Advarra

JUNE 27, 2023

A clinical trial investigating a drug or therapy is typically divided into four phases: Phase I, Phase II, Phase III, and Phase IV. This article explores how the clinical research phases protect study volunteers from harm and ensure new drugs and therapies are developed effectively.

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Drug Discovery World

DECEMBER 9, 2022

The ‘Rare Disease Moonshot’, a new initiative to boost research and development into rare and paediatric diseases, has launched at the European Health Summit. . It aims to speed up research into more than 7000 identified rare diseases, of which a staggering 95% have no approved treatment or cure. .

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Drug Target Review

SEPTEMBER 22, 2023

Organoid technologies are becoming an invaluable solution for preclinical research, with the ability to augment the development of personalised medicine, drug discovery and gene therapies. Organoids for cell therapy and drug discovery. Human organoids in basic research and clinical applications. Elsevier; 2020.

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Conversations in Drug Development Trends

JANUARY 24, 2024

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.

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Conversations in Drug Development Trends

JULY 9, 2024

The discussions at the conference shed light on innovative approaches to enhance long-term outcomes for patients, focusing on combination therapies that not only aid in weight loss but also help preserve muscle mass, an essential component of healthy body composition.

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Drug Discovery World

MAY 11, 2023

Researchers at Université de Montréal have discovered a way to potentially restore vision in patients suffering from degenerative retinal disease. When these cells degenerate due to disease, they are not replaced and the patient suffers vision loss that can progress to total blindness.

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Drug Discovery World

SEPTEMBER 16, 2022

A biologic therapy for very young children with moderate to severe eczema (or atopic dermatitis) has been shown to be safe and effective in an international trial. The therapy is already licensed in the UK for adults and children aged six to 18, and was approved by the FDA in June 2022 for use in younger children.

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Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. billion in 2023 and is expected to grow at a CAGR of 7.0% between 2024 and 2030.

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Vial

DECEMBER 4, 2023

Clinical research is an integral component of the healthcare ecosystem. It is pivotal in the development of cutting-edge treatments, therapies, and interventions for a wide array of diseases. Patient Payments in Clinical Research: Perception Over the Years In the U.S.,

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Drug Discovery World

FEBRUARY 10, 2023

Breast cancer retained its position as the most-studied disease area in clinical trials in 2022, despite a drop in activity, according to analysis from analytics company Phesi. The post Breast cancer still top disease area for clinical studies appeared first on Drug Discovery World (DDW). Download the full report.

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Drug Discovery World

NOVEMBER 24, 2022

Three institutions have received a share of $12 million for the development of antiviral therapies to treat diseases caused by viruses with pandemic potential. . The money was awarded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

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Advarra

MARCH 10, 2023

Having a one in four chance of developing sickle cell disease (SCD) is uniquely, and overwhelmingly, familiar to the African American population. Considered a rare disease, research in finding better therapies – and possibly even a cure – for SCD may be competing for funding with conditions impacting broader populations.

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Drug Target Review

MAY 7, 2024

Why are biomarkers particularly critical in the context of rare diseases? Developing novel therapeutic approaches for rare diseases poses inherent challenges due to the limited populations available for testing. How do AI-enhanced approaches accelerate the drug development process for rare diseases?

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Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. The post Risk Assessment for use of Engineered Genetic Materials in Clinical Research appeared first on Advarra.

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Vial

DECEMBER 8, 2023

With technological innovation and scientific research propelling the development of new therapies, anticipation for the future is high. The goal of this therapy is to replace a disease-causing gene with a healthy one, disable a disease-causing gene, or introduce a new gene to aid in fighting a disease.

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Drug Discovery World

JUNE 25, 2024

Phesi created a digital twin for chronic graft versus host disease (cGvHD) in the primary treatment setting. The digital twin was developed to replicate patients receiving prednisone, the first-line treatment currently used as the standard-of-care for cGvHD, and commonly used in control arms of prospective clinical trials.

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The Premier Consulting Blog

APRIL 18, 2024

Development of cell and gene therapies is growing rapidly, given the major advances in genomic technologies and increasing scientific understanding of genetic regulation and immunology. This blog will outline three characteristics of a successful nonclinical program to support entry into clinical trials for a cell or gene therapy product.

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Drug Target Review

FEBRUARY 21, 2024

Stem cell transplants have saved patients’ lives time and time again, which led us to launch our own Stem Cell Transplant and Cellular Therapy Program. Regarding CAR-T cell therapy, could you highlight the promising findings that have been identified in the early stages of drug discovery, as well as potential challenges?

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Drug Discovery World

APRIL 25, 2023

University of California researchers have dosed the second participant in their clinical trial to identify a potential cure for HIV utilising CAR-T cell therapy. The trial is the first-in-human clinical study investigating the duo CAR-T cell therapy for the treatment of HIV. “We

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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. The last week has seen data emerge on how Omicron infection could protect against influenza, how breast cancer cells evade therapies, and two approvals on rare diseases in the US and EU.

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Drug Discovery World

DECEMBER 7, 2022

If clinical research into collagen maintains this momentum, we can expect to see innovations in wound healing and bone care making their way to patients in the coming years.”. The collagen trials fell into five main categories: skin disease, wound care, bone disease, osteoarthritis, and rheumatoid arthritis. “As

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Drug Discovery World

AUGUST 18, 2023

My chosen news stories this week all discuss pre-clinical research studies that could have a huge impact on our therapeutic approach to several hard-to-treat diseases, helping to overcome drug-resistance and make treatments more targeted in the future. News round-up for 14-18 August by DDW Digital Content Editor Diana Spencer.

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Drug Discovery World

MAY 29, 2024

All 11 trial participants had experienced disease progression in prior immunotherapy treatment before joining the trial. These preliminary findings represent some of the initial positive evidence emerging from the burgeoning field of clinical research on cancer therapies leveraging gut microbiota.

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PPD

JANUARY 5, 2023

In an industry survey led by PPD, Thermo Fisher Scientific’s clinical research business, rare diseases emerged as a top therapeutic area in drug developers’ pipelines, with 39% of global biotech and biopharma leaders pursuing therapies in the broad rare disease space.

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Olympian Clinical Research

MAY 6, 2024

As medical understanding grew, so did the sophistication of the therapies. These targeted therapies revolutionized treatment, offering relief to severe cases by specifically addressing the underlying immune responses causing the disease.

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Drug Discovery World

AUGUST 11, 2023

Pravin Dugel, President, Iveric Bio (An Astellas Company), said: “We are thrilled to receive FDA approval of Izervay and to offer a new therapy to physicians and appropriate patients in the US. Time matters, vision matters, and safety matters in this devastating progressive disease.

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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 22, 2023

The researchers found that in healthy guts there was a specialised subset of gamma delta T cells (V-gamma-4 (Vg4) cells) that were significantly altered and often depleted in inflammatory bowel disease (IBD) samples. They tested whether losing this normal interaction between Vg4 T cells and the epithelium was underpinning disease.

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Drug Target Review

JUNE 9, 2023

This exclusive interview with Dr Sharon Benzeno, Chief Commercial Officer, Immune Medicine at Adaptive Biotechnologies, unveils some ground-breaking research on T- cell therapy for cancer , which has seen the first TCR-based therapeutic candidate progress to clinical development, offering promising advancements in innovative cancer treatments.

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Olympian Clinical Research

FEBRUARY 22, 2024

However, advancements in treatments and ongoing clinical research offer new hope. Understanding Hidradenitis Suppurativa HS is more than just a skin condition; it’s a systemic disease that can lead to severe physical discomfort and emotional distress.

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Drug Discovery World

OCTOBER 17, 2023

They will discuss critical aspects of clinical trial design and leveraging regulatory pathways, in addition to outlining the differences between fast track, break through therapy, priority review regulatory designations and accelerated approval pathways. Register now to secure your place!

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Drug Discovery World

FEBRUARY 10, 2023

The top stories: Study shines a light on representation in clinical research A diversity study has shown that clinical trials should use real world diseases epidemiology data, rather than US Census Bureau race and ethnicity data, to ensure enrolment reflects the populations affected by different diseases.

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PPD

MAY 18, 2023

For neurodegenerative disease research, the care partner, or caregiver, is equally important as the person with dementia. Even with stronger awareness of studies, drug developers must contend with the inherent lack of trust between the dementia community and clinical trials. Recognize and relieve the caregiver burden.

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The Pharma Data

APRIL 8, 2021

Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Merck has the industry’s largest immuno-oncology clinical research program. In the U.S.

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PPD

JUNE 7, 2023

Adults aren’t the only patients affected by the increasing prevalence of liver disease. The number of pediatric patients diagnosed with nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) is on the rise, yet there are currently no approved therapies to treat NAFLD and NASH in adult or pediatric populations.

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Drug Discovery World

FEBRUARY 12, 2024

Leslie Orne, President and CEO, Trinity Life Sciences “AI and ML will play an increasingly important role in the clinical development and commercialisation of cell and gene therapies, which are typically targeted to small patient populations. The challenge is harnessing the power of AI within a highly regulated industry.

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PPD

SEPTEMBER 16, 2024

In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinical research and drug discovery. This can be converted to a clinical trial simulator, which can model a clinical trial before the trial design is finalized and initiated.

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