Amit Kundu

🎙️ New Podcast Alert from Fortrea! 🎙️ Don't miss the second episode of our Project Optimus podcast series! 🎧 In this episode, Dr. Shanthi Sundaramoorthy, Ph.D, Senior Director of Fortrea's Strategic Growth and Delivery Team in Oncology discusses the real-world impact of the shift to optimized doses in oncology drugs and what it means for early-phase trial design. 🎧Listen: https://gag.gl/hT6mtS #Oncology #ClinicalTrials #Podcast #Fortrea

5

Researchers have recently discovered a potent new antibiotic, marking an important breakthrough achieved not by exploring uncharted areas, but by revisiting known paths. https://gag.gl/DXvk10

5

A very insightful article on evolving Biotech landscape and emerging trends in New Drug Development. ICON plc #Biotech #Clinicalresearch #Drugdevelopment

21

🚦 Not all problems are created equal… so why do we act like they are? Early in my career, I had a boss who loved Kepner-Tregoe problem-solving so much that he wanted us to use it for everyCAPA. And don’t get me wrong—it’s a solid tool for technical investigations. If a machine keeps shutting down or a chemical reaction goes sideways, KT (or an Is/Is Not analysis) gives you a great framework to chase the root cause. But when you’re dealing with compliance-only issues? 📝 Applying a heavy, technical tool to an SOP that’s missing required instructions or a process step that literally can’t be followed is like bringing a backhoe to plant a flower. It slows you down and doesn’t actually help you solve the issue. That’s why I’ve learned that the real trick is matching the method to the problem: Technical root cause? KT or Is/Is Not works best. Compliance issue? 5 Whys or a lightweight risk-based check keeps you moving without overcomplicating things. 👉 CAPA is not one-size-fits-all. The smartest thing we can do is right-size our problem-solving method to the type of issue in front of us. I’m curious — what’s your go-to CAPA problem-solving method, and how do you decide when to use it?

23

Our session at ASUG Minnesota highlights how AI-driven insights are reshaping the Revenue Growth Management lifecycle, from Trade Promotion Predictive Modeling and Analytics, Actualization of Trade Performance to Intelligent Claims Management. Thrilled to see how IAP’s technology continues to help our clients achieve smarter, faster, and more sustainable growth. #SAP #DigitalTransformation #Leadership #SAPCCM #RevenueGrowthManagement #IncentiveManagement #S4HANA #ASUGCommunity #B2B #CustomerSuccess #TradeManagement #CPG #SalesProcesses #CustomerBusinessPlanning #SalesFinanceManager #SalesDirector #TradeFinance #SalesFinance #TradePromotionPlanningandManagement #Indirect #Wholesalers #Distributors #Minnesota

6

The Ants and the Cake: Lessons in Collective Success Last weekend, while enjoying coffee on a café patio, I witnessed a simple yet powerful lesson in teamwork and leadership. A small piece of cake had fallen to the ground. Soon, a single ant appeared, inspecting the crumb and attempting to pull it away. Despite its effort, the piece was too large for one ant to move. After assessing the situation, the ant left—only to return moments later with a line of fellow ants. Together, they surrounded the cake and began pulling in unison. Within minutes, they had moved the piece to their nest along the wall. Though it may seem like a small event from nature, this brief encounter carries meaningful insights that can be applied to how teams and organizations operate. 1. Teamwork The first ant recognized the limits of individual effort and sought help. By mobilizing others, the group accomplished what was impossible alone. Business Application: In organizations, success often depends on recognizing when collaboration is needed. Effective teams leverage diverse strengths, share responsibility, and align their efforts toward a common goal—achieving far more together than individually. 2. Leadership The initial ant demonstrated leadership not through authority, but by action—identifying an opportunity, rallying others, and setting direction. Business Application: True leaders inspire through initiative and vision. They identify opportunities, communicate purpose, and motivate teams to act decisively, turning challenges into shared wins. 3. Putting the Organization Before Self Instead of hoarding the find, the ant prioritized the needs of the colony over personal gain. This selflessness ensured collective benefit and long-term stability. Business Application: In business, the greatest results come when individuals act for the greater good—sharing credit, information, and resources. When teams focus on organizational outcomes rather than personal agendas, sustainable success follows. Conclusion: That small scene at the café patio offered a timeless reminder: success is rarely achieved in isolation. Whether in nature or in business, progress depends on collaboration, leadership, and a shared sense of purpose. Like the ants, organizations thrive when their members unite behind common goals—each contributing their strength to move the organization forward.

15

Stephen Hawking pursued a unified theory to simplify the universe. At EVERSANA, we asked ourselves — can we do the same for pharmacovigilance? Introducing EVERSANA ORCHESTRATE™ PV — our AI-powered answer to unifying and simplifying the fragmented world of drug safety. From GenAI-driven literature monitoring to automated aggregate reporting, we’ve reimagined PV as a connected, intelligent ecosystem — built not for complexity, but for clarity, compliance, and scale. Read how we’re Simplifying PV with elegance and precision. https://lnkd.in/dpTicyGG   #pharmacovigilance #AIinPV #drugSafety #Eversana #OrchestratePV #GenAI 

107

4 Comments

Parexel has established a dedicated task force of former FDA experts and others to monitor regulatory developments and provide real-time guidance to clients amid recent FDA policy and staffing changes. In an interview with Nikkan-Yakugyo, Paul Bridges shares that Parexel is advising sponsors to diversify their regulatory engagement across global agencies aligned with ICH principles to mitigate potential risks. Find out below how we're addressing increased interest in the Japanese market amid regulatory changes. 🔗

10

Commandment #1 drops on the blog today. Every good belief system starts with a first commandment — and in IRT, this is where most heresies begin. Before we debate integrations, reconciliation, or user experience, let’s start simple: what is IRT actually for? "The IRT system is to serve only its primary purposes" Check it out https://lnkd.in/ern5QcEq

24

8 Comments