Antidote

APRIL 4, 2024

Before it is released onto the market, the development of any new drug or medical device must undergo rigorous testing , part of which involves clinical trials. Clinical trials are integral to making sure that any new therapy is both safe and effective for individuals, and volunteers are a vital part of the process.

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Quanticate

NOVEMBER 21, 2024

An efficacy endpoint in oncology is a characteristic or variable that measures how beneficial a treatment is to a patient’s feeling, function, and survival in a clinical trial. They are essential for assessing whether new cancer therapies are safe and efficacious [1].

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PPD

OCTOBER 17, 2024

Cell and gene therapy (CGT) studies are rapidly gaining momentum in the Asia-Pacific region, fueled by growing patient demand and a thriving ecosystem of innovation. In China, the high incidence of solid tumors is driving an urgent need for advanced therapies, spurring the push for new treatment approaches.

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Antidote

JANUARY 3, 2023

Before becoming available to patients, every medication, therapy, and intervention must undergo a rigorous approval process: the clinical trial. Clinical trials are divided into phases that are aimed at testing the safety and efficacy of every potential new treatment before it is able to enter the market.

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Clinical Trials Trials Therapies Treatment 97

PPD

DECEMBER 16, 2024

Cost and complexity go hand-in-hand The rising costs and growing complexity in clinical trials are deeply linked, with patient recruitment, extended timelines and meeting regulatory demands emerging as some of the key drivers. Nearly half (49%) of clinical trial sponsors surveyed identified rising costs as their foremost concern in 2024.

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PPD

MARCH 11, 2025

Breaking through research barriers Challenge #1: Small groups of patients Rare diseases impact a small number of individuals, making it difficult to recruit enough participants for clinical trials. Moreover, in some rare disease trials, it is unethical to design a control group of patients with a placebo.

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Drug Development Clinical Trials Disease Trials 52

PPD

AUGUST 14, 2024

Clinical trials have significantly increased in complexity over the last 20 years, creating new challenges. Patients are eager to participate in trials but remain largely unaware of their availability despite growing efforts to recruit. The increase in complexity isn’t just creating challenges for patients.

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Clinical Trials Trials Clinical Research Research 92

Drug Target Review

JULY 4, 2023

These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. The global ADC market is expected to continue this steep upward trajectory and is anticipated to exceed $16 Billion by 2026. 3D rendering of Antibody Drug Conjugate Molecules.

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Conversations in Drug Development Trends

OCTOBER 14, 2024

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. Given the complexity and widespread impact of autoimmune and bone health conditions, developing new therapies is essential.

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Research Clinical Trials Therapies Immune Response 52

PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. Many of these patients’ conditions are disabling.

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Trials Clinical Trials Drug Development Therapies 69

PPD

OCTOBER 8, 2024

With FSO, all clinical trial tasks (e.g., In a hybrid model, one or more FSP offerings are added to a new or existing FSO arrangement to optimize clinical trial operations or address unforeseen circumstances and changing demands. study startup, data management, clinical monitoring, pharmacovigilance, regulatory affairs, etc.)

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Antidote

JULY 29, 2022

The process of getting a new drug to market is an expensive one. billion to bring a new therapy to market. Between 2009 and 2018, U.S. biopharmaceutical companies spent about $1 billion per drug according to an analysis published in JAMA , and other studies have found that it can cost up to $2.8

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Conversations in Drug Development Trends

APRIL 3, 2024

By: Sue Batchelor, Executive Director, Oncology Project Management Radiopharmaceuticals represent a cutting-edge frontier in oncology treatment, offering the promise of highly targeted therapy with the potential to revolutionize cancer care. Are you aware of the challenges you must address for a successful radiopharmaceutical trial?

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Trials Clinical Trials Compliance Treatment 81

Drug Target Review

JUNE 19, 2024

The mission of Lineage Cell Therapeutics is to deliver on some of the early promises of cell therapy. Cell therapy as a concept is a wonderful idea, but many of the early efforts never generated the kind of clinical data that gets people excited and leads to new medicines. Hearing aids also have all sorts of deficits.

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Therapies Small Molecule Pharmaceutical Companies Molecular Biology 84

Antidote

JULY 27, 2023

Before any new therapy can be put on the market, it must be tested to ensure its safety and effectiveness, and the research for this process is done through clinical trials.

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Clinical Research Research Clinical Trials Packaging 98

Antidote

FEBRUARY 22, 2024

Behind every new treatment is the incredible team of doctors, researchers, patients, and clinical trial specialists who worked on the research that made it possible.

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Clinical Trials Trials Doctors Therapies 69

DrugBank

OCTOBER 17, 2024

By harnessing the vast amounts of data generated throughout the development pipeline, pharmaceutical companies can accelerate the discovery of novel therapies, optimize clinical trial design, enhance drug safety monitoring, and deliver personalized medicine, ultimately improving patient outcomes and transforming the future of healthcare.

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Conversations in Drug Development Trends

NOVEMBER 5, 2024

NC: I think the continued growth in cell and gene therapy research and the approvals we’re seeing for genetically-driven rare diseases. Their virtual platform is fantastic, as well as their collaboration with the European Reference Network are all things CROs should leverage to support their trials. DA: Several things!

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Disease Clinical Trials Therapies Clinical Research 52

Drug Patent Watch

DECEMBER 9, 2024

From Lab to Market: The Long Road of Drug Development Once a promising compound is identified, it enters the long and costly process of drug development. While the compound itself couldn’t be patented, various derivatives and combination therapies have been patented, allowing for continued development and distribution.

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PPD

FEBRUARY 10, 2025

By harnessing the full range of innovative technologies and taking advantage of an FSP partners extensive skills and experience, sponsors are able to bring their therapies to market more quickly and within budget even in the face of complicated global regulations and widely fluctuating workloads.

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Clinical Trials Trials Clinical Research Research 52

The Pharma Data

JANUARY 5, 2021

Sponsors of human gene therapy (GT) products for neurodegenerative diseases affecting adults and children should initiate first-in-human clinical trials in adults before undertaking pediatric trials, according to new draft guidance the FDA released last week. Crossover designs may also be considered in such trials.

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Trials Therapies Disease Clinical Trials 52

Drug Target Review

AUGUST 6, 2024

Liver Fibrosis : Targeted therapies using ADCs could help reduce liver fibrosis and prevent the progression to cirrhosis. Expedited programs like the FDA’s Breakthrough Therapy Designation and Fast Track can shorten development timelines and reduce risk. Oncology drugs often command high prices, potentially leading to higher ROI.

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Therapies Pharmaceutical Companies Disease Treatment 119

Cytel

SEPTEMBER 8, 2023

Single-arm trials, unlike placebo-controlled randomized control trials, forgo the use of a placebo or standard-of-care as a control and establish clinical benefit by demonstrating the effects of a new therapy or treatment via comparison with a synthetic control arm (SCA) derived from external sources.

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Trials Therapies Treatment Marketing 59

Antidote

JULY 9, 2024

Though clinical trials are often discussed in the context of medications and therapies, the devices that administer these medications must also be approved by the FDA before they can be released to market.

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Clinical Trials Trials FDA Therapies 52

LifeSciVC

JANUARY 16, 2024

These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. Additional trials (e.g.,

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DrugBank

SEPTEMBER 26, 2024

Due to the less extensive clinical trial requirements and the competitive nature of the biosimilar market, these biologics can be produced and marketed at significantly lower prices than their reference counterparts. Still, significant differences exist between these two major markets.

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Biosimilars Clinical Trials Production FDA 98

Conversations in Drug Development Trends

MAY 1, 2024

This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials. Searching for overlap might allow the investigational product to have a more rapid marketing authorization in multiple regions.

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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.

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Conversations in Drug Development Trends

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.

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Antidote

MAY 1, 2023

Clinical trials are crucial to advancing medical breakthroughs and bringing new therapies or treatments to market. Unfortunately, many clinical trials are not designed with a patient-centered approach. However, for research studies to be effective, it is vital that patients take part.

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Clinical Trials Trials Therapies Treatment 52

Antidote

MARCH 17, 2023

Before any new medication, therapy, or treatment is put onto the market, it must first be approved by the Food and Drug Administration. Part of this approval process is thorough testing through clinical trials to ensure that any therapy is safe and effective before it is released to the general public.

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Clinical Trials Trials Therapies Treatment 52

DrugBank

MARCH 7, 2024

The landscape of weight loss drugs has been rapidly evolving, and 2024 is poised to be another transformative year in this market. Pharmaceutical researchers, in particular, have a keen interest in understanding the unfolding dynamics of this market. Let’s delve into what lies ahead in the coming year.

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Vial

JUNE 18, 2024

The success of clinical trials hinges on increasing access to participation by all eligible patients, including populations that have been underrepresented due to the barriers highlighted below. Representation, Underrepresentation & Diversity in Clinical Trials Studies indicate a need to increase patient accessibility to clinical trials.

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Conversations in Drug Development Trends

MAY 23, 2024

By: Sarah Bly, Regulatory Science and Innovation and Matt Cooper, Executive Director, Therapeutic Strategy Lead, Oncology The European Union (EU) presents a unique set of regulatory challenges and opportunities for clinical trials in oncology. Increased Transparency : Ensures that information on clinical trials is more accessible.

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Trials Clinical Trials Therapies Treatment 52

Drug Target Review

DECEMBER 5, 2024

Viral vectors have been crucial in transforming the gene therapy landscape due to their natural ability to infect cells. 1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2.

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The Premier Consulting Blog

OCTOBER 21, 2024

Accelerated approval is an expedited regulatory pathway designed to hasten the availability of drugs (including biologics) that treat serious conditions, offer advantages over existing therapies, and address unmet medical needs. In essence, these trials are the final step that turns provisional approval into full approval.

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Trials FDA Clinical Trials Disease 52

National Institute on Drug Abuse: Nora's Blog

MARCH 6, 2025

Advancing reduction of drug use as an endpoint in addiction treatment trials astewart Thu, 03/06/2025 - 09:59 Nora's Blog March 18, 2025 Image Getty Images/ SolStock This blog was also published in the American Society of Addiction Medicine (ASAM) Weekly on March 18, 2025.&

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