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As clinicaltrials become increasingly complex, particularly in decentralized trials and rare disease studies, sponsors experience increased challenges in site selection, forecasting and resourcing, and patient recruitment and enrollment. Discover how AI is used to optimize key aspects of clinicaltrial management.
In every early phase clinicaltrial, the transportation, chain of custody, environmental monitoring and subsequent analysis of biological samples are the cornerstones of a successful, robust and quality outcome. Within cell therapy clinicaltrials, apheresis collections contribute to the specific constituents of the given therapy.
Discovered by Daiichi Sankyo, I-DXd is being co-developed with Merck (known as MSD outside of North America) as part of a broader strategic collaboration between the two companies. Addressing a Pressing Clinical Need in Prostate Cancer Prostate cancer remains one of the most prevalent malignancies among men worldwide.
Jayaprakash Kotha, MBBS, PhD, ASCP (SH), Vice President, Bioanalytical Laboratory Satish Kumar, MBB, Head of Process Improvement Continuous Innovation is a Cornerstone of Bioanalysis Approximately 80% of drugs that begin the research process fail to reach approval. What is one contributing factor that sets the 20% that do apart from the rest?
It involves a dynamic and often unpredictable process where every stage, from target identification to clinicaltrials, generates vast amounts of data. Additionally, AI-driven predictive modelling can shorten the preclinical phase by simulating biological responses, leading to more targeted and efficient clinicaltrials.
When it comes to clinicaldevelopment, precision, compliance, and quality assurance are paramount. For clinicaldevelopment organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.
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.
December 1, 2023 — Precision for Medicine, the first global biomarker-driven clinical research organization, is the recipient of a new accreditation from The College of American Pathologists (CAP) for its tissue and histopathology laboratory in Winston-Salem, North Carolina. Winston-Salem, Nc.,
By: Sarah Bly and Aman Khera, Regulatory Science and Innovation The journey of bringing a new therapeutic agent from the laboratory to the marketplace is fraught with challenges, not least of which is navigating the complexities of regulatory feedback, which do not always converge but can diverge.
The treatment is being researched by scientists collaborating from American Gene Technologies, the Laboratory of Immunoregulation and the National Institute of Allergy and Infectious Diseases. The Phase 1 trial is expected to be conducted at sites in Baltimore, Maryland and Washington, DC.
Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinicaltrial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. That is, how many clinicaltrials are actually managed by these organizations?
We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir in both outpatient and hospital settings and plan to provide updates when appropriate,” said Dr. Roy Baynes, senior vice president and head of global clinicaldevelopment, chief medical officer, Merck Research Laboratories.
By aligning their research priorities, Bayer and Tsinghua are aiming to bridge the gap between academic research and industrial development. The goal is to transform laboratory discoveries into clinically relevant therapies that can reach patients faster and more efficiently.
The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinicaltrials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinicaltrials to combat Covid-19.
Drugs developed under the Fast Track program are afforded increased access to FDA staff and may qualify for other programs to further expedite their clinicaldevelopment, such as priority review and accelerated approval. Brilacidin antiviral research to date has been limited to laboratory-based experiments.
Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinicaldevelopment arena. billion and $86.01
Food and Drug Administration (FDA) within 30 days, providing a structured timeline for progressing with clinicaltrials. Early engagement with the FDA can help set expectations for future regulatory steps and ensure that non-clinical and clinicaltrial data meet global regulatory requirements.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinicaltrials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic.
The rest are in Phase I trials for ovarian cancer, AML, MDS, heart failure, HPV+ solid tumors and recurrent respiratory papillomatosis (RRP). Food and Drug Administration (FDA) gave the go-ahead for the company to initiate a Phase I trial of PRGN-2012 in adults with recurrent RRP. On January 5, 2021, the U.S. Most Read Today.
and Canada, announced along with Eisai today that it has new investigational data demonstrating positive top-line results from the Phase III KEYNOTE-581/CLEAR trial (Study 307). The trial looked at a combination of Keytruda from Merck and Lenvima from Eisai for the treatment of advanced renal cell carcinoma (RCC).
TC-210 is currently in a Phase I/II trial for mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. TC-110 is in a Phase I/II trial for CD19-positive adult acute lymphoblastic leukemia (aALL) and with aggressive or indolent non-Hodgkin lymphoma (NHL).
Continued approval was contingent upon verification and description of clinical benefit in confirmatory trials. This indication was approved under accelerated approval based on tumor response rate and duration of response.
Results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials show that response rates for deucravacitinib continued to extend through Week 24 and were maintained through Week 52 in patients with moderate to severe plaque psoriasis. CESTidentified through 52 weeks of knowledge.
These body-on-a-chip (BOC) devices place each tissue type in its own pea-sized chamber and connect them via fluid-filled microchannels into living, integrated biological systems on a laboratory plate. 2] Clinicaldevelopment success rates for investigational drugs. Sci Transl Med. 2019 Jun 19;11(497). [2] Nat Biotechnol.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinicaldevelopment program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. Late Breaking Oral Presentation OALC01LB03. Abstract 2361. Hillier et al.
This approval was based on an exploratory subgroup analysis of the Phase 3 PROpel trial which showed that LYNPARZAplus abi/pred demonstrated clinically meaningful improvements in both radiographic progression-free survival (rPFS) (HR=0.24 [95% CI, 0.12-0.45]) These approvals were based on the data from the Phase 3 PROfound trial.
Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4
Prior to joining Labcorp, she held multiple appointments with The Children’s Hospital of Philadelphia, including Patient Safety Officer, chief of the Division of Transfusion Medicine and Vice-Chief of Pathology and Laboratory Medicine. Abbott Laboratories and TAP Pharmaceuticals. a company previously known as miRagen Therapeutics.
The publication includes safety and efficacy data for 323 relapsed or refractory patients (including 170 with CLL/SLL, 61 with MCL, 26 with Waldenström’s macroglobulinemia and 66 with other B-cell lymphomas) that were enrolled to the BRUIN Phase 1/2 trial as of September 27, 2020. About the BRUIN Phase 1/2 Trial.
The CTS Rotea system is the first Gibco instrument for cell therapy processing applications and facilitates workflows from research through GMP clinicaldevelopment and commercial manufacturing.
A new protein-based antiviral nasal spray developed by researchers at Northwestern University, University of Washington and Washington University at St. Louis is being advanced toward Phase I human clinicaltrials to treat COVID-19. coli, making them more cost-effective to manufacture.
Moreover, ethical considerations regarding the use of laboratory animals further complicate the use of primate polyclonal serum, and successful immunisation is not always guaranteed. FDA no longer needs to require animal tests before human drug trials [Internet]. 1975 Aug;256(5517):495–7. Crescioli S, Kaplon H, Chenoweth A, et al.
In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinicaldevelopment. Risk-Based Training Clinicaltrials are complex, so one-size-fits-all training may not always fit the bill.
The CRO Leadership Awards recognize top CRO partners, determined by feedback from sponsor companies who outsource clinicaltrials. Precision applies novel biomarker approaches to clinical research that integrate clinicaltrial design and execution with deep scientific knowledge, laboratory expertise, and advanced data sciences.
Approval based on data from the largest trial to date in patients with advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor Libtayo now approved by the European Commission for three advanced cancers. Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. “We
of Bioengineering, University of Wisconsin-Madison A lot of time, money, and effort are devoted to developing new drugs. Yet only one of every 10 drug candidates entering human clinicaltrials successfully goes on to receive approval from the Food and Drug Administration (FDA) [1]. Nat Biotechnol. 2014 Jan;32(1):40-51. [2]
While the pilot has been in development for a while, the move comes as the FDA is looking towards a broader shift in its approach to LDTs. Further, footnote 7 in the document explains: “Examples of such clinicallaboratory tests are commonly used and well understood biochemical assays (e.g.,
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Precision applies novel biomarker approaches to clinical research that integrate clinicaltrial design and execution with deep scientific knowledge, laboratory expertise and advanced data sciences. This convergence of trials, labs and data sciences is driving faster clinicaldevelopment and approval.
30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified.
1] It is being developed by Mirati Therapeutics. [1] 1] It is being developed by Mirati Therapeutics. [1] Identification of the ClinicalDevelopment Candidate MRTX849, a Covalent KRASG12C Inhibitor for the Treatment of Cancer.” 2] Research It is undergoing clinicaltrials. [5] 1] It is taken by mouth. [1]
Senior Vice President, Early ClinicalDevelopment, Hematology/ Oncology and Cell Therapy and San Francisco point head. “ LabCentral offers completely permitted laboratory and office space for as numerous as 70 startups comprising roughly 500 scientists and entrepreneurs. AboutBioLabs@NYULangone( New York, NY).
” In the Phase 1/2 LIBRETTO-001 trial, 32 adult patients with 12 unique RET fusion-positive advanced cancer types were enrolled by the efficacy cutoff date of September 19, 2020 (with follow-up through March 19, 2021). Retevmo was approved based on the Phase 1/2 LIBRETTO-001 trial’s endpoints of ORR and DoR.
NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.
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