Fierce BioTech

AUGUST 19, 2024

As advancements in medical science progress, clinical research and development (R&D) are subject to more sophisticated and complex study designs and protocols that require precise global coordi | Market Insights: What’s Driving the Shift Toward FSP Models in Clinical Development?

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LifeSciVC

JULY 17, 2024

Specialty companies can play an important role in accelerating clinical development, especially in rare diseases like cystic fibrosis by being strategically opportunistic and moving quickly. The post Looking for Opportunities to Accelerate Clinical Research in Rare Diseases appeared first on LifeSciVC.

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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.

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PPD

NOVEMBER 9, 2023

Our dedicated, global and highly experienced cross-functional early development team is ready to support you through this journey. The partner you select for your early phase studies is critical in enabling you to achieve your overall development timeline efficiently and within budget.

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PPD

NOVEMBER 21, 2023

To keep a pulse on this rapidly changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 leaders in the biopharma and biotech industries for the second consecutive year. Differences in size, resources and agility have led the two groups to take different approaches to clinical development.

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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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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.

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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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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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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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PPD

SEPTEMBER 19, 2023

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. Benefits of Early Drug Development Services Early development studies include many elements that set them apart from those in later development.

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PPD

OCTOBER 17, 2024

Drug developers of all sizes are working to optimize each step in the clinical research process from site selection to complex logistics, managing evolving regulations, and patient recruitment and retention strategies. When sponsors are armed with this knowledge, it expedites the ability to expand and scale CGT development.

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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:

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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

PPD

SEPTEMBER 6, 2023

Examples of Hybrid Outsourcing Strategies for Clinical Trials For biotech and biopharmaceutical organizations, a strong CRO partner with broad experience in both FSO and FSP engagements is necessary to guide the right mix of service models to use.

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PPD

NOVEMBER 30, 2023

To get a pulse on the changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 biotech and biopharma leaders for the second year in a row to illuminate industry trends, challenges and sentiments.

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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.

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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

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Cytel

MAY 14, 2024

Written by Angela Vinken and Patti Arsenault Key Opinion Leaders (KOLs) — i.e., trusted, well-respected experts — are crucial in clinical research, especially in rare diseases. The challenge, however, is how to use KOLs wisely — they are often clinicians first and researchers second, and their time is in high demand.

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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.

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Clinical Trials Clinical Development Clinical Research Trials 52

PPD

SEPTEMBER 6, 2023

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. Rebadge staffing is a critical part of an FSP model in clinical research. What is rebadging in an FSP model?

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Vial

MARCH 1, 2024

By type of service, clinical research services accounted for the lion’s share of the North American CRO services market, followed by early-phase development services, laboratory services, and consulting services. This acquisition has allowed the company to position itself as a global leader in clinical research services.

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Fierce BioTech

DECEMBER 23, 2024

Logos Attribution 0 Attribution 0 Primary Category Biotech On Demand Off Enable Automatic On Demand On Registration Login Link Already registered?

Pharmacy 52

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Conversations in Drug Development Trends

AUGUST 23, 2023

Her fellow panelists represented a diverse group of stakeholders across clinical research, including patient advocates, sponsors, sites, and the FDA itself. Canary Advisors recommends including patient advisory boards, which a sponsor, CRO, or patient advocacy organization can create in the early stages of clinical development.

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PPD

JULY 6, 2023

How a CRO Accelerates Clinical Development Clinical trials are becoming increasingly complex as the industry evolves. Our recent survey on industry trends found that 51% of drug developers denote the increasing complexity of clinical trials as a top challenge, along with patient recruitment (55%) and regulatory hurdles (46%).

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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.

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PPD

JUNE 13, 2023

To rise above the competition, sponsors must understand the common pitfalls of vaccine development and have strategies in place to avoid them. It is imperative that the right vaccine development partner demonstrates expertise from early clinical development to study design, execution, regulatory submission and commercialization.

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Vaccine Clinical Trials Clinical Research Trials 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.

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Clinical Research Clinical Trials Trials Drug 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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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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Advarra

OCTOBER 15, 2024

The International Council for Harmonisation (ICH) good clinical practice (GCP) guidelines are critical in ensuring the safety and rights of clinical trial participants. Sponsors should ensure a diverse multidisciplinary team of stakeholders supports the design of the study and the clinical development plan.

Clinical Trials 52

Clinical Trials Trials Clinical Research International 52

Vial

APRIL 10, 2024

The strong commitment to innovation allows IQVIA to provide advanced analytics, technology solutions, and industry-specific expertise in the health information technologies and clinical research domains. IQVIA has a vast collection of healthcare information, including over 1.2 increase on a reported basis and an 4.8%

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Conversations in Drug Development Trends

JUNE 13, 2024

However, Project Optimus emphasizes the importance of dose-finding studies in early clinical development. By comparing the minimum biologically active dose with the highest tolerable dose, researchers can maximize the efficacy of the drug while minimizing its toxicity. How Does Project Optimus Impact Your Study’s Operations?

Trials 52

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Precision for Medicine

DECEMBER 1, 2023

December 1, 2023 — Precision for Medicine, the first global biomarker-driven clinical research organization, is the recipient of a new accreditation from The College of American Pathologists (CAP) for its tissue and histopathology laboratory in Winston-Salem, North Carolina. Winston-Salem, Nc.,

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The Pharma Data

JANUARY 27, 2021

“Our commitment to supporting clinical research sites with strategic flexible resources has been increasingly important over the past 12 months in particular. VERONA, Italy , Jan. ” About CROMSOURCE.

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The Premier Consulting Blog

NOVEMBER 20, 2023

Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. billion each year.

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Laboratories FDA Clinical Development Regulations 52

The Pharma Data

JANUARY 4, 2021

From 2016 to 2018, he served as chief development officer for oncology at Pfizer, where he was responsible for leading clinical research, development, and lifecycle management of all promising oncology products.

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