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, 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.

This week’s ARCS Weekly News Wrap dives into the biggest stories shaping pharma, medtech, biotech, and the workforce behind them. From the MAPA-MAPS Summit and student careers fairs to global debates over paracetamol, robotic surgery innovations, and major biotech funding deals — we break it all down and explain what it means for you.Highlights include:The rise of medical affairs and ARCS’ careers outreachPharma headlines from Trump to the TGACutting-edge medtech adoption and diagnostic breakthroughsNext-gen biotech therapies and major investment winsSanofi’s HQ move, workforce pay trends, and hot skills in demandNew ventures and global collaborations driving patient-centred innovationStay informed, stay connected, and join ARCS to be part of the professional community leading Australia’s medtech, pharma, and biotech sectors forward.

Weekly News Wrap – 19 September 2025This week’s ARCS Weekly News Wrap is packed with sector-shaping stories across pharma, medtech, biotech, and leadership. Tim Boyle recaps a milestone few days for ARCS, including a sold-out Leadership & Communications Symposium and a record turnout at our networking night with AMWA.In pharma, Australian science takes the global stage with Pfizer’s breast cancer trial and CSL’s billion-dollar play with Dutch biotech VarmX. Medtech sees big advances as Epworth Eastern adopts robotic bronchoscopy, Siemens Healthineers launches a $9M MRI facility with the University of Sydney, and Avita Medical secures European approval for its RECELL GO device.Biotech breakthroughs abound, with Oncosil, Alterity Therapeutics, Actinogen Medical, and Cleo Diagnostics all reporting promising progress, while Novartis doubles down on acquisitions. Leadership shifts at Ipsen, Clinigen, CSL, and Lilly round out the week, signalling fresh strategies in the sector.Join us as we unpack what these developments mean for you and why being part of the ARCS community matters more than ever.

This week’s ARCS Biopharma & Medtech Wrap dives into the biggest headlines shaping the life sciences sector – from pharma restructures and drug pricing debates to medtech innovation and Australian biotech success stories.We cover:Pharma: Novo Nordisk’s 9,000 job cuts, Lundbeck’s global exits, Takeda’s narcolepsy breakthrough, and the growing debate on PBS and international drug pricing.Medtech: A $160m investment in robotics and AI in Sydney, plus Professor Edward Holmes’ award-winning AI and genomics research.Biotech & Investment: Cartherics and HaemaLogiX shine at the Asia Pacific Cell & Gene Awards, while local biotechs secure funding and approvals.People Movement: Leadership changes at Novartis and BeOne, and Daiichi Sankyo’s recognition as a top employer.We’ll unpack what it means for you – from clinicians and researchers to policy specialists and industry leaders. Plus, we connect the dots to upcoming ARCS events: the Leadership & Communication Symposium (18 Sept, Sydney) and the Global Cell & Gene Summit (25 Feb 2026, Sydney).🎧 Tune in for insights, context, and commentary on the news that matters to Australia’s life sciences community.👉 Join the conversation. Join ARCS today: arcs.com.au

This week on the ARCS Weekly Life Sciences Wrap, we unpack the stories driving the future of medicine, policy, and innovation in Australia. From Canberra to the clinic, it’s been a week of breakthroughs, delays, and bold moves.Health Minister Mark Butler has finally announced the first steps toward reforming Australia’s Health Technology Assessment system — a long-awaited shift that could change how patients access medicines. We explore what this means for industry, clinicians, and patients.We also take you inside the ARCS Clinical Research Workforce Summit, where over 80 leaders came together to tackle the workforce constraints holding back Australia’s clinical trial sector. Plus, we spotlight upcoming ARCS events — including the Leadership & Communication Symposium, AGM, and networking drinks on 18 September, and the Clinical Summit on 19 November.Beyond ARCS, we cover the week’s biggest sector stories: PBS deferrals, new asthma treatments for kids, robotic surgery firsts, biotech highs and lows, and leadership shake-ups across pharma.Tune in for analysis, insights, and a clear-eyed look at what it all means for you.CTA: Be part of the conversation shaping the future of life sciences in Australia — join ARCS today

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 everCommon pitfalls in product design, EMC compliance, and testabilityThe hidden costs of overseas manufacturingThe grey areas of IP ownership and test system controlWhat to look for in a genuine manufacturing partnershipWhether 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 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 optionalUsing influence to embed data-driven thinkingPractical applications of AI and advanced analyticsWhat makes dashboards clear, compelling, and mobile-readyThe mindset shifts needed to unlock data’s full potentialWhether 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.