatics, an IQVIA Company that delivers a NLP-based AI platform. “AI technologies such as natural language processing (NLP) and natural language generation (NLG) can support (not replace) toxicologists and safety experts in finding, extracting, synthesizing and understanding safety data from the increasing volume and velocity of sources,” Reed said. “This will improve safety at all points in the drug pipeline — target liability, compound toxicity, drug safety, pharmacovigilance.”
11. Development and use of digital biomarkers will accelerate
The cost and patient-recruitment benefits of decentralized and hybrid clinical trials are well-known, but what’s discussed less often is how pharmaceutical companies and PROs can ensure trial participant safety while balancing the need to efficiently collect meaningful physiological data, according to Jaydev Thakkar, chief operating officer of Biofourmis. “The answer here is the continued development and utilization of digital biomarkers,” Thakkar said.
The appropriate set of clinically validated digital biomarkers relevant to specific clinical studies enables researchers to take advantage of sophisticated wearable sensors capable of wirelessly collecting meaningful information. Additionally, such biomarkers enables researchers to collect such information in far less time and effort than in-person clinical site visits. “When that data is analyzed through artificial intelligence algorithms and personalized via machine learning, investigators can gather needed insight into therapeutic efficacy much sooner and with greater reliability than analyses that are conducted months or years later,” Thakkar said. “More importantly, these data science technologies are capable of warning researchers of potential adverse reactions in patients and identifying formulations that need to be modified or abandoned earlier before the next trial phase.”
12. Greater use of curated RWD
In 2023, there will be wider acceptance of curated real-world data (RWD) as part of the drug development process, predicted Sujay Jadhav, CEO of Verana Health. “Quality RWD will be an increasingly useful tool for advancing, enhancing and improving clinical trial and post-approval processes,” Jadhav said. “It helps provide insights on patient demographics and helps guide site selection, which can accelerate trial recruitment and promote a more representative set of participants.”
The growing use of RWD supports clinical trial diversity and ultimately contributes to the development of better therapeutics and greater health equity. “Lastly, quality RWD may potentially be used to create synthetic control arms, which can reduce the cost and time associated with traditional clinical trials and safety studies,” Jadhav added.
13. A wave of food allergy therapeutics innovation will arrive
A wave of innovation is paving the way for a new era in food allergy therapeutics, said Anat Binur, Co-founder & CEO of Ukko. “Food allergies have long been a massively underserved disease area, despite the fact that they are a globally prevalent and pervasive problem,” Binur said. “Hundreds of millions of people around the world cope with them, suffering from disruptive to deadly impacts without any substantive solutions offering relief.”
Binur believes that in 2023 and beyond, a growing number of innovators will use the expanded availability of patient data, a newly paved regulatory process and technology advances to develop novel drug development approaches. The resulting drugs will replace or significantly improve current symptom management and avoidance strategies, Binur said. “Companies harnessing cross-disciplinary technologies, such as AI and protein design, will be able to further advance the field of allergy therapeutics by designing smarter medicines that offer precise targeting and delivery, offering new hope for people living with food allergies,” she added.
14. Interest will remain high in detecting novel pathogens
The pandemic showed that we are not at all prepared for how a virus can disrupt our lives, our habits and the global economy, according to Matt McKnight, general manager of Biosecurity at Ginkgo Bioworks. “It was a wakeup call for governments and the public sector that we can’t ignore,” McKnight said.
COVID-19 also demonstrated that rapid scale-up, intervention and response is possible. “We can effectively mitigate pathogens, but we need to remain vigilant,” McKnight said. “Ahead of the next pandemic, we must develop virus ‘radar’ stations and better monitoring tools so that we can detect and intercept pathogens, as well as mobilize swiftly to adapt to the next threat without risking massive economic fallout,” he added. “Pandemics will continue to be disruptive unless emerging biosecurity tools are developed and deployed.”
McKnight says the biggest weak spot related to pandemic preparedness involves the technologies used to monitor biology. “Technological advances in sequencing allow us to treat the genetic code of the planet like digital code, and we must utilize biotechnology to build a robust global monitoring system that will swiftly detect and respond to any pathogen, whether it comes from nature or a bad actor,” he said.
There are reasons for optimism, McKnight says. He points to massive increases in funding for detection programs, including biosecurity tools like wastewater monitoring in communities to track the evolution and spread of a pathogen and epidemiological forecasting to manage and understand risks.
McKnight also highlights Engineered Nucleotide Detection and Ranking (ENDAR), a surveillance tool it developed with Intelligence Advanced Research Projects Activity (IARPA) that can determine if an organism is genetically engineered. “Consider the scale of security monitoring we have for computer systems or people traversing international borders,” he said. “Similar technology exists for biosecurity, but we have not yet been able to scale it in the way that’s necessary to avoid the next pandemic.”
15. Industry will continue to work on building resilient supply chains
Nearly half of pharmaceuticals are sourced from nature, which means the active pharmaceutical ingredients (APIs) we rely on are largely extracted from plants, farmed as crops, according to a spokesperson from Antheia, which aims to develop novel plant-inspired medicines. “Relying on agricultural sources for these critical APIs requires years of growing and harvesting in a process that is vulnerable to pests, climate crises and geopolitical events,” the spokesperson said. “This results in fragile, unpredictable and expensive pharma supply chains and regular drug shortages when the availability of raw materials is compromised.”
The pharmaceutical industry has long tried to make its supply chain more nimble, efficient and resilient. “But for many decades it has not seen consistent and dynamic long-term solutions, particularly when medicines are sourced through traditional agricultural pathways,” the Antheia spokesperson said. “This shortcoming was made starkly apparent during the pandemic when demand for essential medicines (e.g., sedatives for ventilators) rose and global supply chains faltered. As a result, we’ve seen a renewed focus on how, as a global community, we can be better prepared for global events like COVID by building more resilient, diverse, and secure supply chains.”
Filed Under: Data science, Drug Discovery and Development, Genomics/Proteomics, machine learning and AI