Drug Discovery Today

APRIL 28, 2020

Touchlight driving its dbDNA technology towards clinical development in therapeutic and prophylactic vaccines Former J&J Senior Scientific Director and immunology expert joins at a pivotal time.

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Research Clinical Development Vaccine 188

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

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

FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

The Clinical Trials Grants Program provides funding for clinical trials that evaluate the safety and efficacy of potential treatments for rare diseases to help move promising treatments through clinical development.

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Clinical Development Production Clinical Trials Treatment 69

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

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?

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Clinical Development Clinical Trials Clinical Research Trials 52

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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Clinical Development Drug Development Clinical Research Treatment 52

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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Clinical Development Clinical Trials Trials Clinical Research 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.

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Clinical Trials Clinical Development Trials Pharmaceutical Companies 136

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.

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Clinical Development Trials Disease 59

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.

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

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.

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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 (..)

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Clinical Trials Clinical Development Drugs Therapies 113

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 40

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.

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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

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.

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Production Clinical Development Drug Development Marketing 81

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.

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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.

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Clinical Trials Pharmacokinetics Drug Development Clinical Development 98

PPD

MARCH 26, 2024

A large majority of drug developers utilize FSP or hybrid FSP/FSO models, half are “heavy users” Heavy users: Those that use FSP or hybrid FSP/FSO models for most of their clinical development outsourcing. Heavy users leverage these models for nearly three-quarters of their outsourcing.

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Clinical Research Pharmaceutical Companies Clinical Development Drug Development 98

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 72

Clinical Development Therapies 72

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

Cytel

MARCH 11, 2024

In 2023, rare diseases accounted for 30% of product pipeline under development, about half of which comprising non-oncology rare diseases. Clinical development in rare diseases has specific challenges. Effective clinical development strategy for rare diseases requires agility to adapt to accumulating learning.

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Clinical Trials Trials Disease Clinical Development 59

Cytel

NOVEMBER 8, 2023

Written by Natalia Muehlemann, Vice President, Clinical Development, and Ari Brettman, Senior Managing Director, Blackstone Life Sciences When working with investors, it’s critical that drug and device developers consider how their clinical trial design aligns with investment priorities. Let’s take a closer look:

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Clinical Trials Trials Clinical Development Science 59

Fierce BioTech

DECEMBER 13, 2024

Even though AI-designed drugs arent yet a household term for FDA-approved, commercially available therapies, they are a reality in clinical development pipelines. Even though AI-designed drugs arent yet a household term for FDA-approved, commercially available therapies, they are a reality in clinical development pipelines.

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FDA Approval Clinical Development FDA Therapies 52

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

ASPET

JANUARY 23, 2024

These data can help to support potential clinical development with sGC activators, suitable for human use in patients with vasospastic angina. Significance Statement The sGC activator BAY 60-2770 exerted antispastic effects on the coronary arteries in animal vasospasm models as proof-of-concept studies.

Clinical Development 100

Clinical Development 100

Cytel

DECEMBER 29, 2023

Perspectives has explored a myriad of topics this year within clinical development — from adaptive trial design to advice on regulatory submission to clinical data best practices, and so much more — all written by our many expert authors. What a year!

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Clinical Development Trials 59

Cytel

SEPTEMBER 1, 2023

Data is the cornerstone of any clinical trial, driving the decision-making process of drug development, and is a fundamental requirement for approval of new therapies by regulatory agencies like the FDA or EMA.

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Clinical Trials Clinical Development FDA Drug Development 64

KIF1A

MARCH 16, 2024

While genetic disorders like KAND make up only a small part of this number, this represents the need for increased investment in neuroscience research and clinical development. This is even more true for neurological disorders; according to a recent study by The Lancet , approximately 3.4

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Disease Clinical Development Research Treatment 105

ASPET

FEBRUARY 26, 2024

Here, we examined the preclinical and clinical effects of the first-generation FXR agonist, Px-102 (4-[2-[2-chloro-4-[[5-cyclopropyl-3-(2,6-dichlorophenyl)-4-isoxazolyl]methoxy]phenyl]cyclopropyl] benzoic acid), to enable the selection of an analog, cilofexor, with unique properties that reduced side effects yet maintained efficacy.

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Disease Treatment Clinical Trials Clinical Development 100

Chemical Biology and Drug Design

NOVEMBER 13, 2023

The requirement of long-term immunity development, safety, efficacy, stability, vaccine allocation, distribution, and finally, its cost is discussed in detail. Currently, 169 vaccines are in the clinical development stage, while 198 vaccines are in the preclinical development stage.

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Vaccine Laboratories RNA Clinical Development 100

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.

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Treatment Clinical Development Disease Regulations 83