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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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. Drug substance content in Module 3.2.S

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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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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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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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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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Alta Sciences

OCTOBER 30, 2023

Top 10 Life Science Resources pmjackson Mon, 10/30/2023 - 16:16 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below! Watch the video. Read the fact sheet. Read the blog.

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PPD

SEPTEMBER 16, 2024

The convergence of real-world data (RWD), technology and artificial intelligence (AI) is playing a vital role in accelerating drug development. In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinical research and drug discovery.

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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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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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Clinical Development Doctors Drug Development International 52

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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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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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 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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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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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 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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Clinical Development Clinical Trials Trials Clinical Research 52

Drug Target Review

SEPTEMBER 19, 2024

Could you give us an overview of IRLAB’s current drug development pipeline? IRL1117 is expected to be ready to move into clinical development at the end of 2024/first half 2025. See more information about Kristina here: [link] Kristina is a pharmacist and holds a PhD in Medical Science from Linköping University.

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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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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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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. You can expect transparency.

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The Pharma Data

OCTOBER 18, 2020

DUBLIN–( BUSINESS WIRE )– Inflection Biosciences Ltd , a company developing innovative therapeutics for the treatment of cancer, today announced the appointment of industry veteran Gregory I. Greg possesses a wealth of experience in developing new cancer therapeutics across multiple U.S. Berk, MD, to its Board of Directors.

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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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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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The Pharma Data

OCTOBER 27, 2020

28, 2020 /PRNewswire/ — Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, today announces the formation of a new Scientific Advisory Board (SAB). This information was brought to you by Cision [link]. OSLO, Norway , Oct.

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Virus Engineering Clinical Development International 52

PPD

SEPTEMBER 6, 2023

Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster.

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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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The Pharma Data

DECEMBER 13, 2020

Dr. Zhang has around 20 years of experience in research and drug development in both industry and academia in the US. Before that, he was Director of Development at Cobalt Biomedicine leading CAR-T and other cell/gene therapy programs, and R&D Director at OvaScience developing stem cell-based products.

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Medical Schools Clinical Development Therapies RNA 40

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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The Pharma Data

JANUARY 7, 2021

Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007.

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The Pharma Data

SEPTEMBER 15, 2020

Join best-in-class experts from S-Clinica to discuss how IRT and supply forecasting grants sponsors the flexibility to utilize information consistently and accurately, while helping to reduce supply drug waste and efficiently manage study and potential and existing inventory changes.

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Clinical Supply Clinical Trials Doctors Clinical Development 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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The Pharma Data

JANUARY 26, 2021

27, 2021 /PRNewswire/ — BenevolentAI today announced that the biopharmaceutical company AstraZeneca has selected a novel chronic kidney disease (CKD) target to advance to its drug development portfolio, making it the first AI-generated target from the collaboration to enter the Company’s portfolio. . LONDON , Jan.

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The Pharma Data

NOVEMBER 10, 2020

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. By joining Innovent, Dr. Liu will be responsible for global R & D, pipeline strategy, business development and international operations.

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The Pharma Data

JANUARY 20, 2021

” “Dynacure is a leader in rare disease drug development, as evidenced by its lead product candidate DYN101, which is in clinical development for the treatment of Myotubular and Centronuclear Myopathies for which there are no FDA or EMA approved therapeutics,” said Ms. SOURCE Dynacure. Source link.

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The Pharma Data

NOVEMBER 3, 2020

According to the FDA, the purpose of Fast Track designation is to get important new drugs to patients earlier by facilitating the development, and expediting the review, of drugs to treat serious conditions and fill an unmet medical need. For more information, please visit www.logicbio.com. About LogicBio Therapeutics.

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