Vistatec Life Sciences - In Focus Podcast Ep 11 - 2024 In Review with Karen Tkaczyk and María Mateos
Karen Tkaczyk and María Mateos, the hosts of the Life Sciences – In Focus Podcast, take a moment to reflect on the past year. In a special year-end episode, the two seasoned professionals for Vistatec’s Life Sciences Division—shared their perspectives on the trends, challenges, and triumphs shaping the global life sciences industry.
Their conversation touched on everything from the strategic integration of AI in workflows to the evolving regulatory compliance landscape. Here’s a snapshot of the highlights from their thoughtful discussion.
The Role of AI: Finding Balance in a High-Stakes Industry
It’s impossible to talk about 2024 without mentioning artificial intelligence (AI). As María noted early in the conversation, AI has been a pervasive topic, sparking both excitement and caution across the industry.
Karen explained how AI can be effectively—and safely—integrated into life sciences workflows. Using examples ranging from corporate chatbots to regulatory submissions, she emphasized a “human-in-the-loop” approach.
“Hallucinations—when AI makes up something it doesn’t know—can be a disaster,” Karen explained. “For high-stakes content like informed consent forms or regulatory documents, human-led workflows and rigorous quality assurance are non-negotiable.”
María echoed this sentiment, highlighting the importance of customization and risk assessment when deciding where AI fits into the workflow.
“It’s all about balance,” María said. “We use AI where it saves time and money, but always with careful thought and in close collaboration with our clients.”
Regulatory Shifts: A Year of Adjustment
From the EU Medical Device Regulation (MDR) saga to the FDA’s updated diversity guidance, regulatory changes were a recurring theme throughout 2024. María described the impact of these changes as both challenging and transformative.
The MDR, which has led some companies to pause or shift their operations away from Europe, was a hot topic.
Karen expressed hope for improvements in 2025 that could simplify processes while maintaining safety standards. She acknowledged, however, the strain this regulation has placed on smaller and mid-sized companies.
The FDA’s guidance on diversity action plans was another focal point. This new initiative encourages clinical trials to include more underrepresented groups, fostering both healthcare equity and stronger scientific outcomes.
Karen passionately advocated for this shift:
“The science is stronger when trials include diverse participants,” she said. “It’s not just about doing the right thing—it’s about better data and better outcomes.”
Industry Events: Networking and Learning on the Global Stage
The podcast hosts attended numerous industry events in 2024, gaining valuable insights and strengthening client relationships. From the high-energy Scope Summit in February to the Drug Information Association’s annual conference in June, these events provided opportunities to learn about cutting-edge innovations and regulatory updates.
“It’s about meeting people, growing relationships, and ensuring we truly have the subject matter expertise our clients rely on,” Karen explained.
María highlighted the importance of staying connected to evolving industry standards, noting how these events help Vistatec refine its localization programs to serve clients better.
Looking Ahead: Anticipation for 2025
As the episode wrapped up, Karen and María shared their excitement for the year ahead. For Karen, 2025 is about deepening client relationships and ensuring that Vistatec’s programs continue to drive success.
“My greatest joy is seeing science and language connect in the real world,” she said. “Helping clients achieve their goals with customized, multilingual workflows is what motivates me.”
María echoed this sentiment, expressing pride in the success of localization programs launched in 2024 and optimism about their long-term impact.
“We’re already seeing terrific results,” she said. “I can’t wait to see how these programs continue to grow and help our clients reach new audiences, recruit more patients, and expedite submission timelines.”
Final Thoughts
The Life Sciences – In Focus Podcast has established itself as a must-listen for professionals in the industry. Karen and María’s year-in-review episode offered a look back at 2024 and a future roadmap. Their insights into AI, regulatory challenges, and client collaboration underscore the thoughtfulness and expertise they bring to the table.
As we head into 2025, one thing is clear: the life sciences field is evolving rapidly, and Karen and María are ready to guide their clients—and listeners—every step of the way.
Be sure to catch the full episodes of the Life Sciences – In Focus Podcast on Spotify, Apple Podcasts, or YouTube.
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