🎙️ ARCS Weekly News Wrap — Final Episode of 2025
Tim and Anna team up for the final Weekly News Wrap of the year, bringing you the most significant stories shaping Australia’s life sciences landscape. This fast, engaging episode covers the biggest pharma leadership moves, biotech breakthroughs, rare disease reform, PBS milestones, digital health shake-ups, and major medtech developments — including CSL’s new vaccine manufacturing facility.
You’ll also hear key ARCS updates: new strategic partners, upcoming summits, professional development offerings, and a final call for 2026 ARCS Annual Conference abstracts.
To wrap up the year, Tim and Anna share brief insights on what this week’s news means for the sector and what’s ahead for 2026.
In this episode:
• Pharma leadership changes and PBS highlights
• Breakthroughs in biotech and clinical innovation
• Medtech and vaccine capability advancements
• Rare disease strategy momentum and genomics reform
• Digital health transformation risks
• ARCS announcements, events and partnerships
A sharp and informative send-off to 2025 — designed to keep you connected, informed and ready for the year ahead.
Thanks for listening throughout 2025. Join ARCS in 2026 and be part of Australia’s growing community of life sciences professionals.
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 week’s ARCS Weekly News Wrap, Tim Boyle unpacks the headlines shaping Australia’s medicines, medtech and biotech sectors, with a sharp eye on what they mean for professionals working across the product lifecycle. We cover key policy and reimbursement signals, regulatory and manufacturing developments, notable biotech and medtech milestones, and the people moves that hint at where the market is heading next.
You’ll also hear a quick ARCS update from across the community, plus a practical wrap-up on how this week’s news could influence investment, strategy, workforce decisions and day-to-day execution in the sector.
If you want to stay informed, build capability, and connect with the people doing the work, join ARCS as a professional member or explore enterprise membership for your organisation.
#ARCSAustralia #ClinicalResearch #RegulatoryAffairs #MedicalAffairs #Pharmacovigilance #Medtech #Biotech #Pharma #HealthEconomics #Workforce #ProfessionalDevelopment
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 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.
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.
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.
What is Intellectual Property? A Practical Guide for Australia’s Life Sciences Sector
In 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 week’s episode, Anna Megalakakis steps behind the mic to bring you a fast-paced and insightful roundup of the biggest developments across Australia’s life sciences sector. From blockbuster pharma shifts and cutting-edge medtech launches to biotech investment momentum and major leadership movements, this episode unpacks what matters — and why.
Anna also shares the latest from ARCS, including highlights from the HBA Sydney anniversary event, updates on the National Clinical Trials Governance Framework consultations, and fresh opportunities to get involved in the 2026 ARCS Annual Conference and the newly expanded 2025 Clinical Summit. Plus, hear about ARCS’ brand-new Enterprise Partnership model, offering organisations a powerful way to invest in their people.
In this episode:
Pharma: Tirzepatide’s global rise, PBS expansions, and shifting clinical trial landscapes.
Medtech: AI-powered imaging tech, next-gen valves, and long-term innovation partnerships.
Biotech & Investment: Capital milestones, regulatory progress, and clinical breakthroughs.
People Movement: Key promotions, awards, and leadership shifts across the sector.
Partner With ARCS: How enterprise memberships can elevate your workforce and brand.
Whether you work in clinical trials, regulatory affairs, medical affairs, biotech, medtech, policy, or beyond — this episode gives you the insights you need to stay ahead.
Listen now and stay connected to the news shaping Australia’s life sciences future. And if you haven’t already — now’s the perfect time to join ARCS Australia and be part of the country’s largest professional community in our sector.
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.
This week’s episode dives into the biggest stories shaping Australia’s life sciences landscape — from global leadership milestones to biotech breakthroughs and policy reform.
We celebrate Professor Tony Lawler’s appointment as Global Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA), marking Australia’s growing influence in global regulatory science.
In pharma, Takeda, Pfizer, and Boehringer Ingelheim make bold moves, while new funding under the Life Saving Drugs Program delivers long-awaited hope for rare disease patients.
The biotech sector surges ahead with the opening of Australia’s first Viral Vector Manufacturing Facility in Westmead and major international deals, including Novartis’s $18.4B acquisition of Avidity Biosciences.
Meanwhile, medtech innovation keeps pace as CSL Seqirus expands its global vaccine partnerships and Medicare boosts access to diagnostics.
Plus, we spotlight leadership shifts at AbbVie, Uniseed, and PolyNovo, and Nav Lee’s representation of ARCS on the world stage in Cairo.
🎧 Tune in for insights, context, and commentary on how these developments are shaping Australia’s clinical trials, biotech, and medtech future.
Next Generation Nuclear Medicine: Powering the Future of Precision Health
In 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.
ARCS Weekly News Wrap – Week Ending 25 October 2025
This week’s episode covers a powerhouse mix of policy shifts, scientific breakthroughs, and leadership changes shaping Australia’s life sciences landscape.
Join Tim Boyle, CEO of ARCS Australia, as he unpacks:
Pharma: Landmark PBS listings, proactive pharmacovigilance, and new rare disease breakthroughs
Medtech: HTA review tensions, hospital funding reform, and insights from the MTAA Conference
Biotech & Investment: A wave of clinical trials, capital raises, and global research collaborations
People Movement: Leadership transitions at Gilead, Moderna, and Omico that will influence the sector’s next chapter
Partner with ARCS: How collaboration continues to drive innovation and workforce capability across the life sciences ecosystem
It’s a fast-paced, insightful wrap of the week’s most important developments — helping you stay informed, connected, and ahead of the curve.
🎥 Watch the full episode now and don’t miss your chance to be part of the only professional network that connects every corner of the Australian life sciences sector.
👉 Join ARCS today: www.arcs.com.au/join
#ARCSWeeklyWrap #LifeSciences #Pharma #Medtech #Biotech #ARCSAustralia #ARCS2025Leaders
In this week’s ARCS Weekly News Wrap, Tim Boyle returns from Adelaide after the KCA Conference to bring you the top stories shaping Australia’s life sciences sector.
This episode covers:
• Pharma: FDA approval for MSD’s subcutaneous Keytruda, Eli Lilly’s oral obesity drug heading to the TGA, and J&J’s Stelara patent challenge.
• Medtech: AI-assisted diagnostics at Macquarie University and Optain Health’s new Melbourne research hub.
• Biotech and Investment: Momentum from Clarity Pharmaceuticals, Telix, and Chimeric Therapeutics as local innovation continues to accelerate.
• People Movement: Leadership changes across Novartis, Boehringer Ingelheim, and Boston Scientific.
Tim also reminds listeners that early bird pricing for the ARCS Clinical Summit closes 20 October and that places are still available for the upcoming Pharmacovigilance Inspections course.
Stay informed, stay connected, and join the conversation with ARCS Australia – the professional home for Australia’s medtech and pharmaceutical sector.
#ARCSAus #Pharma #Medtech #Biotech #LifeSciences #ClinicalResearch #ARCSWeeklyNewsWrap
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 outreach
Pharma headlines from Trump to the TGA
Cutting-edge medtech adoption and diagnostic breakthroughs
Next-gen biotech therapies and major investment wins
Sanofi’s HQ move, workforce pay trends, and hot skills in demand
New ventures and global collaborations driving patient-centred innovation
Stay informed, stay connected, and join ARCS to be part of the professional community leading Australia’s medtech, pharma, and biotech sectors forward.
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.
Weekly News Wrap – 19 September 2025
This 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.
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.
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
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.