PPD

MARCH 11, 2025

Developing treatments for individuals living with rare diseases is critical, but orphan drug development is laden with unique obstacles that necessitate innovative, multifaceted approaches. DCEs typically produce population-level estimates and require large samples to be robust.

Drug Development 52

Drug Development Clinical Trials Disease Trials 52

PPD

JANUARY 15, 2025

As a result, drug developers make better decisions more quickly (removing 50% of study timeline whitespace) to bring new therapies to market faster. Ready to learn more about how to leverage AI and machine learning to maximize your clinical trial efficiency? Get in touch.

Clinical Trials 95

Clinical Trials Trials Clinical Research Drug Development 95

PPD

MARCH 13, 2024

Due to overall efficiencies and a proactive risk mitigation approach to the cellular supply chain, timelines are continuously adhered to, allowing smooth cohort transitions and the potential to expedite drug development timelines.

Clinical Development 98

Clinical Development Clinical Trials Therapies Trials 98

Conversations in Drug Development Trends

AUGUST 15, 2023

Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. Our consultative approach ensures success by integrating research methodology, regulatory affairs strategy, and clinical operations.

Clinical Development 98

Clinical Development Government Clinical Trials Trials 98

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.

Drug Development 98

Drug Development Clinical Trials Drugs Clinical Research 98

PPD

JUNE 17, 2025

Biopharmaceutical and biotech drug developers have faced increasing challenges in recent years. 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

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Clinical Development International Drug Development Clinical Research 52

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.

Clinical Research 81

Clinical Research Disease Research Clinical Trials 81

Alta Sciences

JUNE 21, 2024

Simpler Clinical Development From Day Dot blussier Fri, 06/21/2024 - 19:10 HTML Connecting the Dots With Comprehensive CRO Solutions When you CONNECT THE DOTS, you open a world of possibilities. With you in mind, we establish a clear and consistent path from drug discovery to delivery—one solution seamlessly connecting to the next.

Clinical Development 52

Clinical Development Clinical Trials Clinical Research Drug Development 52

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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Clinical Trials Clinical Development Trials Pharmaceutical Companies 136

Conversations in Drug Development Trends

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Yet, it becomes a manageable aspect of drug development with careful planning, strategic engagement, and flexible problem-solving.

Clinical Research 69

Clinical Research Trials Clinical Trials Research 69

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.

Clinical Research 98

Clinical Research Pharmaceutical Companies Clinical Development Drug Development 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

Clinical Trials Pharmacokinetics Drug Development Clinical Development 98

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.

Clinical Development 52

Clinical Development Clinical Trials Trials Clinical Research 52

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.

Clinical Development 52

Clinical Development Drug Development Clinical Research Treatment 52

Conversations in Drug Development Trends

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 52

Clinical Research Research Clinical Trials Treatment 52

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.

Therapies 97

Therapies Clinical Trials Clinical Research Trials 97

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.

International 87

International Clinical Development Clinical Trials Clinical Research 87

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.

Clinical Trials 98

Clinical Trials Trials Clinical Research Drug Development 98

Conversations in Drug Development Trends

JANUARY 24, 2024

However, clinical research around Fragile X is considerably robust, making the possibility of clinical trial participation a potential motivation for parents to choose to undergo genetic testing for their children. These datasets can help find providers and patients based on genetic information.

Trials 75

Trials Disease Clinical Trials Clinical Research 75

Drug Target Review

MAY 23, 2025

It takes a family to develop a drug Trembles role at Poolbeg is multifaceted, reflecting the collaborative ethos of the companys scientific team. I take responsibility for identifying pre-clinical research that can support our clinical programs, as well as designing and overseeing its execution, he explains.

Immune Response 52

Immune Response Therapies Treatment Clinical Trials 52

Precision for Medicine

JANUARY 23, 2023

QuartzBio’s suite of end-to-end SaaS solutions provides pharmaceutical and biotech clients with a fully connected data ecosystem linking sample, biomarker, and clinical data to improve collaboration, planning and R&D productivity. This convergence of trials, labs and data sciences is driving faster clinical development and approval.

Clinical Research 40

Clinical Research Research Clinical Development Engineering 40

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. Our mission is a lofty one.

FDA 96

FDA Trials Clinical Trials Disease 96

Alta Sciences

JULY 22, 2024

Insights in FIH studies provide valuable information on potential dosing, efficacy, and safety, and serve as a good guide for the regulatory requirements needed throughout clinical development. jpg Tags Clinical Trials Weight 1

Trials 52

Trials Clinical Trials Clinical Development Clinical Research 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

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

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.

Clinical Research 59

Clinical Research Regulations Packaging Drug Development 59

Fierce BioTech

DECEMBER 23, 2024

First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.), and often require consistent batches of drug product be administered to groups of research participants within a short timeframe, early phase studies present unique challenges for drug developers not typically experienced in later stages of development.

Pharmacy 52

Pharmacy Trials Clinical Trials Clinical Development 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

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.

Clinical Research 52

Clinical Research Clinical Trials Trials Drug Development 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. Harnessing the non-clinical and clinical experience with gene therapy, she then joined Brain Neurotherapy Bio, Inc.

Therapies 111

Therapies Disease Clinical Trials Science 111

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

PPD

JULY 18, 2023

Nearly two-thirds of drug developers’ outsourcing budgets are now allocated to functional service provider (FSP) models or FSP hybrid models, according to research conducted by the PPD clinical research business of Thermo Fisher Scientific. Performance management.

Clinical Development 52

Clinical Development Drug Development International Clinical Research 52

PPD

OCTOBER 16, 2023

This enables deeper and more meaningful real-world insights on clinical study data. Tokenization can accelerate innovation in clinical trials and drug development. Once in the data lake, tokenized data can be linked using a special linking software based on the data usage agreements to create longitudinal patient data.

Clinical Trials 98

Clinical Trials Trials Research Therapies 98

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.

Clinical Trials 52

Clinical Trials Trials Clinical Development Clinical Research 52

PPD

DECEMBER 5, 2023

Non-footprint countries are regions where drug developers lack a physical presence, often in emerging markets or remote areas. These countries offer new opportunities for drug developers to access additional resources, ensure project continuity and rely on localized expertise for recruitment, regulatory insights and more.

Clinical Development 52

Clinical Development Clinical Research Drug Development International 52

Conversations in Drug Development Trends

MARCH 7, 2024

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. The post Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

Clinical Trials 52

Clinical Trials Trials FDA Drug Development 52

PPD

OCTOBER 31, 2023

If recruitment moves slowly or individuals with the wrong skills are selected, the clinical research process stalls, costing sponsors valuable time, money and resources. Selecting the Right Partnership Model Clinical research outsourcing models have changed over time to accommodate the industry’s evolving needs.

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International Clinical Research Clinical Development Research 52