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PODCAST

Cognitio

Welcome to Cognitio, the weekly podcast by ARCS Australia, your go-to source for insights into the evolving world of medtech, pharmaceuticals, and life sciences. Hosted by Dr Tim Boyle, CEO of ARCS, this podcast delivers bite-sized updates, expert discussions, and professional development insights to keep you informed and ahead of the curve. Each episode features hot topics, regulatory updates, sector trends, and practical career guidance, with guest appearances from industry leaders, ARCS members,

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All Episodes

00:02:38

ARCS Weekly Wrap 6 March 2026

Cognitio ·

2026/03/06

What are the three biggest developments shaping Australia’s life sciences sector this week?In this short weekly briefing, ARCS CEO Tim Boyle shares the top stories from across the medicines, medical devices and clinical research ecosystem.This week’s episode covers:• A major step toward professional standards and competency-based accreditation for the clinical trials workforce following discussions at the A-CTEC conference• Updates from the ARCS community and national networking events, including

en-au

00:11:55

From Trial to Market: Navigating Pharmacovigilance...

Cognitio ·

2026/03/02

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

en-au

00:02:49

ARCS Weekly Wrap 27 February 2026

Cognitio ·

2026/02/26

This week in Australian life sciences: a $1.6B digital health acquisition, global momentum in cell and gene therapy, AI in regulatory affairs, and registrations opening for the 2026 ARCS Annual Conference.In this short episode, Tim Boyle breaks down the top 3 stories shaping biotech, medtech, clinical trials and therapeutic product commercialisation across Australia and the Asia-Pacific.Fast insights. Big implications. Stay ahead of the sector.#lifesciences #biotech #medtech #clinicaltrials

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00:11:20

Cell & Gene Therapy in Australia: Are We Ready?

Cognitio ·

2026/02/23

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,

en-au

00:04:27

ARCS Weekly Wrap 20 February 2026

Cognitio ·

2026/02/19

This week’s ARCS sector update covers three major developments shaping Australia’s medtech and pharmaceutical landscape.We unpack the AMR 2026 Summit in Sydney and the release of the Sixth AURA Report, highlighting why antimicrobial resistance is now an economic and national resilience issue.We examine the surge in PBS activity, with more than 20 medicines nearing listing decisions, and what this means for oncology, biosimilars and HTA reform.And we explore Australia’s advanced therapies momentum,

en-au

00:23:58

South Korea: An Emerging Powerhouse in Clinical...

Cognitio ·

2026/02/18

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

en-au

00:02:45

ARCS Weekly Wrap 13 February 2026

Cognitio ·

2026/02/13

Global recognition for the TGA.PBS tensions escalating into legal action.And major leadership shifts across pharma.In this episode, Tim Boyle breaks down the three biggest stories shaping Australia’s life sciences sector this week — and why they matter for regulatory affairs, market access, clinical research and pharma professionals.What does WHO recognition mean for the TGA’s global influence?Is PBS policy entering a new phase of tension?And what do executive changes signal about sector

en-au

00:40:12

Advancing LGBTQIA+ Inclusion in Healthcare

Cognitio ·

2026/02/10

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

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00:02:55

ARCS Weekly Wrap 6 February 2026

Cognitio ·

2026/02/06

A big week for policy, funding and medicine access.In this episiode, I break down my top three life sciences stories for the week and why they matter for Australia’s sector.ARCS members get the full weekly briefing via email. Join ARCS to stay across what matters.

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00:08:14

ARCS Weekly Wrap 5th December 2025

Cognitio ·

2025/12/05

🎙️ ARCS Weekly News Wrap — Final Episode of 2025Tim 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,

en-au

00:32:38

Yarning Up Research: shifting from “done to” to “done...

Cognitio ·

2025/12/01

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

en-au

00:11:44

ARCS Weekly Wrap 28 November 2025

Cognitio ·

2025/11/27

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

en-au

00:43:18

Heart of Australia

Cognitio ·

2025/11/24

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

en-au

00:08:27

ARCS Weekly Wrap 21 November 2025

Cognitio ·

2025/11/21

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,

en-au

00:30:41

Pharmacovigilance and Equity: Medicine Safety for...

Cognitio ·

2025/11/17

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

en-au

00:09:45

ARCS Weekly Wrap 14 November 2025

Cognitio ·

2025/11/14

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

en-au

00:50:07

What is Intellectual Property?

Cognitio ·

2025/11/10

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

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00:08:51

ARCS Weekly Wrap 7th November 2025

Cognitio ·

2025/11/06

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

en-au

00:29:12

AI in Regulatory Affairs: From Burden to Breakthrough

Cognitio ·

2025/11/03

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

en-au

00:08:02

ARCS Weekly Wrap 31st October 2025

Cognitio ·

2025/10/31

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

en-au

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