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. The challenge is harnessing the power of AI within a highly regulated industry. The key challenge for all regulators next year is ensuring that they can keep up with the progress of the technology.”

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Drug Discovery World

AUGUST 18, 2023

Thermo Fisher Scientific has completed its acquisition of CorEvitas, a provider of real-world evidence for approved medical treatments and therapies, for $912.5 We are very excited to welcome our new CorEvitas colleagues to Thermo Fisher,” said Marc Casper, Chairman, President and Chief Executive Officer of Thermo Fisher.

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Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Drug Discovery World

SEPTEMBER 23, 2022

An interesting week for clinical research and drug approvals, with rare diseases being a key focus for both the FDA and European Commission. EC approves first treatment for rare kidney disease. Breast cancer cells ‘regulate their own metastases’. News round-up for 19-23 September by DDW Editor Reece Armstrong.

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Drug Discovery World

JUNE 20, 2024

Now, you might wonder: how exactly can these advanced artificial intelligence models propel clinical research forward? In the context of clinical trials, these models can help us add context to insights. Conventional AI models allow us to extract insights from the clinical data but they do lack context.

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Drug Discovery World

JANUARY 23, 2024

Solving bottlenecks in precision medicine R&D Medical trials underpin modern healthcare yet clinical research is an incredibly complex and time-consuming process for both patients and companies running trials, including pharmaceutical companies and emerging biotech startups.

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Conversations in Drug Development Trends

AUGUST 9, 2024

It broadens recruitment strategies, diversifies the patient population, and expands the study population, thus increasing access to potentially life-saving treatments. These trials increase the chances of success by enabling the early detection of effective treatments in defined populations and focusing efforts on the most promising options.

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Conversations in Drug Development Trends

JUNE 21, 2024

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research.

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Drug Discovery World

JULY 5, 2023

Precision oncology supports targeted therapeutic treatments by determining the specific molecular characteristics of a tumour – the molecular phenotype, as it’s called – to obtain an in depth understanding of the patient’s unique cancer and using it to specifically target the patient’s cancer on a molecular level.

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Drug Discovery World

NOVEMBER 8, 2023

Harnessing AI, researchers have significantly expedited the drug discovery process, achieving what traditionally takes years in just 30 days. This method not only promises more efficient drug development but could also revolutionise clinical research and accelerate trials. NY Post 20 March 2023. Psychology Today 25 January 2023.

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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. That brings us to our next question – so what problems can AI solve in oncology research? So, what does this mean for clinical trials in oncology?

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Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. For example, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition to date 1.

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Vial

JUNE 24, 2024

The fields of artificial intelligence (AI) and machine learning (ML) are increasingly influencing clinical research and development (R&D). Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery.

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Drug Discovery World

APRIL 14, 2023

Kathryn E Wellen, PhD – Outstanding Achievement in Basic Cancer Research Wellen is an investigator at the Penn Epigenetics Institute and Vice Chair and Professor in the Department of Cancer Biology in the Perelman School of Medicine at the University of Pennsylvania. Wherry’s award lecture will be held on Monday April 17 at 3:30pm ET.

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Drug Discovery World

APRIL 14, 2023

Clinical trials are, undoubtedly, an essential part of the drug development process, providing us with valuable information about the safety and efficacy of new treatments and therapies. Additionally, a lack of diversity in clinical trials can result in ineffective treatments for certain patient groups.

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PPD

NOVEMBER 7, 2023

The underrepresentation of diverse groups in clinical research is an area of regulatory, scientific and industry focus, partly due to the recent U.S. Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.”

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Advarra

JANUARY 11, 2024

The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines.

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Olympian Clinical Research

FEBRUARY 13, 2024

Whether it’s aging , acne , or hyperpigmentation, these products are formulated based on clinical research and are proven to deliver results. Investing in products that actually work can save you money and time, reducing the need for multiple products or treatments to correct issues exacerbated by ineffective care.

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Olympian Clinical Research

SEPTEMBER 3, 2020

Sleep is especially important in regulating mood. We just started a clinical trial to explore a new treatment option for patients who suffer from moderate to severe depression. The post Battling Depression In A World Of Isolation: Tips For Managing COVID Depression appeared first on Olympian Clinical Research.

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PPD

AUGUST 9, 2023

Therefore, regulators and the industry must agree on accepted methods for analyzing data collected from wearable devices. Accessing structured, clean data is also a significant challenge because robust data-cleansing processes are typically required before clinical trial data can be used.

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Vial

MAY 28, 2024

In the rapidly expanding world of digital health, Medable and Vial CRO (Contract Research Organization) , two leading technology organizations, are revolutionizing the way clinical research is conducted.

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Olympian Clinical Research

JULY 12, 2022

There are several types of depression, each with its own set of symptoms and recommended treatment methods. Major depressive disorder ( MDD ), also known as clinical depression, is characterized by a persistent feeling of sadness or emptiness lasting for at least two weeks. As a result, many people do not seek treatment.

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Conversations in Drug Development Trends

APRIL 3, 2024

By: Sue Batchelor, Executive Director, Oncology Project Management Radiopharmaceuticals represent a cutting-edge frontier in oncology treatment, offering the promise of highly targeted therapy with the potential to revolutionize cancer care. One such approach is standardizing imaging protocols across your trial sites — consistency is key.

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The Premier Consulting Blog

NOVEMBER 20, 2023

Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. This change is driven by the intent to consistently regulate all producers of such devices. Expanded Definition: FDA aims to reshape the boundaries of IVDs within 21 CFR Part 809.3.

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Olympian Clinical Research

JULY 29, 2021

While we don’t know all the technicalities of what causes migraines on a neurological level, most scientists believe that they are the result of abnormal brain functioning, affecting your brain’s nerve signals, possibly the ones that regulate pain. That’s why it’s important to keep open communication with your child?

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Vial

FEBRUARY 15, 2024

Sponsors often contract a CRO to delegate specific day-to-day tasks, streamlining their research processes and enhancing efficiency. Patient recruitment and retention : Recruiting and retaining a sufficient number of eligible participants is one of the major challenges in conducting clinical trials.

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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Read AgencyIQ analysis here for a detailed discussion of these issues. ].

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Conversations in Drug Development Trends

NOVEMBER 10, 2023

 However, pain treatment shouldn’t resort to a “whatever it takes” approach. Instead,  Instead, the medical community and regulating agencies need to balance all aspects when making decisions, working in partnership with their patients. Collaborating

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Drug Discovery World

JULY 25, 2023

The pharmaceutical industry is constantly developing evidence-based treatments for children while there continue to be scientific advancements related to new modalities and disease understanding. About the authors Justin Hay is a Senior Director at Certara with more than 20 years of clinical pharmacology experience.

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Crown Bioscience

MAY 4, 2021

Why are cancer treatments for children lagging behind the latest advancements in clinical oncology? Crown Bioscience Director Mike Batey takes a closer look at pediatric cancer and how recent regulatory changes and additional research focus may deliver new therapies for kids.

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Drug Discovery World

DECEMBER 8, 2023

The need for cell and gene therapy development standardisation Presently, a total of 3,866 cell and gene therapies are in various stages of development , spanning from pre-clinical research to pre-registration phases. The data needed for analysis takes months to collect and has a high cost.

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Drug Target Review

JUNE 6, 2023

In this IO arena, we continue to search for additional treatments that can further benefit patients. Immune checkpoint inhibitors, a well-established class of IO treatments, are designed to improve the ability of T-cells to fight cancer by removing inhibitory or suppressive mechanisms that may dampen the anti-cancer functions of T cells.

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Advarra

NOVEMBER 29, 2022

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.

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Drug Discovery World

SEPTEMBER 28, 2022

With the advent of natural language processing, algorithms can now also contextualise these data and, combined with trend analysis, can guide researchers towards areas more likely to show promising treatments. . Which areas of drug discovery research stand to benefit most? .

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The Pharma Data

DECEMBER 21, 2020

Extension eliminates out-of-pocket costs for treatment, allowing impacted members to focus on health and recovery for as long as the public health emergency lasts. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. OAKLAND, Calif. , OAKLAND, Calif. ,

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The Pharma Data

DECEMBER 27, 2020

Treatment with orelabrutinib has demonstrated clear benefit for patients. Orelabrutinib is a BTK inhibitor developed by InnoCare for the treatment of cancer and autoimmune diseases. We believe that the approval of orelabrutinib will provide a safe and effective new treatment solution for lymphoma patients in China.”.

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The Pharma Data

MARCH 16, 2021

inhibitor belzutifan (pronounced bell-ZOO-ti-fan), a novel investigational candidate in Merck’s oncology pipeline, for the potential treatment of patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC), not requiring immediate surgery. If not properly regulated, the accumulation of HIF-2?

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