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.

Clinical Research 52

Clinical Research Research Clinical Trials Trials 52

Conversations in Drug Development Trends

JULY 29, 2024

Evolving sentiments recognize obesity as a medical condition and lifestyle choice as well as a chronic disease with genetic, psychological, cultural, and environmental causes (Figure 1). They should include a comprehensive set of outcomes and endpoints to capture multiple areas of potential improvement within obesity as a disease.

Clinical Research 52

Clinical Research Research Clinical Trials Treatment 52

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.

Treatment 106

Treatment Packaging Clinical Research Therapies 106

Olympian Clinical Research

OCTOBER 30, 2020

The disease is more common than many may realize, with approximately 2.6 At Olympian Clinical Research we’ve gotten a chance to work with countless Schizophrenia patients over the years through our clinical trials, and we know just how untrue many of the common assumptions about Schizophrenia really are. .

Clinical Research 98

Clinical Research Clinical Trials Treatment Disease 98

Advarra

MARCH 6, 2025

Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinical research. Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinical trials, which judiciously test and evaluate safety and efficacy.

Clinical Research 52

Clinical Research Research Clinical Trials Bioethics 52

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.

Clinical Research 52

Clinical Research Treatment Research Clinical Trials 52

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.

Trials 98

Trials Clinical Trials Clinical Research Disease 98

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.

Clinical Research 52

Clinical Research Clinical Trials Research Trials 52

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.,

Clinical Research 52

Clinical Research Research Clinical Trials Regulations 52

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?

Disease 59

Disease Clinical Trials Clinical Pharmacology Trials 59

PPD

AUGUST 5, 2024

Pulmonary arterial hypertension (PAH) is a progressive and fatal lung disease that is caused or influenced by multiple factors. The clinical sites working on these trials are highly experienced and have a deep understanding of the complexities of successfully running PAH clinical trials. None offers a cure for PAH.

Clinical Trials 98

Clinical Trials Trials Clinical Research Disease 98

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.

Engineering 52

Engineering Clinical Research Research Virus 52

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.

Clinical Trials 86

Clinical Trials Trials Clinical Research Doctors 86

PPD

MARCH 13, 2024

In combination, they provide confidence in dose escalation or protocol adaptation decisions, which ultimately benefit patients who often have critical and life-limiting diseases. Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy.

Clinical Development 98

Clinical Development Clinical Trials Therapies Trials 98

Drug Target Review

FEBRUARY 29, 2024

During my academic career, I had the opportunity to examine the underlying causes of neurodegenerative diseases like Parkinson’s disease and develop novel animal models to investigate potential disease-modifying therapeutics. AskBio) I continue to work to bring innovative gene therapies to patients in need.

Therapies 111

Therapies Disease Clinical Trials Science 111

Drug Target Review

APRIL 11, 2024

Targeting pathways involved in SMC phenotypic modulation holds promise for developing novel therapeutic approaches for cardiovascular diseases. Can you explain the methodology used to investigate the genetic variants regulating extracellular matrix (ECM) secretion in SMCs, and predict proteins associated with vascular disease?

Disease 59

Disease Engineering Regulations Clinical Research 59

Advarra

AUGUST 8, 2023

Gene therapy research is booming in the clinical setting. In this blog, we summarize the growth, risks, and regulatory requirements for gene therapy research. We also discuss how a centralized biosafety review process can benefit this type of research.

Therapies 52

Therapies Research Engineering Clinical Research 52

Drug Target Review

MARCH 4, 2025

A personalised approach to obesity treatment Traditional obesity treatments have often followed a one-size-fits-all model, despite mounting evidence that obesity is not a singular disease but rather a collection of subtypes. This growing health challenge increases the risk of diabetes, heart disease, and other conditions.

Therapies 52

Therapies Treatment Clinical Trials Science 52

Drug Target Review

OCTOBER 25, 2024

How does precision neuroscience differ from traditional approaches in the treatment of neurodegenerative diseases, and what advantages does it offer? Traditionally, Alzheimer’s disease is diagnosed by clinical examination, medical history and cognitive testing.

Disease 59

Disease Clinical Trials Therapies Science 59

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?

Therapies 65

Therapies Treatment Vaccine FDA Approval 65

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.

Clinical Development 98

Clinical Development Clinical Trials Clinical Research Trials 98

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.

Disease 52

Disease Trials Clinical Trials Clinical Research 52

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.

Therapies 52

Therapies Clinical Trials Trials Treatment 52

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.

Therapies 52

Therapies Clinical Trials FDA Production 52

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.

Therapies 52

Therapies Clinical Trials Small Molecule Immune Response 52

The Premier Consulting Blog

JUNE 18, 2023

One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. However, with rare diseases there may be no available treatments that could serve as SoC or active control in a clinical trial and assigning patients to placebo may be unethical.

Drug Development 52

Drug Development Disease Clinical Trials Drugs 52

Advarra

AUGUST 10, 2023

Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. Now, FDA’s CBER is setting its sights on making ambitious strides toward tackling rare diseases.

Drug Development 52

Drug Development Disease Therapies Engineering 52

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.

Treatment 52

Treatment Small Molecule Clinical Research Immune Response 52

PPD

JANUARY 15, 2025

As clinical trials 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.

Clinical Trials 95

Clinical Trials Trials Clinical Research Drug Development 95

Advarra

MARCH 20, 2023

The Food and Drug Administration (FDA) recently released new guidance regarding cellular and gene therapy products, one of which may significantly impact early-phase clinical trials of such products. This article explores the implications of this guidance, including new approaches for studies focused on cellular or gene therapies.

Therapies 52

Therapies FDA Trials Clinical Trials 52

Olympian Clinical Research

SEPTEMBER 3, 2020

The tough thing about depression is that the disease is wildly indiscriminate, affecting patients of every age, gender, and ethnicity. For patients that struggle with depression, the disease can have devastating impacts both mentally, physically, and emotionally. Sleep is especially important in regulating mood.

Clinical Trials 98

Clinical Trials Treatment Clinical Research Trials 98

FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

Clinical Development 69

Clinical Development Production Clinical Trials Treatment 69

Advarra

JUNE 12, 2023

Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring an institutional biosafety committee (IBC) to provide additional oversight and risk assessment. What Does an IBC Review?

Engineering 98

Engineering Therapies Regulations Research 98

Olympian Clinical Research

NOVEMBER 9, 2022

Although this disease is estimated to affect less than 50,000 Americans, it may be life-threatening, especially for people who are already in poor health. Radiation therapy. Neurological conditions, such as Parkinson’s disease or epilepsy. Immunosuppressive therapy may also be used to treat bullous pemphigoid.

Treatment 52

Treatment Clinical Research Immune Response Therapies 52

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.

Treatment 52

Treatment Clinical Research Clinical Trials Therapies 52

Olympian Clinical Research

FEBRUARY 17, 2022

While the exact cause of PN is unknown, those with a history of eczema, lymphoma, kidney disease, liver disease, anemia, pregnancy, stress, insect bites, or an HIV infection may be more at risk. In addition, blood tests can help rule out other conditions causing a person’s symptoms, such as lymphoma and kidney disease.

Clinical Trials 52

Clinical Trials Clinical Research Therapies Treatment 52

The Pharma Data

MAY 27, 2022

“With today’s approval of cilta-cel in Europe, we are pleased to be delivering a new approach to the way in which healthcare professionals can tackle, and hopefully one day overcome, this complex disease.”. of patients with RRMM responding to therapy (98 percent overall response rate ORR ).1,6

Therapies 52

Therapies Treatment Pharmaceutical Companies Nurses 52