TRIO-US, Inc.

?? The US Food and Drug Administration (FDA) has released a new draft guidance that offers recommendations for multiregional clinical trials (MRCTs) in oncology. The FDA encourages sponsors to ensure that trial results in global oncology clinical development programs that support a marketing application are understandable to US patients. In the draft guidance, FDA noted that the “paramount consideration” when assessing oncology MRCTs is applicability to the US population for the product’s intended use and for standard of care in oncology in the US. As an organization conducting multiple MRCTs, it is critical for TRIO to be aligned with the regulator′s expectations and we are constantly reviewing new guidances and regulations to ensure full compliance with them. More information here: https://lnkd.in/gF8zteXD

???? UCD Ulysses Medal for US oncologist Dr Dennis Slamon who developed breast cancer drug Herceptin ?? An American oncologist credited with saving the lives of hundreds of thousands of women worldwide by transforming the treatment of breast cancer, Dr Dennis Slamon has received the?UCD Ulysses Medal. In presenting Dr Slamon with the Ulysses Medal, UCD recognises that his pursuit of novel therapies for breast cancer for over 30 years has shaped the field of precision medicine and paved the way for other targeted therapies in oncology. “Dr Slamon is one of the most inspirational medical research scientists at work today,” said?UCD President Professor Orla Feely. “His pioneering research resulted in the groundbreaking development of the breast cancer drug Herceptin, which has proven to be a lifesaving therapy for women with HER2-positive breast cancer. “This therapy has saved the lives of hundreds of thousands of breast cancer patients worldwide, including an estimated 1,000 women in Ireland,” added President Feely. “Each and every day, several thousand women around the world begin potentially life-saving and life-prolonging treatments for breast cancer directly linked to Dr Slamon’s scientific discoveries - highlighting the incredible difference that scientific endeavour can make to our world. "Dr Slamon is a most worthy recipient of the UCD Ulysses Medal, the highest honour that University College Dublin can bestow.” The breast cancer drug Herceptin, developed from the work of Dr Salmon, is the first gene-based drug approved by the US Food and Drug Administration to fight cancer. It is now a cornerstone in the treatment of HER2-positive breast cancer. In spearheading its lengthy development, Dr Slamon forged a close relationship with Professor John Crown, a Consultant Medical Oncologist at St Vincent's Hospital in Dublin, who encouraged Ireland's participation in the early Herceptin trials. Since then, hundreds of Irish women have taken part in clinical breast cancer trials led by Slamon and the All-Ireland Cooperative Oncology Research group. Professor Crown, who delivered the citation at the award ceremony, said Dr. Slamon’s “contribution to cancer research is unparalleled.” Dr Slamon serves as director of the Revlon/UCLA Women's Cancer Research Program at the UCLA Jonsson Comprehensive Cancer Centre. He is also chief of the Division of Hematology/Oncology and executive vice chair for research for UCLA's Department of Medicine. A 1975 honours graduate of the University of Chicago's Pritzker School of Medicine, Dr Slamon has received nearly two dozen research awards, including the Lasker-DeBakey Clinical Medical Research Award and the Szent-Gy?rgyi Prize for Progress in Cancer Research. He also won the Sj?berg Prize from the The Royal Swedish Academy of Sciences and Sweden's Sj?berg Foundation, two awards that have historically been significantly predictive of subsequently winning the Nobel prize.

Today, the FDA approved a new drug regimen which helps reduce the risk of breast cancer recurrence for patients with early-stage disease. Adding ribociclib to the standard hormone therapy resulted in a relative reduction in the recurrence rate by as much as 25%. Led by UCLA’s Dennis Slamon, MD, “this is a new option we can now offer patients that can help further minimize their risk of cancer returning.” UCLA Health #breastcancer

TRIO is pleased to share the news that the US FDA, based on the results from the NATALEE (TRIO033) trial, has approved ribociclib in combination with an aromatase inhibitor to reduce the risk of recurrence in patients with HR+/HER2- stage II and III early breast cancer at high risk of recurrence, including those with node-negative disease. This approval broadens the population eligible for?targeted therapies to help reduce the risk of their cancer coming back. Thank you to the TRIO team for your engagement; you can be proud of this achievement. Thank you?to Novartis for this successful collaboration and for putting their?trust in TRIO to conduct this practice-changing trial. Thank you to our investigators and partners for your key contribution to making?this possible. Catherine Marle CEO TRIO

Dr. Peter Fasching gave a great update about the NATALEE study at #ESMO2024 yesterday and how the results are helping to change the treatment standards. We are looking forward to what is coming next how we can continue to help bring change for patients.

Have you visited the TRIO booth 444 at #ESMO2024? Stop by and say hello to our TRIO ambassador Ashpreet Singh in Hall 3.

TRIO is thrilled to be attending the ESMO 2024 Congress in Barcelona! We're looking forward to connecting with global leaders in oncology and sharing our latest advancements in cancer research. See the document below for details on presentations featuring TRIO data.

We are hiring a Clinical Research Associate to join the team at TRIO-US. Full-time position, home-based in the US, with 25% domestic travel. Ideal candidate has oncology, Phase I study, and research site work experience. Must be detail-oriented, organized, and an effective communicator. Do you know someone who fits the bill?

We're #hiring a new Clinical Research Coordinator in Las Vegas, Nevada. Apply today or share this post with your network.

?? Regulatory Update: Expanding Cancer Clinical Trial Eligibility ? The FDA has released three draft guides aimed at increasing diversity and participation in oncology clinical trials by broadening eligibility criteria. These new guidelines focus on laboratory values, washout periods and concomitant medications, and patient performance status. This initiative is part of a broader effort to ensure that clinical trials are more inclusive and reflective of the diverse patient populations affected by cancer. ? Key Highlights: ? ??Laboratory Values: Customizing criteria to match the investigational drug, ensuring unnecessary exclusions are avoided. ??Washout Periods and Concomitant Medications: Justifying time-based washout periods and allowing more patients, especially older ones on multiple medications, to participate. ??Performance Status: Expanding eligibility to include lower-performing patients, enhancing trial diversity and the relevance of results. ? For more details on these important updates, read the original article: https://lnkd.in/ei3MZpzY ? #CancerResearch #ClinicalTrials #FDA #OncologyInnovation