Every early phase trial ends with a number, and with a judgement about whether that number means anything. In this episode of Cognitio, Professor Rory Wolfe of the Monash University Clinical Trial Centre and medical statistician Dr Alan Herschtal set out how biostatistics underpins that judgement, and why it belongs at the first planning meeting rather than the last.

They cover why clinical development is staged the way it is, what a p value actually tells you and what it does not, why confidence intervals carry more information than significance alone, and why getting sample size wrong is an ethical failure and not just a budget problem. The episode closes on phase one specifics: dose escalation, the three plus three design, and the questions worth asking whatever your role.

Medical operations teams are often essential to the work of medical affairs, yet much of their contribution remains unseen. At the same time, growing workloads, limited resources and constant interruptions can leave teams operating in a cycle of reactive support.

In this episode of Cognitio, webinar convener Lee-Mai Pang speaks with Sanofi medical operations leader Menai Johnson about breaking that cycle. Drawing on a practical organisational example, they explore how accountability can gradually shift towards medical operations, why this creates dependency and cognitive overload, and how capability building, clearer governance and risk-based implementation can return responsibility to the appropriate teams. The discussion also considers practical ways to protect capacity, say yes differently and reposition medical operations as a strategic partner focused on outcomes and impact

Artificial intelligence is moving from experimentation into practical use across pharmacovigilance, but adoption brings important questions about accuracy, privacy, validation and accountability.

In this episode of Cognitio, Ata Arkham, Senior Patient Safety Specialist at AstraZeneca, joins webinar moderator Matt Iglesias to explore how AI is being used across global and local pharmacovigilance operations.

The discussion covers:

• AI applications in case processing, signal detection, literature monitoring and document development
• Practical options for smaller pharmacovigilance teams
• Emerging technologies, including agentic and explainable AI
• Data privacy, validation and regulatory readiness
• A staged roadmap for responsible AI adoption
• Why meaningful human oversight must remain central

The episode provides a practical perspective on how pharmacovigilance professionals can use AI to improve efficiency while maintaining quality, compliance and patient safety.

Cognitio is the podcast of LifeSciences Australia, sharing ideas, experience and perspectives from across Australia’s life sciences community.

Clinical trials can offer patients access to new treatments, but geography remains a major barrier for people living in rural, regional and remote communities.

In this episode of Cognitio, Tim Boyle is joined by Katrina Orr and Nadine Herren from the WA Country Health Service Trial Centre.

They share how their team has developed a statewide clinical trial service model designed to bring trial opportunities closer to patients across regional Western Australia.

The discussion explores the governance structures, workforce models, digital systems and community partnerships needed to deliver trials safely across a large and dispersed health service. It also considers culturally appropriate engagement with Aboriginal communities, personalised training for regional clinicians and the challenge of creating a financially sustainable service.

This episode offers practical insights for organisations seeking to improve clinical trial access, strengthen regional capability and embed clinical research within routine healthcare delivery.

In this episode of Cognitio, the podcast of LifeSciences Australia, we revisit a conversation recorded at the 2025 Annual Conference with Associate Professor Pegah Varamini from the University of Sydney.

A clinical pharmacist and cancer researcher, Pegah shares the personal and professional experiences that led her to focus on developing targeted therapies for difficult-to-treat cancers, including triple-negative breast cancer.

She discusses the realities of pursuing translational research and the challenges researchers face when trying to move a promising discovery from the laboratory towards commercialisation and, ultimately, patient care. This includes balancing intellectual property protection with traditional academic expectations, navigating limited funding pathways and finding support for high-risk drug discovery programs.

Pegah also reflects on the importance of mentoring throughout a career. She explains that valuable guidance can come not only from senior leaders, but also from peers who are navigating similar challenges.

The conversation explores the qualities needed to lead innovation in healthcare, with Pegah identifying personal integrity as a foundation for ethical leadership, equity and the empowerment of researchers.

For emerging professionals, her advice is to look beyond the immediate next step. Understanding the broader pathway, anticipating future requirements and preparing for potential disruptions can help innovators navigate complex research and commercialisation environments.

• Translating scientific research into patient outcomes requires perseverance, resilience and long-term commitment.
• Mentoring and peer support can be valuable at every stage of a career.
• Traditional academic measures do not always align with the needs of commercialisation and drug development.
• Personal integrity is essential to ethical and inclusive leadership.
• Innovators should understand the pathway several steps ahead, rather than focusing only on their current stage.
• Success requires working hard, working smart and remaining committed through setbacks.

Associate Professor Pegah Varimini is an academic at the Sydney Pharmacy School at the University of Sydney. Her research focuses on developing novel targeted therapies for challenging cancers, with a particular interest in triple-negative breast cancer.

Originally trained as a clinical pharmacist, Pegah completed her PhD in drug delivery at the University of Queensland before moving into oncology research. She was awarded a National Breast Cancer Foundation Early Career Fellowship in 2016, supporting the establishment of her independent research program.

• Pegah’s transition from clinical pharmacy to cancer research
• The personal motivation behind her work in oncology
• The role of mentoring in developing a research career
• The risks associated with pursuing commercialisation
• Tensions between publishing, intellectual property and research funding
• Challenges within Australia’s innovation and investment ecosystem
• The importance of integrity in healthcare leadership
• Advice for early-career researchers and emerging innovators
• Why perseverance and forward planning matter

Cognitio shares conversations, ideas and insights from across Australia’s life sciences community.

Cognitio is produced by LifeSciences Australia, the community behind every medicine, medical device and discovery.

Key takeawaysAbout the guestIn this episode

In this BioBeacon edition of the Cognitio Podcast, ARCS CEO Tim Boyle speaks with Paul Batten, founder of ObjectivoData, about his unexpected journey from mechanical engineering and McLaren to clinical trial technology.

Paul shares how working on a COVID-era telehealth trial exposed the need for more intuitive, flexible and user-centred clinical trial systems. That experience became the foundation for ObjectivoData, a platform supporting clinical trial management, electronic data capture and customised workflow solutions.

The conversation explores the role of better data systems in reducing friction across clinical trials, the importance of designing technology around real users, and the opportunities for entrepreneurs building capability beyond drugs, devices and diagnostics.

Paul also reflects on what it takes to build a company from the ground up, why relationships matter, and why conferences and sector networks can be game-changing for emerging companies.

This episode is part of ARCS Australia’s BioBeacon series, highlighting innovators, founders and emerging companies shaping the future of Australia’s life sciences sector.

What if you could give a stroke patient more time? That is the question driving Dr Daniel Beard and the team at ShearFlow, a biotech spin-out from the University of Newcastle developed in joint venture with Harvard University.

In this episode, ARCS intern Iqra sits down with Daniel to trace a career that has taken him from a fascination with the brain's blood vessels, through a PhD in stroke research, a postdoctoral fellowship at the University of Oxford, and a cold call to one of Harvard's leading scientists that changed the direction of everything.

Daniel is a Senior Lecturer at the University of Newcastle and the Chief Scientific Officer of ShearFlow, where his team is developing a nanoparticle therapy that selectively targets collateral blood vessels during a stroke to extend perfusion to at-risk brain tissue. The implications for rural and remote Australia, where patients can face transfers of hundreds of kilometres to reach a comprehensive stroke centre, are significant.

In this conversation, Daniel reflects on the role of collaboration in research and commercialisation, the lessons he took from Oxford back to Australia, and what it actually takes to move from scientific founder to company builder. He also shares his perspective on the gap between invention and innovation, and why persistence matters more than resilience.

Topics covered include stroke treatment and the tyranny of distance in Australian healthcare, nanoparticle drug delivery and shear stress-sensitive therapeutics, the University of Newcastle and Harvard University joint venture, postdoctoral research at the University of Oxford, the commercialisation journey from academic discovery to spin-out, intellectual property, tech transfer, and building a founding team, and advice for early career researchers considering the path to innovation.

Cognitio is the knowledge platform of ARCS Australia, the professional organisation for people working across therapeutics, medtech, and the pharmaceutical sciences. Visit arcs.com.au to learn more about membership and upcoming programs.

Guest: Dr Daniel Beard, Senior Lecturer, University of Newcastle; Founder and Chief Scientific Officer, ShearFlow

Host: Iqra, ARCS Australia Intern

Series: Season 2, Episode 13

Artificial intelligence is already reshaping how regulatory professionals work—but with opportunity comes responsibility.

In this episode of Cognitio, we bring you key insights from an ARCS webinar led by Kyle from GXP Vigilance, exploring how AI is being used across regulatory affairs, pharmacovigilance and quality environments, and what professionals need to understand to use it safely and effectively.

This is not a conversation about hype. It’s about real-world application in regulated environments, where accuracy, accountability and patient safety cannot be compromised.

• Why AI adoption is accelerating across the life sciences sector—and what that means for regulatory roles
• The biggest risks of using AI, including hallucinations, fabricated citations and data leakage
• The critical importance of human accountability in all AI-assisted outputs
• Practical guidance on acceptable vs unacceptable uses of AI in regulated settings
• How prompt engineering is evolving—and why it’s becoming a core professional skill
• The difference between public AI tools and enterprise-grade solutions
• What’s coming next in governance, policy and regulatory expectations for AI

AI is a powerful tool—but it is not a source of truth.

Human oversight remains essential. Regulatory professionals are still the final decision-makers and are accountable for all outputs.

Using AI safely requires discipline. This includes avoiding confidential data, validating outputs and understanding the limitations of large language models.

Prompting matters. The quality of input directly impacts the reliability of output, making structured prompting an increasingly valuable capability.

Governance is coming. Organisations will need clear frameworks, policies and controls as regulatory expectations evolve.

As AI becomes embedded in everyday workflows, regulatory professionals must strike a balance between efficiency and compliance.

Those who understand both the capabilities and limitations of AI will be better positioned to lead in a rapidly changing environment—one where professionalism, judgement and trust remain central.

ARCS Australia is the peak body for life sciences professionals, advancing capability across the sector through education, community and advocacy.

🎧 Follow Cognitio for more conversations shaping the future of the life sciences sector
🔗 Learn more at ARCS Australia

What you’ll hear in this episodeKey takeawaysWhy this mattersAbout ARCS Australia

This week on Top 3 with Tim, ARCS CEO Dr Tim Boyle shares the biggest updates shaping the ARCS community and Australia’s life sciences sector.

In this short update:
• Final call for 2026 ARCS Annual Conference early bird registrations
• ARCS announces its new partnership with the Australian Institute of Company Directors (AICD) and the upcoming LifeSciences Company Directors Course
• Highlights from a huge week of sector engagement, including the sold-out Leadership Summit with MAPA, Melbourne member networking, and the Monash University careers roadshow

Tim also looks ahead to International Clinical Trials Day on 20 May, where ARCS will host a free online symposium focused on governance, AI, digital informed consent and the future of clinical trials in Australia.

ARCS continues to champion professionalism, capability building and sector-wide connection across the full life sciences ecosystem.

Join the conversation. Join ARCS today.

How do we separate misinformation from meaningful public health signals, and what happens when digital intelligence is combined with clinical evidence?

In this episode of Cognitio, we explore how online sentiment, AI-powered surveillance and real-world healthcare data can work together to identify, investigate and validate emerging vaccine safety concerns.

Dr Gerardo Luis Dimaguila, Informatics Lead at the Murdoch Children’s Research Institute and Data Innovation Lead at the Centre for Health Analytics, introduces VaxPulse, a digital surveillance learning health system developed since 2021. Using AI, social listening and advanced analytics, VaxPulse monitors vaccine-related concerns and misinformation across online platforms, helping public health professionals detect early warning signs and better understand the information environment shaping vaccine confidence.

Aishwarya Shetty, epidemiologist and vaccine safety specialist at the Centre for Health Analytics, then demonstrates how these digital insights can be translated into rigorous epidemiological investigation. Using VaxPulse data identifying menstrual health concerns following COVID-19 vaccination, Aishwarya presents how large-scale GP syndromic surveillance and broader safety datasets were used to validate public concerns, assess risk and strengthen evidence-based communication.

Together, this episode explores:
• How AI and digital surveillance are reshaping pharmacovigilance
• The growing role of social media as an early signal detection tool
• How misinformation and genuine public concerns can be distinguished
• The integration of digital signals with GP and clinical datasets
• Why transparent, evidence-led communication is critical to vaccine trust

This episode is essential listening for professionals in pharmacovigilance, vaccine safety, epidemiology, regulatory affairs, public health and digital health innovation.

Cognitio is ARCS Australia’s platform for thought leadership, professional development and sector-wide dialogue across the life sciences ecosystem.

Join the conversation. Join ARCS today.