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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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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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 Target Review

AUGUST 28, 2024

Delivered as an autologous cell therapy, these macrophages have been engineered to increase their anti-inflammatory and anti-fibrotic properties, with the aim of delivering more potent and durable clinical effect to patients with end-stage liver disease. He is named on 15 patents relating to drug development in liver disease.

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The Pharma Data

JULY 8, 2021

The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials. Information about the population studied has been previously communicated by Biogen and Eisai, including in the companies’ statement of June 23, 2021. Please see the full Prescribing Information.

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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. See more information about Kristina here: [link]

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Advarra

AUGUST 10, 2023

Given the relatively small populations affected by any one rare disease or condition, a pharmaceutical company developing an orphan drug may reasonably expect the final approved drug to generate relatively small sales (when compared with the drug development costs) and consequently incur a financial loss.

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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. Our mission is a lofty one.

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PPD

OCTOBER 16, 2023

Consent development: Informed consent is the most important step in the tokenization process. This enables deeper and more meaningful real-world insights on clinical study data. Tokenization can accelerate innovation in clinical trials and drug development.

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Alta Sciences

JULY 22, 2024

Recently, we have seen increasing numbers of complex FIH studies in CNS-active drugs to gather comprehensive data with a wider range of doses as early as possible. jpg Tags Clinical Trials Weight 1

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Conversations in Drug Development Trends

JANUARY 24, 2024

However, they lack awareness of specific clinical trials that may be relevant to their patients, and they don’t always feel they have the knowledge to explain certain aspects of clinical trials confidently to patients and their family members. These datasets can help find providers and patients based on genetic information.

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FDA Law Blog: Drug Discovery

MARCH 7, 2024

Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. FDA notes that the distinctions between responsibilities for these groups and DMCs should be clearly defined, particularly with respect to access to unblinded information.

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Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects. View the Driving Simulation Fact Sheet for more information.

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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. Regular review and management of KPIs and budget. Escalations and risk mitigation.

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NIH Director's Blog: Drug Development

SEPTEMBER 26, 2019

For those drug candidates that are ultimately doomed, “failing early” is key to reducing drug development costs. The ultimate goal is to accelerate the translation of basic discoveries into clinical breakthroughs. For more information about tissue chips, take a look at NIH’s Tissue Chip for Drug Screening program.

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Conversations in Drug Development Trends

MAY 14, 2024

As the strategists for Worldwide Clinical Trials’ rare disease sponsors, we design customized solutions that make a difference in achieving successful outcomes. Our approach is informed by our combined 30+ years in rare disease clinical development and our time in various stakeholder roles, such as scientists, CRAs, and project managers.

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Drug Target Review

MAY 7, 2024

How do AI-enhanced approaches accelerate the drug development process for rare diseases? AI holds the potential to revolutionise different aspects of healthcare, particularly in the realm of clinical trials.

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The Pharma Data

DECEMBER 10, 2020

executive vice president of research and development. “We We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible.”. For additional information, please visit www.lexpharma.com. Safe Harbor Statement.

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FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. Other Questions. The Agency recommended that sponsors follow the requirements under 21 CFR 211.84(d)(2)

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The Pharma Data

DECEMBER 15, 2020

The project also seeks to engage the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to identify opportunities for regulatory endorsement of such drug development tools. The Diamyd Medical data includes relevant information about disease progression, drug effects and clinical trial design.

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The Pharma Data

DECEMBER 28, 2020

Dr Reimer will replace Dr Charlotte Russel and be overall medically responsible for Alligator’s drug development candidates, with an emphasis on bringing mitazalimab and ATOR-1017 into Phase II efficacy studies. The information was submitted for publication, through the agency of the contact person set out above, at 9:00 a.m.

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Drug Target Review

SEPTEMBER 10, 2024

The current landscape of protein drug development is characterised by accelerated timelines where new drugs are approved in months rather than years. Hence, in many cases an earlier IND may be prevented by the timely provision of representative Drug Substance (DS) to execute such toxicology studies.

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Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. 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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Drug Target Review

JANUARY 15, 2024

CD8+ T cells are a type of lymphocyte that specialises in scanning information presented by HLA Class I. 3 Conclusion Human evolution has developed an elegant system that allows HLA presentation to open a ‘window into the cell’ and enable very precise immune monitoring of cellular health and disease states.

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Drug Target Review

MAY 1, 2024

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. Jamie Rich, PhD is Senior Director of Technology, ADC Therapeutic Development at Zymeworks Inc.

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PPD

NOVEMBER 14, 2023

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. This comes as the demand for qualified clinical research associates (CRAs) is expected to increase by more than 36% in the next decade.

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FDA Law Blog: Drug Discovery

OCTOBER 2, 2023

Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. In the December 2019 Guidance, FDA writes that the clinical context for a disease (i.e.,

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Conversations in Drug Development Trends

JULY 8, 2024

With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinical development pipeline and are expected to play a crucial role in the future of healthcare. The goal is to deliver a precise radiation dose to the diseased tissues while minimizing damage to surrounding healthy tissue.

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The Pharma Data

OCTOBER 25, 2020

We are advancing the clinical development of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. For more information about the COVE study, click here. About Moderna.

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Conversations in Drug Development Trends

FEBRUARY 21, 2024

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study.

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Alta Sciences

NOVEMBER 15, 2024

4 Essential Topics to Cover in Your First CRO Meeting pmjackson Fri, 11/15/2024 - 19:22 Starting a partnership with a contract research organization (CRO) is a sometimes intimidating—yet exciting—first step in your drug development journey. Be prepared to share necessary information about your study with the CRO,” says Chad.

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The Premier Consulting Blog

JULY 9, 2023

These ICH guidance documents apply at different stages of development and address specific concerns regarding certain types of impurities or degradants. Impurities in new drug substances and new drug products ICH Q3A(R2) addresses impurities in the drug substance, and ICH Q3B(R2) addresses degradants in the drug product.

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The Connected Lab

APRIL 8, 2020

How is AI being applied in Drug Discovery efforts? It is reported that every one of the major pharmaceutical companies has announced a partnership with at least one AI-based drug development company, but how is AI being used to facilitate drug development? A Tough Road: Cost To Develop One New Drug Is $2.6

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Drug Target Review

JULY 26, 2024

We have a dual aim: to use the power of sequencing for more personalised patient care; and to be able to leverage those datasets to progress various programmes within drug discovery. It also produces a dataset that is incredibly interesting for drug discovery. This helps produce a dataset that does lots of different things.

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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.

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PPD

MAY 11, 2023

The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drug developers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when.

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The Pharma Data

MARCH 28, 2022

These drug development programs include our acceleration of priority asset amlitelimab, an anti-OX40L antibody that aims to restore immune homeostasis between pro-inflammatory and anti-inflammatory T cells. For background slides and webcast information, please refer to the following link. CEST / 8 a.m. CEST / 7 a.m.

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