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In the era of digital health transformation, generative AI (GenAI) has emerged as a breakthrough technology in pharmacovigilance, the science dedicated to ensuring drug safety. Pharmacovigilance monitors the lifecycle of pharmaceutical products, from clinical trials to post-marketing surveillance, identifying and mitigating potential risks associated with medications. However, traditional pharmacovigilance methods, largely manual and data-intensive, often face limitations in processing vast amounts of real-world evidence. GenAI, with its advanced capabilities in machine learning, natural language processing (NLP), and automation, is reshaping this field by enhancing the efficiency, accuracy, and scope of drug safety monitoring. The field of pharmacovigilance is essential to public health, yet, it often grapples with challenges such as delayed signal detection, resource constraints, and data overload. These hurdles are exacerbated by the growing complexity and diversity of data sources, from electronic health records (EHRs) and social media posts to published literature and adverse event reports. GenAI addresses these challenges with its ability to process and analyse large datasets in real time, allowing for immediate detection of safety signals and faster reporting. One of the primary strengths of GenAI lies in its capacity to learn from diverse datasets. Unlike traditional algorithms that operate on predefined rules, GenAI can dynamically adapt to new data patterns, recognising complex associations and uncovering insights that might go undetected otherwise. This flexibility enables GenAI to provide a more comprehensive, nuanced analysis of drug safety. Signal detection, the process of identifying potential safety risks, is a cornerstone of pharmacovigilance. Traditionally, signal detection is reactive, relying on periodic reviews of adverse event data to identify patterns. This approach, however, is often too slow to keep up with the vast and continuous influx of data. GenAI transforms signal detection into a proactive process, continuously analysing data to identify emerging safety signals in real time. For example, GenAI can track social media for patient-reported safety information, rapidly identifying adverse reactions and summarising potential safety concerns in aggregate reports. By incorporating real-world patient feedback alongside structured data sources, GenAI enables a more comprehensive and timely approach to safety signal detection. Aggregate reporting involves summarising and analysing large sets of safety data to provide insights into a drug’s overall safety profile. However, traditional aggregate reporting methods are time-consuming and error-prone due to manual data collection, processing, and analysis. GenAI offers a solution by automating much of this process. It can automatically aggregate safety data from multiple sources, including EHRs, regulatory reports, and literature, creating standardised reports with enhanced accuracy and consistency. One example of automated reporting is the generation of Periodic Safety Update Reports (PSURs), which are critical for regulatory compliance. GenAI’s automation reduces human intervention in PSUR generation, minimising errors and improving the reliability of safety assessments. By handling routine reporting tasks, GenAI allows pharmacovigilance professionals to focus on in-depth safety analysis and decision-making. Post-marketing surveillance is essential to capture long-term or rare adverse effects that may not be evident during clinical trials. GenAI enables continuous monitoring of safety data, transforming pharmacovigilance into a real-time process. By analysing real-world evidence from diverse sources such as social media, online health forums, and wearable devices, GenAI provides insights into a drug’s safety profile across broader patient populations. For instance, in cases where certain medications are associated with rare adverse events, GenAI can identify these patterns early by analysing unstructured data sources like social media posts or patient forums. This early detection allows regulatory bodies and pharmaceutical companies to take preventive measures, such as issuing warnings or updating labels, to protect public health. One of the most promising applications of GenAI in pharmacovigilance is predictive risk modelling. By analysing longitudinal patient data and real-world evidence, GenAI can identify factors that may increase the risk of adverse reactions in specific patient populations. This capability enables pharmacovigilance teams to develop personalised safety profiles for patients based on their medical history, genetics, and demographic information. Personalised safety assessments can inform healthcare providers about potential risks associated with a drug for individual patients, allowing for more tailored treatment plans. By predicting adverse events before they occur, GenAI can help optimise patient outcomes and prevent drug-related harm. Despite its many advantages, the integration of GenAI into pharmacovigilance is not without challenges. Data privacy, algorithm transparency, and accountability are critical issues that need to be addressed to ensure the ethical and responsible use of AI in drug safety. Gen AI’s effectiveness depends on its ability to access vast amounts of data, which often includes sensitive patient information. Protecting patient privacy is paramount, especially as data-sharing practices increase to enable more comprehensive safety assessments. Pharmacovigilance teams must ensure secure data handling, anonymisation practices, and strict access controls to prevent unauthorised data breaches. Many AI algorithms, particularly deep learning models, function as “black boxes”, making it difficult for human users to understand how decisions are made. In pharmacovigilance, transparency is crucial, as it allows stakeholders to interpret AI-generated safety signals and make informed regulatory decisions. Developing explainable AI models and providing clear documentation on how safety assessments are conducted can help build trust in GenAI systems. The use of AI in pharmacovigilance raises questions about accountability, particularly when safety decisions are based on AI-generated insights. Clear guidelines on the responsibilities of AI developers, healthcare professionals, and regulatory authorities are needed to ensure that accountability is maintained in cases where AI-driven assessments affect patient outcomes. Additionally, regulatory bodies must establish guidelines and frameworks for AI applications in pharmacovigilance, ensuring compliance and consistency in safety monitoring practices. Looking ahead, GenAI’s potential to transform pharmacovigilance continues to grow. As AI models become more sophisticated, they may incorporate emerging technologies like blockchain and the Internet of Things (IoT) to enhance data security and enable continuous monitoring through connected health devices. Blockchain can address data privacy concerns by providing a decentralised, transparent ledger for storing patient data securely. IoT integration, on the other hand, can allow for real-time data collection from wearable devices, providing continuous health monitoring for pharmacovigilance purposes. This technology can supply pharmacovigilance systems with valuable data on patient reactions to medications, allowing for more timely interventions. As GenAI applications advance, collaboration between pharmaceutical companies, regulatory bodies, and healthcare providers will be essential to fully realise the potential of AI-driven pharmacovigilance. Encouraging data-sharing initiatives, establishing global pharmacovigilance networks, and fostering public-private partnerships can help maximise GenAI’s impact on drug safety. GenAI represents a pivotal advancement in pharmacovigilance, providing solutions to longstanding challenges in drug safety monitoring. By enabling real-time signal detection, automating reporting, and supporting predictive risk modelling, GenAI has the potential to reshape pharmacovigilance practices, making drug safety monitoring more proactive, efficient, and patient-centric. However, realising the full potential of GenAI in pharmacovigilance will require a commitment to ethical principles, regulatory compliance, and collaboration across stakeholders. With these elements in place, GenAI can become a powerful tool for improving drug safety and protecting patient health, marking a new era in the ongoing mission to ensure that medications are safe and effective for everyone. John Praveen is an accomplished pharmacovigilance (PV) and medical writing (MW) professional with over 15+ years of experience in product safety (across pharmacovigilance, medical device vigilance, haemovigilance, and cosmetovigilance). As associate VP at Accenture, he oversees PV/MW portfolio delivery and shared services operations for PV/MW. In his roles, he has been instrumental in establishing end-to-end capabilities in aggregate report writing, signal detection & management, medical device vigilance, cosmetovigilance, haemovigilance, and nutra vigilance at Accenture. Praveen's academic background includes Bachelor’s and Master’s degrees in Biological Science, Microbiology & Immunology, and a Diploma in Medical Entomology and Medical Genetics from St Joseph's University, Bangalore. He also holds a management degree from the Indian Institute of Management, Lucknow, and is certified as an Accenture Business Advisory Expert for PV.Over the weekend, Blake Lively elevated herself into the pantheon of famous Hollywood women who have taken monumental, #MeToo-inspired stands against sexual predation in the entertainment industry. The 37-year-old star not only publicly detailed her own painful experience with sexual harassment on the set of her movie, “It Ends With Us,” in a legal complaint and in a viral New York Times story , she also chronicled the way she was allegedly targeted by a sophisticated social media “smear campaign” during the film’s release in August. The purpose of this campaign, allegedly orchestrated by cunning and craven Hollywood publicists, was to damage her reputation for the sake of advancing the career and the personal brand of her alleged harasser, co-star and director Justin Baldoni. In a statement to the New York Times, Lively valiantly said, “I hope that my legal action helps pull back the curtain on these sinister retaliatory tactics to harm people who speak up about misconduct and helps protect others who may be targeted.” Nearly seven years ago, Lively also voiced her support for women taking a stand against sexual predators in Hollywood during the rise of the #MeToo movement. But unlike now, Lively’s purported advocacy for women speaking up against sexual misconduct was met with skepticism and even backlash. That’s because Lively had chosen to publicly support one of the industry’s most famous alleged predators, Woody Allen. Among other things, Lively praised Allen for his “very empowering” direction after she co-starred in his 2016 film “Cafe Society.” During press interviews for the film, she also refused to address the sexual assault allegations made against him by his own daughter, Dylan Farrow. Indeed, one prominent person speaking out against Lively in late 2017 and early 2018 was Dylan Farrow, who originally accused the filmmaker of molesting her in 1992, when she was 7 years old. While Dylan Farrow praised women in the industry for “taking a stand” to effect change in Hollywood, she also said that Lively and other celebrity #MeToo advocates who had worked with her father were actually complicit “in the culture they are fighting against.” “The people who join this movement without taking any kind of personal accountability for the ways in which their own words and decisions have helped to perpetuate the culture they are fighting against, that’s hard for me to reconcile,” Dylan Farrow said in a statement to the media at the time. When Lively was initially cast in Allen’s “Cafe Society” in 2015, the former TV actor no doubt relished the chance to gain serious acting credibility by working with Allen, then still revered as one of world cinema’s best-loved auteurs. A year later, after “Cafe Society” premiered at the Cannes Film Festival, Lively gushed about joining an elite class of actresses who could be considered Allen “muses,” telling Hamptons magazine that it was “really cool to work with a director who’s done so much.” But it was during the 2016 Cannes Film Festival that public opinion began to turn against Allen, and Lively began to feel some heat. The change was led by Allen’s own son, journalist Ronan Farrow, whose later reporting on the alleged sex crimes of producer Harvey Weinstein helped spur the #MeToo movement. In a stunning May 2016 op-ed for The Hollywood Reporter, Farrow reminded movie fans — and A-list stars like Lively — that his father had allegedly “groomed” his sister with inappropriate touching as a young girl and sexually assaulted her when she was 7. The allegations against Allen first became public in the 1990s, amid his stormy break-up from longtime girlfriend Mia Farrow, Ronan and Dylan’s mother. As Allen vehemently denied the molestation allegations involving Dylan, his “PR engine revved into action,” Ronan Farrow explained in his op-ed. Similar to what Lively would say about Baldoni, Allen had savvy and aggressive publicists working on his behalf to spin a narrative to the public that was favorable to him and harmful to his alleged victim, according to Ronan Farrow. In Allen’s case, this narrative sought to enlist journalists and news outlets in discrediting his own daughter’s account of being molested, Ronan Farrow said. Also similar to Baldoni, Allen’s aim was to salvage his reputation and to continue his career as a filmmaker. Ronan Farrow described how this narrative held power for more than 20 years, largely because media outlets, fearful of Allen’s power in the industry, didn’t want to consider his sister’s side of the story. The journalist described his sister’s “agony in the wake of powerful voices sweeping aside her allegations” and “the press often willing to be taken along for the ride.” He said that it also hurt his sister to see A-list actors, some of whom were personal heroes, line up to star in his movies. The day after Ronan Farrow published his op-ed piece, Vulture asked Lively for a comment on being one of the actors who presumably hurt Dylan Farrow by lining up to star in her father’s movies. She demurred, saying she hadn’t read the piece. “I think that’s dangerous,” she said. “I don’t want to speak about something I haven’t read.” Lively also told the Los Angeles Times that any news coverage of Allen’s personal life didn’t register with her when she was making the movie. “I could (only) know my experience,” she said. “And my experience with Woody is he’s empowering to women.” Lively came to Allen’s defense in other ways by ripping into a Cannes official who made a joke about Dylan Farrow’s allegations before the “Cafe Society” screening, Variety reported. She said film festivals are meant to be “beautiful” events for the purpose of celebrating movies and artists, and they shouldn’t be tarnished by someone making jokes about “something (like sexual abuse) that wasn’t funny.” More than a year later, Ronan Farrow, writing for the New Yorker, joined New York Times reporters Megan Twohey and Jodi Kantor in publishing investigative stories that revealed Harvey Weinstein’s decades-long history of alleged sexual harassment and assault against scores of women. The Weinstein revelations quickly spurred many other women to come forward about sexual misconduct perpetrated by powerful men in media. As the #MeToo movement took off, Dylan Farrow gained a new platform to re-litigate her claims against her father in the court of public opinion. She wrote an op-ed for the Los Angeles Times, in which she called out Lively, Kate Winslet and Greta Gerwig for choosing to work with her father but then refusing to “answer questions about it.” Now in 2024, Lively has become a #MeToo-style hero by going public with her allegations against Baldoni. That status was helped by the fact that her claims were detailed by the New York Times report, in a report co-authored by Twohey, one of the reporters who originally broke the Weinstein story. As with Lively’s bombshell legal complaint filed in California, the Times story also focuses on the alleged efforts by Baldoni and his publicists to damage Lively’s reputation, in order to pre-empt her claims about his sexually inappropriate behavior on set. But over the years, Lively still has not addressed her support for Allen or her refusal to discuss Dylan Farrow’s allegations. Unlike Greta Gerwig and some other actors, she also has not voiced regret for choosing to work with Allen, even after Ronan Farrow presented evidence of his father’s P.R. efforts to discredit his own daughter. But given Lively’s recent, allegedly harrowing experience with Baldoni, maybe she’ll finally feel willing to speak up about whether she regrets working for Allen.
Maharashtra's New Leadership: A Coalition Power Play
South Korea’s parliament impeached Acting President Han Duck-soo, dealing another blow to a government already reeling after President Yoon Suk Yeol’s suspension less than two weeks ago for his brief martial law decree. Lawmakers voted 192-0 in favor of Prime Minister Han’s impeachment on Friday, according to National Assembly Speaker Woo Won-shik. He said before the vote that a simple majority in the 300-seat parliament was needed for the motion to pass, instead of the two-thirds required to suspend a president. The main opposition Democratic Party, which holds 170 seats, filed the motion to impeach Han on Thursday after he resisted pressure to immediately appoint three judges to the Constitutional Court, which would boost the likelihood of a ruling to finalize Yoon’s removal from power. Dozens of ruling party members protested by chanting slogans calling for Woo’s resignation and boycotting the vote. Han said in a statement that he would respect the National Assembly’s decision and suspend his duties. This is the first time an acting president has been impeached in South Korea. Han took over the role after Yoon was impeached by parliament following his Dec. 3 decision to impose martial law, a move that was reversed six hours later. The crisis has rattled financial markets and disrupted Seoul’s diplomacy efforts with partners like the U.S., all while the country’s facing mounting economic challenges and nuclear threats from North Korea. Finance Minister Choi Sang-mok, who now steps in as interim leader, said he will work to minimize any confusion in government operations. He has also instructed the Joint Chiefs of Staff to increase monitoring of North Korea to prevent any provocations that might arise, he said in a statement. It would be nearly impossible for Choi to effectively manage all the roles including finance minister, acting president and acting prime minister simultaneously, according to Shin Yul, a political science professor at Myongji University in Seoul. “This is not a normal situation in a country,” he said. The South Korean won declined 0.6 percent against U.S. dollar after the vote. The currency earlier fell as much as 1.1 percent to the lowest since 2009 on Friday. Han said in an emergency public address Thursday that he would hold off on approving the three judges nominated by parliament. He added that the right to approve the judges rests with the president of the nation. Choi didn’t indicate in his statement whether he would follow Han’s position on the appointment of judges. The Democratic Party has called on Choi to make the appointments immediately. Court process The court, which can still rule with six judges, held its first pre-trial hearing Friday and has until June to make a decision. Yoon has vowed to fight in court, saying he declared martial law to protect the nation from an opposition that’s trying to paralyze the government with impeachment motions and cuts to budget plans. The case against the president is more important and urgent than any other impeachment motion involving government officials, Constitutional Court judge Cheong Hyungsik said at the hearing on Friday, according to a pool report. The court has scheduled the next preliminary hearing for Jan. 3. The political turmoil adds to the risks facing South Korea’s economy, which is expected to grow at a slower pace next year. Export momentum is weakening due to lower semiconductor demand, and companies are bracing for Donald Trump’s return to the White House and his protectionist policies. Recent surveys show confidence among South Korean consumers and businesses has slumped the most since the COVID-19 pandemic. Policymakers have pledged “unlimited liquidity” if needed to reassure market participants and mitigate the economic fallout. The central bank said it would cut its benchmark interest rate next year while considering financial risks and economic conditions. Shin said the political uncertainty could spark an outflow of foreign capital. This would worsen the balance sheets of companies due to their large amounts of dollar-denominated debt, he added.