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Health

Xtalks Announces its Life Science Webinar Calendar for September 2024

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Upcoming free, educational webinars from Xtalks will feature topics on biomarkers, cell and gene therapy, clinical trials, commercialization & HEOR, drug discovery & development, drug safety, healthcare, laboratory technology, medical device, pharma manufacturing & supply chain and pharmaceutical regulation.

TORONTO, Sept. 1, 2024 /PRNewswire-PRWeb/ — Stay on top of current hot topics through free webinars presented by leading experts in the pharma, biotech and medical device industries. Access to all webinars is free, so be sure to register today to save your place! Participate in the discussion and stay relevant in your field!

Visit http://www.xtalks.com to see our upcoming webinars:

BIOMARKERS
September 4 – A New Paradigm in the Detection of Amyloid Pathology: The Emergence of Highly Accurate Blood Tests
September 16 – Advancing Oncology Care: The Evolving Role of Diagnostic Labs in Biomarker-Driven Therapies

CELL AND GENE THERAPY
September 17 – Next-Generation CAR-T Therapies: Optimizing Opportunities and Operationalizing Patient-Centric Oncology Clinical Trials
September 18 – Spatial Visualization of Capsid-Dependent Viral Tropism using RNAscope ISH Technology

CLINICAL TRIALS
September 5 – Advancing Precision Oncology: Radionuclide Conjugate and Antibody-Drug Conjugate (ADC) Development Strategies
September 6 – Sarcopenia: Changes and Challenges in Body Composition with GLP-1 Receptor Agonist-based Weight Loss Therapies
September 9 – Strategic Advantages of Early-Phase Oncology Clinical Development Across Australia and the USA
September 9 – Why Authenticity and Patient Voice Are Critical When Driving Clinical Trial Diversity
September 11 – Beyond Numbers: The Value of In-Trial Interview Data for Regulatory and Health Technology Assessment (HTA) Decision-Making
September 11 – Clinical Data Analysis: Avoiding Obstacles to Success
September 12 – How Artificial Intelligence is Transforming Clinical Development
September 13 – Streamlining Clinical Trial Imaging Workflows: From Collection to Completion
September 16 – Shifting Ophthalmology Retina Market: Proactive Planning for Late-Stage Clinical Success
September 17 – Accelerating Clinical Product Development through Centralized Content Work Streams
September 17 – Advancing MS Clinical Trials: Integrating Medical Imaging, Precision Motion Analysis, and eCOA Data for Enhanced Outcomes
September 19 – Patient First: Enhancing Strategies for Effective Patient Engagement, Recruitment and Diversity in Clinical Trials
September 24 – Community-Based Research Series: Engaging New-to-Research Physicians within Community Healthcare
September 26 – Bridging the Gap: Direct-to-Patient Strategies to Support Diversity in Clinical Trials
September 30 – From Extra to Essential: Scaling Mobile Apps for Future-Proofed Patient Engagement and Universal Sponsor Adoption

COMMERCIALIZATION & HEOR
September 5 – Driving Commercial Success for Precision Medicine: Understand the Market to Maximize Patient Identification and Therapy Adoption

DRUG DISCOVERY & DEVELOPMENT
September 4 – The Power of DNA Mutant Libraries: Accelerating Revolution in Research
September 9 – Enabling Clinical Programs Through Antibody Glycosylation
September 10 – Mastering the Art of Developing a Successful Bispecific Antibody
September 18 – Accelerating Neurodegenerative Clinical Drug Development with AI
September 19 – New Era of Obesity Drug Development
September 23 – Advancing Epilepsy Research: New Strategies for Drug-Resistant Epilepsy and Associated Comorbidities
September 27 – Global R&D Insights in Drug Development: Insights from Industry on the Future of Pharma

DRUG SAFETY
September 12 – Mastering RMPs and RMMs: Tech-driven solutions for patient safety

HEALTHCARE
September 20 – Digital Health Tools That Will Transform Cancer Treatment

LABORATORY TECHNOLOGY
September 13 – Criticality of STAT Osmolality Testing: Identifying Toxic Alcohol Ingestion
September 16 – Enhancing NGS Sample Preparation from Sample to the Sequencer
September 30 – Exploring the Range of Electron Microscopes: Resolution, Size and Users

MEDICAL DEVICE
September 12 – Changes are Coming to Prefilled Injectable Drug Delivery Systems
September 25 – Key Pathology Considerations for Successful Preclinical Medical Device Studies, from Protocol to Report
September 30 – Creating Software as a Medical Device (SaMD) Technology in the Ever Changing Regulatory Environment

PHARMA MANUFACTURING & SUPPLY CHAIN
September 4 – Considerations for Oligonucleotide Therapeutics in CMC
September 11 – Advanced AAV Processing and Potency through Characterisation of Capsid and Payload Heterogeneity
September 26 – Quality by Design in mRNA Manufacturing

PHARMACEUTICAL REGULATION
September 10 – Regulatory Submission Writing for NDA Success
September 20 – Medicare Part D Price Negotiation Update
September 24 – Compliance Risk in Technology: How Can IT and Quality Teams Root it Out
September 24 – The Journey to Approval: Navigating the Road from EoP2 to NDA Submission
September 25 – The New Era of Project Optimus: Implications for Oncology Development Strategy

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit https://www.xtalks.com/

Media Contact

Ayesha Rashid, Xtalks, +1 (416) 977-6555 x272, [email protected], https://www.xtalks.com/

SOURCE Xtalks

Health: Addiction

Segal Trials and Cook MyoSite Achieve Groundbreaking Milestone with Nation’s First Injection of Iltamiocel in Women Suffering from Chronic Fecal Incontinence

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Segal Trials and Cook MyoSite Achieve Groundbreaking Milestone with Nation’s First Injection of Iltamiocel in Women Suffering from Chronic Fecal Incontinence in the DigniFI Study

NORTH MIAMI, Fla., Aug. 31, 2024 /PRNewswire-PRWeb/ — Segal Trials is proud to announce the completion of the first injection procedure in the DigniFI Study. The Women’s Health Team, under the leadership of Principal Investigator Steven Chavoustie, M.D., FACOG and Sub-Investigator Brittany Berre MSN, ARNP, FNP-C, worked diligently to prepare for this vital women’s health study. The study’s first injection procedure was performed on August 19, 2024.. Segal Trials also completed the first muscle tissue procurement procedure for the study on March 21, 2024.

Chronic fecal incontinence from an obstetrical injury (e.g., episiotomy, perineal tear) can affect up to 1 in 10 women over their lifetime1. This innovative and new potential treatment option may provide relief from this life-altering condition and improve quality of life, if successful.

“On behalf of Cook MyoSite, we are very excited to announce the first participant treated as part of the DigniFI Study,” said Ron Jankowski, Vice President, Regulatory and Scientific Affairs at Cook MyoSite. “We continue our dedicated efforts toward researching and advancing personalized cell therapy treatments for underserved and serious quality of life conditions which, unfortunately, are all-too common in the realm of women’s health. Today marks an important milestone in advancing potential treatment options for women experiencing chronic fecal incontinence symptoms, an understated and serious condition with unmet medical need.”

“This milestone is a testament to the incredible teamwork and dedication of our staff,” said Dr. Steven Chavoustie, the principal investigator for this study at Segal Trials. “We are thrilled to have been at the forefront of such a significant advancement in women’s health. The successful completion of this procedure opens new doors for the future of muscle repair therapies, and we are excited to continue our collaboration with Cook Myosite in advancing clinical research.”For more information about participation in the DigniFI study or other clinical research initiatives at Segal Trials, please contact 305-722-8444 or [email protected], or visit https://dignifistudy.com/.

About Segal Trials:

Segal Trials, founded in 1998, is a privately held network of research sites throughout South Florida conducting Phase I-IV research trials that have led to 56 FDA-approved medications and devices. The company’s trials focus on psychiatry, neurology, addiction, insomnia, infectious diseases, and women’s health in outpatient and inpatient settings. 

About Cook MyoSite:

In 2002, Cook MyoSite, Incorporated was formed to guide the Cook Group organization into the expanding world of cellular technologies. Today, Cook MyoSite is dedicated to the development and subsequent commercialization of technology related to the collection, selection, and expansion of human skeletal muscle cells for the treatment of various disorders. Learn more at www.cookmyosite.com and www.cookgroup.com.

About Iltamiocel

Iltamiocel is a personalized, regenerative cell therapy product being investigated by Cook MyoSite, Inc. Iltamiocel is created from a patient’s own muscle cells and are theorized to engraft into existing dysfunctional or weakened target tissue to improve muscle function. To date, more than 700 participants have contributed to the iltamiocel clinical program. For more information on the iltamiocel clinical program, visit www.ClinicalTrials.gov.

About the DigniFI Study

The DigniFI Study is an FDA-regulated clinical trial evaluating the safety and efficacy of an investigational cell therapy product created from a woman’s own muscle cells in treating chronic fecal incontinence in women with a history of obstetric anal sphincter injury, such as an episiotomy or perineal tear. Learn more at https://dignifistudy.com

1. Whitehead WE, Borrud L, Goode PS, Meikle S, Mueller ER, Tuteja A, et al. Fecal

incontinence in US adults: epidemiology and risk factors. Gastroenterology. 2009;137(2):512-7,

7 e1-2. doi: 10.1053/j.gastro.2009.04.054. PubMed PMID: 19410574; PubMed Central PMCID:

PMCPMC2748224.

2. SOLACE Foundation. (n.d.). https://www.solaceforwomen.org/support

Media Contact

Segal Trials, Segal Trials, 1 8777342588, [email protected], segaltrials.com

SOURCE Segal Trials

Health

Viscera-3® for Comprehensive Gut Health This Labor Day–Available on Amazon!

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