Episodes

  • Vistatec Life Sciences - In Focus - Ep 28 - Kiran Khan
    Jun 29 2026

    That perspective perfectly captures the insights shared by Kiran Khan, Manager, Regulatory Affairs at Kymera Therapeutics, in the latest episode of the Life Sciences – In Focus podcast.

    As drug development becomes increasingly complex, regulatory affairs professionals are stepping into more strategic roles than ever before. From navigating accelerated approval pathways to leveraging artificial intelligence responsibly, Kiran offers a thoughtful and practical perspective on the future of regulatory affairs and the skills professionals will need to succeed. The discussion explored the evolution of regulatory strategy, global harmonization, health authority engagement, and why curiosity remains one of the most valuable traits in the profession.



    00:00 - Welcome and Introduction to Kiran Khan

    01:06 - Kiran’s Journey into Regulatory Affairs

    05:28 - How Regulatory Affairs Became a Strategic Function

    07:12 - AI’s Impact on Regulatory Strategy and Submissions

    10:37 - Navigating Accelerated Approval Pathways

    13:56 - Global Harmonization vs Regional Regulatory Requirements

    17:58 - Changing Health Authority Engagement and Communication Skills

    21:45 - The Future of Regulatory Affairs and Key Industry Trends


    About Life Sciences - In Focus

    Life Sciences - In Focus Podcast by Vistatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics. Follow Life Sciences - In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple podcasts. Life Sciences - In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division.


    About Vistatec

    We have been helping some of the world’s most iconic brands to optimize their global commercial potential since 1997. Vistatec is one of the world’s leading global content solutions providers. HQ in Dublin, Ireland, with offices in Mountain View, California, USA. To learn more about Vistatec, please visit https://www.vistatec.com


    Social Media:

    LinkedIn - https://www.linkedin.com/showcase/vistatec-life-sciences

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    28 mins
  • Vistatec Life Sciences - In Focus - Ep 27 - Julie Moon
    May 26 2026


    About Life Sciences - In Focus

    Life Sciences - In Focus Podcast by Vistatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics. Follow Life Sciences - In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple podcasts. Life Sciences - In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division.


    About Vistatec

    We have been helping some of the world’s most iconic brands to optimize their global commercial potential since 1997. Vistatec is one of the world’s leading global content solutions providers. HQ in Dublin, Ireland, with offices in Mountain View, California, USA. To learn more about Vistatec, please visit https://www.vistatec.com


    Social Media:

    LinkedIn - https://www.linkedin.com/showcase/vistatec-life-sciences

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    21 mins
  • Vistatec Life Sciences - In Focus - Ep 26 - Karen Tkaczyk and Simon Hodgkins
    Apr 28 2026

    "AI is powerful, but in life sciences, it's an augmentation, not a shortcut." This episode of Life Sciences – In Focus features Simon Hodgkins, Chief Marketing Officer at Vistatec AI, as we explore one of the industry's most debated topics: artificial intelligence.


    Host Karen Tkaczyk takes on both interviewer and contributor roles. This creates a dynamic conversation, rich with insights, that explores the promise of AI and its practical realities in regulated environments.


    00:00 – Welcome and Role Reversal Introduction

    01:25 – Simon’s Perspective on AI in Life Sciences

    03:10 – Industry Challenges and Regulatory Complexity

    05:04 – AI vs Reality in Regulated Environments

    06:10 – Translation, Compliance, and Cultural Nuance

    08:55 – Human-in-the-Loop: Why It Matters

    10:15 – Data Privacy, Security, and AI Costs

    13:36 – Regulations, EU AI Act, and Risk Classification

    23:57 – Multilingual Communication and Meaningful Engagement



    About Life Sciences - In Focus

    Life Sciences - In Focus Podcast by Vistatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics. Follow Life Sciences - In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple podcasts. Life Sciences - In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division.


    About Vistatec

    We have been helping some of the world’s most iconic brands to optimize their global commercial potential since 1997. Vistatec is one of the world’s leading global content solutions providers. HQ in Dublin, Ireland, with offices in Mountain View, California, USA. To learn more about Vistatec, please visit https://www.vistatec.com


    Social Media:

    LinkedIn - https://www.linkedin.com/showcase/vistatec-life-sciences

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    28 mins
  • Vistatec Life Sciences - In Focus - Ep 25 - Karen Tkaczyk and Sara Brueck Nichols
    Mar 31 2026

    Host Karen Tkaczyk sits down with Sara Brueck Nichols, President of McCreadie Group, for a Life Sciences - In Focus Podcast episode that moves seamlessly between personal experience, industry insight, and practical innovation.


    About Life Sciences - In Focus
    Life Sciences - In Focus Podcast by Vistatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics. Follow Life Sciences - In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple podcasts. Life Sciences - In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division.







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    28 mins
  • Vistatec Life Sciences - In Focus Ep 24 - Karen Tkaczyk - Daniela Blanco
    Feb 25 2026

    In the latest episode of the Life Sciences - In Focus Podcast, Karen Tcazyk speaks with Daniela Blanco, whose journey spans continents, disciplines, and industries, from chemical engineering in Venezuela to building AI-powered tools that are reshaping how scientists run experiments.


    What makes Daniela’s story especially compelling is not just what she’s building, but why.


    00:00 - Welcome and Guest Introduction

    00:54 - Daniela’s origin story, from Venezuela to chemical engineering and sustainability

    03:16 - Founding Synthetics: from NYU competition to startup launch

    03:43 - Why Synthetics pivoted from solar chemistry to AI-driven experimentation

    05:47 - The state of AI adoption in chemistry and life sciences

    06:28 - Making AI work with small datasets and winning early industry trust

    10:21 - Funding lessons for technical founders and the power of non-dilutive capital

    14:50 - What’s next for Synthetics, hiring, conferences, and how to connect



    About Life Sciences - In Focus

    Life Sciences - In Focus Podcast by Visatatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics. Follow Life Sciences - In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple podcasts. Life Sciences - In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division.


    About Vistatec

    We have been helping some of the world’s most iconic brands to optimize their global commercial potential since 1997. Vistatec is one of the world’s leading global content solutions providers. HQ in Dublin, Ireland, with offices in Mountain View, California, USA. To learn more about Vistatec, please visit https://www.vistatec.com


    Social Media:

    LinkedIn - https://www.linkedin.com/showcase/vistatec-life-sciences

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    28 mins
  • Vistatec Life Sciences - In Focus - Ep 23 - Karen Tkaczyk and Ana Sofía Correia
    Jan 28 2026

    Host Karen Tkaczyk welcomes a guest who brings a vital but often underappreciated perspective to the life sciences ecosystem on this episode of the Life Sciences - In Focus Podcast. Ana Sofía Correia is a freelance medical translator and writer, as well as a medical translation mentor, with nearly two decades of experience working at the intersection of language, medicine, and patient communication.

    This episode marked a first for the podcast: a dedicated conversation with a linguist, and it quickly became clear why this voice matters.


    00:00 - Welcome and Guest Introduction

    01:48 - Ana’s Origin Story and Career Path

    04:08 - The Breadth of Work in Life Sciences Linguistics

    07:40 - Becoming a Subject Matter Expert as a Linguist

    12:00 - Passion, Patients, and Fair Access to Information

    17:11 - AI in Translation: Risk, Reality, and Responsibility

    24:55 - Final Advice: Bring Language Experts in Early


    Ana shared a final piece of advice that resonated strongly. Language professionals should not be treated as the final step in the process. Bringing translators, editors, and localization experts in earlier allows them to advise on structure, clarity, and usability while the content is still being shaped.

    This early involvement leads to smoother workflows, higher-quality outputs, and fewer downstream problems. It reframes language not as a mechanical task, but as a strategic component of life sciences communication.

    About Life Sciences - In Focus

    Life Sciences - In Focus Podcast by Visatatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics. Follow Life Sciences - In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple podcasts. Life Sciences - In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division.


    About Vistatec

    We have been helping some of the world’s most iconic brands to optimize their global commercial potential since 1997. Vistatec is one of the world’s leading global content solutions providers. HQ in Dublin, Ireland, with offices in Mountain View, California, USA. To learn more about Vistatec, please visit https://www.vistatec.com


    Social Media:

    LinkedIn - https://www.linkedin.com/showcase/vistatec-life-sciences

    Show More Show Less
    28 mins
  • Vistatec Life Sciences - In Focus - Holiday Special - María Mateos - Karen ​Tkaczyk
    Dec 30 2025

    Life Sciences In Focus podcast takes a reflective turn. Instead of welcoming a new

    guest, hosts Karen Tkaczyk and María Mateos sit down for a holiday special to look

    back at the conversations that shaped 2025 and to share what they see on the

    horizon for 2026. Their discussion offers a warm, candid look at the themes, people,

    and ideas that defined an eventful year in life sciences.


    00:00 - Welcome to the holiday special

    0:44 - Themes from 2025 webinars and podcast episodes

    01:30 - Amplifying patient voices and engaging non English speakers

    02:46 - Clinical research insights with Jonathan Gardo

    03:28 - Regulatory trends and expert conversations

    05:27 - Mentorship in regulatory affairs with Angelina Lisa

    07:59 - Therapeutic area spotlight, ophthalmology in 2025

    11:59 - Looking ahead to 2026 and closing reflections


    About Life Sciences - In Focus

    Life Sciences - In Focus Podcast by Visatatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics. Follow Life Sciences - In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple podcasts. Life Sciences - In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division.


    About Vistatec

    We have been helping some of the world’s most iconic brands to optimize their global commercial potential since 1997. Vistatec is one of the world’s leading global content solutions providers. HQ in Dublin, Ireland, with offices in Mountain View, California, USA. To learn more about Vistatec, please visit https://www.vistatec.com


    Social Media:

    LinkedIn - https://www.linkedin.com/showcase/vistatec-life-sciences

    Show More Show Less
    28 mins
  • Vistatec Life Sciences - In Focus - Ep 21 - María Mateos - Andrei Ninu
    Nov 25 2025

    Regulatory expert Andrei Ninu joins Host María Mateos in this episode of Life Sciences - In Focus to discuss one of the most complex challenges facing the medical device industry today: navigating the dual requirements of the EU Medical Device Regulation (MDR) and the newly enacted EU AI Act.Ninu, who specializes in functional and software safety, as well as AI applications in healthcare, offered a practical and grounded perspective on what these overlapping regulations mean for manufacturers, particularly those developing AI-powered medical technologies.00:00 - Meet Andrei Ninu: Regulatory Expert in AI and Medical Devices01:41 - MDR vs. EU AI Act: Understanding the Dual Compliance Landscape03:59 - Why 80% of MDR Documentation Helps with AI Act Compliance08:11 - AI Model Training10:45 - Compliance Tips for Small and Mid-Sized MedTech Companies14:35 - Real-World Example: Data Partitioning and Clinical Relevance19:58 - Going Beyond Accuracy: Metrics that Truly Matter in AI Evaluation25:03 - Final Advice: Engage Early with Notified Bodies for SuccessAbout Life Sciences - In Focus Life Sciences - In Focus Podcast by Visatatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics. Follow Life Sciences - In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple podcasts. Life Sciences - In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division.About Vistatec We have been helping some of the world’s most iconic brands to optimize their global commercial potential since 1997. Vistatec is one of the world’s leading global content solutions providers. HQ in Dublin, Ireland, with offices in Mountain View, California, USA. To learn more about Vistatec, please visit https://www.vistatec.comSocial Media:LinkedIn - https://www.linkedin.com/showcase/vistatec-life-sciences

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    28 mins