PPD

JULY 29, 2024

In today’s data-driven world, AI has become valuable and indispensable, enabling organizations to extract valuable insights from vast amounts of data, make informed decisions and drive innovation across different sectors — including drug development.

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Perficient: Drug Development

OCTOBER 3, 2023

Physician blogs are a great way to get your physicians’ messages out to the public. Blog articles that include your physicians’ bylines and consumer-friendly, understandable language help position your team of physicians as thought-leaders in their fields of expertise.

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Doctors Clinical Trials Marketing Engineering 52

Labcorp Drug Development

FEBRUARY 3, 2023

Welcome to the February 2023 Labcorp Drug Development Decentralized Clinical Trial (DCT) blog. With Rare Disease Day coming soon on February 28, we are going to focus on how patients, sites and investigators can benefit by improving the design and execution of rare disease trials. What is Rare Disease Day?

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Trials Disease Clinical Trials Drug Development 52

H1 Blog

DECEMBER 4, 2023

As the pharmaceutical and biotech industries continue to push for faster drug development, the importance of equity and diversity in clinical trial recruitment cannot be overlooked. Let’s dive in to uncover the role of digital health and data in driving faster drug development through improved diversity.

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Clinical Trials Trials Pharmaceutical Companies Drug Development 59

FDA Law Blog: Drug Discovery

MAY 4, 2023

Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.

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Clinical Trials Trials FDA Production 59

Alta Sciences

JANUARY 15, 2024

How Is Your CRO Handling Your Trial Data? We highlight best practices and approaches to mitigate challenges, and show how integration and collaboration build the strongest datasets for your drug development program. ACCESS THIS ISSUE Speak with an expert to learn more about our service offering. Have a few more minutes?

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Trials Clinical Trials Drug Development Research 52

FDA Law Blog: Drug Discovery

OCTOBER 11, 2023

Snow — On September 18, 2023, FDA published an updated, final iteration of guidance for immediate implementation entitled, “ Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.” hurricane) or public health emergency (e.g.,

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Clinical Trials Trials FDA Drug Development 64

Predictive Oncology

AUGUST 8, 2024

A recent white paper released by Predictive Oncology’s highlights the challenge of late-stage clinical trial failures and the company’s ability to better navigate those obstacles and increase the probability of technical success which is a key metric in target selection, clinical trial design and pipeline replenishment.

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Drug Development Clinical Trials Animal Testing Drugs 52

FDA Law Blog: Drug Discovery

MAY 1, 2024

proudly announces the return of attorney Sarah Wicks to its drug development and compliance group. Sarah brings a wealth of experience and a proven track record of advising innovative drug and biologics companies through the intricate landscape of product development and commercialization.

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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 Development Disease Clinical Trials Drugs 52

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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FDA Law Blog: Drug Discovery

JULY 17, 2024

An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.

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FDA Disease Clinical Pharmacology Science 105

Conversations in Drug Development Trends

MAY 23, 2024

By: Sarah Bly, Regulatory Science and Innovation and Matt Cooper, Executive Director, Therapeutic Strategy Lead, Oncology The European Union (EU) presents a unique set of regulatory challenges and opportunities for clinical trials in oncology. Increased Transparency : Ensures that information on clinical trials is more accessible.

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Trials Clinical Trials Therapies Treatment 52

Alta Sciences

FEBRUARY 8, 2024

Altasciences’ ability to design and conduct specialized tests, combined with our partnership with CRC, allows us to seamlessly incorporate driving simulation elements into your clinical trials. Tags Clinical Trials Weight 12 View the Driving Simulation Fact Sheet for more information.

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Clinical Trials Trials Clinical Pharmacology Clinical Development 52

H1 Blog

SEPTEMBER 26, 2023

Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. A recent McKinsey analysis of drugs and vaccines developed since 2000 shows that it takes nearly ten years to go from clinical testing to approval. First let’s look at some challenges and then opportunities.

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Trials Clinical Trials International Regulations 59

H1 Blog

JULY 19, 2023

Streamlining recruitment and reporting to support advanced oncology drug development In March of 2023, the U.S. In order to qualify for accelerated approval, drug manufacturers must demonstrate that the medication provides meaningful clinical benefit to patients with life-threatening illnesses during their clinical trials.

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Clinical Trials Trials FDA Treatment 52

FDA Law Blog: Drug Discovery

SEPTEMBER 28, 2023

Hear about the new requirements under FDORA related to increasing diversity in clinical trials, strategies for increasing the participation of subjects from historically underrepresented groups, and how these new requirements and approaches should be considered in clinical trial and other related agreements.

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Clinical Trials Trials Hospitals Drugs 52

Conversations in Drug Development Trends

MAY 30, 2024

Authors: Rich Worldwide Clinical Trials Exec. This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. Director, Therapeutic Area Medical Lead.

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Treatment Clinical Trials Small Molecule Therapies 81

FDA Law Blog: Drug Discovery

APRIL 23, 2023

Because an external control can involve the use of real-world data (“RWD”), the Draft Guidance notes that this guidance is being issued to satisfy, in part, requirements from the 21st Century Cures Act on the use of real-world evidence (“RWE”) in regulatory decision-making, similar to other recent efforts in this arena that we have blogged about.

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Trials Clinical Trials FDA Treatment 49

NIH Director's Blog: Drug Development

OCTOBER 27, 2020

Similarly, COVID-19 patients taking antipsychotic drugs like haloperidol that target SIGMAR1 were half as likely as those taking other types of antipsychotic drugs to require mechanical ventilation. More research is needed before we can think of testing these or similar drugs against COVID-19 in human clinical trials.

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Drug Development Drugs Virus Science 52

Plenge Gen

MAY 28, 2021

My response was programmable therapeutics, a topic which I have blogged about in the past. In this blog I define programmable therapeutics and provide a few recent examples (severe combined immune deficiency and mRNA vaccines).

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Vaccine Drug Development Trials Drugs 52

Pharmaceutical Development Group

DECEMBER 19, 2021

Effective use of Real World Data (RWD) and Real World Evidence (RWE) can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services , expedite a FDA Pre-Submission Review, and lead to FDA Approval. PDG is a subsidiary of Biotech Research Group Corporation.

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FDA Approval FDA Clinical Trials Drug Development 52

FDA Law Blog: Biosimilars

AUGUST 23, 2023

DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites. DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites.

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Production Clinical Trials FDA Drugs 52

Alta Sciences

OCTOBER 30, 2023

Discover the considerations and assessments necessary for performing preclinical research for ophthalmic therapies in this new eBook, that covers everything you need to know, from species selection and routes of administration, to preparing for first-in-human trials. Read the blog. Read it now. The Altascientist : Issue No.

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Science Clinical Trials Pharmacokinetics Clinical Pharmacology 52

H1 Blog

JULY 5, 2023

The success of drug development and approval relies heavily on the ability to identify diverse patient populations for clinical trials. From trial site feasibility to successful trial recruitment, diversity within a trial population helps ensure the safety and efficacy of drugs that reach the market.

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Clinical Trials Drugs Trials Drug Development 52

FDA Law Blog: Biosimilars

AUGUST 28, 2023

Lenz, Principal Medical Device Regulation Expert — Following up on our first post discussing Digital Health Technologies (DHTs) ( here ), this post will focus on development and qualification of DHTs for use in clinical trials for drug development.

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Clinical Trials Production Drugs Trials 59

FDA Law Blog: Drug Discovery

DECEMBER 13, 2023

Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.” GeMDAC’s mandate is to advise the Agency on these complicated issues in this challenging area of medical product development. Note that FDA is currently soliciting applications to staff this committee.

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Disease Production FDA Drug Development 59

Alta Sciences

JULY 18, 2024

Inside The Altascientist: How to Achieve Optimal Preclinical Formulation and Drug Product Manufacture aasimakopoulos Thu, 07/18/2024 - 20:33 Formulating and manufacturing drugs for preclinical testing is an early—and necessary—step towards pushing your molecule through to human clinical trials.

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Production Clinical Trials Drugs Compliance 52

The Premier Consulting Blog

JUNE 26, 2023

1 With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant unmet need in oncology. Rare cancers account for 25-30 percent of all new cancer diagnoses and 25 percent of cancer deaths.

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FDA Clinical Trials Therapies Trials 52

H1 Blog

SEPTEMBER 14, 2023

As pharmaceutical companies turn to CROs (Clinical Research Organizations) for trial design and technology, there are new opportunities emerging with healthcare data intelligence that can help ensure a bright future for the industry and to make trials more effective, efficient and accessible. million data points.”

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Clinical Trials Pharmaceutical Companies Trials Pharmaceuticals 59

The Premier Consulting Blog

APRIL 18, 2024

This blog will outline three characteristics of a successful nonclinical program to support entry into clinical trials for a cell or gene therapy product. As in all nonclinical drug development programs, the goal is to identify potential safety issues in humans. Can you identify a safe AND efficacious clinical dose?

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Therapies Clinical Trials Small Molecule Immune Response 52

Perficient: Drug Development

AUGUST 2, 2023

In my last two blogs, we discussed the Introduction to Sitecore Content Serialization and Sitecore CLI configuration for SCS. In this blog, we are going to configure the Sitecore for Visual Studio. For learning purposes, you can request a trial license as well. Note: Sitecore TDS trial version is valid for 30 days.

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Packaging Licensing Licensing Trials 52

FDA Law Blog: Drug Discovery

JANUARY 2, 2023

Comprehend the structure of FDA and the roles of the three major agency centers: CDER, CBER and CDHR, master the basics of the application and approval processes for drugs and biologics, gain a practical working knowledge of clinical trial process for pharmaceutical products and much more! Clinical trials for drugs and biologics.

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FDA Clinical Trials Trials Production 59

Alta Sciences

OCTOBER 15, 2024

He then became an associate toxicologist providing administrative and scientific support to study directors, and subsequently moved into a project management position overseeing Phase I to III clinical trials. Keep your curiosity about life sciences fresh and keep learning about the drug development process! jpg Weight 1

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Pharmacokinetics Clinical Trials Drug Development Science 52

H1 Blog

JULY 30, 2024

Increasing diversity in clinical trials not only makes the findings more relevant to various patient groups, but also enhances knowledge about the disease or medical product being studied. This allows the trial to achieve more precise results at the indication level through leveraging comprehensive information from across the globe.

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FDA Clinical Trials Compliance Pharma Companies 59

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. the single trial) is and (2) how robust and convincing the confirmatory evidence is.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

The gene therapy demonstrated that it increased Factor IX (“FIX”) plasma levels at 6 months, the original primary endpoint of the Phase 3 trial. Again, this was despite the fact that subjects in the trial had demonstrated durable FIX activity to this point, with a mean of 41.5%

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Therapies FDA FDA Approval Treatment 119