Parexel

📃Why Your Data Strategy Makes or Breaks Regulatory Success 📃 In a real-world example, Parexel's Christiane Niederlaender shared how one company faced multiple FDA revision rounds not because of clinical issues, but because their potency assay results were unclear. In this article from GEN, Christiane demonstrates why getting your analytics right is critical for regulatory success with advanced therapies. Her advice for ATMP developers: ▪️Profile your product thoroughly from the start ▪️Identify critical quality attributes early ▪️Maintain analytical continuity throughout development ▪️Build a comprehensive CMC data collection strategy ▪️Create a thoughtful regulatory interaction roadmap A strategic roadmap for regulatory interactions and a thorough gap analysis will help sponsors avoid asking "the right questions in the wrong way." Find out more ➡️https://lnkd.in/eRGRWpbr

At BioFuture 2025, Parexel’s Tala Fakhouri, Ph.D., M.P.H., joined a panel discussion focused on charting a path forward in clinical research that is more connected, efficient and patient-centric. Dr. Fakhouri (second from the left), formerly with the FDA, serves as Vice President, Regulatory Consulting: AI & Digital Policy, Real-World Research. The panel discussion, “AI & Quantum Computing: Revolutionizing Healthcare,” explored how these transformative technologies are driving innovation, advancing data-driven decision-making and reshaping the future of healthcare and life sciences. #BioFuture2025 #AI #QuantumComputing

Broadening inclusion in breast cancer trials isn't just ethical, it's essential for scientific rigor, regulatory progress and market access. Nearly one-third of new breast cancer cases are in women aged 70+, and up to 42% of women have at least one comorbidity, yet both groups are often excluded by eligibility criteria. In this edition of the New Medicines, Novel Insights newsletter, Parexel experts explore why inclusive representation across age, gender, geographies, comorbidities and more is key to generating data that reflects real-world populations. We dive into how strategic site selection, modified eligibility criteria, and community partnerships can help sponsors reach underserved patients and meet evolving expectations from regulators and HTA bodies. Read the full article to discover how inclusive trial design drives stronger evidence, faster development, and better outcomes for all. #BreastCancerAwarenessMonth #BCAM #BreastCancer #ClinicalTrials #Oncology #NovelInsights

“Every role will touch AI, every day. You won’t be able to do your jobs without touching AI. How do we help the many thousands of people in our sector to be ready for the wave of change that’s coming?”   Parexel’s Stephen Pyke sat down with Nagaraja Srivatsan on the Life Sciences DNA Podcast to discuss the state of AI adoption in the industry.   In short ─ We must prepare teams today for a near future where AI is everywhere, used every day and in every role in clinical development. Watch the full episode🎥 https://lnkd.in/eH2pvR6F Parexel’s “Optimizing the Clinical Research Workforce” report explores how organizations are adapting to AI, what’s working and how we can better invest in talent, culture and capabilities to move the industry forward. Find it here 🔗https://lnkd.in/eNdS3pmZ Agilisium Consulting #LifeSciencesDNA #AIinClinicalTrials 

Now live: Clinical Trialblazers episode 9! Tune in for an insightful conversation with Dr. Geeta Vemuri, Founder and Managing Partner of Agent Capital.    In this episode, Dr. Vemuri offers a compelling look into her career positioned at the unique intersection of life sciences and venture capital as she delves into the characteristics that help biotech companies and CEOs stand out to investors. Dr. Vemuri emphasizes the critical balance between scientific innovation and strong management teams, the significance of capital efficiency in building sustainable companies and the value of board membership.    To hear Dr. Vemuri’s optimistic outlook on the future of biopharma, listen to the latest episode of Clinical Trialblazers wherever you get your podcasts: https://lnk.to/episode-9 #ClinicalTrialblazers

Inclusion and belonging at Parexel are not just ideals but foundational elements that energize and drive our mission to accelerate the delivery of new therapies for patients everywhere. Our 2024 sustainability & impact report outlines some of the latest milestones: ✨ 46.6% women at VP+ level (up from 33.5% in 2014) 👥 90%+ favorable leadership ratings through our “Managers Matter” program 🏆 Named a Best Place to Work for Disability Inclusion (2024, Disability Equality Index®) 🏅Named to HRC Corporate Equality Index, ranking 85 out of 100 and improving our score year-over-year 📥 Download the full sustainability & impact report to see how we’re driving meaningful change: https://lnkd.in/eTzB9eJk

The Joint Clinical Assessment (JCA) framework aims to streamline product assessment and support equitable patient access to medicines in the EU. However, it introduces new complexities for sponsors: Aligning regulatory and market access data packages, navigating multiple PICOs across diverse healthcare systems and adapting to national HTA processes. Our JCA playbook offers practical strategies for biopharma companies to prepare, from early integrated evidence planning to comprehensive stakeholder engagement and early economic model development. A case study highlights our work helping a biotech company align regulatory and HTA strategies for their oncology JCA submission, ensuring evidence acceptability across all assessment bodies. Download the full playbook to learn how to successfully navigate this evolving landscape and accelerate market access across the EU. https://lnkd.in/eS44853Q #JointClinicalAssessment #JCA

We’re looking forward to joining oncology leaders across the globe this week at #ESMO2025 in Berlin! Our oncology and regulatory experts will be on-site, ready to connect and discuss how we’re helping sponsors bring innovative therapies to patients faster, 𝘞𝘪𝘵𝘩 𝘏𝘦𝘢𝘳𝘵. Visit Parexel at booth 4004 and schedule a meeting with our team to explore strategies across clinical development and regulatory pathways that can help accelerate your programs. https://lnkd.in/ehK6RJrG #Oncology #ESMO

“I saw my father's diabetes medication coming off the production line—millions of pills. That moment transformed my perspective. These glimpses of real-world impact remind me why we do everything With Heart™." Meet Chirag Patel, Executive Business Development Director at Parexel Biotech, who combines scientific expertise with personal connection. When we see the human impact of our work, we find deeper purpose in overcoming challenges. 💡 What you can learn from Chirag's approach: • Authenticity builds stronger partnerships • Bridging perspectives creates value • Resilience comes from purpose Discover how professionals at Parexel Biotech work across multiple sponsors, gaining diverse experience while making visible, valued contributions: https://brnw.ch/21wWzPt

Looking for a career with purpose? Join Parexel's Talent Community today! Sign up to receive personalized job alerts that align with your expertise and passions. Whether you're currently job hunting or just curious about future possibilities—join our network to be first to know about opportunities to impact patient lives. Sign up here: https://brnw.ch/21wWxjr #ClinicalResearchCareers #ParexelCareers