PPD

NOVEMBER 11, 2024

Accelerate your drug development and clinical trial goals and benefit from our 360° CDMO and CRO solutions and expertise. Partner with us The post Redefining Acceleration of the Drug Development Journey appeared first on PPD.

Drug Development

Quanticate

JUNE 13, 2025

Clinical research generates vast amounts of diverse data from laboratory tests, patients, medical equipment, and outside sources. By organising and analysing this information, researchers can extract actionable insights that improve patient outcomes, data accuracy, drug efficacy and speed up trials.

Clinical Trials

FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

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. In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2

Clinical Development

Conversations in Drug Development Trends

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

Research

Drug Target Review

APRIL 7, 2025

A surrogate endpoint is a marker used in clinical trials as a substitute for a direct clinical outcome. Diagnostic biomarkers typically confirm or establish a diagnosis and are often used in selecting patient populations for clinical trials.

Clinical Development

PPD

MARCH 11, 2025

While individual rare diseases affect populations that are small in numbers, collectively they impact millions globally, posing significant health and research challenges. Moreover, in some rare disease trials, it is unethical to design a control group of patients with a placebo.

Drug Development

PPD

FEBRUARY 10, 2025

In the past, these developers mostly used in-house resources for their clinical monitoring and site management capabilities, whereas today they often prefer functional service provider (FSP) or full-service outsourcing (FSO) models, or a hybrid of the two, to ensure on-time and on-budget delivery of clinical operations.

Clinical Trials

Drug Target Review

JULY 3, 2025

It is becoming increasingly evident that generative artificial intelligence (GenAI) is a resourceful tool for helping pharmaceutical companies reduce manual tasks required by clinical trials. Because LLMs are trained on extensive, internet-scale datasets, they can learn to identify contexts linking words and language.

Drug Development

Drug Target Review

DECEMBER 16, 2024

Dr Pooja Hingorani, Senior Medical Director of Oncology Early Development at AbbVie , shares her journey in STEM, from her early days in New Delhi to her impactful career in oncology research and drug development. In addition to this, I also chaired national trials evaluating an anti-GD2 antibody in pediatric osteosarcoma.

Medical Schools

Advarra

DECEMBER 17, 2024

2024 has been a year of growth and evolution in clinical research. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinical research, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.

Clinical Research

Drug Target Review

AUGUST 14, 2025

Until recently, treatment has largely focused on controlling symptoms, but the rise in engineered cell therapies has prompted researchers to explore new ways to restore immune balance, offering patients the possibility of lasting remission. That early-stage research would later prove pivotal.

Engineering

PPD

DECEMBER 16, 2024

The drug development industry faces rising costs and increasingly complex protocols as top challenges, with 49% of developers citing costs as their primary concern and 39% pointing to protocol complexity as a key hurdle, according to a recent survey of 150 drug developers worldwide by the PPD clinical research business of Thermo Fisher Scientific.

Drug Development

Advarra

NOVEMBER 14, 2024

In an era where clinical trials are increasingly global, it’s more imperative than ever to leverage international expertise. Data and safety monitoring boards (DSMBs), also known as data monitoring committees (DMCs), play a critical role in overseeing a clinical trial’s safety and efficacy.

Clinical Trials

Broad Institute

NOVEMBER 25, 2024

Ladders to Cures (L2C) Accelerator By Maria Nemchuk November 25, 2024 Breadcrumb Home Ladders to Cures (L2C) Accelerator The Ladders to Cures (L2C) Accelerator aims to catalyze progress across the research ecosystem and accelerates advances leading to treatments and cures for patients with rare genetic diseases. Visit broad.io/L2C2023

Clinical Trials

PPD

JANUARY 2, 2025

Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. clinical operations, pharmacovigilance, regulatory) across various medicinal products, a portfolio of studies or the entire company.

Clinical Development

PPD

JULY 29, 2025

Biopharma and biotech industries are facing remarkable challenges as the cost of developing new drugs has surged dramatically and clinical trial timelines have extended significantly. For example, over the past decade, the average time required to complete a clinical trial has increased by approximately 20-30%.

Clinical Trials

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

Drug Target Review

MAY 23, 2025

At the forefront of this development is Dr Liam Tremble, Principal Scientist at Poolbeg Pharma, whose background as an immunologist and cancer researcher gives him a unique perspective on this promising drug. Our goals are to progress our pipeline and position each asset for clinical and commercial success.

Immune Response

Quanticate

FEBRUARY 27, 2025

Wearable technologies have become a driving force in modern healthcare, transforming how data is collected, monitored, and analysed in clinical research.

Clinical Trials

The Pharma Data

JUNE 15, 2025

Clinical Development Plans and Future Outlook Intellia’s ongoing Phase 3, randomized, double-blind, placebo-controlled HAELO trial is currently assessing the safety and efficacy of lonvo-z at the 50 mg dose in a larger patient population.

Treatment

Drug Target Review

MARCH 4, 2025

Phenomix Sciences, built on over a decade of clinical research at the Mayo Clinic, is disrupting this outdated approach. The research demonstrated that obesity is not one disease, but many; each of which should be treated with different interventions, says Bagnall.

Therapies

Advarra

JULY 3, 2025

10 areas that may impact your organization The third revision (R3) of the ICH E6 Guideline for Good Clinical Practice represents a significant modernization of global clinical research standards. Quality by Design (QBD): Are your trials fundamentally incorporating QBD concepts in development? These include: 1.

Compliance

PPD

JULY 18, 2025

Effective communication with regulatory authorities is critical for small biotech companies, as it is often the key to success in clinical trials. Before these meetings, it is important to do the necessary research on the agency involved and what information they will want.

Regulations

KIF1A

JUNE 20, 2025

Wearable Digital Data Collection Is On the Horizon: Meet BioSensics KIF1A.ORG is thrilled to announce an exciting new initiative to enhance our natural history study and accelerate progress toward clinical trials: wearable digital data collection in partnership with BioSensics , a leading innovator in digital health monitoring for rare diseases.

Clinical Trials

Alta Sciences

DECEMBER 31, 2024

One of the most important factors to consider during the course of your early-phase clinical research is drug-drug interactions (DDIs), which occurs when one drug alters the effect of another, either by reducing its effectiveness or elevating systemic concentrations to potentially dangerous levelsultimately causing side effects.

Therapies

ProRelix Research

MAY 14, 2025

In the ever-advancing field of pharmaceutical development, regulations surrounding drug clinical trials in the United States serve a critical purpose.

Clinical Trials

PPD

JUNE 17, 2025

In the past decade alone, the time needed to complete a clinical trial has increased by 20–30%, and the cost to bring a new drug to market has risen to an average of about $2.6 Biopharmaceutical and biotech drug developers have faced increasing challenges in recent years.

Clinical Development

PPD

JUNE 20, 2025

The complexity of diagnosing IPF, understanding its root causes, and translating preclinical findings to clinical success make it a challenging disease for drug development. However, recent advancements and strategic approaches in clinical trials offer hope that additional treatments are on the way.

Clinical Development

ProRelix Research

MAY 13, 2025

The landscape of Indian clinical trial regulations has undergone a profound transformation over the past two decades.

Clinical Trials

PPD

FEBRUARY 12, 2025

Its important for your clinical research organization (CRO) to continually assess and invest in capabilities that help drive the success of your clinical program. There are three core areas we are strategically addressing this year. They include: 1.

Clinical Supply

Fierce BioTech

JULY 17, 2025

Overcome Critical Retention Challenges in Obesity Trials Ready to transform your obesity trial outcomes? smarcus Thu, 07/17/2025 - 17:29 Ready to transform your obesity trial outcomes? Avacare Clinical Research Network Resource Type Whitepaper avacare_clinical_research_network_logo-250x190.png

Trials

Conversations in Drug Development Trends

NOVEMBER 5, 2024

In preparation for World Orphan Drug Congress Europe, we interviewed Nathan Chadwick, Senior Director, Therapeutic Strategy Lead, Rare Disease, and Derek Ansel, MS, LCGC, Vice President, Therapeutic Strategy Lead, Rare Disease, to hear their insights into the current progress in rare disease research and their hopes for 2025.

Disease

thought leadership

JULY 31, 2025

A  Contract Research Organization (CRO)  is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. CROs offer a wide range of services, including:

Pharmaceuticals

The Pharma Data

JUNE 12, 2025

Disease Activity Improvement at Week 48 — Primary Endpoint Met The Phase 3 PHOENYCS GO study, a multicenter, double-blind, placebo-controlled trial, investigated dapirolizumab pegol’s ability to reduce disease activity in people living with SLE, a complex, chronic autoimmune disease predominantly affecting women.

Disease

thought leadership

AUGUST 14, 2025

Staffing has become one of the most critical and complex challenges in the success of Functional Service Providers (FSP) within clinical research. Unfortunately, traditional recruitment methods often fall short, leaving timelines, compliance, and quality gaps.

Compliance

The Pharma Data

JUNE 20, 2025

The SUNMO trial evaluated subcutaneous Lunsumio in combination with intravenous Polivy in comparison to R-GemOx, a standard salvage regimen for transplant-ineligible LBCL. With a median follow-up of 23.2 months , the study demonstrated a 59% reduction in the risk of disease progression or death with the investigational combination.

Treatment

New Drug Approvals

JULY 8, 2025

Clinical Trials: Pritelivir is currently in phase II clinical trials, with ongoing research into its effectiveness and safety. Research and Development: Pritelivir is being developed by AiCuris Anti-infective Cures, building upon research from Bayer. Johnston, C. 316 (23): 2495–2503. 2016.18189.

Virus