Cognitio

ARCS Australia
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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, and emerging innovators from BioBeacon. Whether you're a seasoned professional or just starting

  1. 2일 전

    Cell & Gene Therapy in Australia: Are We Ready?

    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.

    11분

  2. 6일 전

    ARCS Weekly Wrap 20 February 2026

    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, as Peter MacCallum Cancer Centre doses the first patient in a locally developed CD19 CAR T trial. What do these shifts mean for regulatory, clinical, market access and quality professionals? Listen now to stay ahead of the signals shaping 2026.

    4분

  3. 2월 18일

    South Korea: An Emerging Powerhouse in Clinical Trials and Pharmacovigilance

    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.

    24분

  4. 2월 13일

    ARCS Weekly Wrap 13 February 2026

    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 recalibration? If you work in medtech, pharma or biotech, this is your weekly sector briefing.

    3분

  5. 2월 10일

    Advancing LGBTQIA+ Inclusion in Healthcare

    Advancing LGBTQIA+ Inclusion in Healthcare and Research In 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.

    40분

  6. 2월 6일

    ARCS Weekly Wrap 6 February 2026

    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.

    3분

  7. 2025. 12. 05.

    ARCS Weekly Wrap 5th December 2025

    🎙️ 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.

    8분

  8. 2025. 12. 01.

    Yarning Up Research: shifting from “done to” to “done with” in Aboriginal health trials

    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.

    33분
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예고편

소개

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, and emerging innovators from BioBeacon. Whether you're a seasoned professional or just starting

정보

  • 제작진
    ARCS Australia
  • 방송 연도
    2025년 - 2026년
  • 에피소드
    43
  • 등급
    전체 연령 사용가
  • 저작권
    © ARCS Australia
  • 웹사이트 보기
    Cognitio