Digital Innovation Conference Debut from ISPE Australasia

At Last!

It’s all about digital these days—digitization, digitalization, digital transformation, generative and innovative solutions. Australia has a strong reputation for breakthroughs and transformations in medical science and research, but there have been limited offerings locally on computerized systems and technologies. Until now.

In September, ISPE Australasia hosted its two-day ISPE Australasia Digital Innovation Conference in Sydney, Australia, which provided a splendid synergy of knowledge-sharing resources and networking in the heart of a spectacular city.

As the current Chair of the ISPE GAMP® Global Community of Practice, and a 10-year resident in Australia, it was a pleasure to be invited onto the conference committee by the ISPE Australasia Affiliate Board and a great opportunity to get to know my local peers.

Conference Summary

Over 60 industry professionals gathered at the conference. They were warmly welcomed by ISPE Australasia President Kerry Dranganoudis, Director at Compliance Connection. The opening presentation explored how GAMP enables innovation and improved patient outcomes through its evolving computerized systems management approaches. This was followed by a healthy dose of the real world from Gerry McKiernan, Director/Principal Consultant at Increment 4 in Australia, discussing both failed and successful digital deployments and what contributed to each. Tim Boyle, CEO of ARCS Australia, gave an inspirational talk on the impact of AI within life sciences and Louise McGrath, Head of Industry Development and Policy with Australian Industry Group, demonstrated that alliteration contributes to a good presentation in her talk on digitalization, decarbonization, and diversification.

ISPE Australasia President Kerry Dranganoudis welcomes attendees to the ISPE Australasia Digital Innovation Conference in Sydney, Australia

The first day continued with a call to strengthen Australia’s sovereign capability for robotics and AI adoption in a presentation from Andrew Kiloni, Commercial Director at Industry Capability Network (ICN) in Australia, and Samuel Jesuadian, Chief Operating Officer of Advanced Robotics for Manufacturing Hub (ARM Hub) in Australia.. The audience was appreciative of Jennie Burton, APAC Operations IT Regional Lead with AstraZeneca in Australia, sharing the digital journey that AstraZeneca is taking, offering relatable insights and examples for the audience. Deepa Thakkur, Senior Manager with Clayton Utz in Australia, followed up with her presentation proving that data governance is more than just a GxP requirement; she brought her viewpoint as a lawyer to the presentation and used a brilliant analogy to make data management clear for all.

Sarah Taylor, Senior Validation Specialist at PSC Biotech and an ISPE Emerging Leader, and I duetted the final presentation of the day covering data integrity and data quality before the speakers, attendees, and exhibitors all enjoyed a two-hour networking reception where new friendships were formed, and everyone came together collaboratively.

A lively networking reception, building new connections and refreshing existing ones

Day Two of the conference, chaired by ISPE Australasia Affiliate Vice-President Abdul Fneiche, Process Performance Lead at ANSTO, kicked off with an extended session from Brandi Stockton, Founder and Managing Partner of The Triality Group, LLC, co-lead of the GAMP Software Automation and AI Special Interest Group (SIG), and an active member of the new ISPE AI Community of Practice, sharing the framework and lifecycle approach for AI/ML developed by the SIG. After a caffeination break, the audience was treated to hearing both sides of a low code/no code implementation project from Bob Buhlmann, Head of Quality and Digital Computer Strategy at AstraZeneca in the US and Manuh Pitasari, Lead Consultant Manufacturing and Quality Solution at FactoryTalk in Thailand, ); this was a perfect example of leveraging critical thinking and creating an innovative approach to the control and validation of a very different kind of computerised system, exactly as ISPE GAMP^® 5 (Second Edition) encourages industry to do. Great work, Bob and Manuh!

(On a side note, Sarah, Manuh, and I all serve on the GAMP South Asia Steering Committee, and this was the first time we three could catch up face to face since the committee formed in 2023—I love working remotely, but it doesn’t get better than networking in person).

The interest and engagement continued with Andreas Hauser, PhD, CEO of AIQURIS, in Singapore, presenting his company’s solution to AI risk and vendor assessment (along with a little European-based humour that maybe the attendees missed but I certainly enjoyed as an expat).

There was no slump after lunch, thanks to Ben Sauer, APAC Lean Academy Lead with AstraZeneca, in Australia) actively showcasing the need for disruption to effect change (which he quipped was very useful for improving the design of paper aeroplanes), and how to use multiple roof shots as the precursors to the all-important moon shot. Brad Watmuff, PhD, Senior Scientist at Cortical Labs in Australia, brought a little ‘Frankenscience’ to the conference with talk of brain cells in a lab being ultimately trained to play the video-game Doom (something that adolescent boys seemed to manage with no training at all back in the day). The final presentation was from Ian Lucas, Partner and Director at SeerPharma in Australia, sharing his history of involvement in digital innovation and his hopes for future collaboration.

But wait! There was more! Attendees got engaged and interactive during a panel discussion with Bob, Brad, Andreas, and Ian, moderated by Ben. It was a fantastic way to end the conference and judging by the responses, appreciated by the attendees.

Reflections

As always, serving on a conference committee takes time and dedication, and can be hard to juggle with a day job and hopes for a home life. A few inevitable aspects still managed to throw the plans off track, but flexibility and fast reflexes to build contingency plans got us over any hurdles.

As the first time ISPE Australasia had hosted a conference around digital topics, the conference committee had to really start from scratch in recruiting speakers, exhibitors, and even attendees, and the conference committee members invested a lot into the event, for which we are very grateful.

Conference Committee (left to right): Charlie Wakeham, Ben Sauer, Ian Lucas, Abdul Fneiche, Gerry McKiernan and Kerry Dranganoudis.

The energy and engagement from Day One of the ISPE Australasia Digital Innovation Conference showed that every effort to bring opportunities and knowledge-sharing to the pharmaceutical industry in a localized setting is justified. Attendee feedback supported this assessment, with comments such as: “Each presenter was knowledgeable and passionate about their topics”; “The agenda was well-structured and planned”; and “[The conference was] volunteer led and extremely professional.” The positive feedback made it very worthwhile. My sincere thanks to the ISPE Australasia Affiliate Board for the fortitude and dedication to make this event happen, and to all the amazing speakers.

Let’s do it again sometime!

Charlie Wakeham

WakeUp to Quality