January, 2024

article thumbnail

Why amplifying the patient voice is crucial to clinical trial success

pharmaphorum

Amplifying the patient voice is essential for the success of clinical trials. Learn why it is crucial for patient engagement, recruitment, and overall trial success, and how it can address challenges such as transportation and financial barriers.

article thumbnail

Enhancement, Efficiency, Equity, and Engagement: Four Trends Shaping Clinical Trials in 2024

ACRP blog

Historically, patient recruitment and retention have been pressing issues within the clinical trial space. Eighty-five percent of trials fail to recruit enough patients, while 80% are delayed due to other factors like participant dropouts. These high rates are influenced by financial, emotional, and logistical barriers to participation, such as geographic location and travel-related costs, which prevent patients from enrolling in trials and accessing life-changing medicine.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

10 clinical trials to watch in the first half of 2024

Bio Pharma Dive

A non-addictive pain pill faces its definitive test, while study results in ALS, a rare heart disease and lung cancer could have far-reaching implications.

article thumbnail

Clinical trial patient recruitment: 5 common misconceptions

Antidote

Though clinical trial patient recruitment is an integral part of the medical research process, it is often one of the most difficult aspects of conducting a study. There are various reasons for this challenge, and among them is the widespread existence of misconceptions about participating in research that many patients may see as a barrier to entry.

article thumbnail

Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

article thumbnail

January 8, 2024: Pragmatic Trials Researchers Share Lessons From Collecting Patient-Reported Outcomes in the Electronic Health Record

Rethinking Clinical Trials

In a new article from the NIH Pragmatic Trials Collaboratory, investigators from 6 of the program’s pragmatic clinical trials share case examples of the challenges they encountered in collecting patient-reported outcomes (PROs) in their trials and the strategies they used to address them. The article was published this week in Contemporary Clinical Trials.

Trials 298
article thumbnail

Patient Perspective: Jamie Troil Goldfarb shares her clinical trial experience [video]

Antidote

For individuals living with a condition like melanoma, volunteering to participate in a clinical trial can be a rewarding experience. Not only will patients be able to gain access to potential new treatments, but they will also be directly contributing to research that can save lives — something that Jamie Troil Goldfarb has experienced firsthand. Jamie received a diagnosis of stage IV melanoma in 2011, only 11 weeks after giving birth to her child.

More Trending

article thumbnail

Expert analysis: the latest in HIV research and clinical trials 

Pharmaceutical Technology

A new report from Novotech delves into the multifaceted landscape of HIV, focusing on its impact, treatment, and global initiatives.

article thumbnail

CAR-T for lupus: the ‘tip of the iceberg’ for cell therapy in autoimmune disease

Bio Pharma Dive

Since a landmark paper in 2022, drugmakers have begun nearly a dozen trials of cell therapies for lupus, with more set to start. Here’s why their efforts are worth watching.

Trials 353
article thumbnail

Former Pfizer statistician found guilty of insider trading on Paxlovid trial results

Fierce Pharma

A jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in federal court in the Southern District of New York. | A federal jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in Manhattan. The jury convicted Amit Dagar, 44, of Hillsborough, N.J., of using advance information on successful trial results for Pfizer’s COVID-19 treatment Paxlovid to make more than $270,000 in stock trades.

Trials 143
article thumbnail

January 3, 2024: Special Biostatistics Series Concludes With Missing Data in Cluster Randomized Trials

Rethinking Clinical Trials

In this Friday's PCT Grand Rounds, Rui Wang of Harvard Medical School will offer the final session in our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with "Methods for Handling Missing Data in Cluster Randomized Trials." The session will be held on Friday, January 5, at 1:00 pm eastern. Wang is an associate professor of population medicine and the director of the Division of Biostatistics in the Department of Population Medicine at Harvard Medical School and

Trials 298
article thumbnail

The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

article thumbnail

JPM: Four ways FDA is seeking to buoy gene therapy

pharmaphorum

Dr Peter Marks, director of the FDA Center for Biologics Evaluation and Research told a packed house in San Francisco for JPM that FDA wants to support gene therapies in 2024.

article thumbnail

DDW Winter 2023/2024

Drug Discovery World

The DDW Winter issue asks whether AI can deliver better immunotherapies for cancer and includes expert predictions on what to expect from the sector in 2024, alongside a supplement looking at SLAS2024 and an exclusive guide exploring therapeutic antibodies. DDW Winter 2023/2024 The post DDW Winter 2023/2024 appeared first on Drug Discovery World (DDW).

Antibody 124
article thumbnail

Merck is on the lookout for more opportunities within immunology

Pharmaceutical Technology

At the JP Morgan Healthcare conference, Merck (MSD) indicated its eagerness to continue to establish its place in the immunological space.

362
362
article thumbnail

A new startup from Feng Zhang and an ex-Illumina executive zeroes in on the epigenome

Bio Pharma Dive

Moonwalk Biosciences, the latest biotech cofounded by the gene editing scientist, joins other startups aiming to alter gene expression without changing DNA.

article thumbnail

How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

article thumbnail

Millions of doses of Pfizer's Paxlovid will go to waste in UK, EU as COVID demand plummets

Fierce Pharma

On the heels of a major Paxlovid inventory write-off in the United States, many more doses of Pfizer's COVID-fighting antiviral are going to waste overseas. | At the end of November, more than 1.5 million courses of Pfizer’s Paxlovid had expired unused in European countries, analysts at Airfinity said in a new report. The total tally of expired doses in Europe is expected to hit 3.1 million by the end of next month, representing a value of $2.2 billion.

144
144
article thumbnail

How Kyverna Therapeutics Is Pioneering Cell Therapy for Autoimmune Diseases

XTalks

Affecting millions of people worldwide, autoimmune diseases present a complex and often debilitating set of challenges for patients. To that end, the quest for innovative treatments has led to the convergence of technology, research and patient-centric care. Over 80 distinct autoimmune disorders exist, with the most prevalent ones being multiple sclerosis, irritable bowel syndrome (IBS), lupus, type 1 diabetes, psoriasis and rheumatoid arthritis.

article thumbnail

Data-driven disease research harnessing the genome

pharmaphorum

Discover how the UK Biobank is leveraging technology and the power of genomics in data-driven disease research. Join the digital revolution in understanding and combating diseases using cutting-edge techniques and large-scale genomic data analysis.

Genome 125
article thumbnail

Patient Engagement Collaborative Announces Eight New Members

CTTI (Clinical Trials Transformation Initiative)

Today, the U.S. Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) announced eight newly selected representatives for the Patient Engagement Collaborative (PEC). The group of 16 patients, caregivers, and patient group representatives meets with the FDA several times a year and discusses a variety of topics such as improving communication, education, and patient engagement related to medical product regulation.

article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

article thumbnail

Moderna leads the development of mRNA vaccines in infectious diseases

Pharmaceutical Technology

The rapid sequencing of the SARS-CoV-2 and the subsequent development of mRNA vaccines led to the authorisation of the first of these vaccines in late 2020.

article thumbnail

Kyverna sets plans for IPO in test of biotech market

Bio Pharma Dive

The offering is the fifth outlined by a biotech startup this month, suggesting companies are becoming more willing to gauge investors’ appetite for new stock offerings.

Marketing 309
article thumbnail

Pfizer's layoff campaign ramps back up with dozens of SF-area cuts expected next month

Fierce Pharma

The start of the new year doesn’t seem to have dulled the zeal of Pfizer’s global cost-cutting campaign, which has already left hundreds of jobs in its wake. | Come mid-February, Pfizer will lay off some 52 employees at a facility in South San Francisco, according to a recent Worker Adjustment and Retraining Notification Act alert. The site is the former headquarters of Global Blood Therapeutics.

136
136
article thumbnail

CAR-T therapy could “alter the treatment paradigm” of multiple sclerosis

Drug Discovery World

Kyverna Therapeutics has revealed plans to progress to Phase II trials of KYV-101 for multiple sclerosis (MS) following a green light from the US Food and Drug Administration (FDA). KYV-101 is an autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate for use in B cell-driven autoimmune diseases. “This approval is a critically necessary step that paves the way to enrol patients with treatment-refractory progressive MS for whom there are no currently available

Trials 124
article thumbnail

2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

article thumbnail

Novavax: Creating tomorrow’s vaccines today

pharmaphorum

Novavax is a leading pharmaceutical company dedicated to creating protein-based vaccines for diseases like COVID-19 and malaria. Learn more about their innovative vaccine development process and their commitment to creating a healthier future.

article thumbnail

What to know after a colon cancer diagnosis

Antidote

Colorectal cancer (often shortened simply to colon cancer) is the fourth-most commonly diagnosed cancer in the United States, and it is estimated that around 150,000 Americans are diagnosed each year. While the average age of diagnosis is 66, young adults are getting diagnosed in higher numbers every year, and researchers are still unsure as to why.

Research 122
article thumbnail

AbbVie and Umoja to develop new CAR-T therapies for cancer

Pharmaceutical Technology

AbbVie and Umoja Biopharma partnered for the development of in-situ CAR-T cell therapy candidates for oncology targets.

article thumbnail

AstraZeneca, Daiichi aim for first pan-tumor ADC approval

Bio Pharma Dive

The FDA is reviewing the companies’ application for a “tumor agnostic” indication for their drug Enhertu, which would break new ground for antibody-drug conjugates.

Antibody 303
article thumbnail

An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

article thumbnail

JPM24: Pfizer CEO promises 'year of execution' after recent struggles, Seagen buyout

Fierce Pharma

Pfizer knows it had a bad year in 2023. Speaking to reporters at the 2024 J.P. | Pfizer knows it had a bad year in 2023. Speaking to reporters at the 2024 J.P. Morgan Healthcare Conference on Monday, the company’s CEO, Albert Bourla, spoke bluntly about the hits the company took, and he acknowledged the underperformance of certain key launches.

137
137
article thumbnail

Does CNS Drug Development Need to Evolve to Include Objective, Longitudinal and Broad-Spectrum Data?

XTalks

To date, the lack of objective longitudinal measures in central nervous system (CNS) clinical studies has resulted in less than 6 percent of drugs in this space making it to market. Many of the validated cognitive assessments today are paper based, introducing the potential for bias and limiting ethnic and geographic diversity in clinical studies. Additionally, blood biomarkers only provide a snapshot in time and do not provide insight into cognitive function.

article thumbnail

MHRA’s post-Brexit mutual recognition framework goes live

pharmaphorum

The UK medicines regulator has launched its mutual recognition framework for authorising medicines in a move that it says will help to bring new drugs to patients in the UK more quickly.

article thumbnail

Living with PSC: What to know about primary sclerosing cholangitis

Antidote

An estimated 1 in 10,000 people have primary sclerosing cholangitis (PSC) , a condition that impacts the bile ducts that run between the liver, the gallbladder, and the small intestine. The liver produces bile to transport to the gallbladder for storage, or to the small intestine where it aids in the digestion of fats. In the case of PSC, there is inflammation in the bile ducts (cholangitis) which leads to scarring (sclerosis) that narrows the ducts.

122
122
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time