Dominique Hess (Gatto)

Join the Australasian Gene and Cell Therapy Society for two e-Seminars organized as part of the AROUND THE WORLD SERIES, in collaboration with the Coalition of International Gene Therapy Societies. When: Thursday 26 September 2024 Australian Eastern Standard Time (AEST): 10.00 PM Central European Summer Time (CEST): 2.00 PM Eastern Time Zone US (EDT): 8.00 AM Topics Covered: Back to Base-ics: Developing targeted base-editing approaches for NF single nucleotide substitutions - Dr. Alexandra O’Donohue A transient modified mRNA encoding Myc and Cyclin T1 induces cardiac regeneration and improves cardiac function after myocardial injury - Dr. James Hudson Register at: https://lnkd.in/dKzZeT2z #genetherapy #celltherapy

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Race Oncology is pleased to share a feature report from The Australian on the submission of the human ethics application package for bisantrene RC220 Phase 1 trial in solid tumour patients.   Conducted in two stages, the Phase 1 clinical trial will examine the safety and tolerability of the reformulated #bisantrene, RC220, in particular the drug’s cardioprotective ability when used in combination with doxorubicin, a form of anthracycline commonly used in chemotherapy. The ethics submission is a milestone after a year’s preparation, with the first patient recruitment expected to take place in Q1 2025.    Read the full news article via this link: https://lnkd.in/gf4vfuXt   #cardioprotection #oncology #drugdevelopment #ethicssubmission

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RANZCOG’s Clinical Guideline (C-Obs 44) “Pre-pregnancy and pregnancy-related vaccinations” (Signposting) has received an interim update to summarise new information published in the Australian Immunisation Handbook on respiratory syntical virus (RSV). Respiratory syncytial virus (RSV) is an RNA virus causing respiratory tract infections. The greatest illness burden impacts children less than 2 years of age, with highest risk for infants less than 6 months, premature infants and those with susceptible medical conditions. In Australia, vaccination is now recommended for pregnant women at 28-36 weeks gestation to protect the infant (Abrysvo). Use of a monoclonal antibody (Nirsevimab) is also recommended for infants <6 months at higher risk for RSV and infants whose mothers were not vaccinated when pregnant. Maternal immunisation reduces the risk of severe RSV disease in infants <6 months of age by around 70%. This is the result of passive protection by transplacental transfer of RSV-specific antibodies from the mother to the fetus during pregnancy. Clinicians are encouraged to review the new Australian recommendations in the updated guideline on the College’s website: https://lnkd.in/gqGBuK4B

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Just over 4weeks left for ASCO 2024. I am unable to attend this year but grateful to have contributed to this research from West Australia. From personalised mRNA cancer vaccines to ctDNA in colon cancer to AI and personalised peptide vaccines, stay tuned for some exciting data. 1. The phase 3 INTerpath-002 study design: Individualized neoantigen therapy (INT) V940 (mRNA-4157) plus pembrolizumab vs placebo plus pembrolizumab for resected early-stage non–small-cell lung cancer (NSCLC). Abstract: TPS8116 | Poster Bd #: 377b 2. INTerpath-001: Pembrolizumab with V940 (mRNA-4157) versus pembrolizumab with placebo for adjuvant treatment of high-risk stage II-IV melanoma. Abstract: TPS9616 | Poster Bd #: 391b 3. Immunogenicity of an AI-designed personalized neoantigen vaccine, EVX-01, in combination with anti-PD-1 therapy in patients with metastatic melanoma. Abstract: 9561 | Poster Bd #: 345 4. Circulating tumor DNA analysis guiding adjuvant therapy in stage II colon cancer: Overall survival and updated 5-year results from the randomized DYNAMIC trial. Abstract: 108 5. Real world impact of pembrolizumab availability for deficient mismatch repair metastatic colorectal cancer. Abstract: e15569 6. A phase 3 trial of IMC-F106C (PRAME x CD3) plus nivolumab versus standard nivolumab regimens in HLA-A*02:01+ patients with previously untreated advanced melanoma (PRISM-MEL-301). Abstract: TPS9602 | Poster Bd #: 384b 7. Individualized neoantigen therapy mRNA-4157 (V940) plus pembrolizumab in resected melanoma: 3-year update from the mRNA-4157-P201 (KEYNOTE-942) trial. Abstract: LBA9512 8. Triplet combination treatments with pembrolizumab (pembro) for anti–PD-(L)1–refractory advanced melanoma: Preliminary results of the phase 1/2 KEYMAKER-U02A study. Abstract: 9506

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CStone announces the submission of clinical trial application in Australia for CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) with first-in-human study registered on Clinicaltrials.gov (NCT number: NCT06741644). CS2009, a leading asset from CStone's Pipeline 2.0, is positioned as a potential FIC or BIC next-generation immuno-oncology backbone. CS2009 features an innovative molecular design that targets PD-1, VEGFA, and CTLA-4 simultaneously, maintaining balanced affinity for PD-1 and CTLA-4. Preclinical data also indicate that its anti-VEGF activity exhibits significant synergistic effects with its immune checkpoint inhibitory functions—crosslinking with VEGFA markedly enhances both anti-PD-1 and anti-CTLA-4 activities. CStone plans to initiate a multi-regional, first-in-human clinical trial for CS2009 in Australia in early 2025, followed by expansion into China and the United States. Read more: https://lnkd.in/gVSieH4b #PD1 #VEGF #CTLA4 #Trispecificantibody #CS2009

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👀 Get ready for an eye-opening session at Medicines Management 2024! 💊 Join us for a must-attend talk from Associate Professor Katherine Isoardi, an expert in emergency medicine and clinical toxicology, who will delve into the alarming rise of synthetic opioids like nitazenes in Australia. This week Assoc. Prof. Isoardi spoke to AJP about these potent drugs — up to 1000 times stronger than morphine — which pose serious public health risks, especially as they are being detected in non-opioid drugs like MDMA and THC. https://buff.ly/3Aas6DT Assoc. Prof. Isoardi’s session, ‘Synthetic Opioids,’ will cover crucial insights on overdose identification and harm reduction. This is an important conversation for healthcare professionals, as the community’s awareness and understanding of synthetic opioids are critical in managing this emerging threat. AdPha is committed to this cause as well. Our Hospital Pharmacy Practice Update: 'Take-home Naloxone in Australian hospitals' highlights the role pharmacists play in making this life-saving antidote more accessible and educating the public on overdose symptoms: https://buff.ly/3YzAnKR

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Important Update on Australia's GCP Inspection Program Published: 15-May-2024 by the #TGA Clinical researchers and sponsors in Australia should be aware of key update to the TGA's Good Clinical Practice (#GCP) Inspection Program: In May 2024, the program's scope expanded to include clinical trials of medical devices and investigations of medicines and biologicals. All clinical trial teams must familiarise themselves with current GCP guidelines and the TGA's inspection program requirements. Proactively reviewing processes and documentation for GCP compliance can ensure you are inspection-ready. #clinicaltrials #GCP #regulatorynews #medicalresearch #TGA #pharmout

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Thanks for publishing in PharmacoEconomics

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Australia's PBAC has effectively stymied a proposal by MSD and BMS to deliver faster access to their funded therapies for #cancerpatients by changing the way PD-(L)1s are funded on the PBS. Rare Cancers Australia CEO Christine Cockburn says RCA has been advocating for pan-tumour listings since 2017 "and this latest development is simply another example of arguing about the life-jacket whilst the patient is in the water drowning”. MSD Australia & New Zealand and RCA expressed disappointment at the PBAC outcome, which called for simplified funding submissions to be made 'within tumour types' rather than #genomic expression, its outcome statement reminiscent of a PBAC outcome released six years ago that also limited funding evaluation to tumour location. Is Australia's health technology assessment (#HTA) process keeping pace with changes in science and innovation? Can and should PBAC think differently, or is the risk of change too great? Lots of questions and few answers. #cancerfunding #patientscantwait #medicinesaccess

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📉 #AustraliaDiscountRate Australia's discount rate has remained unchanged for over 30 years, posing challenges for companies introducing new treatments. Dive into Medicines Australia's post below to discover how the current 5% rate hinders swift innovation and learn about their advocacy to align the discount rate for PBS-listed medicines with other OECD countries at 1.5%. 💊🚀 #HealthcarePolicy #InnovationChallenges 🌐

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⚠️Medicine shortage update - Orencia (abatacept) medicines⚠️ Bristol-Myers Squibb Australia (BMS) has advised us that Orencia (abatacept) 125 mg/mL ClickJect autoinjector for subcutaneous injection and prefilled syringe for subcutaneous injection are now in shortage. The shortage of these products has started earlier than anticipated. As a result, most patients will need to switch to other medicines now. • Prescribers should contact their patients urgently to reassess their treatment. • If patients who are prescribed an Orencia subcutaneous injection have not been contacted by their specialist, they should speak to them as soon as possible. We have met with BMS and relevant healthcare professional associations to develop guidance for patients, prescribers and pharmacists, which includes a plan for prescribers with patients who cannot switch to other medicines during the shortage. Visit our website for more information: https://lnkd.in/gv-JAXxq

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Understanding the Clinical Trials Process The clinical trials process in Australia ensures the safety, efficacy, and scientific validity of new medical treatments through a structured and rigorous framework aligned with international standards: Ethics Approval: Approval from a Human Research Ethics Committee (HREC) is required. The HREC reviews the Investigator Brochure and Protocol and all other subject-facing materials such as diaries, advertisements to ensure ethical standards and participant safety.  In Australia, generally and for the majority of clinical trials there is NO regulatory review and you do not need to have an open-IND. Regulatory Approval: Sponsors must notify the Therapeutic Goods Administration (TGA) via the Clinical Trial Notification (CTN) scheme, or less commonly, obtain Clinical Trial Approval (CTA). The HREC handles scientific and ethical review, while the TGA oversees the process. Phase I Trials: Involving a small group of healthy volunteers or patients, these trials assess safety, pharmacokinetics, pharmacodynamics, and appropriate dosage ranges. Phase II Trials: Conducted on a larger patient group, these trials evaluate preliminary efficacy, further safety, and refine the dosing regimen. Phase III Trials: Large-scale studies confirm therapeutic efficacy, monitor adverse reactions, compare with standard treatments, and gather comprehensive safety data. Regulatory Review and Approval: In Australia, positive Phase III results allow sponsors to submit a dossier to the TGA for marketing authorisation. The TGA thoroughly reviews the clinical data to ensure safety, efficacy, and quality. This is different to the US process where sponsors submit a New Drug Application (NDA) to the FDA; the FDA conducts a thorough review of the clinical data and must approve the NDA before the product can be marketed. Post-Market Surveillance: Phase IV trials monitor long-term effects, optimise treatment regimens, and identify rare adverse events. Ongoing pharmacovigilance ensures continued safety and effectiveness. Throughout this process, protecting participants and maintaining data integrity are paramount. Compliance with Good Clinical Practice (GCP) guidelines and continuous oversight ensure that clinical trials in Australia meet the highest ethical and scientific standards. For expert service for all your clinical trial needs, please contact or Founder and Director, A/Prof Tina Soulis, at: [email protected] https://lnkd.in/gJZ-Fxcv #bio2024 #clinicaltrials #australia

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Today at #SITC2024 we will be presenting our latest findings on spatial immunometabolic heterogeneity in non-small cell lung cancer (#NSCLC). This work, in collaboration with Arutha Kulasinghe from the The University of Queensland, reveals groundbreaking insights into the tumor microenvironment (TME) and its role in immunotherapy response. Don't miss to check out our poster #212 for more details! Title: Multi-Omic Spatial Data Integration Resolves Immunometabolic Heterogeneity Associated with Nivolumab Response in NSCLC Patients Presented by: Filippo Pullara, PhD 📍 Exhibit Hall | 🗓️ Saturday, Nov. 9 Poster Reception : 7:00 - 8:30pm Using our #SpaceIQ™ platform, we integrated multiplex immunofluorescence and RNA expression data from Nivolumab-treated NSCLC tissue samples to identify spatially-driven #microdomains associated with treatment response. Key #pathways such as lipid metabolism, immune cell differentiation, and mitochondrial function were highlighted, providing valuable insights into how specific metabolic and immune processes in the tumor microenvironment (#TME) impact immunotherapy outcomes. This integrative approach opens new doors for understanding how spatially defined regions in the TME impact #immunotherapy outcomes, moving us closer to more effective strategies for NSCLC treatment. Catch us at Booth #838 for #SpaceIQ demo, attend our #symposium with spatial biology #experts from academia and industry on Nov 9, 12:30pm (Room #320A, adjacent to Grand Ballroom) and join the #poster sessions to learn more about our findings! Full Abstract is accessible now: https://lnkd.in/eAre82se #SITC2024 #SpatialBiology #CancerResearch #OncologyInnovation #PrecisionOncology #Immunotherapy #MultiOmics #TumorMicroenvironment #AIinHealthcare #CancerBiomarkers #SpatialMedicine #Collaboration #ImmunoOncology #BiomedicalResearch #CancerTreatment Dusty Majumdar, PhD , S. Chakra Chennubhotla , Craig Cinquina , Akif Burak Tosun , Brian Falkenstein , Raymond Yan , Shannon Quinn Kenneth O'Byrne Professor John Fraser James Monkman Queensland Spatial Biology Centre (QSBC) Society for Immunotherapy of Cancer (SITC)

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➖ QUARTERLY REPORT ➖   #Amplia has today released its Quarterly Activities and Cash Flow Report for the quarter ended 30 June 2024.    Key highlights for the quarter include:   ✔ Updated data and analysis from the Phase 1b ACCENT trial in pancreatic cancer presented at the prestigious annual meetings of the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO) ✔ Recruitment in the ACCENT Phase 2a trial has progressed well and in early June we reported 24 of 26 patients had been recruited.  ✔ The inaugural meeting of the Company’s Clinical Advisory Board was held.   Read today’s ASX release here 👉 https://lnkd.in/gtiCG5QN   $ATX #ASX #research #innovation #cancerresearch #pancreaticcancer #clinicaltrial

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Latest TGA News on Pharmacovigilance Obligations!   Any company supplying a medicine, including a complementary medicine, in Australia must have a pharmacovigilance programme in place. This is mandatory!   The TGA has opened their Pharmacovigilance Inspection Program Risk Assessment Survey which is for medicine sponsors to complete. The survey remains open until 20 December 2024. * Medicine sponsors that do not complete this survey will be assigned the highest survey risk score.* This means you are more likely to be selected by the TGA for a Pharmacovigilance Inspection. Read about the survey and access either the MS Word or PDF version of the survey here https://lnkd.in/gPX2ZnP Our two-hour training course - Pharmacovigilance obligations - comes with a complete set of SOPs and forms that together provide a complete PV system. These can be adopted by your business to ensure you meet your pharmacovigilance obligations.   The course is presented by Mary Nteris, PhD, a specialist in this area who can also act as your “Qualified person responsible for pharmacovigilance in Australia (QPPVA)”. The QPPVA must be trained and experienced in pharmacovigilance and relevant legislation in Australia.   This has been a popular course with excellent feedback. A recent attendee left us the following review:   “We recently completed the Pharmacovigilance Obligations course with Regulatory Training Direct and found it both informative and engaging. The course was structured in a clear and easy to follow way, making the complex topics we feared, accessible and enjoyable. We gained invaluable knowledge and now feel extremely confident in our understanding, ready to handle any potential Pharmacovigilance tasks. Highly recommend this course to anyone looking to deepen their expertise!” Read about the course and book here: https://lnkd.in/dBsQainn   #medicinesafety #regulatoryaffairs #complementarymedicines #TGA #dietarysupplements #nutraceuticals #specifications #sunscreens #suppliers #GMP #training #pharmacovigilance

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Good News for FSP Aspirants Update on FSP Eligibility Criteria Changes In response to feedback regarding the recently announced eligibility changes, the RACGP has decided to pause the implementation of the new criteria for the 2025.2 intake. This decision allows for further consultation and review to ensure the best outcomes for all stakeholders. An updated application handbook will be published shortly.

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ACADI and Diabetes Australia launch the Australian Diabetes Clinical Trial Network! ACADI and Diabetes Australia have joined forces to announce the Australian Diabetes Clinical Trial Network (ADCTN), a research initiative designed to increase the number of diabetes clinical trials in Australia. Speaking at the launch in Brisbane this weeek, ACADI Director Professor Elif Ekinci emphasised the importance of Clinical Trials. “Clinical trials are essential to inform new ways to prevent, detect, or treat diabetes,” Professor Ekinci said. “By advancing our understanding of how different treatments work and evaluating their impact, clinical trials play a crucial role in improving the care of people living with diabetes. Their results contribute to the development of more effective, safer healthcare options and help inform evidence-based practices in medicine.” The ADCTN will be a facilitatory trials network, meaning it will assist researchers in the development of their clinical trial protocols. It will also join many other clinical trial networks as a member of Australian Clinical Trials Alliance to promote better health through best evidence. Diabetes Australia Group CEO Justine Cain said clinical trials are a cornerstone of medical research and innovation because of their real-world application. “Clinical trials ensure that new treatments deliver real benefits to people, while also identifying any potential risks or side effects. Our new network will increase the number of diabetes clinical trials being conducted in Australia. This will make a huge difference in the lives of people living with diabetes because it means new and innovative treatments and interventions can be tested and hopefully become available.” The ADCTN is an important milestone for ACADI as part of its funding from the Australian Government's TTRA program - powered by MTPConnect. It will start to review new trials in the coming months. To keep informed about the ADCTN sign up to the mailing list: https://lnkd.in/gJCcEp38

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We are pleased to share that results from our Phase 1 pharmacokinetic, pharmacodynamic and bioavailability study of S-pindolol benzoate in healthy volunteers have been published in The Journal of Cachexia, Sarcopenia and Muscle. The study met all pre-defined objectives and is a key clinical milestone supporting the further clinical development of S-pindolol benzoate.   Read the full announcement: https://lnkd.in/ea4RvBEU   Access the publication: https://lnkd.in/e_HefvM8

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