Cognitio

Australia’s R&D Tax Incentive is one of the most significant programs driving investment and innovation in the life sciences. But how does it really work in practice, and what do the latest transparency data tell us about the companies claiming it?In this episode of the ARCS Cognitio Podcast, host Tim Boyle brings you highlights from a recent ARCS webinar with experts from EY. Together they unpack:The first tranche of R&D Tax transparency data and what it means for biotech, medtech, and clinical research.How companies can structure their claims and avoid common pitfalls.Key differences between Australian-owned and foreign-owned R&D arrangements.What regulators are focusing on in their compliance reviews.Whether you’re part of a multinational pharma, a startup biotech, or a contract research organisation, this episode provides practical insights into maximising the benefit of the R&D Tax Incentive while staying compliant.Listen now to understand how the program can support your organisation—and where the risks lie.

In this episode of the Cognitio Podcast, Tim Boyle introduces a powerful conversation on innovation, access, and equity in clinical trials. Featuring Julia Linda from Eli Lilly Australia and Melissa Reilly from Heart of Australia, the episode explores how clinical research can be delivered to regional, rural, and First Nations communities through innovative models and strong cross-sector partnerships.Julia shares the unmet needs she sees across Australian clinical research, and how thoughtful innovation can expand access to under-represented populations. Melissa provides an inside look at Heart of Australia’s mobile specialist service and the creation of the Heart of Australia Research Institute—bringing cutting-edge clinical trials to communities that typically miss out.Together they reveal what it takes to build, operationalise, and sustain clinical trials outside metropolitan centres, and why this work is essential for health equity and representative research.A must-listen for clinical researchers, sponsors, CROs, healthcare professionals, and anyone passionate about improving access to innovation across Australia.

In this episode of the Cognitio Podcast, host Tim Boyle explores one of the most critical equity challenges in Australian healthcare: ensuring safe, effective, culturally informed use of medicines for First Nations peoples.Tim is joined by four respected leaders in medicine safety: Karen Battat (AstraZeneca), Vinham Mehta (Novartis), Marcela Bade (former TGA pharmacovigilance inspector) and Matt Iglesias, who together unpack the unique risk factors, data gaps and cultural considerations that influence pharmacovigilance in First Nations communities.The conversation highlights why First Nations representation in safety data remains low, the impact this has on signal detection and patient outcomes, and what meaningful, practical steps the sector can take — from culturally grounded educational materials to strengthened community partnerships and more robust system design.This episode is essential listening for anyone working in regulatory affairs, pharmacovigilance, clinical operations, public health or industry leadership. It’s a powerful reminder that medicine safety is not just a technical obligation, but a commitment to fairness, respect and culturally responsive practice.Join the ARCS community as a Professional Member — or bring your whole organisation on board — to stay connected, informed and engaged with the conversations shaping the future of the life sciences sector.

What is Intellectual Property? A Practical Guide for Australia’s Life Sciences SectorIn this episode of Cognitio, Tim Boyle takes listeners on a clear and engaging tour of the intellectual property landscape, guided by three specialists from Spruson and Ferguson Lawyers. IP sits at the core of innovation and commercialisation in the life sciences, yet it is often misunderstood or overlooked until problems arise. This conversation breaks it down in a way that is accessible, practical, and directly relevant to researchers, clinicians, entrepreneurs, and anyone navigating discovery-to-market pathways.Dr Katherine Winbanks opens with an IP 101 masterclass, covering patents, trade marks, copyright, confidential information, and the risks of early disclosure. Sylvie Tso then steps through the commercialisation process, unpacking licensing, assignments, royalties, valuation challenges, and how to structure deals that actually create value. Finally, Katrina Crooks explains what happens when IP is infringed and how disputes are managed, from demand letters to litigation, injunctions, and enforcement of rights.Across the episode, the message is clear: strong IP strategy is essential for protecting innovation, attracting investment, and strengthening Australia’s position as a global life sciences leader.If you work in research, biotech, medtech, clinical trials, or commercialisation, this is an episode you won’t want to miss.

In this episode of The Cognitio Podcast, ARCS Australia CEO Tim Boyle introduces highlights from a thought-provoking ARCS Interest Area webinar, Automating Life Science Workflows through AI, presented by Dr Rishi Verma, CEO and Founder of Stethy AI.Dr Verma, a physician and engineer, takes listeners inside the fast-evolving world of artificial intelligence in the life sciences. Drawing directly from his presentation, he explains — in his own words — how AI is transforming the daily realities of regulatory affairs and pharmacovigilance, from document authoring and quality control to horizon scanning and compliance monitoring.Through real-world examples, including a compelling case study from Roche, Dr Verma demonstrates how AI can reduce manual workloads, improve accuracy, and accelerate submissions — while keeping human expertise firmly at the centre of every decision.This episode is a must-listen for regulatory professionals, clinical researchers, and anyone navigating the intersection of technology, compliance, and patient safety.🎧 Tune in to learn how AI is reshaping the way we work — not by replacing professionals, but by empowering them to focus on strategy, quality, and innovation.

Next Generation Nuclear Medicine: Powering the Future of Precision HealthIn this episode of ARCS Cognitio, ARCS Australia CEO Tim Boyle leads a compelling conversation on the rapidly evolving world of next-generation nuclear medicines — where physics meets biology to transform how we diagnose and treat disease.Joined by a panel of industry leaders — Christian Behrenbruch (Telix Pharmaceuticals), David James (formerly Sirtex Medical and OncoSil), Rosanne Robinson (Clarity Pharmaceuticals, ex ANSTO, and Cylotek), and Brad Walsh (Glytherix) — the discussion explores the technologies, supply chain challenges, and investment opportunities shaping the future of this dynamic sector.From emerging isotopes and theranostics to Australia’s unique position as a regional hub for radiopharmaceutical innovation, this episode offers deep insights into one of the most exciting frontiers in modern medicine.Tune in to discover how collaboration, capability, and clinical excellence are driving the next era of nuclear medicine — and how Australia can lead the charge.🎧 Listen now and join the conversation at arcs.com.au.

In this episode of the Cognitio Podcast, Goce Bogeski FMPP shares his reflections on the often-overlooked similarities between pharmaceuticals and medical devices. Drawing on years of experience across both fields, he explains how market access processes converge, where inefficiencies exist, and why evidence plays such a critical role in reimbursement decisions. From the challenges of the prosthesis list to the differences in trial design, Goki highlights what really matters: patient outcomes, cost-effectiveness, and the science that underpins it all.He also leaves us with a powerful message.... that skills are transferable, opportunities are abundant, and collaboration across disciplines is essential for getting therapies to patients faster. Whether you’re in clinical trials, regulatory affairs, or market access, this episode will remind you that we are all part of one process, united by the same aim.

In this episode of the ARCS Cognitio Podcast, we explore the regulatory framework for in vitro diagnostic (IVD) medical devices with international regulatory affairs expert Dr Adel Schneider.IVDs—from pregnancy tests to advanced blood screening assays—play a critical role in healthcare by providing the information that guides diagnosis and treatment. But how do regulators ensure these devices are safe, reliable, and trustworthy?Dr Schneider takes us through the key elements of IVD regulation, including definitions, classifications, essential principles, clinical evidence, quality systems, and post-market surveillance. With more than 30 years’ experience working across Europe, Asia Pacific, the Middle East and Africa, she offers a clear overview of the global regulatory landscape and why trust in IVDs is so vital.Join us as we unpack the complexities of IVD regulation and its impact on patients, professionals, and the broader life sciences community.

How do you know if a new product can be marketed in Australia? The answer lies in the very first questions you ask.In this episode of the Cognitio podcast, ARCS Australia CEO Tim Boyle sits down with Dr Helena Dickinson, a regulatory affairs consultant with over 30 years of experience in medicines and medical devices. Together, they unpack the critical steps in classifying a product and determining its eligibility for approval.Helena shares practical insights on:Why country of manufacture and GMP clearance are the first hurdles to clearHow ingredient names and monographs shape eligibilityThe importance of dosage forms and poison scheduling in classificationHow claims and indications can bump a product from listed to OTC—or OTC to prescriptionCommon pitfalls when relying on overseas approvalsWhether you’re working with listed medicines, OTCs, or prescription products, this episode offers a step-by-step framework to guide your initial review and avoid costly delays.🔗 Learn more about ARCS and join the community shaping the future of medicines, devices, and data at arcs.com.au.

This week in the ARCS Australia Weekly Medtech & Pharma Wrap we delve into the stories that are shaping our industry. From quantum blood testing and vaccination patches that are needle-free, through blockbuster drug wars, policy debates, and company culture – the picture is clear: innovation is racing, and access and capacity need to keep up.Watch the newest episode now and stay one step ahead of the trends that are shaping medicine in Australia and worldwide.

In this episode of Cognitio, ARCS CEO Tim Boyle is joined by Professor Andrew Wilson, Co-Director of the Menzies Centre for Health Policy and Economics at the University of Sydney and Chair of the Implementation Advisory Group for HTA Reform.Drawing on his deep experience as former Chair of the PBAC and now a central figure in shaping reform, Professor Wilson reflects on the challenges of translating more than 50 recommendations into meaningful change. He discusses the complexities of sequencing reforms, balancing equity and timely access, and the importance of collaboration across government, industry, clinicians, and consumers.Listeners will gain unique insight into the realities of HTA reform in Australia — what’s happening now, what lies ahead, and why implementation detail matters.This episode also features a message from our ARCS Partners, whose support helps drive conversations that advance professionalism and innovation in the life sciences.Stay tuned until the end for a clear call to action on how you can be part of the conversation shaping the future of healthcare by joining ARCS Australia.

In this Cognitio episode, host Tim Boyle is joined by Adele Barnard to explore the fast-changing world of implantable medical device regulation in Australia. Drawing on Adele’s first-hand industry experience, the episode unpacks the TGA’s definition of medical devices, the full lifecycle from pre-approval to post-market surveillance, and the critical steps that sponsors and manufacturers must navigate. Listeners will hear real-world case studies — from multimillion-dollar penalties to high-profile media scrutiny — that have shaped recent reforms. We look at how global alignment, stronger clinical evidence requirements, and robust registry data are redefining compliance, patient safety, and market access. Whether you’re in regulatory affairs, product development, or executive leadership, this is essential listening for staying ahead in the evolving MedTech regulatory landscape.

In this episode of Cognitio, ARCS Australia CEO Tim Boyle speaks with leadership and team performance coach Matt Brown about one of the defining capabilities of our time: resilience.Drawing on over 25 years of experience helping leaders and teams navigate disruption, Matt unpacks how to build resilience at both an individual and organisational level. From understanding the VUCA (Volatile, Uncertain, Complex, Ambiguous) world we work in, to using tools like mindfulness, gratitude, and purpose, this conversation offers practical, evidence-based strategies you can apply immediately.You’ll hear how psychological safety fuels performance, why resilience starts from the inside out, and the one simple habit Matt says every leader should try this week.Links and Resources:ARCS Australia – Learn more about our work and upcoming events.Unearth Your Resilience Program – Matt Brown (Insert actual link)ARCS Membership – Join the conversation. Join ARCS today.Subscribe & ReviewIf you enjoyed this episode, please subscribe to Cognitio on your preferred podcast platform and leave us a review—it helps more professionals discover these conversations.

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 backThe push for “the ICH-GCP of data sharing”What ethics committees are getting right—and wrongTools and templates your team can use right nowTo learn more or access the tools discussed, visit ctiq.org.au or arcs.com.au.

🎧 Episode Description – Cognitio PodcastMentorship Matters – From Insight to ImpactPresented by ARCS AustraliaIn 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 week’s ARCS Weekly News Wrap, Tim Boyle recaps a major week for Australia’s life sciences sector during National Clinical Trials Week. The episode covers key developments across pharma, medtech, biotech, policy and investment, along with insights from ARCS’ activities in Melbourne, including the launch of the Clinical Workforce White Paper, the new ARCS and MAPA strategic alliance, and sector input into the national One Stop Shop.Tim also explores the biggest industry stories of the week, from global acquisitions and breakthrough imaging technology to advancing clinical trials and company milestones. The episode closes with reflections on the momentum across the sector and an invitation for professionals and employers to join the ARCS community.Listen for a clear and engaging overview of the trends shaping Australia’s life sciences landscape.

This week’s wrap brings you the biggest developments across Australia’s life sciences sector — all in one quick, engaging update. We cover major pharma moves, medtech breakthroughs, biotech investment momentum, regulatory updates, and the latest people movements shaping the industry.From gene therapy and GLP-1 dealmaking to AI in radiology and standout Australian clinical results, this episode highlights the trends influencing policy, access, capability and commercialisation right now.If you want to stay informed, connected and ahead of sector shifts, this is the update you don’t want to miss.Watch now and get the week’s essential insights — fast.