PPD

JUNE 24, 2024

In the realm of vaccine development, mega trials — studies enrolling 5,000 subjects or more — have been instrumental in the fight against many pathogens, including influenza, rotavirus, malaria, RSV and most recently in the rapid development of vaccines against COVID-19.

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Vaccine Trials Clinical Trials Laboratories 97

BioPharma Drive: Drug Pricing

OCTOBER 25, 2023

An under-the-skin injection of Leqembi performed about the same as the already marketed intravenous form, according to trial results presented Wednesday. A new approval application is expected by the end of March.

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Trials Marketing Drugs 173

Conversations in Drug Development Trends

MAY 10, 2024

Over the past two decades, industry-sponsored clinical trials have targeted treatments for BPD, yielding some promising outcomes; however, broader psychiatric research often excludes BPD patients, a trend that extends to the emerging field of psychedelic studies.

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Clinical Trials Trials Treatment Drug Development 95

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

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Clinical Development Production Clinical Trials Treatment 69

Codon

NOVEMBER 3, 2024

Still, while these developments provide cause for hope, each drug or vaccine faces a variety of challenges, ranging from financial incentives for clinical trials to the difficulty of discovering new antimicrobials that pass safety and efficacy tests. A phase 3 clinical trial for M72/AS01E, funded by the Gates Foundation, began this year.

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Conversations in Drug Development Trends

NOVEMBER 12, 2024

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.

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Therapies Clinical Supply Clinical Trials Trials 72

PPD

AUGUST 5, 2024

Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success. Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success.

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Clinical Trials Trials Clinical Research Disease 98

PPD

OCTOBER 9, 2023

“Patient-centric” is used frequently to describe today’s clinical trial and health care landscape. The industry applauds that point of view and strives to include a patient-centric approach in all aspects of clinical trial designs. Patient centricity has become more than a key consideration.

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Clinical Trials Trials Compliance International 98

Drug Target Review

MARCH 24, 2025

Today, researchers must progress through multiple stages of testing: starting with in vitro studies (experiments in test tubes or petri dishes), they then move to animal studies (preclinical testing) before finally advancing to human clinical trials. Nevertheless, developing such complex models presents enormous technical challenges.

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Clinical Trials Animal Testing Pharmacokinetics Drugs 59

Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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Trials Clinical Trials Regulations FDA 80

PPD

MAY 18, 2023

Yet, four out of five care partners of people with neurodegenerative disorders have never been informed of clinical trial opportunities , according to a survey of more than 250 caregivers conducted by PPD, the clinical research business of Thermo Fisher Scientific. There’s little time to lose.

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Clinical Trials Trials Clinical Research Doctors 86

SugarCone Biotech

MARCH 2, 2025

Where TGF- is present there is no or limited IFN- secretion by T cells and that means no PD-L1 expression within the tumor microenvironment, aka the TME. No chemotherapy regimen is used in the trial. Note one important difference in the trials is the inclusion of HPV-positive patients, which the Bicara trial will exclude.

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Therapies Clinical Trials Trials Clinical Development 67

PPD

AUGUST 28, 2024

For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. This is why oncology trials must be built around patient needs, and sponsors need to balance the complexity of oncology trials with a patient-centric mindset. Many of these patients’ conditions are disabling.

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Trials Clinical Trials Drug Development Therapies 69

Quanticate

APRIL 5, 2024

Clinical trial professionals are well aware of the unique challenges presented by oncology, a therapeutic area dedicated to the prevention, diagnosis, and treatment of cancers. In this article, we delve into key CRF design considerations for oncology clinical trials.

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Trials Clinical Trials Treatment 52

Fierce BioTech

DECEMBER 23, 2024

As Phase 1 clinical trials include several different design types with multiple objectives (e.g. png Listing Introduction Join this webinar to receive expert guidance and learn key considerations for successfully planning pharmacy activities in early phase trials. Listing Image DrVince_ListingLogo_250x190.png

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Pharmacy Trials Clinical Trials Clinical Development 52

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

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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Treatment Trials Clinical Trials Drugs 68

PPD

NOVEMBER 7, 2023

Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.” Diversity in Dermatologic Disease Prevalence, Presentation and Outcomes Skin conditions affect all skin types and all racial and ethnic groups.

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Clinical Trials Trials Clinical Research Disease 59

Vial

JUNE 24, 2024

Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery. As clinical trials grow in complexity, the volume of data being gathered and utilized for these studies is expanding.

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Clinical Trials Trials Clinical Research Treatment 52

Drug Target Review

FEBRUARY 10, 2025

In just two years, CTMC has advanced eight therapies into clinical trials, harnessing genetic engineering to enhance T-cell effectiveness in the fight against cancer. This circular process presents unique challenges, but the model Bock has developed at CTMC is tailored to overcome these hurdles efficiently.

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Therapies Treatment Engineering Clinical Trials 64

Vial

JUNE 12, 2024

PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. What are PROs in clinical trials? In a study on cancer clinical trials, Pe et al. In a study on cancer clinical trials, Pe et al.

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Clinical Trials Trials FDA Clinical Research 52

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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Drug Development Clinical Trials Compliance Trials 52

PPD

OCTOBER 17, 2024

There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. Site selection presents barriers and opportunities As cell therapies expand in Asia-Pacific, areas with large hospitals are often the main hubs for innovation.

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Therapies Clinical Trials Clinical Research Trials 97

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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Clinical Trials Trials Clinical Research Research 52

SCIENMAG: Medicine & Health

MARCH 11, 2024

Credit: Insilico Medicine A study published in Nature Biotechnology presents the entire journey of INS018_055, from AI algorithms to Phase II clinical trials for the first time. Raw data from 13 preclinical experiments and 3 clinical trials referenced in this study can be accessed by visiting Insilico’s data room.

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Clinical Trials Trials 91

DrugBank

JULY 20, 2023

Rare diseases, therefore, present compelling opportunities for Drug Development. Since each disease is present in small groups of patients, this research is also fraught with complex challenges. We're excited to expand our data offering by launching a new Rare Disease add-on to complement our Clinical Trial dataset.

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Disease Clinical Trials Trials FDA 98

Conversations in Drug Development Trends

AUGUST 29, 2024

By: Nathan Chadwick, Therapeutic Strategy Lead, Rare Disease Over the last few years in clinical trials, particularly within the rare disease community, a notable shift is underway, where patients and caregivers are taking the lead in reaching out to clinical trial sites rather than the other way around.

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Clinical Trials Trials Disease Drug Development 52

Conversations in Drug Development Trends

JULY 8, 2024

By: Lisle Kingery, PhD, Therapeutic Strategy Lead, Neuroscience With depression rates at an all-time high and limited new treatments available, depression clinical trials are more important than ever. Treatment Treatment can take various forms, including therapy, medication, a combination of both, or a clinical trial.

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Clinical Trials Trials Treatment Therapies 52

Advarra

AUGUST 14, 2023

The clinical research industry is only becoming more complex and competitive as organizations are inundated with multiple trials and tight deadlines. The clinical trial process is both expensive and time-consuming, and ends more often in failure than success. of respondents reported they know what clinical trials are.

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Clinical Trials Trials Clinical Research Research 52

PPD

SEPTEMBER 7, 2023

Drug developers — from both the government and private sector — can overcome setbacks and accelerate their research by partnering with a contract research organization (CRO) that’s been at the forefront of HIV clinical trials since the earliest days of the epidemic.

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Clinical Trials Trials Clinical Research Drug Development 52

Broad Institute

NOVEMBER 25, 2024

As a proof of concept, a drug designed to target a newly discovered biological node is showing efficacy in treating rare genetic diseases in the kidney, the eye, and the brain and is now making its way to clinical trials in collaboration with a pharmaceutical partner. You can learn more about how clinical trials work here.

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Clinical Trials Disease Trials Therapies 52

Drug Hunter

JUNE 25, 2023

According to a company presentation, the 480 mg BID dose covers the ~paEC50 (~650 ng/mL) for >24 h, with a half-life of 12 hours. Oral Allosteric AR Modulator s request a trial You don’t have time to read everything, but you can’t afford to fall behind. Get ahead now by requesting a trial. already a member?

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Targeted Protein Degradation Computational Chemistry Trials Licensing 130

On Medicine

FEBRUARY 8, 2024

This is in contrast to reactive deprescribing, which is stopping a medicine in response to present harm, e.g., when side effects of a medicine cause a person to fall. Why is the CHARMER trial important? The CHARMER trial aims to i ncorporate proactive deprescribing as a routine aspect of care in Older People’s Medicine wards.

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Hospitals Trials Doctors Clinical Research 109

Chemical Biology and Drug Design

MAY 11, 2023

Abstract Parkinson's disease is among the most common forms of neurodegenerative illness, with present treatment being primarily symptomatic and frequently coming with substantial adverse effects. The figure depicts the neuroprotective role of crocin in Parkinson's disease.

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Disease Research Clinical Trials Treatment 100

SCIENMAG: Medicine & Health

JUNE 8, 2023

Researchers from Edith Cowan University (ECU) are leading ground-breaking global trials which could save lives by changing how we treat cancer in the near future.

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Treatment Vaccine Trials Research 90

Conversations in Drug Development Trends

JUNE 13, 2024

The FDA Oncology Center of Excellence (OCE) is committed to further enhancing oncology research and as a result, has recently implemented several projects aimed to revolutionize oncology clinical trials. BOIN presents a simpler alternative, particularly advantageous for researchers using a Bayesian methodology for the first time.

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Trials Clinical Trials Drug Development Clinical Development 52

DrugBank

SEPTEMBER 27, 2023

” Throughout the two days, we were able to attend a number of great presentations. Highlights include an examination of clinical trial termination reasons and an exploration of novel target groups. Check out the presentation yourself, and let us know if you have any questions.

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