Cognitio

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.

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

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 clear

• How ingredient names and monographs shape eligibility

• The importance of dosage forms and poison scheduling in classification

• How claims and indications can bump a product from listed to OTC—or OTC to prescription

• Common pitfalls when relying on overseas approvals

Whether 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.