Drug Discovery World

FEBRUARY 12, 2024

In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. We’re already seeing biotechs making breakthroughs with AI in this area, with more than 150 small molecule drugs discovered and 15 already in clinical trials.

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Drug Discovery World

MAY 17, 2024

Deepika Khedekar , Associate Centralized Clinical Trial Lead at IQVIA Inc, looks at the challenges of utilising artificial intelligence (AI) in oncology clinical research. MIT research 4 tells us a hard truth: about 95% of these trials fall short, leaving behind a trail of broken hopes for cancer patients each year.

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Drug Discovery World

NOVEMBER 8, 2023

Deepika Khedekar , Associate Centralized Clinical Lead at IQVIA, explains how artificial intelligence could make clinical trials more accurate, accessible and standardised. Tapping into the capabilities of AI One reason AI may accelerate clinical trials is its ability to rapidly process and analyse vast amounts of data.

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Clinical Trials Clinical Trials Trials Drugs 72

pharmaphorum

JANUARY 6, 2023

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.

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Clinical Trials Clinical Trials Trials Vaccination 107

pharmaphorum

FEBRUARY 11, 2022

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.

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XTalks

APRIL 24, 2023

Rare disease clinical trials are complex due to the additional scientific, medical, operational and regulatory requirements of newly emerging advanced therapies, such as gene therapy,” says Dr. Terence Eagleton, MB BS, Senior Medical Director at the global clinical research organization (CRO) Medpace. Reference: Chung DC, et al.

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Cloudbyz

APRIL 4, 2023

Clinical trials are crucial in bringing new treatments and therapies to patients. However, traditional clinical trial processes are often time-consuming, costly, and inefficient. DCTPs are designed to be user-friendly and accessible to anyone involved in the clinical trials process, including researchers, patients, and regulators.

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Clinical Trials Clinical Trials Trials Genome 52

XTalks

JANUARY 17, 2024

To gain insights into how clinical trials for lupus can be enhanced with RWD sources, we spoke with Frederico Calado, VP of Global Real-World Solutions at Alira Health , and Dr. Kaleb Michaud, Professor, Division of Rheumatology, University of Nebraska Medical Center. Kaleb Michaud: In developing lupus solutions, RWD plays a crucial role.

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Clinical Trials Clinical Trials Trials Life Science 52

XTalks

NOVEMBER 7, 2022

These tumor-derived entities are used to derive genomic and proteomic data. Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials.

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Clinical Trials Clinical Trials Trials FDA Approval 98

pharmaphorum

JANUARY 29, 2021

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.

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pharmaphorum

MARCH 10, 2021

bluebird bio is to ask regulators to restart clinical studies of its LentiGlobin for sickle cell disease, after an investigation concluded that a case of acute myeloid leukaemia (AML) was “very unlikely” to be caused by the gene therapy. The post bluebird seeks gene therapy trial restart after cancer scare appeared first on.

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XTalks

NOVEMBER 19, 2021

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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Drug Discovery World

MARCH 6, 2024

Guiding neurological drug discovery and development to success The 20 years since the Human Genome Project has seen transformational advances in the molecular understanding of cancers and rare genetic diseases, leading to genetically informed, personalised selection of therapies and massively improved outcomes for many patients.

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Drug Discovery World

DECEMBER 15, 2022

Now, after nearly 35 years of research and more than a decade of preclinical progress, several different gene editing modalities are being tested in early phase clinical trials. Early phase clinical trials for gene editing therapies. Gene editing challenges and potential solutions. Expand representation across global populations.

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Gene Editing Gene In-Vivo Genome 52

Drug Discovery World

JANUARY 26, 2023

The modernisation of R&D models could be key to reducing spend on new drugs, a point that Deloitte makes about the need to transform the clinical trials process. At the height of the pandemic, DCTs were seen as a viable alternative to keeping the engines running on clinical trials when non-critical in-person care was paused.

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pharmaphorum

DECEMBER 20, 2022

Genomic profiling has made it possible to diagnose and treat patients with far greater precision. Often, the initial focus is on participating in the data revolution by expanding genomic sequencing capacity, implementing electronic health records (EHRs), and so on.

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Cloudbyz

AUGUST 9, 2023

As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. Unified Data Management Clinical trials generate vast amounts of data, from patient records to lab results and monitoring findings.

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Clinical Research Research Clinical Trials Clinical Trials 52

pharmaphorum

DECEMBER 21, 2021

In a recent webinar held by pharmaphorum, in partnership with IQVIA, a discussion was held looking at how to make academic and commercial medical research more efficient, while also looking at the opportunity of genomic data to bring benefits to patients and healthcare systems. The potential to leverage genomic data.

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Drug Discovery World

JULY 12, 2023

Clinical trials for these conditions can present inherent challenges such as a small patient pool, and can be further restricted by rigid inclusion or exclusion criteria. This is a tpar with an often incomplete understanding of the disease and its natural history to inform a trial’s end-point 2. Pizzamiglio C, et al.

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XTalks

SEPTEMBER 9, 2021

The federal regulator suspended BioMarin’s currently ongoing Phase I/II studies of the gene therapy based on interim safety findings from a preclinical study which revealed that mice treated with the therapy at high doses developed tumors on their liver. The preclinical study was being conducted to assess the durability of the treatment.

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pharmaphorum

DECEMBER 8, 2022

The advent of biologic therapies in the 1970s along with the decoding of the human genome in 2003 heralded an explosion in pharmaceutical innovation. This has led to an increase in products coming to market with single‑arm Phase 3 data and surrogate endpoints or Phase 2b data, with planned confirmatory data to be released in the future.

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Big Data Gene Therapy Medicine Marketing 70

Advarra

NOVEMBER 10, 2022

The proposal “Protection of Human Subjects and Institutional Review Boards” would revise 21 CFR Part 50 and harmonize the FDA regulations to match the 2018 revised Common Rule across several inconsistent areas, including informed consent and continuing review. . Again, this is similar to what HHS regulations currently permit. .

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XTalks

FEBRUARY 27, 2024

Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial. These regulations offer benefits such as tax credits, grant funding and extended market exclusivity for approved drugs. These approaches help ensure that trials address the needs and concerns of the rare disease community.

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The Pharma Data

MAY 17, 2021

Regeneron resumes enrollment in lymphoma drug trials ( Reuters ). Incyte’s vitiligo treatment meets main goal in late-stage trial ( Reuters ). At Illumina, the ‘era of the genome’ has arrived. Indian makers of Sputnik V may seek waiver for local Phase-3 trials ( Economic Times ).

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Drug Discovery World

MARCH 26, 2024

More importantly, it also highlighted that significant challenges remain in selecting the right therapies for the right patients despite the progress made through genomic testing and implementation of circulating tumour (ct) DNA analyses. Results of that Phase I trial are expected to be presented later this year.

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The Pharma Data

JANUARY 10, 2021

SH ) submitted its pivotal phase III clinical trial application (IND) of national class I innovative drug Chiauranib to NMPA, for the treatment of Small Cell Lung Cancer (SCLC) as a single agent for the patients after 2nd-line systemic chemotherapy and recurrence afterwards. SHENZHEN, China , Jan.

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Clinical Trials Clinical Trials Drugs Trials 52

The Pharma Data

DECEMBER 9, 2020

Hepion will also conduct Fibroscans and examine a multitude of candidate biomarkers of NASH resolution and CRV431 efficacy including Pro-C3, Enhanced Liver Fibrosis (ELF) markers, collagens, matrix metalloproteinases, transcriptomics, liver transaminases, and full-scale lipidomic and genomic signatures.

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Clinical Trials Clinical Trials Trials Genome 40

Drug Discovery World

MAY 6, 2024

billion on R&D during 2021, with Germany and Switzerland being the biggest contributors, and around one fourth of clinical trials worldwide were performed in Europe 1. The city is host to many innovative biotech companies, including relative newcomers Orexa, a company that recently launched its first Phase II clinical trial.

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Drug Discovery World

JULY 18, 2023

Rolf Turk , Senior Manager, Genomics Medicine at Integrated DNA Technologies, examines how CRISPR is being used to enhance cancer therapies. These methods offer safer CAR T-based therapies, laying the foundation for clinical trials and the rapid development of a new generation of CAR T cells for both autologous and allogeneic use.

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Drug Discovery World

SEPTEMBER 26, 2022

Indeed, having a safety profile already established could entice patients to enter clinical trials more readily than with ‘unknown’ compounds. . Panna Sharma is the President and CEO of Lantern Pharma, a company utilising artificial intelligence (AI), machine learning and genomics to advance the timeline of drug discovery and development.

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Drug Discovery World

FEBRUARY 6, 2024

As AI-designed drugs start to enter large-scale clinical trials, DDW’s Diana Spencer investigates how new digital tools are reinventing and reshaping drug discovery for the future. Automation is also being applied to genomics sample preparation, an area that requires particular robustness and scalability.

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Marketing Medicine Genome Genomics 69

pharmaphorum

APRIL 14, 2021

A coalition of European academy networks has called upon European Union (EU) leaders to rethink how General Data Protection Regulation (GDPR) rules are applied to health data. The authors said there was a “statutory conflict between EU fundamental rights and other countries’ regulation”. Multiple and complex mechanisms.

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Drug Discovery World

NOVEMBER 23, 2023

Artificial Intelligence (AI) has become a popular buzzword in the drug discovery and development lexicon but not all approaches to AI-driven drug discovery produce meaningful insights that translate into real compounds which ultimately demonstrate clinical efficacy in human trials. In other words, garbage in, garbage out.

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Camargo

NOVEMBER 11, 2020

Labeling regulations prohibit reminder ads for products with boxed warnings, which the FDA requires when a drug product has very serious risks. The generic drug must also have the same labeling as the RLD (except for differences permitted under the Agency regulations). for patients with NTRK fusion cancer across all solid tumors.

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The Pharma Data

DECEMBER 28, 2020

The AMBITION trial is the first placebo-controlled study of CRV431 in NASH patients with evidence of moderate-to-severe fibrosis. The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. To date, there are no approved drugs to treat NASH.

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Clinical Trials Clinical Trials Trials Development 40

pharmaphorum

JANUARY 4, 2023

The proposed EHDS Regulation 1 ( Proposal ), introduced in May 2022 by the European Commission (EC), aims to reform the “situation of fragmentation” that depicts the existing approach to health data access across Europe 2 through the establishment of a centralised data system. European Health Data Space: Regulation 2022/0140.

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The Pharma Data

SEPTEMBER 7, 2020

The decision was made under accelerated approval, marking Genentech’s sixth approval from the US regulator within lung cancer. While the approval has been awarded, the FDA warned that continued approval may be dependent on Genentech reinforcing these positive data with a future confirmatory clinical trial. Matt Fellows. Source link.

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