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Articles by Div
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Audience Segmentation: The Future of Personalization in HCP Omnichannel Communication
Audience Segmentation: The Future of Personalization in HCP Omnichannel Communication
Co-authored by Div Khetia and Donna Judd In the rapidly evolving healthcare landscape, delivering the right message to…
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Div Khetia, PharmD, MBA reposted thisDiv Khetia, PharmD, MBA reposted thisStrong Medical Affairs strategies start with strong voices at the table. We're proud to introduce the Medical Affairs Advisory Board for Fierce Pharma Week 2026 and recognize the leaders helping shape this year's agenda, content, and attendee experience: Jamie DeMaria | Boehringer Ingelheim Arshi Gupta | Syneos Health Annie Herrington | Pfizer Lance Hill | Within3 Daniel Jones | Biogen Div Khetia, PharmD, MBA | Pfizer Lori Lebson | KalVista Pharmaceuticals Peter Lee | Kura Oncology Mary Chi Michael | Otsuka Diana Morgenstern, MD, FACP | Viatris Alicia OConnor | Lundbeck Stephanie Otis, PharmD CHC | Ferring Pharmaceuticals Paul O'Grady | ADMA Biologics Avni Patel, PharmD | Jazz Pharmaceuticals Sagar Shah | Pharmacosmos Therapeutics Gaurav Sharma, PharmD | Agios Pharmaceuticals Kirk Shepard | PDS Biotechnology Jolan Terner-Rosenthal PhD | Mirum Pharmaceuticals April Thompson | Otsuka Maria Urso, PhD | Isto Biologics Davida J. White, M.D. | Kailera Therapeutics Nick Willhoft | IQVIA Donnie Wooten Jr. Pharm.D. | AstraZeneca Join us in Philadelphia this September to learn from the leaders helping shape the future of Medical Affairs. Register today and save up to $1,100 with early bird pricing. https://loom.ly/jXjHPrI #FiercePharmaWeek #PharmaLeadership #LifeSciences #PharmaMarketing #MedicalAffairs #Commercialization #PharmaInnovation #HealthcareMarketing #PharmaIndustry #DigitalHealth #HealthcareCommunications #FutureOfPharmaFierce Pharma Week 2026 Medical Affairs Advisory BoardFierce Pharma Week 2026 Medical Affairs Advisory Board
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Div Khetia, PharmD, MBA shared thisLast week was one of those weeks that makes you pause and reflect. Alongside my incredible colleagues Donna Judd, PhD and Jennifer Soffing, PharmD. and Amy Rojas, PharmD, I had the opportunity to spend time with inspiring founders, innovators, and media leaders who are helping shape the future of healthcare, technology, and communication. A special thank you to our partners at Publicis Health Media for hosting such thoughtful and energizing PHM HealthFront 2-day summit. It was amazing. One of the highlights was spending time at the NYSE with Jeff Tangney , founder of Doximity, alongside other medical affairs pharmaceutical professionals to discuss opportunities to help advance medical engagement in ways that better support clinicians and patients. Grateful for the connections, conversations, and the opportunity help drive precision engagement strategies that help shape the future of digital medical engagement.
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Div Khetia, PharmD, MBA shared this𝗣𝗵𝘆𝘀��𝗰𝗶𝗮𝗻 𝗔𝗜 𝗮𝗱𝗼𝗽𝘁𝗶𝗼𝗻 𝗷𝘂𝗺𝗽𝗲𝗱 𝗳𝗿𝗼𝗺 𝟯𝟴% 𝘁𝗼 𝟴𝟭% 𝗶𝗻 𝗼𝗻𝗲 𝘆𝗲𝗮𝗿. Most Medical Affairs strategies didn’t evolve with it. That’s the gap. And it’s growing. 𝗖𝗹𝗶𝗻𝗶𝗰𝗶𝗮𝗻𝘀 𝗻𝗼 𝗹𝗼𝗻𝗴𝗲𝗿 𝗼𝗽𝗲𝗿𝗮𝘁𝗲 𝗶𝗻 𝗮 𝘀𝗶𝗻𝗴𝗹𝗲 𝗰𝗵𝗮𝗻𝗻𝗲𝗹. They move across AI tools, peer platforms, search, and evidence databases—i𝗻 𝘁𝗵𝗲 𝘀𝗮𝗺𝗲 𝘄𝗼𝗿𝗸𝗳𝗹𝗼𝘄. 𝗩𝗶𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗶𝘀 𝗻𝗼 𝗹𝗼𝗻𝗴𝗲𝗿 𝗮𝗯𝗼𝘂𝘁 𝗯𝗲𝗶𝗻𝗴 𝗲𝘃𝗲𝗿𝘆𝘄𝗵𝗲𝗿𝗲. 𝗜𝘁’𝘀 𝗮𝗯𝗼𝘂𝘁 𝗯𝗲𝗶𝗻𝗴 𝗮𝗿𝗰𝗵𝗶𝘁𝗲𝗰𝘁𝘂𝗿𝗮𝗹𝗹𝘆 𝗿𝗲𝘁𝗿𝗶𝗲𝘃𝗮𝗯𝗹𝗲 𝘄𝗵𝗲𝗿𝗲 𝗱𝗲𝗰𝗶𝘀𝗶𝗼𝗻𝘀 𝗮𝗿𝗲 𝗮𝗰𝘁𝘂𝗮𝗹𝗹𝘆 𝗳𝗼𝗿𝗺𝗲𝗱. That’s the shift from 𝗢𝗺𝗻𝗶𝗰𝗵𝗮𝗻𝗻𝗲𝗹 → 𝗢𝗽𝘁𝗶𝗰𝗵𝗮𝗻𝗻𝗲𝗹 → From volume-driven to signal-driven → From all channels to the right channels → From consistency to behavioral intelligence → From search to AI-driven retrieval This isn’t a marketing evolution. It’s a 𝘀𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰 𝗿𝗲𝗱𝗲𝘀𝗶𝗴𝗻 𝗼𝗳 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗔𝗳𝗳𝗮𝗶𝗿𝘀 𝗲𝗻𝗴𝗮𝗴𝗲𝗺𝗲𝗻𝘁. If you had to choose only 3 channels for the next 6 months… Which ones would you bet on—and why? 𝗙𝘂𝗹𝗹 𝗯𝗿𝗲𝗮𝗸𝗱𝗼𝘄𝗻 𝗼𝗳 𝘁𝗵𝗲 𝗢𝗽𝘁𝗶𝗰𝗵𝗮𝗻𝗻𝗲𝗹 𝗺𝗼𝗱𝗲𝗹 𝗶𝗻 𝘁𝗵𝗲 𝗰𝗼𝗺𝗺𝗲𝗻𝘁𝘀.
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Div Khetia, PharmD, MBA shared thisMost roles in Medical Affairs talk about impact. This one is built to deliver it. Dror Bacher is hiring a Medical Digital Health Lead at Pfizer and this role sits right at the intersection of where our field is heading next: • Digital health is no longer experimental • AI-enabled solutions are moving into real clinical workflows • And governance matters just as much as innovation This role isn’t about pilots. It’s about building, scaling, and operationalizing medical digital health solutions that actually hold up in real-world environments. You’ll work across Medical, R&D, Regulatory, Legal, and Commercial You’ll shape solutions from idea → evidence → impact And you’ll help define what “medical-grade digital health” looks like at scale. If you’ve been waiting for a role where strategy meets execution, this is one of those moments.Div Khetia, PharmD, MBA shared thisWe’re hiring: Medical Digital Health Lead! We’re hiring a Medical Digital Health Lead to join our Medical Digital Health team within US Medical Affairs at Pfizer. This is a great opportunity for someone who is energized by medical innovation, thrives in complex environments, and wants to play a meaningful role in shaping how medical digital health solutions are developed, scaled, and governed. In this role, you’ll work closely with therapeutic areas and a broad set of cross‑functional partners — including Medical, Digital, Regulatory, Legal/Compliance, R&D, and Commercial — supporting medical digital health initiatives across their full lifecycle, from early ideation through evidence generation and ongoing portfolio oversight. If you have experience with medical‑grade digital health solutions (including SaMD), enjoy leading in a matrix environment, and are motivated by turning strategy into real‑world impact, this could be an exciting next step. Apply here:https://lnkd.in/ecwu23t5 Feel free to reach out — and please share with your network. #Hiring #DigitalHealth #MedicalAffairs #SaMD #HealthcareInnovation #PfizerCareers
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Div Khetia, PharmD, MBA shared this𝗜𝘁 𝗶𝘀 𝘁𝗶𝗺𝗲 𝘁𝗼 𝗮𝗱𝗱 𝗔𝗜 𝗔𝗴𝗲𝗻𝘁𝘀 𝘁𝗼 𝘆𝗼𝘂𝗿 𝗼𝗿𝗴 𝗰𝗵𝗮𝗿𝘁. 𝗡𝗼𝘁 𝗮𝘀 𝗮 𝘁𝗼𝗼𝗹. 𝗔𝘀 𝗮 𝘁��𝗮𝗺 𝗺𝗲𝗺𝗯𝗲𝗿. Give them a title. Assign them tasks. Hold them "accountable" to outcomes. The teams winning right now are thinking about how to permanently reassign the work that was quietly consuming their best people with AI Agents that never sleep. Weekly dashboard upkeep. Meeting synthesis. Data pulls and calculations. Inbox triage. Deck formatting. That is not your analyst's or data scientist's job anymore. That is your AI agent's job. When you free a talented person from four hours of repetitive work a week, you do not get a slightly more efficient employee. You get a different person. One who finally has the bandwidth to think, create, and lead at the level you hired them for. Anthropic's CoWork just made this real for enterprise teams this week. The org chart of 2027 already exists inside the companies building it today. Where does your first AI Agent sit on yours?
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Div Khetia, PharmD, MBA shared this𝟴𝟭% 𝗺𝗼𝗿𝗲 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝗶𝘃𝗲. 𝟱𝟰% 𝗺𝗼𝗿𝗲 𝗰𝗿𝗲𝗮𝘁𝗶𝘃𝗲. 𝟱𝟯% 𝗯𝗲𝘁𝘁𝗲𝗿 𝗮𝘁 𝗰𝗼𝗺𝗽𝗹𝗲𝘅 𝗽𝗿𝗼𝗯𝗹𝗲𝗺-𝘀𝗼𝗹𝘃𝗶𝗻𝗴. Recent research surveys show that is what AI-fluent teams can achieve. The real question is not what AI can do. It is: how do you build that fluency inside your team. 𝗪𝗵𝗮𝘁 𝗜 𝗮𝗺 𝗳𝗼𝗰𝘂𝘀𝗲𝗱 𝗼𝗻 𝗿𝗶𝗴𝗵𝘁 𝗻𝗼𝘄: → Orgs I lead are using AI in everyday work, not just when stuck → People who challenge and refine AI outputs, not accept blindly → Leaders who own decisions, even when AI informs them The gap between AI potential and performance is not technology. 𝗜𝘁 𝗶𝘀 𝗔𝗜 𝗳𝗹𝘂𝗲𝗻𝗰𝘆. I wrote about what separates teams hitting these numbers from those that don't: 👉 https://lnkd.in/ePkR5mZr 𝗔𝗰𝗰𝗲𝘀𝘀 𝘁𝗼 𝗔𝗜 𝗶𝘀 𝘁𝗮𝗯𝗹𝗲 𝘀𝘁𝗮𝗸𝗲𝘀. 𝗙𝗹𝘂𝗲𝗻𝗰𝘆 𝗶𝘀 𝘁𝗵𝗲 𝗲𝗱𝗴𝗲.
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Div Khetia, PharmD, MBA shared this𝗣𝗢𝗦𝗧𝗜𝗡𝗚 𝗙𝗢𝗥 𝗥𝗘𝗔𝗖𝗛 — Donna Judd, PhD, an outstanding leader within our Medical Affairs Channel Strategy organization, is hiring a Digital Medical Engagement Director. This role sits at the center of how Pfizer continues to redefine and lead the industry in Digital Medical Engagement. 𝗪𝗲’𝗿𝗲 𝗹𝗼𝗼𝗸𝗶𝗻𝗴 𝗳𝗼𝗿 𝗮 𝗹𝗲𝗮𝗱𝗲𝗿 𝘄𝗵𝗼: • Builds strategy across emerging digital channels • Translates scientific content into high-value HCP engagement • Operates with clarity, rigor, and compliance • Wants to help shape the future of modern Medical Affairs If that sounds like you — this is a rare opportunity to drive meaningful impact at scale. 🔗 𝗥𝗼𝗹𝗲 & 𝗱𝗲𝘁𝗮𝗶𝗹𝘀: https://lnkd.in/ePS32ndg Please share with anyone who would be an exceptional fit. #DigitalEngagement #MedicalAffairs #Hiring #Leadership #PfizerCareers
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Div Khetia, PharmD, MBA shared this𝗣𝗿𝗲𝗰𝗶𝘀𝗶𝗼𝗻 𝗲𝗻𝗴𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗶𝘀 𝗯𝗲𝗰𝗼𝗺𝗶𝗻𝗴 𝘁𝗵𝗲 𝗻𝗲𝘄 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱 𝗶𝗻 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗔𝗳𝗳𝗮𝗶𝗿𝘀 𝗗𝗶𝗴𝗶𝘁𝗮𝗹 𝗮𝗽𝗽𝗿𝗼𝗮𝗰𝗵𝗲𝘀 𝗮𝗻𝗱 𝗻𝗼𝘁 𝗮𝗹𝗹 𝗰𝗵𝗮𝗻𝗻𝗲𝗹𝘀 𝗮𝗿𝗲 𝗲𝗾𝘂𝗮𝗹 𝗼𝗿 𝗺𝗮𝘁𝘁𝗲𝗿. Most omnichannel efforts generate activity without results. Why? Because not all channels are equal, and treating them as such dilutes impact. An 𝗢𝗣𝗧𝗜-channel operating model shifts from "reach everyone everywhere" to "reach the right HCP in the right channel at the right time" through: ✓ Unified behavioral intelligence across all touchpoints ✓ Individual-level (not segment-level) HCP insights ✓ Channel probability modeling that predicts engagement likelihood ✓ Strategic content-to-channel alignment ✓ Closed-loop optimization from real engagement signals The result? Precision engagement with measurable impact.
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Div Khetia, PharmD, MBA shared thisMost omnichannel strategies create activity, not impact. The leaders pulling ahead are doing one thing differently: They’re concentrating resources on the handful of channels that actually influence clinical practice and patient care. 𝗔 𝗳𝗲𝘄 𝗿𝗲𝗮𝗹𝗶𝘁𝗶𝗲𝘀 𝗻𝗼𝘄 𝗱𝗲𝗳𝗶𝗻𝗲 𝘁𝗵𝗲 𝗹𝗮𝗻𝗱𝘀𝗰𝗮𝗽𝗲: • HCP attention is tightening • Evidence volume is accelerating • AI can predict where engagement is most likely to occur Under these conditions, broad presence stops creating value. Precision becomes the advantage. 𝗢𝗽𝘁𝗶𝗰𝗵𝗮𝗻𝗻𝗲𝗹 𝗶𝘀 𝗱𝗶𝘀𝗰𝗶𝗽𝗹𝗶𝗻𝗲𝗱 𝗲𝘅𝗲𝗰𝘂𝘁𝗶𝗼𝗻: • focus on the specific HCP audiences (not just KOLs or broad specialties), • the channels where they truly engage, • and the formats that reduce friction and increase relevance — • and stop investing in everything else. For Medical Affairs leaders, this shift isn’t optional. It’s where the performance gap is about to widen. 𝗙𝘂𝗹𝗹 𝗽𝗲𝗿𝘀𝗽𝗲𝗰𝘁𝗶𝘃𝗲: 🔗 https://lnkd.in/esb5w6h3
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Div Khetia, PharmD, MBA liked thisDiv Khetia, PharmD, MBA liked thisThis #ProstateCancerAwarenessMonth, I was #PfizerProud to see colleagues join patients, advocates, caregivers, and communities across the country in support of the ZERO Prostate Cancer Run/Walks. Events like these remind us that progress against prostate cancer extends beyond research and treatment. They create opportunities to connect, share experiences and bring greater attention to the needs of patients and families. Thank you to everyone who participated and helped shine a light on the prostate cancer community this month. Seeing so many people come together around a common cause was a powerful reminder of what's possible when we work toward the same goal: improving outcomes for people affected by prostate cancer.
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Div Khetia, PharmD, MBA liked thisDiv Khetia, PharmD, MBA liked thisYou can build and run successful companies from Australia and Harrison.ai is scaling fast. We're headquartered in Sydney where our 64x NVIDIA B200 cluster is located. We train our own frontier clinical models here, and 100% of our AI R&D talent is here. None of that has held us back: - Raised a $179M Series C 18 months ago ($789M valuation) - Contracted ARR has grown 4x since then to $40M, and it's accelerating - Multi-year contracts with over 95% customer renewal with majority on 2-5 years terms with an expanding product offering. - In clinical use at 1,000+ of the world leading health systems and enterprises across 25 countries, including 150+ UK hospitals - Over 40% of our revenue now comes from the US But the number I care about most is 12 million: the patients our technology helps clinicians diagnose every year, as we work towards our mission of helping more than a million patients every day. AI that supports critical diagnoses has to be built right. We spent years on deep R&D, building the clinical evidence and track record for patient safety, before turning to commercial growth. If we want sovereign capability in AI that changes lives, we have to back companies through that critical early stretch. Dimitry Tran and I are grateful to the team, investors, customers and partners who got us here. Now we scale our impact to reach more patients. Thanks to Daniel Van Boom at Forbes Australia for the conversation. https://lnkd.in/gdyZhYym
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Div Khetia, PharmD, MBA liked thisDiv Khetia, PharmD, MBA liked thisThe AI Acceleration team at Pfizer is growing, with greater ambition to build our Marketing AI Product. Apply to join our team, or let me know if you have any questions.
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Div Khetia, PharmD, MBA liked thisDiv Khetia, PharmD, MBA liked thisToday is World Pharmacists Day, and it is a fitting moment to say this: every vaccination season is built long before it begins. Pharmacists do far more than fill prescriptions. They counsel, they educate, and for many patients they are the most accessible healthcare professional in their community, and the one they turn to first. On World Pharmacists Day, thank you for the care and counsel you provide every day. This week, I spent time with teams at CVS Health and Walgreens at NYC. Across more than 10,000 pharmacies, pharmacists, pharmacy technicians, and store operations, healthcare and district leaders are getting ready to serve patients this fall. That readiness takes partnership and execution at an extraordinary scale. Behind it are months of work from pharmacies and all our colleagues across marketing, sales, trade, account management, supply, medical, and customer operations, who partner with these teams every day. To all of you: this is your work, and it shows. Thank you to our partners at CVS Health and Walgreens, and especially to the teams on the front lines, for everything you do for patients each season. I look forward to more time with the teams delivering care and all the partners making it possible this season. As the days get shorter and cooler, it is a good time to ask your pharmacist or healthcare provider what vaccinations are recommended for you this season. I rolled up my sleeves. Have you? Samantha Picking, PharmD Alina Shames, PharmD David Cooper Vinny Natale Julie Caldwell, RPh, BS Pharm Kathy Schwartz Deven Singh, MBA Christopher Hurst Suzanne Halstrom Emily Adeyemi, MPH Karen Akly 🪢 Caleb Nigusse Telfort Francia Luke Barnes Tim Ducharme Rakesh Patel Scott M. Sullins, Pharm.D. Blair Robinson Lauren Rolf-Kehrer Abdul Bilal Jackie Fonte Andrew Noval Tom Rutkowski Courtney Ricciuti Adam Lane Vijay Chandrasekaran #WorldPharmacistsDay #Pharmacists #PublicHealth #Pharmacy #Healthcare #PFEColleague
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Div Khetia, PharmD, MBA liked thisDiv Khetia, PharmD, MBA liked thisMy first time caring for Veterans was at the VAMC in Ann Arbor. What began there became a weekly VA clinic for nearly eight years, first in Ann Arbor and later in Pittsburgh. What always stayed with me was how much Veterans had given in service and how little they asked for in return. At Abridge, we’ve had the opportunity to improve the care delivery experience for many more Veterans than I could have ever seen as a doctor in a clinic. We’ve supported VA clinicians with cutting edge tools that help them spend less time staring at a computer screen and more time focusing on the Veteran in front of them. We started with a pilot deployment at 5 VA medical centers, which has since grown to more than 75 sites across the country. Now, Abridge has been selected to bring our clinician intelligence platform to Veteran care nationwide through the VA enterprise contract for ambient AI. As the VA undertakes one of the largest electronic medical record transitions in history, its clinicians remain committed to delivering exceptional care to Veterans. They deserve tools that ease documentation demands, create more space for connection during each encounter, and help preserve important details across visits and care teams. Abridge meets VA clinicians where they are, by being fully operational on both VistA/CPRS and the Federal EHR. This is the level of care that Veterans deserve and the VA's mission demands. It is our privilege to serve the needs of those who have served and the clinicians who care for them. Read more here: https://lnkd.in/gTTW8UGn
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Div Khetia, PharmD, MBA liked thisDiv Khetia, PharmD, MBA liked thisThis month marks an important transition in my career. In August, I said goodbye to incredible friends and colleagues at Vertex, and this week I started a new role as Vice President, Head of Development Quality Assurance at Immunome. Two years ago, I packed up and moved across the country to Boston to join the talented team at Vertex. I was recruited away from Pfizer and this was an opportunity I couldn't pass up. I'm grateful for the experience. I had the privilege of working alongside exceptional people, leading the Research & Development Quality organization, and contributing to a company whose commitment to patients with unmet medical needs is evident in everything it does. The experience challenged me, helped me grow, and left me with friendships and professional relationships that I will value for years to come. Outside of work, Boston was an adventure of its own. I quickly came to appreciate its history, neighborhoods, walkability, culture, and true sense of pride in the community (and sports teams 🙂). What began as a temporary move became a place that truly felt like home, and I will miss it. At the same time, I am excited to be returning to Seattle and begin a new chapter with Immunome. The opportunity to join a growing biotechnology company at such a pivotal stage, help build and scale the Development Quality function, and returning to the world of innovative oncology therapies was simply too compelling to pass up. Seattle has always been home, and I am thrilled to be back. A sincere thank you to everyone at Vertex who made the last two years so rewarding. I'm looking forward to staying connected and to seeing all that you continue to accomplish. And to my new colleagues at Immunome, I'm excited to get started.
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Div Khetia, PharmD, MBA liked thisDiv Khetia, PharmD, MBA liked thisWe’re excited to welcome Vivek Mukhatyar, Senior Director – Medical AI Team Lead at Pfizer, as a speaker at Articulate 2026: The Communication Revolution. Vivek brings a unique perspective shaped by experience across Medical Affairs, Generative AI, field medical, regulatory affairs, and scientific research. At Articulate 2026, Vivek will join “From Quill to AI: The New Craft,” alongside Rebecca Goldstein, PhD, Vai Katkade, MD, PhD, Manish Tewani, and Julie Guery, moderated by Francine Carrick. The conversation will explore what happens to the craft of scientific communication as AI becomes part of the workflow: Where AI can accelerate synthesis and strengthen communication, where human judgment remains essential, and how teams can protect scientific nuance, evidence, and quality. Looking forward to having Vivek bring his Medical Affairs and AI perspective to the conversation. 📅 October 1, 2026 📍 Museum of the American Revolution, Philadelphia, PA Register: https://lnkd.in/eU-qe53U #Articulate2026 #MedicalAffairs #AI #ScientificCommunications #LifeSciences
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Josh Corriveau PharmD MBA
Josh Corriveau PharmD MBA
Otsuka Pharmaceutical Companies (U.S.)
5K followersCharleston, South Carolina Metropolitan Area
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Tyrone McClain
Pfizer • 4K followers
A resilient, reliable medicine supply chain isn’t just a logistics win. It’s a lifeline for hospitals and the patients who depend on them every day. This feature from The New York Times sheds light on the complexity of global sourcing and highlights the critical importance of collaboration across the healthcare ecosystem. At Pfizer, I’m proud to help drive our ongoing commitment to strengthening access and affordability by partnering with supply chain leaders, hospital systems, and organizations like US Pharmacopeia to ensure every patient receives the care they deserve.
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Robert Sexton
Syneos Health Commercial… • 3K followers
AI is reshaping Patient Support—and the real opportunity isn’t just adopting new technology, but implementing it strategically without getting tripped up by compliance hurdles. At the upcoming Patient Support Services Congress, I’ll be speaking on: “Navigating the AI Compliance Maze – Ensuring Regulatory Adherence in Patient Support.” I’ll share a practical view on how organizations can design and deploy AI-enabled support models that accelerate impact while remaining aligned with evolving regulatory expectations. We’ll explore how to build AI strategies that innovate responsibly and strengthen the business. If you’re attending, I’d love to connect.
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Andrew Powaleny
PhRMA • 4K followers
A new report highlighted from PhRMA shows the growing promise of cell and gene therapies—with a robust pipeline of potential treatments that could transform care for patients with serious and rare diseases. But scientific progress alone isn’t enough. As innovation accelerates, persistent barriers—including reimbursement challenges, complex logistics and limited treatment infrastructure—continue to slow patient access to these groundbreaking therapies. Across the health system, stakeholders will need to work together to ensure that patients can benefit from the next generation of potentially curative treatments. Read more about the report and what it means for the future of innovation and patient access: https://lnkd.in/ew6p8aRf #CellTherapy #GeneTherapy #RareDisease
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Chiara Stella Cochetti
Cytel • 3K followers
RWE is now CORE, not optional. The FDA is reducing pre-approval trials. What does this mean for RWE? • Less randomized evidence → more uncertainty at launch • Regulators lean on post-market data • RWE demand = 🚀 Let’s break this down: 1️⃣ Post-approval RWE needs explode: safety, effectiveness, label expansions, confirmatory commitments 2️⃣ Earlier RWE pre-approval is needed: external controls, natural history cohorts, single-arm trial context 3️⃣ Quality is king: regulator-grade, protocolized, fit-for-purpose. Low-quality RWE won’t cut it Where it matters most: • Regulatory ✅ • HTA & payers 💰 • Lifecycle & commercial strategy 📈 💡 Bottom line: Fewer trials = RWE is now core, not optional. #RWE #Pharma #DrugDevelopment #RegulatoryScience #MarketAccess
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