In this episode of the Cognitio Podcast, we sit down with Brenton Judge, Executive General Manager at Hendon Semiconductors, to explore the real-world challenges and considerations in outsourced manufacturing. With over three decades of experience in large-scale operations across Asia and Australia, Brenton shares frank insights into what makes—or breaks—a vendor relationship.

We cover:

• Why early vendor involvement matters more than ever

• Common pitfalls in product design, EMC compliance, and testability

• The hidden costs of overseas manufacturing

• The grey areas of IP ownership and test system control

• What to look for in a genuine manufacturing partnership

Whether you're navigating contract manufacturing for the first time or rethinking your outsourcing model, this episode offers grounded advice that will help you de-risk your next product launch.

In this episode, ARCS CEO Tim Boyle speaks with Greg Taylor from the Copyright Agency about one of the most overlooked risks in the pharmaceutical and medtech sectors: copyright compliance. Greg unpacks what copyright means in an Australian context, how it applies to regulatory affairs, pharmacovigilance, and clinical research workflows, and why simply buying or accessing an article isn’t the same as having permission to share it.

Through real-world examples and practical advice, this 25-minute episode highlights common myths, outlines licensing solutions tailored to the life sciences, and offers clear guidance on how to stay compliant — ethically and legally.

Whether you work in a sponsor company, CRO, or advisory role, this is essential listening for anyone handling published literature in a professional setting.

What does it take to create a future-proof framework for data sharing in clinical research?

In this episode of Cognitio, Tim Boyle is joined by Dr Lisa Eckstein, Program Director of CT:IQ, to unpack a major national initiative reshaping how Australian researchers think about data access, consent, and governance.

Lisa shares insights from her work with the Australian Research Data Commons (ARDC) on the Clinical Research Data Sharing Frameworks project—covering everything from the development of the Informed PICF template to benchmarking ethics committee decision-making across the country.

Whether you're a researcher, sponsor, or ethics reviewer, this conversation offers a timely look at the enablers and barriers to responsible data sharing, and how the sector can better align on legal, ethical, and participant-centred approaches.

🎙️ Highlights include:

• Why outdated consent forms are holding research back

• The push for “the ICH-GCP of data sharing”

• What ethics committees are getting right—and wrong

• Tools and templates your team can use right now

To learn more or access the tools discussed, visit ctiq.org.au or arcs.com.au.

🎧 Episode Description – Cognitio Podcast
Mentorship Matters – From Insight to Impact
Presented by ARCS Australia

In this episode of Cognitio, we explore the transformative power of mentorship with one of Australia’s most respected Medical Affairs professionals—Dr. Leon Rozen.

Blending sharp insight, practical strategies, and a dash of Greek mythology, Leon unpacks what it really means to mentor and be mentored. From dismantling common myths to exploring modern approaches like reverse mentoring and coaching hybrids, this conversation moves beyond theory and into the reality of how people grow—together.

Hosted by ARCS CEO Tim Boyle, this documentary-style episode draws on Leon’s decades of leadership and people development expertise to illuminate how mentorship shapes careers, builds confidence, and fosters capability across the life sciences sector.

Whether you’re an emerging professional or a seasoned leader, this is your invitation to reflect on the role mentorship has played in your journey—and how you can pay it forward.

🔗 Visit arcs.com.au to learn more about our leadership and mentoring programs.

In this special anniversary episode, ARCS CEO Tim Boyle takes listeners on a journey through the 40-year history of ARCS Australia—tracing its evolution from a volunteer-run group hosting wine and cheese nights to becoming the national peak body for life sciences professionals.

Featuring the voices of founders, past presidents, long-time volunteers, and TGA collaborators, this episode reveals how ARCS was born out of frustration with regulatory uncertainty and grew through grassroots passion, professionalisation, and purposeful partnerships.

Discover how ARCS has shaped careers, influenced regulation, and built a professional community dedicated to advancing innovation in healthcare—and why the next chapter may be the most exciting yet.

🎧 Listen now to hear the story of ARCS—told by those who lived it.

🔖 #ARCSAustralia #LifeSciences #RegulatoryAffairs #ClinicalResearch #ProfessionalDevelopment #ARCS40Years

Welcome to the Cognitio Podcast — a new audio companion to ARCS Australia's flagship magazine. In each episode, we bring you behind the scenes of the medtech, pharmaceutical, and life sciences sectors, featuring expert insights, member stories, and in-depth conversations with leaders shaping the future of therapeutic development.

Whether you're in regulatory affairs, clinical research, medical affairs, or anywhere along the product lifecycle, Cognitio is your place to stay informed, inspired, and connected.

Subscribe now and join the conversation.

In this episode of the ARCS Australia podcast, we feature highlights from the webinar "Unlocking the Power of Data in Medical Affairs – Part 2" with Nick Gillan, Technology and Data Governance Manager at Asthma Australia.

Nick unpacks what it really takes to become a data influencer in medical affairs—moving beyond collection to creating impact. Through real-world examples, he explores how to build a culture of data excellence, overcome quality challenges, and apply AI and dashboards for smarter, faster decision-making.

We also meet ARCS newsest team member Ariane Purdea and unpack the power of purpose and how it drives her career.

💡 Key themes include:

• Why data quality is foundational—not optional

• Using influence to embed data-driven thinking

• Practical applications of AI and advanced analytics

• What makes dashboards clear, compelling, and mobile-ready

• The mindset shifts needed to unlock data’s full potential

Whether you’re just starting your data journey or looking to take your insights to the next level, this episode offers valuable takeaways to apply in your own organisation.

🔗 Learn more and access future webinars at www.arcs.com.au

In this episode of Cognitio, we explore the power of data and the people transforming healthcare across Australia. Varun Pant kicks off the episode with a compelling take on why data is like uranium—not just powerful, but risky without proper governance. He breaks down what high-quality data means for medical affairs and how future business models may depend on patients owning their own health data.

Then, we take a trip into the outback with Julia Linda of Eli Lilly and Melissa Reedy from Heart of Australia, who are making clinical trials more accessible than ever for rural, regional, and First Nations communities. Their story is one of practical innovation, community trust, and bold action.

We finish with ARCS member Elaine Blair, who shares her professional journey, the power of backing yourself, and the importance of staying curious in a fast-changing sector.

This episode is packed with real-world insight, personal stories, and a strong reminder of the value of purpose-driven leadership in health innovation.

In this episode of the Cognitio Podcast, Associate Professor Natalie Carvalho unpacks how we measure the value of vaccines—and why our current health technology assessment (HTA) models might be missing the mark. From discount rates to broader societal benefits, Natalie offers a compelling look at the challenges and opportunities in vaccine evaluation, drawing on lessons from COVID-19 and beyond.

We’re also joined by Cathey Saha, the 2025 Katrina Campion Scholarship recipient, who shares the activities she will undertake as an ARCS Scholarship holder and what inspires her as an emerging leader in the sector.

Whether you're in policy, clinical research, or health economics, this episode offers timely insights into how we define value, equity, and impact in Australia's healthcare system.

🔗 Key topics:

• What health economics really values—and what it overlooks

• The long-term benefits of vaccines and the role of discounting

• Why broader impacts like mental health and economic resilience matter

• Global equity and Australia's role in regional vaccine access

• An earkly career perspective on the future of the medtech and pharmaceutical sector and its impact on public health

🎧 Tune in for a conversation that goes beyond the jab—and gets to the heart of what makes a health intervention truly valuable.

In this episode of Cognitio, ARCS Australia CEO Dr Tim Boyle explores the vital role leadership plays in fostering innovation across the MedTech and pharmaceutical sectors. Featuring insights from biotechnology expert Viv Lozato, the episode delves into how organisational culture, constraints, and personal mindset shape innovative outcomes.

Through compelling real-world examples—from AI initiatives to radical breakthroughs under time pressure—Viv shares his experiences on what enables transformation. Tim unpacks these clips with practical reflections on how leaders can create environments that embrace experimentation, challenge the status quo, and empower individuals to drive continuous improvement.

Whether you're leading a team or growing your career, this episode offers valuable strategies to help you think ahead, adapt faster, and lead with purpose in a rapidly evolving world.

Listen now to discover how the best innovation begins with great leadership.