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The work of pharmaceutical companies can bring new hope to patients delivering solutions to unmet medical needs. It can also turn a small market cap play into a giant – but it’s a process that’s not easy, it’s risky and it can take a lot of money and patience.
Our webinar explores what it takes for ASX-listed companies to get new health care developments – whether that be drugs, apps or other technologies – through the complexities of Australia’s Therapeutic Goods Association approvals process.
Demystifying the clinical trials & approvals process
The TGA sits under the Federal Department of Health, and regulates the safety, efficacy and quality of everything from sunscreens to vitamin supplements, prescription medicines and medical devices. America’s big brother to the TGA is the US Food and Drug Administration. Some companies target the FDA first – looking to tap into a bigger market from the start.
Our webinar guests are:
- Race Oncology (ASX:RAC) CEO Dr Daniel Tillett who joins us online. Race Oncology is advancing a reformulated version of bisantrene, namely RC220, to treat the likes of myeloid leukaemia, while avoiding heart damage which can be caused by other chemotherapies;
- Recce Pharmaceuticals (ASX:RCE) Chief Scientific Officer and co-inventor Michele Dilizia. Recce is in advanced testing of a patented antibiotic called R327. It’s being trialled in Australia and abroad for treating sepsis, UTIs and burns. The company has achieved Fast Track Designation by the FDA;
- And Brian Leedman from BlinkLab (ASX:BB1). BlinkLab’s launching FDA trials of a Princeton University-developed, AI-driven smartphone app to screen for autism and ADHD through a blink reaction test. Brian Leedman has plenty of experience with approvals – he was behind the ResApp Health cough analysis app that was sold to Pfizer in a $179 million deal.
We also feature insights from Bioshares editor, Mark Pachacz.
Bioshares is an online investor resource delivering research notes specific to Health Care sector companies. Bioshares also has a Biotech Summit which will be held in Fremantle, July 12-13.
While the TGA did not respond to our invitations to join the webinar panel, you can also look at our special report on the topic – which can be downloaded free from The Market Online here. The report is titled: What it takes to get a new drug to market in Australia – Demystifying the clinical trials and approvals process.
The material provided in this article is for information only and should not be treated as investment advice. Viewers are encouraged to conduct their own research and consult with a certified financial advisor before making any investment decisions. For full disclaimer information, please click here.
