Worldwide Clinical Trials

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Your CRO can also play a crucial role in helping you to understand existing precedents and how they apply to your study and overall development journey.

Clinical Research 173

Clinical Research Trials Research Clinical Trials 173

FDA Law Blog

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.

Production 69

Production Clinical Development Development Regulation 69

Worldwide Clinical Trials

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

Trials 242

Trials Clinical Trials Clinical Trials Development 242

Worldwide Clinical Trials

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. One diagnostic example that I discussed in my presentation is autism.

Genetics 189

Genetics Trials Clinical Trials Clinical Trials 189

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 3, 2023

Researchers at the Indian Institute of Science (IISc) have found that picolinic acid, a natural compound produced by mammalian cells, can block several disease-causing viruses such as SARS-CoV-2 and influenza A viruses. The Institute is now looking for partners in pharma companies to pursue further clinical development of the findings.

Pharma Companies 189

Pharma Companies Research Clinical Development Development 189

Worldwide Clinical Trials

JANUARY 21, 2025

Jayaprakash Kotha, MBBS, PhD, ASCP (SH), Vice President, Bioanalytical Laboratory Satish Kumar, MBB, Head of Process Improvement Continuous Innovation is a Cornerstone of Bioanalysis Approximately 80% of drugs that begin the research process fail to reach approval. What is one contributing factor that sets the 20% that do apart from the rest?

Clinical Trials 195

Clinical Trials Clinical Trials Drugs Trials 195

XTalks

NOVEMBER 19, 2024

In clinical research, diversity is more than a prerequisite for a successful drug — it’s a critical component that enhances the validity and applicability of clinical trial outcomes. Diversity Action Plans have now moved from being a “nice-to-have” to a “must-have” in clinical trial designs.

Clinical Trials 64

Clinical Trials Clinical Trials Trials Production 64

pharmaphorum

JANUARY 19, 2021

A survey by rare disease patient network Raremark found that 86% of the community members asked were interested in taking part in clinical trials. CEO Jeremy Edwards looks at how decentralised trial models can solve some of the challenges for clinical trial recruitment in rare disease.

Trials 133

Trials Research Clinical Trials Clinical Trials 133

Worldwide Clinical Trials

OCTOBER 31, 2023

Last year, we witnessed a significant milestone in oncology clinical development, with almost 50% of all development programs focused on oncology assets. To encourage further expansion and innovation in cancer studies, it’s critical to consider what contributes to success in an oncology trial.

Trials 189

Trials Clinical Trials Clinical Trials Clinical Development 189

ACRP blog

OCTOBER 10, 2024

It’s even being used to review investigator invoices and automate financial reconciliations—a monthly headache every contract research organization, sponsor, and clinical trials operator will be more than happy to resign to machines. Integrating AI tools into complex workflows will require time and understanding.

Clinical Trials 69

Clinical Trials Clinical Trials Trials Life Science 69

XTalks

MAY 28, 2024

The traditional clinical trials model is facing scrutiny. VivoSense , a pioneering company in the field of digital health technologies (DHTs) and digital endpoints for clinical trials, is aiming to enhance the efficiency and efficacy of clinical research.

Clinical Development 116

Clinical Development Development Clinical Trials Clinical Trials 116

XTalks

JUNE 4, 2024

In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinical trials is increasing. This surge in complexity is driven by escalating drug development costs, heightened competition and advanced scientific innovations. This is the storm that we find ourselves in the midst of.”

Clinical Development 110

Clinical Development Development Clinical Trials Clinical Trials 110

XTalks

APRIL 3, 2025

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.

Trials 59

Trials Clinical Trials Clinical Trials Genetics 59

CTTI (Clinical Trials Transformation Initiative)

OCTOBER 17, 2024

A new CTTI publication , published in Clinical Pharmacology & Therapeutics , reviews current applications of disease progression modeling (DPM) and opportunities to advance the awareness and value of DPM in clinical trials.

Clinical Trials 81

Clinical Trials Clinical Trials Trials Production 81

XTalks

FEBRUARY 5, 2025

In this episode, Ayesha spoke with Mario Marcondes, MD, PhD, VP Head of Clinical Development at Nektar Therapeutics , a company focused on the discovery and development of novel therapies for autoimmune disorders and cancer. Dr. Marcondes is a licensed and trained physician, specializing in oncology and immune oncology.

Clinical Development 59

Clinical Development Development Life Science Clinical Trials 59

XTalks

OCTOBER 23, 2024

In this episode, Vera spoke with Morgan Hanger, Executive Director of the Clinical Trials Transformation Initiative (CTTI). CTTI is a public-private partnership dedicated to improving the quality and efficiency of clinical trials, with an ambitious “Transforming Trials 2030” vision.

Clinical Research 64

Clinical Research Clinical Trials Clinical Trials Life Science 64

Pharmaceutical Technology

DECEMBER 1, 2022

Rebyota’s safety and efficacy were analysed in the largest trial programme in the microbiome-based therapeutics field, including five trials enrolling over 1,000 subjects. The latest development is based on the findings from the clinical programme including the double-blind, randomised, placebo-controlled Phase III PUNCH CD3 trial.

FDA Approval 264

FDA Approval Trials Clinical Development Development 264

Worldwide Clinical Trials

JUNE 13, 2024

In the last few decades, oncology research has witnessed countless innovations and breakthroughs, significantly extending the lives of those affected by cancer and improving their quality of life. However, Project Optimus emphasizes the importance of dose-finding studies in early clinical development.

Trials 130

Trials Clinical Trials Clinical Trials Clinical Development 130

Pharma Mirror

JUNE 8, 2022

According to the Endpoints ASCO session: “China and the US are the world’s largest oncology research destinations, and the. The post Novotech Sponsors Endpoints ASCO 2022 Expert Panel on Accelerating Oncology Clinical Trials in China appeared first on Pharma Mirror Magazine.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Clinical Development 130

Pharmaceutical Technology

OCTOBER 14, 2022

It is currently being assessed in combination with Merck’s anti-PD-1 therapy, Keytruda, as an adjuvant treatment for high-risk melanoma patients in a Phase II clinical trial being conducted by Moderna. The company said that the data from the ongoing Phase II trial will be reported in the fourth quarter of this year.

Vaccination 289

Vaccination Vaccine Development Immune Response 289

Pharmaceutical Technology

MAY 22, 2023

SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile. The company dosed the first healthy participant in a Phase I clinical first-in-human (FIH) clinical trial in June 2022.

Immune Response 273

Immune Response Clinical Trials Clinical Trials Antibody 273

XTalks

JANUARY 22, 2025

The VLA1553-321 trial, conducted in Brazil, was the first to assess the vaccine in an endemic region. Importantly, the vaccine was well tolerated, with no safety concerns identified during the trial. Valneva is also advancing its investigational Lyme disease vaccine candidate, VLA15, currently in Phase II clinical development.

Immune Response 59

Immune Response Vaccination Vaccine Trials 59

Worldwide Clinical Trials

JULY 29, 2024

Clinical development programs must acknowledge the complexity and variability of obesity as a condition. Partnering with a CRO that emphasizes the complexity of the patient’s voice and harnesses the nuances of clinical trial design is crucial for executing successful clinical research.

Clinical Research 130

Clinical Research Research Clinical Trials Clinical Trials 130

Camargo

JULY 30, 2021

Barry Mangum talks the importance of pediatric research, its evolution over the years, and the obstacles and opportunities that the industry faces as it moves forward. How long have you been in pediatric clinical research, and how did you enter the field? So I’ve been working in that space about 43 years.

Clinical Research 226

Clinical Research Research Gene Therapy Drugs 226

XTalks

DECEMBER 12, 2024

In clinical research, 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. This distrust is further compounded by a lack of visible accountability and representation in the research process.

Clinical Trials 59

Clinical Trials Clinical Trials Clinical Research Trials 59

Worldwide Clinical Trials

MAY 14, 2024

By: Amy Raymond, Derek Ansel, Nathan Chadwick, & Juliane Mills When choosing a CRO for a rare disease study, what truly sets them apart is their methodology: the CRO’s mindset, their approach to each unique study, and their agility in navigating the inherent complexities of rare disease research. Engage stakeholders EARLY.

Trials 204

Trials Clinical Trials Clinical Trials Research 204

pharmaphorum

MARCH 12, 2021

COVID-19 has transformed the way we think about patient participation in trial design – but there are still many barriers to overcome in improving engagement. Speakers at the NIHR’s recent virtual event for the pharma industry discussed best practices for bringing patient insights into research.

Trials 132

Trials Research Pharma Companies Clinical Trials 132

Pharmaceutical Technology

OCTOBER 21, 2022

Hookipa Pharma and Roche have signed a strategic partnership and licence agreement for developing HB-700 and another undisclosed arenaviral immunotherapy. Under the deal, Hookipa will carry out research and initial clinical development through Phase Ib for HB-700 to treat KRAS-mutated cancers.

Development 278

Development Production Licensing Licensing 278

Pharmaceutical Technology

NOVEMBER 30, 2022

The latest development is based on data obtained from an open-label clinical trial of Biktarvy. According to the trial findings, the treatment was demonstrated to be effective and well-tolerated through 24 weeks in adolescents who are virologically suppressed and children with HIV infection.

Marketing 246

Marketing FDA Approval Clinical Trials Clinical Trials 246

pharmaphorum

NOVEMBER 17, 2020

Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research. Improving the design of commercial research by listening to the patient voice.

Clinical Trials 116

Clinical Trials Clinical Trials Trials Life Science 116

XTalks

MARCH 26, 2025

In the fast-evolving field of clinical research, 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 clinical research: 1.

Clinical Research 52

Clinical Research Research Branding Clinical Trials 52

Pharmaceutical Technology

JUNE 12, 2023

Six cannabinoids have recently completed or are undergoing Phase II trials. In 2022, Pfizer acquired the drug, with the promise of accelerating clinical development via new, differentiated, and best-in-class approaches, enhancing optimism for further drug development.

Drugs 358

Drugs Development Clinical Development Sales 358

XTalks

AUGUST 22, 2023

Recruiting participants is perhaps the most challenging aspect of any clinical trial, 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 Clinical Trials For All?

Clinical Trials 97

Clinical Trials Clinical Trials Trials Clinical Research 97

Outsourcing Pharma

DECEMBER 8, 2020

An expert from the clinical research technology specialist discusses how trial teams can use real-world evidence to improve study inclusivity.

Trials 119

Trials Clinical Research Research Clinical Development 119

Worldwide Clinical Trials

APRIL 15, 2024

As the clinical research landscape continually evolves, the choice of a Contract Research Organization (CRO) partner can significantly impact the success of drug development programs.

Clinical Trials 130

Clinical Trials Clinical Trials Clinical Development Clinical Research 130

XTalks

JANUARY 17, 2024

Estimates based on publicly available information suggest more than 40 percent of all new therapies in development are cancer treatments. Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense.

Clinical Trials 124

Clinical Trials Clinical Trials Trials Gene Therapy 124

XTalks

FEBRUARY 9, 2023

Leading clinical trials technology platform provider Medable announced a new partnership with Nova Scotia Health Innovation Hub for a two-year pilot study to improve oncology trial access for patients in rural Nova Scotia through Medable’s decentralized clinical trial (DCT) platform.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98