PPD

SEPTEMBER 16, 2024

Our comprehensive approach, integrating various aspects of drug development, such as clinical development, post-approval activities and market access, ensures optimal utilization of tools and strategies. Ready to learn more about convergence of real-world data and technology for clinical trials?

Clinical Development 98

Clinical Development Clinical Trials Clinical Research 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

MARCH 13, 2024

Enhance Your Cell Therapy and Rare Disease Clinical Program with an Early Development Services Partner Our dedicated, global and highly experienced clinical logistics monitoring team can assist you through the Phase Ib journey.

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Clinical Development Clinical Trials Therapies Trials 98

thought leadership

FEBRUARY 26, 2025

Rare diseases are defined in the Orphan Drug Act as diseases or conditions that affect less than 200,000 people in the United States.

Clinical Development 52

Clinical Development Disease Production FDA Approval 52

BioPharma Drive: Drug Pricing

NOVEMBER 4, 2024

As novel therapeutics become more complex — and costly — to bring to market, drug developers are looking to unified clinical development platforms to streamline operations.

Production 204

Production Clinical Development Drug Development Marketing 204

Cytel

JANUARY 10, 2024

A clinical development strategy is a comprehensive plan designed to establish the safety and efficacy of new therapeutics. Developing an effective plan requires multidisciplinary expertise and adapting to accumulating learning and changes in clinical practice and the market environment.

Clinical Development 52

Clinical Development Production Marketing Disease 52

Cytel

JANUARY 15, 2024

After explosive and frenetic activity in the clinical trial industry during the COVID era, the past two years have seen challenging market dynamics and a drop-off in activity. Every one of us working in clinical development has felt this slowdown, but as we begin 2024, there is reason for optimism. The future looks promising.

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Clinical Development Clinical Trials Trials Marketing 64

BioPharma Drive: Drug Pricing

AUGUST 6, 2024

Italy and Germany, while ending most clinical development work. The company plans to limit sales of the hemophilia gene therapy to the U.S.,

Clinical Development 176

Clinical Development Therapies 176

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. At Altasciences, we connect the dots, so you don’t have to.

Clinical Development 52

Clinical Development Clinical Trials Clinical Research Drug Development 52

Cytel

AUGUST 28, 2023

A clinical development plan — a comprehensive strategy for developing an investigational product through regulatory submission — is a critical component of drug development and helps ensure that new therapies are safe, effective, and of high quality.

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Clinical Development Drug Development Therapies Production 52

thought leadership

AUGUST 26, 2024

In the dynamic world of pharmaceuticals and biotechnology, small Sponsor companies are often the unsung heroes driving innovative therapies through the complex journey from concept to clinic.

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Clinical Development Therapies Pharmaceuticals Compliance 71

The Premier Consulting Blog

AUGUST 21, 2024

As clinical development of an investigational product proceeds, Sponsors often conduct global clinical trials which require preparation of content to support dossiers in multiple geographies, meeting the regulatory requirements of each region. QOS – optional Module 3.2.S QOS – optional Module 3.2.S

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Clinical Development Pharmaceuticals Clinical Trials Trials 52

Fierce BioTech

JULY 19, 2023

Don't miss this opportunity to gain valuable insights and explore the future of clinical development. png Listing Introduction Join us for an engaging webinar that explores how innovative automation capabilities are transforming the landscape of clinical development in the life sciences industry. Click here to login.

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Clinical Development Science Pharmaceuticals Treatment 52

Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.

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Clinical Development Compliance Clinical Trials Trials 52

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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Clinical Development Marketing Clinical Research Science 52

ASPET

OCTOBER 23, 2024

Aneurysmal subarachnoid hemorrhage (aSAH) may be associated with cerebral vasospasm, which can lead to delayed cerebral ischemia, infarction, and worsened functional outcomes.

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Clinical Development Treatment Pharmacokinetics Drugs 100

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.

Clinical Development 52

Clinical Development Drug Development Clinical Research Treatment 52

Covalent Modifiers

SEPTEMBER 3, 2023

Herein, we report our structure-based drug design approach that led to the identification of 14, AZD4747, a clinical development candidate for the treatment of KRASG12C-positive tumors, including the treatment of central nervous system (CNS) metastases.

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Clinical Development Treatment Drugs 214

Covalent Modifiers

MAY 9, 2024

BIIB129 (25) demonstrated efficacy in disease-relevant preclinical in vivo models of B cell proliferation in the CNS, exhibits a favorable safety profile suitable for clinical development as an immunomodulating therapy for MS, and has a low projected total human daily dose.

Treatment 208

Treatment Clinical Development Disease Regulations 208

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.

Clinical Development 52

Clinical Development Clinical Trials Trials 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.

Clinical Trials 136

Clinical Trials Clinical Development Trials Pharmaceutical Companies 136

PPD

JANUARY 15, 2025

About us The PPD clinical research business of Thermo Fisher Scientific , the world leader in serving science, enables our customers to accelerate innovation and increase drug development productivity. Ready to learn more about how to leverage AI and machine learning to maximize your clinical trial efficiency?

Clinical Trials 95

Clinical Trials Trials Clinical Research Drug Development 95

Drug Hunter

JULY 21, 2023

semaglutide/Ozempic), this month features a pair of ultra-hot non-peptide oral GLP-1R modulators in clinical development. With the popular success of diabetes and weight-loss peptide drugs from Novo (e.g.

Structure Based Drug Design (SBDD) 227

Structure Based Drug Design (SBDD) Targeted Protein Degradation Clinical Trials Trials 227

Cytel

JANUARY 17, 2024

Despite accumulating learnings from early phases, several uncertainties remain to be addressed when designing pivotal trials. Adaptive trials can help mitigate uncertainties; however, the trade-offs and their impact differ in the confirmatory setting.

Clinical Development 59

Clinical Development Trials Disease 59

PPD

NOVEMBER 11, 2024

Companies can benefit from solutions such as our Accelerator Drug Development, leveraging the combined strength of Thermo Fisher Scientific’s 360˚ Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) services , which provides CDMO, CRO and clinical trial supply chain capabilities that further streamline (..)

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Drug Development Clinical Trials Drugs Small Molecule 97

Drug Discovery Today

FEBRUARY 16, 2021

Celltrion has constructed a COVID-19 antibody portfolio and clinical development platform to help combat the spread of the virus mutations CT-P59 demonstrated neutralising capability against key emerging mutations, including the UK variant in addition to six variant genome mutations of SARS-CoV-2.

Clinical Development 113

Clinical Development Virus Treatment 113

Drug Discovery Today

JANUARY 20, 2022

Cambridge and Wetherby, UK, 18 January 2022: Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™ platforms announces that the next pre|CISION™ drug candidate, AVA3996, has been selected for pre-clinical development (..)

Clinical Trials 113

Clinical Trials Clinical Development Drugs Therapies 113

Alta Sciences

FEBRUARY 19, 2025

Regulatory Considerations for Oligonucleotide Drug Development and Safety In 2024, the U.S. It also outlines recommendations for drug-drug interaction assessments during clinical development, such as the assessment of appropriate biomarkers that reflect modulation of the target protein.

Drug Development 52

Drug Development Clinical Pharmacology Immune Response Drugs 52

Fierce BioTech

MAY 27, 2025

Can an alternative approach expedite clinical development of small molecule oncology drugs and benefit patients? jgrcic Tue, 05/27/2025 - 11:55 Tue, 05/27/2025 - 11:55 Resource Type Whitepaper Promotion Start Tue, 05/27/2025 - 12:06 Use of healthy volunteers in first-in-human trials with oncology small molecules.

Small Molecule 52

Small Molecule Trials Clinical Development Drugs 52

Fierce BioTech

OCTOBER 21, 2024

Carl Sailer is Vice President of Full Service Solutions at Syneos Health®, a leading fully integrated biopharmaceutical solutions organization providing clinical development and commercialization s | In this conversation with Fierce Biotech, we explore the ever-evolving biotech landscape.

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Marketing Clinical Development Drug Development Drugs 98

Drug Discovery Today

JULY 28, 2020

Cancer Research UK, the University of Southampton and Touchlight Genetics, a London based biotechnology company, today (Wednesday) announce a new clinical development partnership to progress a therapeutic DNA vaccine, TGL-100, into an early phase clinical trial targeting head and neck squamous cell carcinoma (HNSCC).

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Vaccine Clinical Trials Research DNA 100

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.

Trials 98

Trials Clinical Trials Clinical Development Clinical Research 98

Fierce BioTech

JUNE 18, 2024

Experts recommend that CGT manufacturers proactively design a comprehensive market access strategy early in clinical development and commercial planning timelines, ideally more than three years pri | CGT companies should consider developing a market access strategy early in clinical development, ideally more than three years prior to launch.

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Marketing Clinical Development 75

Drug Hunter

JUNE 5, 2023

Recent Applications of Ring-Closing Metathesis in Drug Discovery and Development A selection of representative macrocycles in drug discovery where ring-closing metathesis has been applied to their synthesis are shown below, highlighting chemically diverse macrocycles from programs that have reached clinical development.

Process Chemistry 206

Process Chemistry Drugs Production Clinical Development 206

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.

Clinical Trials 98

Clinical Trials Pharmacokinetics Drug Development Clinical Development 98

Drug Target Review

APRIL 30, 2025

Her work has enabled the production of critical cGMP-compliant materials, accelerating clinical development and commercialisation. She has also championed workforce development, creating education programmes from school level to higher education to build a skilled talent pipeline.

Therapies 90

Therapies Drugs Clinical Trials Trials 90

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 87