Craig Rayner: The accidental alchemist

The man behind the remarkable success

Craig Rayner

Adjunct Research Professor and Distinguished Alumnus, Dr Craig Rayner.

As Moderna’s Director of Translational Medicine for Infectious Diseases Development, Monash Adjunct Research Professor and Distinguished Alumnus Craig Rayner stands at the forefront of one of the world’s most innovative fields. However, his journey to the peak of his profession is as unconventional as it is inspiring. In fact, if it weren’t for a teenage mistake it may never have happened at all. We explore the remarkable career of an accidental alchemist.

Craig Rayner’s impressive career journey probably never should have happened. Growing up in Canberra in a farming and trades-related family, he had his heart set on becoming a physiotherapist.  However, Craig made a mistake when filling out his university application form at the end of high school, so his second choice of pharmacy prevailed. By the time he realised, it was too late to change.

Not that he minded too much, given his mind was well away from his studies and more on enjoying the extracurricular life university offered. “I was not a very committed student in the beginning,” he admits. “I spent more of my first year at the uni bar than in my books.”

That began to change, Craig says, when he met his now wife Michelle - a fellow Monash student - who suggested he was wasting his opportunity. When he began applying himself in second year, he found that he loved studying pharmacy.

“Scientifically, it was very, very stimulating,” he says, “You really had to like science to do well, and I found that I did. I was also fortunate enough to be taught by some fantastic scientists and educators, many of whom have become mentors for the rest of my journey.”

Craig specifically mentions his former chemistry lecturer John Hurley, former Dean Bill Charman, as well as MIPS Director, Chris Porter as major influences on his career trajectory. But he says, it was his microbiology lecturer, Dr Griffiths, who stood out the most at the time.

“He really was a formidable man,” Craig says. “It was very hard to excel in microbiology, but I really loved it and did quite well. He wrote me a letter at the end of it, to say ‘congratulations on doing such a great job’. I guess he wrote to other students too. But it’s something I was very proud of and will always remember.”

Pursuing clinical research in the USA

Pipettes

To complete his training in pharmacy, Craig did an internship in the Kimberley where he worked in indigenous communities and spent time with the Royal Flying Doctors. This, he says, “lit his fire” for wanting to do clinical pharmacology research in global health and infectious diseases but also a desire to dig further into medicine. And this led him to the United States to study a PharmD, specialising in clinical pharmacology at the University at Buffalo.

“At the time, clinical pharmacology was not a large specialisation in medicine in Australia,” Craig explains. “The Buffalo PharmD however, was a doctoral program within both the schools of pharmacy and medicine, and it involved pharmaceutical sciences, medical sciences, advanced therapeutics, clinical pharmacology and clinical research.”

“For me, this was the bee’s knees, and it was a much faster path into clinical pharmacology practice and research, than remaining in Australia.” However, after working briefly in US hospitals, he returned to Monash as faculty and soon became co-founder/director of the newly-established Facility for Anti-infective Development and Innovation.

“It was a great role because it allowed me to combine education with very patient-focused clinical research. I was working with some great people and really enjoyed being able to do several things at once. It also helped me build a reputation in clinical pharmacology and infectious diseases.”

“But I did find academia a little frustrating because it felt like you would sometimes do a nice study, and the end result would be that it would get published and then gather dust on a shelf. I really wanted to make an impact and focus on the patient.”

From Australian academia to Swiss business

In many respects, it is the next step in Craig’s career that may seem the most random. He was plucked out of seeming obscurity by global healthcare giant Roche, who moved him to Switzerland to take on a director role in clinical pharmacology. However, Craig says that, while he was working as an academic, he was also studying business (something that would eventually lead to him also obtaining an MBA).

This put him in touch with consultants who had connections in global healthcare, who recommended him as the perfect candidate for the role. It proved to be a masterful stroke for both parties, as he rose through the ranks to become clinical pharmacology lead for Oseltamivir, or Tamiflu - now a staple in the world’s pharmacies but then very much a breakthrough drug that became the only effective antiviral against swine flu.

“I got to join the light side - not the dark side,” Craig jokes. “I worked with the most brilliant, wonderful kinds of people who operate in cross-functional teams with the singular purpose of trying to move a molecule to become a medicine or vaccine.”

Craig says that one of the most interesting projects he’d worked on, at least scientifically, was the opportunity to conduct extensive investigations into neurological side effects, to determine whether these were caused by the drug, or by influenza itself.

“It meant presenting before FDA advisory committee hearings; these were televised live,” he explains. “We had spent a couple of years on clinical trials - including even doing lumbar punctures and looking at the cerebrospinal fluid to see if it gets in there, as well as polysomnography studies where we’d look at the impact of the drug on sleep. We also conducted large preclinical and real-world evidence research programs.  And we managed to establish it really was influenza causing these neurological effects.”

“But in doing so, we got to undertake really important research that answered foundational questions about how influenza worked, and this also helped inform people’s understanding of the neurological complications of COVID-19, years later.”

Craig was promoted to Roche’s Global Due Diligence Director. Based in Switzerland, he led large cross-functional teams to evaluate potential medicines for licensing or acquisition, giving him insights into the entire product development life-cycle for medicines and the art of integration. When family brought him back to Australia, Roche hired him again, allowing him to use his broad understanding of the medicine development business in a global role uniquely based out of Melbourne.

Building a new business

Playing a pivotal role in modern medicine development may have been enough for many people, but the businessperson in Craig meant had always had a desire to grow something from scratch. After finishing an MBA, he founded D3 Medicine, a consulting company focused on clinical pharmacology, drug development, and translational medicine.

“I started D3 Medicine to address a gap in the clinical pharmacology field that I could see really needed to be filled,” he says. “There was a lack of consulting firms focused on contemporary drug development approaches.”

“D3 Medicine was possibly the first clinical pharmacology consulting firm globally, but it was still a start-up and I was no longer just doing research, as a founding CEO I was doing everything.”

“I was lucky I had co-founders, including friend Patrick Smith, who actually taught me in Buffalo, and my wife who was in strategy in banking and finance and also has an MBA to help out. But I didn’t draw a salary myself for seven or eight months. When it took off, it took off quickly, and within a couple of years, we were responsible for double-digit millions in revenue. Then, within three years and nine months of starting up, we’d sold it.”

The buyer, Certara, was a US-based company with strengths in software and pharmacometric modelling, and Craig describes the complementary skills of the two organisations as a “match made in heaven”. He stayed on after the acquisition, moving to Princeton to become President of Certara’s consulting division, a role which he says delivered enormous satisfaction.

“I like building things and the leadership side, but I still just love the science and the clinical. So I have to do both. If I'm spending too much time doing one or the other, generally my happiness starts to slide. So I’ve kind of got to do both, which I got to do in that role.”

In 2020, Craig received an expert invitation to attend the first WHO meeting for the emerging coronavirus. Throughout the pandemic, he advised NGOs, industry and government on the virus and made leading contributions to research and clinical trials on COVID-19 treatments.

“In 2020 I wasn’t just advising on COVID-19, I also got to guide Certara through their IPO, which was a pretty significant one, raising over A$1 billion.”

Keeping up with the classroom and global perspectives

Craig Rayner teaching

From 2011 onwards, and throughout all of his incredible career moves, Craig also taught at Monash in an adjunct capacity. Initially an Adjunct Associate Professor in the Faculty of Pharmacy and Pharmaceutical Sciences, in 2022 he became Adjunct Professor (Research). Then, in late 2022, Moderna appointed him Director - Regional Research Centre for Respiratory Medicines and Tropical Diseases.

“Moderna had put down roots in Melbourne and they were looking for someone to start up R&D in the region. I was really enamoured with their science - especially the mRNA platform potential to treat many diseases - and they had committed to establishing a regional research centre for respiratory medicine and tropical diseases and that’s what I’d been doing my whole career.”

“I was also given the opportunity to help decide what Moderna’s R&D footprint was going to be like here, and I wanted it to be integrated into the global team.”

“We’ve been executing on a strategy to make Australia a centre of excellence for translational science and medicine, and there’s real merit in this approach given the strengths that Australia has in translational science and early clinical trials”.  “There is also an opportunity for Australia to contribute to large seasonal infectious diseases trials too.  When the northern hemisphere is not having their flu season, we are. So we get to basically flip between hemispheres and keep the research going year round.”

“We’ve also looked at strategic partnerships we can make in Australia, and one of these has been with Monash: the quantitative pharmacology accelerator. Another was aggregating some various institutions together to look at how we do really creative early-stage clinical trials.”

Midway through this year, Craig was promoted once again, this time to Director - Translational Medicine, Infectious Diseases Development.

“I'm now a global clinical development lead on specific programs, based in Melbourne. I also provide translational medicine expertise across infectious diseases programs” he explains.

“Moderna, like Roche, has done something which most other biotechs or pharma never do - and that’s make Australia a genuinely integral part of its operations. I also think the D3 Medicine and Certara journey had already proven that highly innovative development programs can be driven from Australia”

Despite Australia’s rising status as a centre for pharmaceutical science and translational medicine, Craig encourages recent graduates to still look overseas for experience.

“I am very fortunate to have worked with many amazing people around the world on numerous medicine approvals, including treatments for bacterial infections, influenza and river blindness as well as contributing to debunking and uncovering potential COVID-19 treatments during the pandemic,” Craig says.

“Unlike when I graduated you don’t need to go overseas to have a great career anymore. But at the same time, it can give you a different perspective and different experiences which can also help you understand the world more, and your place in it.”

“More than anything what I’d encourage graduates to do is to ‘swim across swimlanes’. Don’t feel you have to do anything one way, or do just one thing.”