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.

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Drug Target Review

JULY 18, 2024

Why is detecting cancers via liquid biopsy before they become visible on imaging important for drug development, not just diagnostics? We believe liquid biopsy is very helpful for oncology drug development because the reduction and clearance of circulating DNA occurs quickly before radiographic imaging is available.

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Drug Development Clinical Trials Drugs Vaccine 59

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

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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Alta Sciences

MAY 29, 2024

How to Optimize Your Early-Phase Drug Development Program pmjackson Wed, 05/29/2024 - 20:32 The Challenges With Outsourcing Drug Development In a Biopharma Dive survey, 45% of the over 143 biopharmaceutical executives surveyed cited the inability to adhere to tight deadlines as a common challenge in preclinical and Phase I clinical development.

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Drug Development Drugs Clinical Development 52

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.

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Clinical Trials Pharmacokinetics Drug Development Clinical Development 98

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

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.

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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.

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Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

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Drug Development Treatment FDA Approval Therapies 52

The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.

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Clinical Pharmacology Drug Development Pharmacokinetics Drugs 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.

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Clinical Research Pharmaceutical Companies Clinical Development Drug Development 95

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

Alta Sciences

JUNE 9, 2023

Accelerating Global Drug Development Timelines With Ethnobridging rmaloney Mon, 06/12/2023 - 16:07 HTML Safe Strategy to Save Time and Money Avoid repeating Phase I studies for drugs intended for the Asian market. Speak with an expert today to discuss your next clinical program. Watch the webinar.

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Drug Development Clinical Trials Biosimilars Pharmacokinetics 40

The Premier Consulting Blog

JUNE 18, 2023

This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.

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Drug Development Disease Clinical Trials Drugs 52

Drug Target Review

FEBRUARY 1, 2024

But commitment to neuroscience drug development is critically important given the significant unmet medical needs and the ways in which patients, caregivers, and families suffer. Not failed drugs, but failed studies. As soon as drug developers can begin to develop conviction, momentum increases.

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Therapies Drug Development Disease Clinical Development 104

Advarra

AUGUST 10, 2023

Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. The Orphan Drug Act creates incentives for developing orphan drugs to treat such diseases.

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Drug Development Disease Therapies Engineering 52

Drug Target Review

JANUARY 8, 2024

We are at the forefront of drug development in an area of research called cellular rejuvenation, which is an approach that has the potential to address many diseases of ageing by restoring aged and injured cells to a more youthful and resilient state. What evidence is there that we can reverse aging with drugs?

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Science Disease FDA Approval Clinical Trials 145

Drug Target Review

SEPTEMBER 5, 2024

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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Drug Target Review

AUGUST 28, 2024

Available from: [link] About the author Cliff Brass, MD PhD FAASLD, Chief Medical Officer at Resolution Therapeutics Cliff Brass is an expert in clinical development with special expertise in liver disease and over 25 years of experience in pharma. He is named on 15 patents relating to drug development in liver disease.

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Therapies Disease Engineering Medical Schools 116

NIH Director's Blog: Drug Development

SEPTEMBER 26, 2019

Researchers circulate blood-mimicking fluid through the chip, along with chemotherapy drugs. But, when treated with diclofenac, liver cells on the chip were reduced in number by about 30 percent, an observation consistent with the drug’s known liver toxicity profile.

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Drugs Science Treatment Clinical Trials 72

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. Another area in need of attention is central nervous system (CNS)-safety testing.

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Drugs FDA Disease Animal Testing 111

Broad Institute

NOVEMBER 2, 2023

Bayer and Broad Institute extend cancer therapy research collaboration By Corie Lok November 2, 2023 Breadcrumb Home Bayer and Broad Institute extend cancer therapy research collaboration Long-standing industry-academia collaboration has already resulted in three clinical oncology candidates.

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Alta Sciences

AUGUST 18, 2023

Webinar— A Square Peg in a Round Hole–Navigating the Unique Attributes of Psychedelic Drug Development iianiro Fri, 08/18/2023 - 19:49 URL [link] Description Save the date—Join us for a complimentary webinar for an overview of the draft FDA guidance on early-phase clinical development of psychedelics and how Altasciences can guide you through the process, (..)

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Drug Development Compliance Clinical Development FDA 40

Conversations in Drug Development Trends

NOVEMBER 21, 2023

Since the advent of modern medicine, the scientific community has developed more than 3,000 drugs for thousands of diseases. As a provider of end-to-end clinical development solutions, we plan to leverage our expertise to refine drug-disease matches identified by Every Cure’s use of AI and data analysis.

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Disease Treatment Clinical Trials Clinical Development 78

Pharma Manufacturing

JUNE 14, 2022

Comprehensive strategies to save time and reduce cost in end-to-end clinical development

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Drug Development Clinical Development Drugs 40

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

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.

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Cytel

SEPTEMBER 11, 2023

As a drug developer, you have to live with the answers and comments you get from regulatory authorities. Therefore, it’s essential that you choose your questions carefully and avoid questions you don’t need answers to. Let’s take a closer look at how to approach these meetings:

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Drug Development Drugs Clinical Development 105

PPD

JULY 6, 2023

As a result, sponsors must decide whether to leverage a CRO partner even earlier in their drug development timelines to ensure proper planning for these constraints. How a CRO Accelerates Clinical Development Clinical trials are becoming increasingly complex as the industry evolves.

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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. Leverage our global footprint and hands-on support to quickly and safely address unmet medical needs.

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Therapies Clinical Trials Clinical Research Trials 88

Drug Target Review

MAY 1, 2024

How have advancements in antibody-drug conjugates (ADCs) expanded treatment options for different types of cancer? The advent of monoclonal antibodies paired with improvements in each ADC design component has led to the approval of 11 ADCs with more than 180 ADCs currently in clinical development.

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Drugs FDA Approval Organic Chemistry Small Molecule 69

KIF1A

SEPTEMBER 30, 2023

Read the Guide FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies One frustrating aspect of traditional drug development, especially for rare disease communities, is the tempo of regulatory decisions on potential drugs.

Disease 111

Disease FDA Clinical Trials Therapies 111

Cytel

OCTOBER 27, 2023

Speakers discussed investigator, regulatory (FDA), industry, and patient perspectives during the special symposium “Challenging the Status Quo of Early Phase Clinical Trial Design: Project Optimus.” Since its launch in 2021, Project Optimus has been reforming the dose optimization and dose selection paradigm in oncology drug development.

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Clinical Trials Trials Clinical Pharmacology Clinical Development 64

Drug Target Review

DECEMBER 13, 2024

7,8 The discovery of these biomarkers provides valuable insights into prognosis and disease progression, while also guiding the clinical development of new targeted immunotherapies. Next-generation approaches Antibody Drug Conjugates (ADCs) Lung cancer therapy is enhanced by advancements in ADC technology.

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Therapies Treatment Clinical Trials Drugs 98

Cytel

DECEMBER 6, 2023

Chemistry, Manufacturing, and Controls (CMC) is a critical component of drug product development. As a Senior Consultant in Drug Development, I serve as a representative for sponsors with the Contract Development and Manufacturing Organization (CDMO). This is a long-term relationship.

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Clinical Trials Drugs Trials Drug Development 64

PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. When imaged, the hiPSC showed a stable beating rate.

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Drugs Pharmacokinetics FDA Approval Drug Development 52