Synterex

At our recent RAPS webinar, we asked the audience: “Which of the following do you believe is the most pressing cybersecurity concern related to the development and deployment of AI?”. Among the respondents, the main concern was: Data breaches and privacy violations (50%) The era of AI in healthcare is here, and we need to be equipped with knowledge and skills to ensure data compliance, safety, and integrity. Turn to our many experts who can help you navigate this environment, and stay tuned as we continue to explore these critical topics. In the meantime, check out our blog post on how to tackle these issues: https://lnkd.in/gBC4g8qt. #AIinHealthcare #Cybersecurity #DataProtection #AgileWriter

A recent survey from the Deloitte US Center for Health Solutions shows that life sciences leaders aren’t just adapting to the current market—they’re actively driving innovation, creating value, and navigating industry shifts with artificial intelligence (AI) and digital transformation at the forefront. Here is a key takeaway: Reevaluating Research and Development (R&D) and Product Development – More than half of executives say they need to update their strategies within the next year to remain competitive. This highlights a critical shift—organizations must be agile, adapting not just to current trends but preparing for future disruptions as they arise. What does this mean?  • Enhancing collaboration across teams and stakeholders  • Optimizing clinical trial designs with AI-powered tools As the landscape continues to evolve, Synterex remains dedicated to supporting the industry in navigating these changes and making the most of new opportunities for growth and innovation. Learn more here: https://lnkd.in/gBQQyrxT. #Pharma #Biotech #Collaboration #AgileWriter 

And the correct answer to yesterday's trivia is... B) Zidovudine (AZT). Approved in 1987 for HIV/AIDS, AZT was the first drug to use the FDA's Accelerated Approval Program. #RegulatoryScience #RegulatoryAffairs #Trivia 

From our President, Jeanette Towles, on the Spring Roundtables hosted by the American Medical Writers Association on April 6th: "The Spring Roundtables hosted by the American Medical Writers Association (AMWA) New England Chapter were nothing short of energizing! I had the pleasure of leading a lively and thoughtful discussion on regulatory writing—from what it is, to how to get started, and what it’s like in the real world. It was wonderful to hear everyone's questions, experiences, and enthusiasm for the field. Along the way, I had the chance to connect with so many talented individuals aspiring to become medical writers. Their curiosity and drive are exactly what this profession needs, and I’m excited to see where their journeys take them. I also got to catch up with old friends and familiar faces—always a highlight of any AMWA event. Thanks again to AMWA-NE for organizing such a warm and welcoming space to learn and share. If you’ve ever been curious about medical writing, this community is a great place to start." #AMWA #MedicalWriting #RegulatoryWriting #AMWANE

It’s Regulatory Trivia time! FDA’s Accelerated Approval Program allows drugs for serious conditions to reach patients faster based on surrogate endpoints—measurable signs that predict clinical benefit; for example, tumor shrinkage in cancer trials. This process can shave years off traditional approval timelines instead of waiting for long-term survival data. Which drug was the first to receive FDA approval under the Accelerated Approval Program? A) Imatinib  B) Zidovudine (also known as azidothymidine [AZT])  C) Pembrolizumab D) Trastuzumab Drop your answer in the comments and come back tomorrow for the correct answer reveal. #RegulatoryScience #RegulatoryAffairs #Trivia 

"Generative AI offers potential efficiencies in drafting various document types in medical writing. However, when facing the opportunity to adopt generative AI, heads of medical writing departments have reported being under immense organizational pressure to demonstrate immediate cost savings by reducing headcount. While AI can certainly streamline processes, focusing solely on workforce reduction overlooks a critical long-term metric: medical writing staff retention." Read more on the hidden KPI in AI-enabled medical writing: https://lnkd.in/gG7xdKJU. #StaffRetention #AIinHealthcare #MedicalWriting #AIAdoption #Synterex

We are honored to sponsor the Life Science Cares Boston Impact Breakfast again this year. Tomorrow, we will attend to celebrate Life Science Cares' partners, donors, and volunteers for their hard work in alleviating the effects of poverty in and around Boston, MA. If you know someone who will be there, tag them in the comments so we can say hello! #LSC #LifeScienceCares #ImpactBreakfast

As AI continues to reshape the pharmaceutical industry, regulatory agencies are working to ensure its responsible use. American Medical Writers Association (AMWA)’s recent article highlights key developments, including the EU AI Act and FDA’s ongoing efforts to regulate AI in drug development: https://lnkd.in/ggAXpH-t. We embraced a technology-agnostic approach and built AgileWriter™ as a modular and adaptive AI-enabled clinical documentation tool to allow for incorporation of technical and regulatory changes as they occur. By proactively integrating AI and staying on top of regulatory shifts, we are shaping the future of clinical and regulatory writing. Read more about the role of medical writers in creating AI-enabled tools here: https://lnkd.in/geKptBsU. #AI #ClinicalTrials #AIinHealthcare #Innovation

Former director of the CDC Dr. Thomas Frieden once said walking is "the closest thing we have to a wonder drug." Walking has a wide range of benefits, some of which may be surprising. According to Harvard Medical School, these are the five most unexpected benefits of putting one foot in front of the other: 1. Supports weight control 2. Reduces sweets cravings 3. Diminishes the risk of breast cancer 4. Alleviates joint pain 5. Boosts immunity The next time you have the choice between driving and walking, lace up those sneakers! Read more here: https://lnkd.in/gk72ypz. #WalkToWorkDay