Drug Target Review

APRIL 7, 2025

In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drug developers for phase I trials, second only to navigating regulatory compliance (- 38 percent). To qualify as endpoints, biomarkers used in early phases must be relevant to later stages of drug development.

Clinical Development 69

Clinical Development Clinical Trials Clinical Pharmacology Trials 69

Vial

DECEMBER 4, 2023

Clinical research is an integral component of the healthcare ecosystem. The success of clinical research hinges crucially on patient participation; however, attracting and retaining participants can often pose significant challenges. Patient Payments in Clinical Research: Perception Over the Years In the U.S.,

Clinical Research 52

Clinical Research Research Clinical Trials Regulations 52

Quanticate

JULY 5, 2024

It’s essential for maintaining ethical standards, high-quality outcomes and facilitating global standardisation, enabling multi-center and multinational studies, thereby streamlining the development and approval process for new medical treatments, and maintaining public trust in clinical research.

Clinical Research 111

Clinical Research Drug Development Treatment Research 111

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

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 52

Clinical Trials Trials Clinical Research Research 52

Advarra

MARCH 14, 2023

Investigational new drugs (INDs): Storage for INDs. Review sessions: Enable organizations to grant limited eReg access to both internal and external monitors in order to more easily review documents. The post eReg Benefits for Clinical Research: Use Cases for all Types of Sites appeared first on Advarra.

Clinical Research 52

Clinical Research Research Compliance Clinical Trials 52

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

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.

Drugs 111

Drugs FDA Disease Animal Testing 111

PPD

JUNE 7, 2023

Food and Drug Administration (FDA) for approval , much work remains for drug developers aiming to advance treatments for pediatric populations. Reflecting Patient Diversity in NASH Trials Data from NASH clinical trials within adult populations may support clinical research into treatment for pediatric populations.

Trials 98

Trials Clinical Trials Clinical Research Disease 98

PPD

AUGUST 5, 2024

Historically, the available drugs and U.S. Food and Drug Administration (FDA)-approved therapies for treating PAH were primarily vasodilators, designed to overcome the imbalance between vasoactive and vasodilator mediators and to restore endothelial cell function. From that experience, we offer seven key takeaways.

Clinical Trials 98

Clinical Trials Trials Clinical Research Disease 98

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.

Trials 75

Trials Disease Clinical Trials Clinical Research 75

PPD

MARCH 13, 2024

This significance and focus are ever more apparent when the starting cellular material is imperative to drug product success. Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy.

Clinical Development 98

Clinical Development Clinical Trials Therapies Trials 98

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. About QuartzBio QuartzBio helps overcome the data chaos inherent in modern drug development.

Clinical Research 40

Clinical Research Research Engineering Clinical Development 40

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.

International 52

International Clinical Research Clinical Development Research 52

Advarra

JUNE 18, 2024

Clinical research is complex and resource-intensive, and to understand just how far an organization’s resources can go, assessing a study’s feasibility is critical for success. Evaluating feasibility elements enable organizations to make informed decisions and allows for seamless execution and reporting of clinical studies.

Clinical Trials 97

Clinical Trials Trials Clinical Research International 97

The Pharma Data

DECEMBER 11, 2020

Among the targets, the majority are vaccine makers that have COVID-19 vaccines in various stages of clinical trials. One is a clinical research organization involved in trials, and one has developed a COVID-19 test,” Microsoft said.

Vaccine 52

Vaccine Drug Development Government Clinical Research 52

PPD

JULY 16, 2024

By staying abreast of shifting regulatory considerations and delivering thoughtful, timely guidance on how those changes affect real-world drug and device development, PPD FSP Pharmacovigilance solutions experts ensure that our clients remain compliant. China: In 2020, China overhauled its PV requirements.

Compliance 98

Compliance Regulations Production Trials 98

Conversations in Drug Development Trends

AUGUST 9, 2024

However, implementing adaptive trial designs within MRCTs requires careful consideration of international regulatory standards to optimize patient outcomes and resource efficiency. The International Council for Harmonisation of Technical Pharmaceuticals for Human Use provides guidelines, but local adaptations and interpretations still vary.

Trials 80

Trials Clinical Trials Regulations FDA 80

Vial

JUNE 12, 2024

Utilizing PROs enables the active participation of patients in their care outcomes – both in a clinical setting and in clinical research. PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated.

Clinical Trials 52

Clinical Trials Trials FDA Clinical Research 52

The Pharma Data

JUNE 26, 2021

Despite the established clinical efficacy of tamoxifen and AIs in early breast cancer, many patients experience disease recurrence because of resistance to therapy, non-adherence or premature discontinuation of their adjuvant therapy. For further information, please visit the EORTC website: www.eortc.org.

Clinical Trials 52

Clinical Trials International Trials Therapies 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

Advarra

JULY 18, 2022

To protect human subjects in clinical research, the Food and Drug Administration (FDA) maintains and enforces specific regulations. Research stakeholders must track, document, and store the required information for trial oversight and monitoring to comply with regulations. What Documents are in an eISF?

Research 52

Research Clinical Trials Compliance Regulations 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

PerkinElmer

FEBRUARY 18, 2021

Industry leaders reveal how high throughput screening is changing in R&D What do you think are the major trends in drug discovery R&D? Here, we summarize the top 10 survey findings on drug discovery trends for the top 20 Pharma leaders in R&D. Top 10 trends in pre-clinical drug discovery at top 20 Pharma 1.

Biochemical Assays 52

Biochemical Assays Drugs Small Molecule Pharma Companies 52

The Pharma Data

DECEMBER 24, 2020

24, 2020 — Two widely used types of blood pressure drugs aren’t tied to an increased risk of COVID-19 infection or complications, according to a new study. To learn more, the researchers analyzed data from more than 1.1 THURSDAY, Dec. ” © 2020 HealthDay.

Clinical Research 52

Clinical Research Hospitals International Research 52

The Anticancer Fund

NOVEMBER 16, 2022

17 November 2022 Language EN Drug repurposing is a strategy for identifying new uses for approved drugs, outside the scope of the original indication. Below, we have listed recent findings about the repurposing of generic drugs in oncology. It is one of the focus areas of the Anticancer Fund.

Drugs 52

Drugs Clinical Trials Trials Treatment 52

The Pharma Data

NOVEMBER 1, 2020

CAMBRIDGE, England–( BUSINESS WIRE )– Mission Therapeutics (“Mission”), a drug discovery and development company focused on selectively inhibiting deubiquitylating enzymes (DUBs), has appointed Dr Suhail Nurbhai as Chief Medical Officer (CMO) with immediate effect. 2, 2020 08:00 UTC. This press release features multimedia.

Clinical Pharmacology 52

Clinical Pharmacology Small Molecule Clinical Research Science 52

Conversations in Drug Development Trends

NOVEMBER 3, 2022

BioPharma Dive interviewed our Derek Ansel on how to conduct psychedelic clinical research. In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. Looking to diversify the reach of your orphan drug trial? altogether.”.

Disease 52

Disease Clinical Trials Trials International 52

Alta Sciences

SEPTEMBER 13, 2023

Pain models can be important clinical tools to characterize a novel analgesic, and determine its potential effectiveness in models simulating varying pain stimuli. Thermal pain models Thermal models involve testing and researching the effects of analgesic drugs utilizing heat-induced pain and sensitivity.

Clinical Trials 52

Clinical Trials Treatment Trials Drug Development 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

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. Ready to work with a transformative FSP partner?

Clinical Development 52

Clinical Development Drug Development International Clinical Research 52

Advarra

AUGUST 1, 2023

Efficient and compliant data capture can make or break the success of a clinical research trial. For example, if there are questions about lab results, staff can work internally with the care team to identify any clinically significant findings. Defining eSource and EDC First, it may be helpful to define e Source and EDC.

Compliance 52

Compliance Clinical Research Trials Research 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.

FDA Approval 52

FDA Approval FDA Clinical Development Clinical Research 52

Vial

MAY 15, 2024

Vial | Pros and Cons The unprecedented consequences of the COVID-19 pandemic gave rise to the advent of decentralized clinical trials (DCTs), which are studies that use telemedicine and remote or local healthcare professionals to enable participants to join from different locations. billion and now functions as a subsidiary.

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

Vial

MARCH 27, 2024

The Costs of Working with a CRO Running clinical trials is an integral part of the pharmaceutical industry, crucial to the development and approval of new drugs and treatments. For new drugs approved by the US Food and Drug Administration (FDA) , pivotal phase 3 studies cost a median of $41,117 per patient.

Clinical Trials 52

Clinical Trials Trials International Compliance 52

Conversations in Drug Development Trends

APRIL 3, 2024

Complying with Unique Radiopharmaceutical Regulations The regulatory landscape for radiopharmaceuticals is intricate, reflecting the drugs’ complexity. By emphasizing transparency and patient autonomy, trials can maintain ethical standards while fostering trust and participation.

Trials 81

Trials Clinical Trials Compliance Treatment 81

The Pharma Data

JANUARY 14, 2021

Dr. Dickstein enjoyed 30 years in the pharmaceutical field before retiring in 1998 as the vice president of clinical research for Transcend Therapeutics, Inc. Factors such as position, noteworthy accomplishments, visibility, and prominence in a field are all taken into account during the selection process.

Laboratories 52

Laboratories Clinical Research Hospitals Pharmaceuticals 52