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The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and selected pharma and medical device companies have launched the European Coalition for Access to Comprehensive Genomic Profiling (ECGP), to promote the routine use of comprehensive genomic profiling.
Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment. One diagnostic example that I discussed in my presentation is autism.
As antimicrobial resistance (AMR) poses a growing threat to global public health, challenging the effectiveness of antibiotics and other antimicrobial drugs, medical experts suggest whole genome sequencing as a viable option to identify and characterize the bacteria, viruses, fungi or parasites, along with their transmission pattern.
Here he gives us a deeper look at how genomic medicine is evolving and the barriers that are preventing it from reaching its full potential. I saw this, in particular, with the finishing of the human genome,” says Charlie. “At In reality, finishing the human genome was the first step of what is a long journey.”.
Recent funding rounds in the digital health arena feature digital pathology startup Aignostics, remote care specialists TCC, Yazen Health, and Nema Health, wearables developer Alimetry, and clinical trial automation startup Research Grid.Digital pathology specialist Aignostics, which develops artificial intelligence algorithms to glean information (..)
The application of whole genome sequencing (WGS) to derive a more complete understanding of cancer has been a central goal of cancer researchers even before the first human genome was decoded in 2003. Ultima Genomics has already partnered with other leading biotech startups.
The last few months have marked the publication of research emerging from projects designed to collect and analyse genomic data on a wider scale than was previously thought possible. The post Magazine: Genomic projects exploit scale as clinical applications play catch-up appeared first on Pharmaceutical Technology.
You have just received the results from your whole genome sequencing test, offered through your public health provider, and discovered that you have a 75% chance of developing a rare form of cancer. Alternatively, there are vaccines ready to enter decentralised third-phase clinical trials, so you can enrol quickly. It is the year 2030.
Around 8% of human DNA is made up of genetic sequences acquired from ancient viruses. These sequences, known as human endogenous retroviruses (or Hervs), date back hundreds of thousands to millions of years – with some even predating the emergence of Homo sapiens. Our latest research suggests that some ancient viral DNA sequences in the […]
Verge Genomics has joined a select group of biotechs who have taken a drug discovered and developed using artificial intelligence into human testing. The post Verge Genomics takes AI-sourced drug for ALS into clinic appeared first on.
At the recent World Orphan Drug Congresses (WODC) in Europe and the United States, Worldwide Clinical Trials Derek Ansel , Vice President, Therapeutic Strategy Lead, Rare Disease, facilitated roundtable discussions to explore the operational challenges and ethical barriers surrounding genetic testing.
David Del Bourgo (CEO and co-founder, Whitelab Genomics) has always been passionate about introducing disruptive, innovative technologies to markets. We founded Whitelab Genomics after realising the potential to use data, data science, and AI in a more systematic way to develop genomic therapies,” Del Bourgo says.
Alongside drugs and therapeutics, data collection and technology enhancements have redefined the traditional healthcare experience, especially within oncology, and genomic profiling has become a significant factor in allowing for personalised care. Tailored oncology. Navigating barriers to access.
Silently tucked away in our genomes, some of these bits of foreign DNA can get passed down through the generations. When viruses pay us a visit, they sometimes leave parts of themselves behind. They were long thought inactive, but we’ve since learned these stowaway sequences can be turned back on to wreak all sorts of […]
The UK regulator has authorised Eli Lilly’s targeted cancer drug Retsevmo for tumours with RET fusion positive lung cancers and thyroid cancers, which the company said could herald a new era of genomic medicine for the NHS. The post New era of genomic medicine begins as UK approves Lilly’s Retsevmo appeared first on.
A group representing pharma companies selling precision therapies for cancer has called for a change to the way genomic testing is done in Scotland, to make sure patients get access to targeted drugs. The post Genomic testing ‘should be offered to all cancer patients in Scotland’ appeared first on. Why not lead?”
Illumina, a DNA sequencing and array-based technology specialist, is supporting the Belgian Society of Medical Oncology (BSMO) in a pilot study examining the use of comprehensive genomic profiling (CGP) in 864 patients with advanced metastatic cancer.
Genetic testing provides patients with a diagnosis for their illness, helps patients and family members to understand risks of developing new diseases, and can be used to support clinical trial advancement. Can prior genetic testing results be utilized in a trial, or should a new genetic sample be taken before participating?
C2i Genomics plans to make sophisticated AI-informed cancer diagnostics and tumor monitoring available throughout the world, regardless of where patients or clinical trials are located.
Verge Genomics dosed its first patient in a Phase I trial studying VRG50635, while Stealth Bio's SBT-272 was granted Orphan Drug designation by the FDA.
NCI-MATCH precision medicine trial makes major contributions to the use of tumor gene testing to select treatment for patients; new data has broad relevance in medicine and provides a roadmap for future precision medicine trials Credit: ECOG-ACRIN Cancer Research Group Five years ago, the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and National Cancer (..)
As drug companies have embarked on an initiative to launch affordable medicines for rare diseases in India, experts have called for using pharmacogenetics to develop treatments and whole genome sequencing to identify etiologies.
Both the Pfizer and Moderna vaccines copied RNA sequence from the virus genome and found a way to manufacture it at scale with high-level processes and quality control. Another consideration is that while in traditional vaccine development, clinical trials are carried out in sequence. 1455NO-HEALTH-CORONAVIRUS_VACCINES_PFIZER_O_.
Repotrectinib, a tyrosine kinase inhibitor (TKI), is in an ongoing registrational Phase I/II trial (NCT03093116) for patients ROS1+ advanced non-small cell lung cancer (NSCLC) and NTRK+ advanced solid tumors, that are either TKI-naïve or TKI-pretreated. The ROS1 gene is altered in approximately in 1-2% of lung cancer patients.
When research and clinical care are deliberately integrated in an embedded pragmatic clinical trial, the nature and extent of investigators’ obligations to patient-subjects are blurred, as is the clinician’s duty to participate is such research. Wilfond, Sinem Toraman Turk, Stephanie A. Kraft, Elliott M. Weiss, Philip I.
Also companies like the healthtech startup HaystackAnalytics are engaged in developing India’s first Universal Infectious Disease (UID) genomic test, which highlights the need to put in place preventive health strategies. On the occasion of the […]
CAMP4 Therapeutics raised another $100 million in financing to advance its approach into the “dark side of the genome” and drive two therapeutics into clinical trials next year.
The drug regulator, in a drug alert issued, said that a batch of Typbar, manufactured by Bharat Biotech International Ltd in Genome Valley in Hyderabad, Telangana, failed […]
The two companies will work to advance precision cancer medicine by harnessing genomics data in trial design, recruitment, site selection and other areas.
The company is planning Phase III trials in bipolar disorder and Alzheimers. The company recently reported topline results from its Phase I/II trial of AURN001, an allogeneic cell therapy for corneal edema. The Phase I/II trial showed significant improvements in vision and corneal clarity. million in Q4 2024.
With COVID-19 forcing a shift towards decentralised trials, two digital health firms – Medable and Seqster – have teamed up to offer ways to also incorporate real-world data into remote study designs. . Patients want clinical trials to fit into their real-world experience, not the other way around,” according to Longmire.
The first ever clinical data with a CRISPR/Cas9 drug used to edit the genomes of cells within the body has yielded impressive results in patients with ATTR amyloidosis, a life-threatening rare disease. . Intellia and Regeneron’s phase 1 trial looked at patients who had nerve damage (polyneuropathy) as a result of the disease.
Bottom Line: Genomic sequencing of tumors from pediatric cancer patients experiencing a relapse enabled 107 patients to receive an appropriate matched therapy that is not the standard of care, according to data from the international clinical trial MAPPYACTS.
The cancer immunotherapies will mainly be provided in the context of clinical trials over the alliance, which extends out to 2030, but also covers supply of commercial therapies if approved in the interim. The post UK partners with BioNTech on clinical trials of mRNA cancer therapies appeared first on.
Data from the first patients enrolled into Regenxbio’s trial of its gene therapy for rare inherited disease mucopolysaccharidosis type I (MPS I) – also known as Hurler syndrome – has shown the first signs of clinical activity. The post Regenxbio expands MPS I gene therapy trial after first look at data appeared first on.
The Department of Health Abu Dhabi (DoH) has signed a memorandum of understanding with integrated healthcare company M42 and AbbVie Biopharmaceuticals to advance personalised medicine and genomics in the city. M42 was created through the combination of Mubadala Health and G42 Healthcare.
The rise in the use of decentralised clinical trial (DCTs) designs forced by COVID-19 looks set to outlast the pandemic, and digital health company Seqster has formed another partnership to tap into the shift from traditional site-based studies. The post UBC, Seqster join forces on patient-centric, remote trials appeared first on.
Among premenopausal women with hormone receptor (HR)-positive, early-stage breast cancer enrolled in the SOFT trial, those with a high score on a genomic assay called Breast Cancer Index (BCI) had increased risk of distant recurrence, and those with low BCI benefited more from the addition of ovarian suppression therapy to endocrine therapy after 12 (..)
Credit: Mary Ann Liebert, Inc., publishers New Rochelle, NY, January 19, 2021–Gene editing therapies, including CRISPR-Cas systems, offer the potential to correct mutations causing inherited retinal degenerations, a leading cause of blindness.
Pharma has a great opportunity ahead of it when it comes to conducting representative clinical trials. The processes used are now seeing huge infrastructure commitments, in order to cement their place in the development of future products and trials. But our drug development processes are not perfect.
When using genetic screening to identify clinical trial volunteers, a sponsor’s obligations for further testing and disclosure of results to patients and families are unclear, especially when the results have no impact on medical management. Guidance in this area is much needed. Read the full article!
Genome editing is an exciting but still nascent field, and companies in the area face as many obstacles as they do opportunities. ZFPs can be engineered to make zinc finger nucleases, or ZFNs, which are proteins that can be used to edit genomes by knocking select genes in or out to specifically modify DNA sequences.
Finch Therapeutics’s Phase III PRISM4 trial for recurrent Clostridioides difficile infection (CDI) and MaaT Pharma’s Phase III trial in steroid-resistant acute graft-versus-host disease were both put on hold. While the French MaaT Pharma has submitted further information to the FDA, its trial remains on hold. with placebo.
Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.
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