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.

What does it really mean to design healthcare with patients?In this episode of the Cognitio Podcast, Georghien Wiley, ARCS Convener for the Patient Engagement Interest Area, leads a powerful and deeply personal discussion on patient co-creation.Through real-world experiences, this episode explores the realities of navigating the healthcare system in Australia, particularly for patients and carers in regional settings. From access challenges and fragmented care to the often-overlooked role of carers, the conversation highlights critical gaps between system design and lived experience.It also reframes a key idea for the life sciences sector:Lived experience is not supplementary to evidence. It is a form of expertise that should shape how we design services, clinical trials and patient support programs.Key themes explored include:• The impact of fragmented and uncoordinated care• The hidden burden and invisibility of carers• Health literacy and communication challenges• The importance of trust, equity and inclusion in co-design• Moving beyond tokenistic engagement to meaningful partnershipThis episode is essential listening for professionals across clinical research, regulatory affairs, medical affairs, pharmacovigilance and market access who are looking to embed patient-centred approaches into their work.

Cell and gene therapies such as CAR-T are transforming modern medicine, offering new treatment options for cancers and rare diseases. But getting these breakthrough therapies to patients is not straightforward.In this episode of the Cognitio Podcast, Warwick Shaw from Johnson & Johnson explores how advanced therapies move from regulatory approval to reimbursement in Australia. The discussion examines the role of the Medical Services Advisory Committee (MSAC), the National Health Reform Agreement, and the complex coordination between federal and state governments that influences patient access.The conversation also highlights the growing pipeline of cell and gene therapies, the use of outcomes-based reimbursement models, and the policy changes needed to ensure Australian patients can access these life-changing treatments sooner.

In this episode of Cognitio, Tim Boyle speaks with Dr Natalie Anderson about the evolving regulatory landscape for non-animal models in pharmaceutical development.We explore global reforms at the US FDA and European Medicines Agency, the application of the Three Rs, and how Australia’s TGA is responding to advances in organoids, organ-on-chip technologies and in silico modelling. The discussion covers regulatory acceptance pathways, policy shifts, funding challenges and what this means for sponsors and regulatory professionals.A must-listen for those working in regulatory affairs, nonclinical development and health policy as science and regulation continue to evolve.

In this episode of Cognitio, ARCS CEO Tim Boyle explores the behavioural science behind leadership, compliance and decision-making in regulated environments.Despite extensive training and detailed SOPs, deviations still occur. So what’s missing? This conversation dives into the psychology of identity-based leadership, the forgetting curve, grey zone decision-making, and how culture shapes compliance in clinical research, regulatory affairs and life sciences.If you work in clinical trials, medical affairs, pharmacovigilance, quality or regulatory, this episode will challenge how you think about training, integrity and performance under pressure.Leadership isn’t memory. It’s identity.#Leadership #ClinicalResearch #RegulatoryAffairs #Pharmacovigilance #LifeSciences #ProfessionalDevelopment

What changes when a therapy moves from clinical trials to the real world?In this episode of the Cognitio podcast, ARCS Australia CEO Tim Boyle speaks with Carl Bufe about the critical differences between clinical development safety management and post-market pharmacovigilance.From SUSAR reporting and ICH E6 to ICH E2D, signal detection, spontaneous adverse event reporting and scaling safety systems, this discussion explores how compliance, data volumes, accountability and risk management evolve across the product lifecycle.Essential listening for professionals in regulatory affairs, clinical research, medical affairs and drug safety.Join the conversation. Join ARCS.

Cell and gene therapies are transforming medicine — from CAR-T in oncology to next-generation gene therapies targeting rare disease.Ahead of the ARCS–DIA Cell & Gene Therapy Summit, Tim Boyle and Anna Megalakakis unpack Australia’s advanced therapies landscape. They explore manufacturing capability, workforce shortages, funding reform, regulatory pathways, and whether Australia can scale beyond clinical trials to become a regional CGT leader.A practical, strategic discussion for regulators, industry professionals, scientists and clinical research leaders.🎧 Listen now to understand where Australia stands — and what must happen next.

South Korea has rapidly established itself as one of the world’s leading destinations for clinical research. With dense urban populations, advanced hospital infrastructure and a highly structured regulatory framework, it is now consistently ranked among the top countries globally for clinical trial activity.In this episode of the Cognitio Podcast, we explore what makes South Korea such a compelling jurisdiction for multinational development programs. Joining us from Seoul are Sophia Choi, Country Lead at ClinActis Korea, and Sophie and Soun from Bayer Korea’s pharmacovigilance team.Together, they unpack the practical realities of running clinical trials in Korea. We discuss MFDS approval pathways, IND timelines, translation requirements, import permits and contracting considerations. The conversation then turns to safety reporting, including SUSAR timelines, DSUR submission requirements and the implementation of ICH E2B R3 electronic reporting with Korean-specific data extensions.For ARCS members working in regulatory affairs, clinical operations or pharmacovigilance, this episode provides a grounded and practical overview of how Korea’s system operates and what sponsors need to consider when incorporating Korea into a global program.If you are involved in multinational trials or global safety reporting, this is an episode not to miss.

Advancing LGBTQIA+ Inclusion in Healthcare and ResearchIn this episode of Cognitio, ARCS Australia CEO Tim Boyle explores why LGBTQIA+ inclusion is no longer optional in healthcare, clinical research, and the life sciences sector.Drawing on insights from an ARCS webinar featuring guests from Proud Science Alliance and ACON, this episode unpacks the real-world consequences of under-representation, data gaps, and systemic barriers faced by LGBTQIA+ communities. From social determinants of health and minority stress, to exclusionary research protocols and gaps in workforce training, the discussion highlights how invisibility in data leads directly to inequity in outcomes.The episode also examines emerging progress, including regulatory and policy shifts, evolving expectations for inclusive clinical trials, and what national workforce data reveals about allyship, wellbeing, and organisational culture across healthcare and medtech sectors.This is a practical, evidence-informed conversation for professionals working in medicines development, clinical research, healthcare delivery, and policy, focused on translating inclusion from principle into action.Inclusive research is ethical research. Inclusive healthcare delivers better outcomes for everyone.

Inclusive clinical research is not a box to tick. It is a way of working.In this episode of the Cognitio Podcast, Tim Boyle is joined by webinar presenters Jane Gaunson, Olivia Payne, Mariam Hachem and Bernard Kelly-Edwards to explore practical strategies for partnering with Aboriginal and Torres Strait Islander communities in clinical research.The conversation highlights the role of the Victorian Aboriginal Community Controlled Health Organisation (VACCHO) and the guiding principles of marra mgarrgoo, marra goorri — the Victorian Aboriginal Health, Medical, and Wellbeing Research Accord — as a pathway to embed cultural safety and self-determination in research practice. The team also shares lessons from the Flash GM study, including what co-design looks like on the ground, why relationships and trust must come first, and how culturally informed consent approaches can strengthen participant understanding and engagement.Whether you’re a sponsor, CRA, site leader, investigator, ethics professional or work in governance, this episode offers grounded insights to help clinical trials deliver research that is respectful, relevant, and genuinely impactful.Brought to you by ARCS Australia.

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.