Cognitio

What can elite sport teach us about leadership in the workplace?

In this episode of the Cognitio Podcast, Tim Boyle sits down with Tomek Szklarski, Head Coach of the Australian National Handball Team, to explore how high-performance sporting environments develop resilient leaders, build trust under pressure, and create cultures where teams thrive.

Drawing on his experience as both a professional athlete and national coach, Tomek shares practical lessons from elite team sport that translate directly into leadership, management and team development within professional environments.

Together, Tim and Tomek discuss:

• Why resilience matters more than talent in sustained high-performance environments
• The transition from peer leadership to formal leadership
• How trust is built, broken and rebuilt under pressure
• Why great leaders create capability rather than dependency
• The role of vulnerability and self-awareness in leadership
• Practical strategies for developing resilience in yourself and others

Whether you lead a team, manage stakeholders, or are looking to strengthen your own professional resilience, this episode offers valuable insights into what it takes to lead when the pressure is on.

Tomek Szklarski is Head Coach of the Australian National Handball Team and a former professional European handball player. He has represented Sydney University, New South Wales and Australia at elite levels of competition, and has played a key role in developing handball talent nationally. Tomek brings a unique perspective on leadership shaped by years of experience as both a player and coach in high-performance sporting environments.

About the Guest

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 partnership

This 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.

Three signals this week point to a sector at a turning point.

Australia’s life sciences industry is accelerating—with stronger local capability, growing global engagement, and a more coordinated national R&D strategy taking shape.

But there’s a critical question we need to address.

As we move toward a more economically driven innovation model, how do we ensure health and medical research remains grounded in patient outcomes—not just commercial return?

In this week’s Top 3, I cover:
• The Ambitious Australia R&D strategy—and what it means for our sector
• A major capability investment in clinical trials infrastructure here in Sydney
• Why international partnerships will define our next phase of growth

If we get the balance right, we have a real opportunity to strengthen both our sector and outcomes for patients.

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 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 the return to Perth and the latest Brisbane event
• Why professional recognition in life sciences is becoming increasingly important, with applications now open for the ARCS College of Fellows

The episode also recognises International Women’s Day, highlighting the extraordinary contribution women make across the life sciences sector, including the fact that 73% of ARCS members are women.

This short weekly podcast provides a fast overview of the key developments in Australia’s pharmaceutical, biotechnology, medtech and clinical trials sectors.

ARCS members receive the full weekly life sciences news summary, so if you want to stay fully across what’s happening in the sector, consider joining ARCS.

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.

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 #regulatoryaffairs

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.