PPD

MARCH 26, 2024

The PPD clinical research business of Thermo Fisher Scientific conducts an annual survey of more than 150 leaders at pharmaceutical companies around the globe to assess trends in drug discovery and development, including preferences around outsourcing and functional service provider (FSP) utilization.

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PPD

NOVEMBER 9, 2023

However, over the past decade, a trend toward incorporating multiple study populations into one protocol has slowly gathered momentum among drug developers. Improved prioritization Promising pipeline candidates with a strong early development protocol may see a positive impact to the net present value of an early-stage asset.

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PPD

NOVEMBER 21, 2023

The drug development industry is constantly adapting and evolving to bring novel therapeutics to market to improve the lives of patients across the globe. While the drug development industry experienced setbacks during the COVID-19 pandemic, the field  is again gaining momentum reminiscent of its pre-pandemic pace.

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Conversations in Drug Development Trends

DECEMBER 7, 2023

These survey results also highlight the importance of evaluating a variety of potential CRO partners of different sizes to choose the best match for your clinical development goals and corporate culture. At Worldwide, we understand that every program is different, which means every drug development path forward will be unique.

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Drug Target Review

JUNE 9, 2023

This exclusive interview with Dr Sharon Benzeno, Chief Commercial Officer, Immune Medicine at Adaptive Biotechnologies, unveils some ground-breaking research on T- cell therapy for cancer , which has seen the first TCR-based therapeutic candidate progress to clinical development, offering promising advancements in innovative cancer treatments.

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Treatment Packaging Clinical Research Therapies 105

PPD

SEPTEMBER 6, 2023

Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster.

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Drug Development Clinical Trials Drugs Clinical Research 98

PPD

SEPTEMBER 19, 2023

During the drug development process, companies have a choice of different approaches based on their development plan requirements. Whichever route a company takes, deliberate decision-making around the nature and timing of early phase studies is important to manage risks in the clinical development process.

Clinical Trials 98

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PPD

OCTOBER 8, 2024

The highly dynamic biotech industry has a core need to remain as flexible and agile as possible across the spectrum of clinical development activities. One primary way these companies create a nimble and adaptive environment is by outsourcing some portion of clinical development functions.

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Trials Clinical Trials Clinical Development Clinical Research 98

PPD

OCTOBER 17, 2024

This expansion represents a significant opportunity for both drug developers and patients, while also presenting a new and diverse set of challenges for drug developers, particularly in clinical trial execution.

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Therapies Clinical Trials Clinical Research Trials 96

LifeSciVC

JULY 17, 2024

By Mike Cloonan, Chief Executive Officer of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC The drug development process in rare diseases is rife with challenges especially when companies target significant differentiation or first-in-class targets.

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Clinical Research Disease Research Clinical Trials 44

Drug Target Review

SEPTEMBER 26, 2023

These cells demonstrate considerable promise for uncovering drug-induced perturbations to neuronal function such as seizure, and their use extends further to sedation, anti-epileptic drug discovery and modelling of neurological diseases. Another area in need of attention is central nervous system (CNS)-safety testing.

Drugs 111

Drugs FDA Disease Animal Testing 111

PPD

OCTOBER 21, 2024

Meeting the never-ending challenges of drug development in this active environment — including pressure to identify drug prospects earlier and hire more conservatively — frequently leads biotech companies to outsource some portion of clinical development functions.

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International Clinical Development Clinical Trials Clinical Research 76

Cytel

JANUARY 23, 2023

This has aligned with the broader curation of a number of new dose-escalation and efficacy designs for clinical development in oncology. A nuanced understanding of these considerations enables sponsors to ask more complex questions like:

Clinical Development 52

Clinical Development Trials Clinical Research Treatment 52

Conversations in Drug Development Trends

JANUARY 24, 2024

Much of what we discuss I covered in my presentation, “Leveraging Genetics to Support Rare Disease Clinical Trials,” at last year’s World Orphan Drug Congress (WODC) EU. In my capstone, I focused on how, if, and when genetic counselors discuss clinical trials with their patients in the context of a counseling session.

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Trials Disease Clinical Trials Clinical Research 75

The Pharma Data

SEPTEMBER 29, 2021

The new FIND-CKD study extends our clinical research for finerenone to a non-diabetic population where the unmet need is high for brand spanking new treatments to delay disease progression.”. In July, finerenone was approved under the name Kerendia® by the us (U.S.)

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Clinical Development Disease Clinical Trials Trials 52

PPD

NOVEMBER 30, 2023

As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drug development shaped the pharma and biotech industries. These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. Five Predictions for the Drug Development Industry in 2024 1.

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Clinical Trials Trials Clinical Research Drug Development 98

Cytel

NOVEMBER 29, 2022

Bayesian methods have continuously played a key role in transforming clinical research in therapeutic areas such as oncology and rare diseases, and in addressing clinical development challenges for COVID-19 drugs, devices, and biologics.

Clinical Trials 52

Clinical Trials Trials Clinical Development Clinical Research 52

Drug Target Review

DECEMBER 13, 2024

7,8 The discovery of these biomarkers provides valuable insights into prognosis and disease progression, while also guiding the clinical development of new targeted immunotherapies. Next-generation approaches Antibody Drug Conjugates (ADCs) Lung cancer therapy is enhanced by advancements in ADC technology.

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Therapies Treatment Clinical Trials Disease 98

Alta Sciences

JULY 22, 2024

Recently, we have seen increasing numbers of complex FIH studies in CNS-active drugs to gather comprehensive data with a wider range of doses as early as possible. jpg Tags Clinical Trials Weight 1

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Trials Clinical Trials Clinical Development Clinical Research 52

Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

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Conversations in Drug Development Trends

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. Discover how Worldwide is positioned to meet your needs with agility, expertise, and a truly personalized approach.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Research Pharmaceutical Companies 52

Conversations in Drug Development Trends

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.

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PPD

JULY 6, 2023

As a result, sponsors must decide whether to leverage a CRO partner even earlier in their drug development timelines to ensure proper planning for these constraints. How a CRO Accelerates Clinical Development Clinical trials are becoming increasingly complex as the industry evolves.

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Creative Biolabs

MAY 25, 2022

These cytotoxic drugs include DNA base analogs, antimetabolic drugs, tubulin inhibitors, etc. However, most of these chemotherapeutic drugs show a low therapeutic index, and serious side effects are usually attributed to the exposure of non-specific drugs to off-target tissues.

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Therapies Drugs DNA Treatment 52

The Premier Consulting Blog

JUNE 18, 2023

This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.

Drug Development 52

Drug Development Disease Clinical Trials Drugs 52

PPD

OCTOBER 2, 2024

Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Research Trials 52

Drug Target Review

FEBRUARY 29, 2024

Through further research and work as a principal investigator on clinical studies for several central nervous system indications, I laid the groundwork for a career in gene therapy drug development. This could bring more viable candidates to the clinic, leading to improved therapies for patients in need.

Therapies 111

Therapies Disease Clinical Trials Science 111

PPD

SEPTEMBER 6, 2023

Under the stresses of the COVID-19 pandemic, drug development organizations faced difficult decisions about keeping staff employed and productive. Benefits of Rebadging Under an FSP Model in Clinical Research A functional service partnership (FSP) model in clinical research can help sponsors navigate unforeseen staffing challenges.

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Clinical Research Regulations Packaging Drug Development 59

Vial

MARCH 1, 2024

Leading Global CROs To advance new therapies, pharma, biotech, and medical device sponsors engage CROs to help navigate the complex landscape of drug development and regulatory pathways and to manage clinical trials efficiently, ethically, and in compliance with good clinical practice ( GCP ) standards. billion by 2029.

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Clinical Trials Clinical Research Trials Laboratories 52

Conversations in Drug Development Trends

JUNE 13, 2024

Their webinar highlighted key initiatives like Project Optimus, recent study design trends, and the benefit a Bayesian model can have on your drug development program. However, Project Optimus emphasizes the importance of dose-finding studies in early clinical development.

Trials 52

Trials Clinical Trials Drug Development Clinical Development 52

Drug Target Review

JUNE 6, 2023

Clinical development of IL-18 therapies has been curtailed, however, by the protein’s lack of efficacy. Our deep interest in the interplay between immune cells, cytokines, and the tumour microenvironment has informed our clinical research to date as well as our IO pipeline program.

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Engineering Immune Response Biochemical Pharmacology Clinical Trials 98

PPD

JUNE 22, 2023

If your company is struggling to hire qualified clinical research associates (CRAs), you’re not alone. A decade-long CRA talent shortage intensified as the COVID-19 pandemic increased strain on the clinical research industry at large. What is causing a shortage of CRAs?

Clinical Research 52

Clinical Research Clinical Trials Trials Drug Development 52

PPD

NOVEMBER 14, 2023

Clinical research requires vast talent across a variety of roles and specialties, as well as across global locations. In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development.

Clinical Research 52

Clinical Research Clinical Development International Engineering 52

Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. Vial adopts a fixed-fee pricing model devoid of change orders to streamline cost-effectiveness in drug development.

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Clinical Trials Trials Clinical Research Compliance 52

The Pharma Data

JANUARY 6, 2021

7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. HELLERUP, Denmark , Jan. About orismilast.

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Vial

MARCH 25, 2024

With neuroscience experience in Alzheimer’s Disease (AD) and dementia, neurology , pain and addiction, rare and other diseases, and psychiatry, Worldwide has been involved in neuroscience research since the 1970s. Clinical trial designs are expected to become more complex, generating more data volume and diversity.

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Clinical Trials Trials Clinical Development Clinical Research 52

Drug Target Review

OCTOBER 16, 2024

It’s an exciting process—anticipating development risks, predicting outcomes, and aligning these with the greater vision of medical advancement. The true joy comes from navigating these complexities and asking the right questions early on, because these foundational steps are critical to the success of any clinical development process.

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