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The Indian lifesciences sector is making strides by integrating quantum computing, artificial intelligence (AI), machine learning (ML), advanced analytics, big data, internet of things (IoT) and blockchain into their research and development efforts.
As the Union Budget approaches, the lifesciences sector anticipates substantial support to enhance innovation and investment in the development of new chemical entities (NCEs) and new biological entities (NBEs). The lifesciences sector in India has shown remarkable resilience […]
This prestigious acknowledgment places Cloudbyz among the top-performing companies globally, known for delivering scalable and intuitive CTMS solutions that empower clinicalresearch teams. Our mission is to enable faster, more efficient trials, ultimately supporting the delivery of life-saving therapies.”
In this episode, Vera spoke with Morgan Hanger, Executive Director of the ClinicalTrials Transformation Initiative (CTTI). CTTI is a public-private partnership dedicated to improving the quality and efficiency of clinicaltrials, with an ambitious “Transforming Trials 2030” vision.
Despite advancements in neuroscience and psychiatry, clinicaltrials for mental health conditions such as major depressive disorder (MDD), schizophrenia, bipolar disorder and generalized anxiety disorder face unique challenges. One of the main challenges lies in defining and selecting appropriate trial populations.
Global rare disease clinicaltrials face unique challenges due to small patient populations, complex logistics, diverse regulatory environments and cultural differences. ClinicalTrial Manager/Sr. These measures enhance recruitment, retention and overall trial success.
BlueRock Therapeutics, a subsidiary of Bayer AG, is making waves in the treatment of Parkinsons disease by advancing its investigational cell therapy, bemdaneprocel, to a Phase III clinicaltrial. In the Phase I trial, 12 participants received the therapy and were observed for two years. As of 2023, there were approximately 2.7
This Act is poised to significantly change the clinicaltrials landscape within the lifesciences sector. As AI increasingly becomes a cornerstone in clinicalresearch and drug development, it is crucial for industry stakeholders to grasp the extensive implications of this regulation.
The surge in MASH cases stresses the need for early diagnosis, timely intervention and precise, reliable methodologies in clinicaltrials to evaluate new therapies effectively. Read on to gain insights from Medpace experts about advancements in imaging, histology and innovative techniques for MASH clinicaltrials.
The same is true in lifesciences. As the technology develops, however, it will offer more opportunities to expedite drug discovery processes, streamline clinicaltrials, and speed up regulatory approvals. MGI puts the value of this contribution to clinical development at $15 billion to $25 b illion.
Syros Pharmaceuticals announced that its cancer drug tamibarotene failed to meet its primary endpoint in the SELECT-MDS-1 Phase III trial. The placebo-controlled SELECT-MDS-1 trial involved 190 patients with complete response rate (CRR) being the study’s primary endpoint. percent and 18.8
Experts in the life-sciences industry are of the view that doing away with human studies for new drugs in India is unscientific and risky as patients here have different anthropometry.
Their discussion shows how meaningful partnerships, deep listening and unwavering patient-centricity can transform clinicalresearch, trial design and care delivery in rare conditions such as HPP. Early collaborations in clinicaltrial design enabled both teams to integrate critical patient insights into study protocols.
Following the success of Issue 3 , which focused on the critical importance of patient diversity in clinicalresearch, Xtalks is thrilled to announce Xtalks Clinical Edge Issue 4. These prominent leaders will share their experiences, strategies and visions about whats next for clinicalresearch.
In the trial, platelet response, defined as achieving at least 50,000 platelets per microliter or doubling baseline counts, was seen in 65 percent of patients on rilzabrutinib, compared to 33 percent on placebo. Participants received either rilzabrutinib or placebo for 24 weeks, followed by an open-label extension.
In the fast-evolving field of clinicalresearch, thought leaders do more than just keep up; they lead the charge and shape the direction of the industry. Heres how thought leaders are currently making an impact in clinicalresearch: 1.
In the dynamic world of lifesciences, where innovation is paramount, the integration of cutting-edge technologies is crucial for accelerating clinical operations and driving breakthroughs in healthcare. Salesforce’s recent announcement of its LifeSciences Cloud marks a significant stride towards this goal.
In clinicalresearch, diversity is more than a prerequisite for a successful drug — it’s a critical component that enhances the validity and applicability of clinicaltrial outcomes. Diversity Action Plans have now moved from being a “nice-to-have” to a “must-have” in clinicaltrial designs.
The clinicalresearch community has been disrupted in a number of ways due to COVID-19 and sparked a spirit of collaboration and innovation. Worldwide ClinicalTrial’s Aman Khera gives five predictions of how clinicalresearch could change in 2021. clinicaltrial diversity.
Clinicaltrials have been steadily leaving the UK for years. of patients recruited to global trials were from the UK. Thats not to say we dont still have some clout (the UK ranks fourth globally for Phase II trials ), but the trending outflow needs to be addressed. In 2021, just 2.2%
In the lifesciences, like many industries, working from home will likely remain more prevalent than it was pre-pandemic even after it’s safe for employees to return to the office. However, this trying year has highlighted the shortfalls the lifescience industry continues to struggle with.
Menarini Group has announced positive topline data from the Phase III BROADWAY and TANDEM clinicaltrials, evaluating obicetrapib and the fixed-dose combination of obicetrapib with ezetimibe. Meanwhile, the TANDEM trial evaluated a fixed-dose combination of obicetrapib with 10 mg ezetimibe in a similar patient population.
For example, during the height of the pandemic, NIHR’s integrated health research system was able to compare COVID-19 hospital caseloads to COVID-19 research activity in real time. This enabled rapid recruitment to multiple COVID-19 clinicaltrials throughout England/UK. . About the panellist’s.
In clinicalresearch, this includes designing trials that elevate the patient voice, reduce barriers to participation, and represent the diverse populations who will ultimately use these medical products. Access to information: Limited resources and educational materials hinder informed decision-making about trial participation.
Diversity, equity and inclusion (DEI) have become important elements in the landscape of clinicalresearch. Xtalks spoke with Stacy Weil, DHI, Senior Vice President, Business Operations and Patient Centricity, Premier Research, to gain insights into incorporating DEI practices and plans in clinicalresearch.
Pharmaceutical companies often struggle to actively involve patients in the design phase of clinicaltrials but doing so can have huge benefits for the sustainability and success of research. He works with patient groups and advocates globally, with academics and industry, and with researchers and clinicians.
Taking action to increase and diversify the clinicalresearch workforce is a high priority at Merck, known as MSD outside the U.S. Merck and the Association of ClinicalResearch Professionals (ACRP) are partnering on two pivotal new programs to grow and diversify the clinicalresearch workforce for sites.”.
Recruiting participants is perhaps the most challenging aspect of any clinicaltrial, regardless of the therapeutic area. Yet this one piece is also the most vital, with a trial’s ability to enroll and retain participants being a key predictor of a study’s future success. What is ClinicalTrials For All?
Changes taking place in the United States and internationally may affect the clinicaltrials landscape in the months and even years to come. … The post Keeping ClinicalTrials on Track: Navigating Supply Chains, Tariffs, and Regulatory Shifts. appeared first on Imperial ClinicalResearch Services Blog. .…
Pediatric rare disease clinicaltrials are vital to determining the safety and efficacy of medications for children living with a rare disease. Therefore, pediatric rare disease clinicaltrials are vital to determining the safety and efficacy of medications for children living with a rare disease. adults).
The landscape of rare disease clinicaltrials has seen significant transformation over the past decade. However, many challenges remain in ensuring patient access, optimizing trial design and leveraging technological advancements to improve outcomes.
Merck KGaA recently shared positive results from its Phase III MANEUVER trial on pimicotinib, an investigational oral therapy for tenosynovial giant cell tumor (TGCT). These findings align with early trial results, reinforcing pimicotinib’s promise for improving daily function in TGCT patients. percent of patients.
Eli Lilly shared new Phase II trial data showing that its experimental siRNA therapy, lepodisiran, leads to reductions in levels of lipoprotein(a) (Lp(a)) a genetically inherited risk factor for heart disease in adults with elevated levels of the marker. The 400 mg dose was the highest lepodisiran dose in the trial.
XTALKS WEBINAR: Redefining Womens Cancer Care: Delivering Smarter, Safer ClinicalTrials Live and On-Demand: Thursday, April 10, 2025, at 11am EDT (4pm BST/UK) Register for this free webinar to explore innovative approaches to enhancing clinicaltrials for breast and gynecological cancers.
Data in clinicaltrials For example, huge amounts of data can be mined from electronic health records (EHRs) and other sources to optimise clinicalresearch, from drug identification to treatment plan design.
As a strategic brand consultant at ramarketing, Laura Childs combines her extensive background in clinicalresearch with strategic leadership and creative expression.
Despite its potential to slow cognitive decline, the delays highlight the challenges of timely drug approval for life-threatening conditions. Notably, the FDA can now mandate that confirmatory trials begin before approval, ensuring proactive validation of clinical benefits.
Previously viewed as a ‘nice to have’ for the pharma industry, virtual trials were already moving from a theoretical to a practical proposition before COVID-19 accelerated their transition. Increasing patient access to clinicaltrials. Ensuring new types of trial designs remain patient friendly.
Building on this history of success, Novocure recently revealed promising Phase III results from the PANOVA-3 clinicaltrial, marking a significant milestone in pancreatic cancer treatment. Novocure’s broader pipeline underscores the versatility of TTFields therapy.
Who owns the clinicaltrial data generated in industry sponsored or investigator initiated clinicaltrials? What responsibilities do Sponsors, CROs, or Sites have when it comes to sharing clinicaltrial results with patients? To answer these questions and more, I invited Darshan Kulkarni to the show.
Navigating regulatory affairs in the biopharma industry requires a skilled talent pool, according to Benjamin James, HR Leader, Asia-Pacific, Cytiva Lifesciences – a global lifesciences (biopharma) company. in 2021 to 5.60 […]
Xtalks’ recent discussion with Rebekah Angove, PhD, Executive VP of Research and Evaluation at the Patient Advocate Foundation (PAF), offers a deeper understanding of incorporating patient narratives into clinicaltrials. Patients frequently approach us, exploring clinicalresearch as a potential care option.
In this episode, Ayesha talked about some of the trends in the lifesciences to watch out for in 2024. Hear about the latest technologies and approaches that will help drive innovations in drug discovery, clinicalresearch and medical device design this year.
Current treatment options remain limited, and many patients have not had opportunities to participate in trials specifically tailored to their condition. Interim results from Longboard’s Phase II PACIFIC study, involving DEE participants aged 12 to 65, previously supported bexicaserin’s transition to this Phase III trial.
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