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AI Can't Fix Clinical Trials Without The Right People, New Parexel Report
AI Can't Fix Clinical Trials Without The Right People, New Parexel Report

Forbes

time16-05-2025

  • Business
  • Forbes

AI Can't Fix Clinical Trials Without The Right People, New Parexel Report

Parexel's research found 6% of surveyed executives say their organizations are "exceptionally ... More prepared" to handle AI-driven drug development — more than 50% named AI training as a high priority. The potential of artificial intelligence in pharmaceutical research is intriguing. AI software is making its way into clinical research workflows from predictive analytics through to pharmacovigilance. However, based on new research from global clinical research organization Parexel — and the company's Chief Business Officer, Keri Mattox — there is a much more important variable determining trial success: humans. Published Thursday, Parexel's staffing report provides one of the fullest pictures to date of how the biopharma sector is rising to the challenge of technological disruption. Based on a global survey of 501 professionals, the report looks at where AI is being utilized, what is successful and where talent deficits could hinder advancement. 'There's an explosion of data across the clinical landscape,' Mattox said during a Thursday fireside chat at the Financial Times U.S. Pharma and Biotech Summit. 'But that data only becomes useful if you have a workforce that knows how to harness it —critically, thoughtfully and in service of the patient.' AI use is a bit patchy within the CRO space right now, Parexel's study finds. Fewer than 40% of respondents reported regular use of AI tools across their clinical workflows. Enthusiasm is growing, nonetheless, particularly for narrow but high-value use cases such as automated site reports, regulatory monitoring bots and early-stage data synthesis. Mattox gave one unexpectedly simple example, 'There are regulatory websites that won't push updates to us. Someone had to sit and manually refresh those pages. Now, we've got AI bots scanning them in real time. That small automation translates into measurable acceleration when you multiply it across thousands of trials.' This chase is not surface-level. With clinical trial complexity and costs on the rise, AI offers a chance to shift from reactive to proactive R&D — if businesses invest in the talent to make it happen. Mattox's sentiments mirrored the implicit message of Parexel's report: the biopharmaceutical industry is not yet ready to leverage AI to its fullest capabilities. Just 6% of surveyed executives feel their organizations are "exceptionally prepared" to handle AI-driven drug development. Over half indicated that training in AI capabilities is now a high priority. 'More than half of [biopharma leaders] say that AI experts are going to be the most important role to fill in the next three to five years,' Mattox noted. 'And that training them to actually use AI is a top priority. It's not just about teaching someone how to use a tool. It's training people to know when that tool adds value, when it doesn't and how to interpret what comes out of it.' According to the Parexel study, AI is proving to be a useful tool for clinical research. However ... More there is near term need for more and better "human-in-the-loop" AI training in the sector. Contrary to headline fears that robots will displace scientists, near-term reality is more collaborative. Parexel's report substantiates the notion that AI will thrive in "human-in-the-loop" systems where humans remain responsible for verifying conclusions, identifying biases and guiding outcomes. Mattox echoed the same sentiment. 'AI isn't a substitute for clinical expertise. It's a new arrow in the quiver — a powerful one — but its value depends entirely on how well humans can engage with it. That's why we're focused on upskilling at every level of the organization.' Surprisingly, the report found that frontline workers are more proficient in entering data than in understanding AI-generated outputs. The asymmetry in capability comes with some risk — most particularly as regulatory processes become increasingly data-intensive and dispersed. AI is also reinventing classic job roles. Parexel's survey says "multi-fluent" roles — roles that are a combination of clinical, technical and data smart — will be the future norm. In addition to bringing in AI specialists, organizations need to create staff members who can manage ambiguity, work across functions and identify patterns that machines can't. 'We're seeing AI added to nearly every role, not just isolated to new job titles,' Mattox explained. 'Junior team members are using AI to sift through thousands of pages of data, while senior leaders are being trained to make final decisions based on AI-assisted insights.' Yet that uptake is not unqualified. Sponsors are being careful about introducing AI into data sets that are already under regulatory scrutiny, Mattox indicated. 'There's not a fear of AI per se, but there's real sensitivity around when and where it gets used — especially if it could influence submission outcomes.' In addition to tech savviness, the report identifies a second, less apparent revolution – culture. Top-performing organizations aren't only investing in AI technologies, they're building cultures in which continuous learning, mentorship and meaning flourish. Parexel's research demonstrates that face-to-face, hands-on training leads to greater retention and more successful outcomes than web-based modules by themselves. 'We're hearing from experts across the field that the best way to train people is in person. It's hands-on mentoring. And the companies doing that are retaining those workers better,' Mattox explained. That clarity of purpose is more than an inspirational mantra. It's a retention strategy in an open-talent market where AI-enabled workers are in increasingly high demand across industries because AI natives drive results. 'We tie everything — AI adoption included — back to our core mission of getting therapies to patients faster,' she said. 'If we can show that you can close a trial 35% faster using AI at three touchpoints, even the skeptics become supporters,' she said. As sponsors demand more efficient, adaptive and patient-centric trials, CROs such as Parexel are evolving their role as talent engines instead of service providers. Regardless of whether full-service outsourcing or hybrid approaches are used, the capability to quickly mobilize trained, AI-enabled talent is emerging as a strategic differentiator. Finally, the report and Mattox's comments meet at one place: AI can drive the future of clinical development, yet human capacity will dictate how quickly —and how far — we get there.

At conference, drugmakers tout AI efforts as US tariffs cast shadow
At conference, drugmakers tout AI efforts as US tariffs cast shadow

Reuters

time26-02-2025

  • Business
  • Reuters

At conference, drugmakers tout AI efforts as US tariffs cast shadow

HYDERABAD Feb 26 (Reuters) - The rising adoption of artificial intelligence in the pharmaceutical industry dominated discussions at a conference in India this week, while executives largely preferred to wait for more clarity on U.S. President Donald Trump's tariff threats. Drugmakers such as Amgen (AMGN.O), opens new tab and contract manufacturers including Parexel highlighted AI's role in reducing the time taken to conduct certain parts of the trials. U.S.-based Parexel said it was piloting an AI model to generate drug safety reports 30-45 minutes faster than the manual process. The AI-generated reports are then verified by an expert. AI can help halve the cost and time taken to develop a drug, from discovery through commercial production, compared to the traditional process, said Chaitanya Royyuru, partner at consulting firm EY. Royyuru estimated that the process currently takes more than 10 years and costs about $1 billion. Discovering new molecules and drug repurposing, or using a drug for a condition outside of its approved indication, are other areas where AI is being utilized, executives said. Beyond drug discovery processes, AI is also being used in medical image reading, where it is able to assist doctors in finding anomalies. "Sometimes, when we look at an X-ray and we think it's normal, but AI says look, there's a small cancer you're missing," said Nageshwar Reddy, chairman, Asian Institute of Gastroenterology. "And when we actually look at it very carefully and follow the patient, there's a cancer coming there," Reddy said. Ken Washington, chief technological officer, Medtronic, said, "The bottom line is that AI has to be everybody's job." WAIT AND WATCH ON TARIFFS Trump's plans to levy tariffs on pharmaceutical imports had cast a shadow over the two-day conference as India is among the top exporters to the U.S., especially of cheaper versions of popular drugs. However, drugmakers including Dr Reddy's ( opens new tab said they were still waiting for clarity on the tariffs. "Right now, it's wait and watch. There is no clarity on what the tariffs are, if any, or if there is a transition period," said Nandini Piramal, chairperson at Piramal Pharma, which provides contract manufacturing and development services.

At conference, drugmakers tout AI efforts as US tariffs cast shadow
At conference, drugmakers tout AI efforts as US tariffs cast shadow

Yahoo

time26-02-2025

  • Business
  • Yahoo

At conference, drugmakers tout AI efforts as US tariffs cast shadow

By Kashish Tandon, Bhanvi Satija and Rishika Sadam HYDERABAD (Reuters) - The rising adoption of artificial intelligence in the pharmaceutical industry dominated discussions at a conference in India this week, while executives largely preferred to wait for more clarity on U.S. President Donald Trump's tariff threats. Drugmakers such as Amgen and contract manufacturers including Parexel highlighted AI's role in reducing the time taken to conduct certain parts of the trials. See for yourself — The Yodel is the go-to source for daily news, entertainment and feel-good stories. By signing up, you agree to our Terms and Privacy Policy. U.S.-based Parexel said it was piloting an AI model to generate drug safety reports 30-45 minutes faster than the manual process. The AI-generated reports are then verified by an expert. AI can help halve the cost and time taken to develop a drug, from discovery through commercial production, compared to the traditional process, said Chaitanya Royyuru, partner at consulting firm EY. Royyuru estimated that the process currently takes more than 10 years and costs about $1 billion. Discovering new molecules and drug repurposing, or using a drug for a condition outside of its approved indication, are other areas where AI is being utilized, executives said. Beyond drug discovery processes, AI is also being used in medical image reading, where it is able to assist doctors in finding anomalies. "Sometimes, when we look at an X-ray and we think it's normal, but AI says look, there's a small cancer you're missing," said Nageshwar Reddy, chairman, Asian Institute of Gastroenterology. "And when we actually look at it very carefully and follow the patient, there's a cancer coming there," Reddy said. Ken Washington, chief technological officer, Medtronic, said, "The bottom line is that AI has to be everybody's job." WAIT AND WATCH ON TARIFFS Trump's plans to levy tariffs on pharmaceutical imports had cast a shadow over the two-day conference as India is among the top exporters to the U.S., especially of cheaper versions of popular drugs. However, drugmakers including Dr Reddy's said they were still waiting for clarity on the tariffs. "Right now, it's wait and watch. There is no clarity on what the tariffs are, if any, or if there is a transition period," said Nandini Piramal, chairperson at Piramal Pharma, which provides contract manufacturing and development services.

India on the verge of becoming clinical trials hub, says Parexel executive
India on the verge of becoming clinical trials hub, says Parexel executive

Khaleej Times

time26-02-2025

  • Health
  • Khaleej Times

India on the verge of becoming clinical trials hub, says Parexel executive

India is ready to step in as an alternative site for early-stage clinical trials to help mitigate the impact of disruptions such as the Russia-Ukraine war, an executive at contract research firm Parexel told Reuters on Wednesday. The US-based company plans to boost its headcount in India by more than 2,000 over the next three to five years, from about 6,000 currently, said Sanjay Vyas, who heads Parexel's India operations. Vyas said India is well-placed to attract clinical trials disrupted by geopolitical conflicts such as the Russia-Ukraine war, as well as efforts by global drugmakers to reduce reliance on China. Ukraine, along with Russia, had become important countries for studying new drugs before Russia's attack in 2022. In subsequent years, however, large companies and researchers have reported disruptions to trials there. Vyas said Parexel plans to hire for roles that could help build innovation hubs. "Because the cost of failure in India is much less than in other parts of the world," he said on the sidelines of the ongoing BioAsia conference in the southern state of Telangana. Durham, North Carolina-headquartered Parexel, among the world's top clinical research organisations, operates between 100 and 150 trial sites in India, located across states including Maharashtra, Karnataka, Telangana and Tamil Nadu. India's clinical trials data market is estimated to touch $1.51 billion in 2025, according to US-based GrandView Research. While India's reputation as a trusted region for conducting trials is improving, several challenges, such as a lack of standardised regulations for some early-stage studies, remain before it can become a top choice for drugmakers. "If you don't do phase 1 trials, the same patient will have to wait for a phase 3 (late-stage) trial to happen for the drug to come into the market. So you have the time lost, which you could have gotten earlier on if the molecule was already introduced in advance," Vyas said. He also highlighted a lack of awareness about experimental treatments among patients and doctors, as well as establishing trial sites in remote areas, as other challenges in India.

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