- 2 years ago
9 August 2021
Former TGA Assistant Secretary and Head of Prescription Medicines Authorisation Branch Adrian Bootes has retired from public service after five years with the regulator and has now joined a specialist consultancy while offering a high-level advisory service to industry clients through his own company.
After years of driving from his northern beaches home in Sydney to Canberra, the keen cyclist and surfer known throughout industry for his depth of expertise combined with a friendly and approachable demeanour, Bootes told MedNews he was looking forward to living full-time with his family, particularly as one of his three teenagers was doing the HSC.
However, Bootes said he was also incredibly proud of his many career achievements at the TGA where the number of registration pathways increased from one to seven during his years there, and in representing the Federal Government at the first World Health Organisation (WHO) Covid-19 meeting held in Geneva in February 2020.
A former ARCS Australia CEO and Australian Red Cross Blood Service Regulatory Director prior to joining the TGA, Bootes was already incredibly well known in the Australian pharma and clinical research sectors before stepping in to lead a team of 100 people who evaluate and approve new and amended prescription medicines in Australia.
Yet Bootes says when he took on the job of Branch Head in Prescription Medicines in 2016, Australia had a single standardised path to registration and there were clearly issues that needed to be resolved.
“A personal highlight has been the implementation of a far better regulatory process,” Bootes said. “When I took on the role of Branch Head, one of my first observations was how fewer medicines were being submitted for approval in Australia compared to overseas.
“I was also aware of a time delay and lack of transparency around some affiliates being allowed to submit and the contortions the regulator sometimes went through to bring medicines to Australia for patients.
“The distance between the TGA and industry was also evident and the need to find common ground on big issues was paramount because of the potential to enact reforms that would enable Australia’s regulation system to be the best in the world.
“We all needed to put away the war stories and pull together various global approaches, creative thinking, mutual trust and understanding to bring forward a fresh approach.”
This progressive thinking resulted in the TGA collaborating with industry to author legislative changes and convince the Government and Parliament to implement new Priority and Provisional Review pathways for the benefit of Australian patients.
Today, there are seven options including the Comparable Overseas regulator (COR) A and B paths, Project Orbis and the Australia-Canada-Singapore-Switzerland-UK (Access) Consortium track.
Bootes describes the introduction of the new Priority and Provisional tracks as “amazing”, adding the provisional track has come into its own for Covid-19 treatments and vaccines – an outcome he had envisaged due to his earlier pharmacovigilance experience with AIDS patients when he worked with the late Professor David Cooper to implement AZT and repurposed treatments.
“The early work on the AIDS medicines was instructive for me when designing the provisional pathway,” he said. “Elements of it were used in a very flexible way some 30 years ago for AIDS and the pathway we built would have been formally used if it had been available at that time.”
The new tracks are not only working to bring more medicines to Australia – the number of major applications is increasing by 20 to 30 per cent year-on-year – but are also faster. Even the standard pathway is now an average 190 working days from submission to approval while a reduction in appeals and the overwhelmingly positive response directed at the TGA in the 200-plus submissions made to the Parliamentary Inquiry into New Drugs and Novel Medical Technologies are further evidence of the quality of the Branch’s work.
The urgency of Covid
Bootes says attending a WHO meeting with Director-General Dr Tedros Adhanom Ghebreyesus and new EMA head Dr Emer Cooke in Geneva last February was an unforgettable career highlight, but was also alarming.
“Sitting next to and hearing of the unexpected and sudden decline of patients during sessions from the Head of Infectious Diseases at Shanghai University Hospital made it abundantly clear to me the enormity of the pandemic we were facing,” he said.
“I then actively contacted and solicited the application for remdesivir from Gilead.
“We pulled together a large TGA evaluation team to look at the application rapidly,” he said, adding he also attended video conferences with more than 100 regulators globally to assess therapies and vaccines coming through for Covid.
“That something I am also very proud of,” he said. “It set the scene for many more excellent and rapid assessments thereafter.”
Now keen to use his extensive knowledge in the private sector, Bootes has commenced in a permanent part-time capacity as Director of Drug Development and Regulatory Affairs at consultancy MyMedical Department and will also provide high-level advice and board input through his own company, CR Consult.
He also hopes to use his immense experience and skills as a Board Director while helping bring new therapies to fruition through educational and teaching roles, so is likely to still be a familiar and smiling face around the sector.
“I’m looking forward to the new challenges that lie ahead while continuing to work to ensure Australian patients have access to the best and latest medicines and medical devices,” he said.