- 2 years ago
13 September 2021
Orin Chisholm has worked in and with industry for so long and taught so many people in the sector it’s easy to believe she is in some way connected to just about everyone working in the regulatory affairs scene.
Chisholm is, indeed, a household name within regulatory affairs – an icon renowned for her expertise in regulatory systems globally, so much so that when they say she wrote the textbook on it, they’re not kidding. She actually did.
Earlier this month, Chisholm was named a prestigious Fellow of the Regulatory Affairs Professionals Society (RAPS) – one of just four new members globally to join the venerated ranks of the organisation for 2021. It was high praise and global acknowledgement of her role as a mentor, author, speaker and one who “goes above and beyond” to nurture the profession.
Australia is indeed fortunate to count amongst its number one of the world’s leading regulatory professionals. Until the end of last year, Chisholm was potentially best known for her role as Associate Professor and Program Director of Pharmaceutical Medicine (PharmMed) at the University of NSW. It was a role she had taken on eight years earlier in what was effectively the third phase of her distinguished career, and a role she relished.
Hundreds of students passed through the course over those years, some already working in industry, others now employed in various pharma roles. While the course was growing strongly, last December it became yet another Covid casualty and was permanently closed.
Among other things, Chisholm is now consulting but, having gone from a research career to a pharma career to a teaching career, it is the latter where she has found the greatest sustenance. While she continues to teach, the cost of closing the UNSW course she poured so much into is hard to bare.
From Scotland and back
The daughter of a Scottish immigrant from north of Inverness, the name Orin originated in the area and reflects her father’s – and her own – strong ties to their Scottish heritage. Chisholm initially cut her teeth in academia, working in blood cell development and leukaemia research both in New York and around Australia but, with many postings being just one or two years, the desire for “a normal life” saw her look to transition to an industry role.
Like many academics, she wasn’t sure how her research skills would translate to a professional career but a regulatory affairs manager at Wyeth, Karen James, took a punt – a gamble Chisholm still recalls fondly as being a defining moment in her career and her life.
“It was the Year 2000 and there weren’t a lot of PhD people in industry at that point,” she says. “Karen had previously employed PhD people in regulatory functions and was confident I could make the transition. She was a wonderful manager.”
Having broken into industry, Chisholm later moved to a much broader role at Genzyme followed by a year at Medicines Australia under another industry icon in Deborah Monk. Stints at Merck Serono and Boehringer Ingelheim followed.
“I tell my students you will have a number of different careers throughout your lifetime and you have to have a continuous learning mindset, be flexible and adaptable and able to move across different careers,” says Chisholm. “I use myself as an example.”
Following an extended overseas family holiday that included a visit to Scotland, Chisholm successfully applied for the Program Director role at UNSW, saying she thought the job “would enable me to blend my industry background, my connections in industry, and my interest in teaching”.
Over the next decade, she watched as a stream of part-time students passed through her lectures and tutorials. She tried to give each one the practical experience and tools they would require to secure good jobs in pharma – and to hit the ground running. She restructured the program to make it more relevant to industry needs, looking to narrow the gap between skills provided and what the industry wanted.
“It has always been difficult to get into the pharmaceutical industry – I don’t think that’s changed,” she says. “Students need the terminology and the understanding of how the industry works – that’s what I was focusing on. All the jobs advertised, even entry-level jobs, often require at least two years of experience. Providing students with some practical experience enables them to get offered the job they are looking for.
“When I started at Wyeth, Karen James put a lot of effort into training me. I spent time with a sales rep, at the manufacturing site, and shadowing different functions across the organisation so I could understand how they worked and interacted. Nowadays, people are just expected to walk in and be able to do their job.”
Following the closure of the course, Chisholm now runs an online global regulatory affairs course through Arizona State University from her Sydney home, as well as consulting. She has made a significant contribution to the Fundamentals of International Regulatory Affairs textbook – the ‘bible’ of regulatory affairs professionals – and is writing a new chapter on regulating cell and gene therapies.
Orin on the future of pharma
Having traversed both sides of the divide when it comes to academia and industry – two sectors that invariably don’t get along – Chisholm refers to the US for how it should work.
“In the US, there is more fluidity between government, academia and industry and they all work together. In Australia, it is still too siloed and has a long way to go to break those silos down. We need more collaboration and cooperation between academia, government and industry – we need to work together.”
She also sees a growing need for ways to inform patients so they can take control of their own health journey, saying the patient of the future will “partner” with their doctors to make decisions regarding their health – a shift that will also require an attitudinal change for doctors – while data and digital will be more integrated into healthcare.
Tertiary education will be more geared to “micro-credentialling”, allowing people to upskill as they dip in and out of areas of interest, while ethics guardrails will be required around emerging areas such as artificial intelligence and 3D printing.
For Orin Chisholm, her hope is to very much be a part of these changes, once again through tertiary teaching and guiding young people with a dream of working in pharma.
As she recalls with just a tiny hint of satisfaction the countless pharma careers she has watched launch and blossom, there is no doubt the many who have benefited from her wisdom over the years are equally keen to see Associate Professor Chisholm back where she belongs – mentoring a group of eager students, all dreaming of a life in pharma.