Perficient: Drug Development

AUGUST 2, 2023

For learning purposes, you can request a trial license as well. Purchase/Trial Sitecore TDS and SVS license Step 01: Goto the TDS site Step 02: Click on the Free Trial link Step 03: Click the Try TDS button Step 04: Submit the TDS free trial form. Step 05: After submission, you need to download a package and install it.

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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% That brings us to the product’s approval.

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Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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The Pharma Data

NOVEMBER 5, 2020

Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

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PPD

MARCH 13, 2024

In every early phase clinical trial, the transportation, chain of custody, environmental monitoring and subsequent analysis of biological samples are the cornerstones of a successful, robust and quality outcome. Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy.

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Perficient: Drug Development

OCTOBER 4, 2023

CLIENT An American multinational corporation that develops medical devices, pharmaceuticals, and consumer packaged goods. INDUSTRY BACKGROUND The importance of better understanding and engaging patients and members has never been more important than it is today.

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Drug Patent Watch

DECEMBER 12, 2024

This includes drug substance and drug product development, clinical trial logistics, product labeling, supply chain management, commercial packaging, and more. Full-Service Capabilities A full-service CDMO should provide comprehensive, end-to-end capabilities that support the entire pharmaceutical development and manufacturing process.

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The Open Targets Blog

OCTOBER 24, 2023

  Together with Ray Kamalika, a research bioinformatician at OMass Therapeutics, he developed Otargen , an R package offering a suite of functions to facilitate the retrieval and analysis of Open Targets Genetics data, including specialised plotting functions to help visualise the information.   Have you used Otargen?

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PLOS: DNA Science

OCTOBER 19, 2023

Last week DNA Science covered a setback in a clinical trial of a gene therapy for Duchenne muscular dystrophy (DMD). The two conditions and the therapeutic approaches differ, but their clinical trials illustrate the importance of selecting patients whose characteristics suggest that they are the most likely to respond.

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Drug Target Review

AUGUST 7, 2024

The preclinical role of often-overlooked artwork During preclinical stages, labelling decisions can significantly impact clinical trials and eventual drug commercialisation. Packaging is typically the patient’s first interaction with a product, and it is critical for communicating safety and benefit-risk information.

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LifeSciVC

AUGUST 21, 2024

Clinical Trials Are your clinical trials on track? What has the impact of summer been on recruiting efforts and the ability to manage clinical trial participants? Have you identified and reached out to the PIs and potential clinical trial sites? Or maybe you are nearing the clinic. Do you have ample drug supply?

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The Pharma Data

JANUARY 13, 2021

Prior to joining Usona, Mr. Barrow served as Chief Operating Officer of Olatec Therapeutics where he oversaw the execution of numerous early- and late-stage clinical trials in the fields of analgesics, rheumatology, immunology and cardiovascular disease.

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Advarra

SEPTEMBER 23, 2022

Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . The post How the IND 30-day Hold Impacts Clinical Trial Activities appeared first on Advarra. Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks. .

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Perficient: Drug Development

MARCH 27, 2024

You can have a trial or subscription as needed for practical purposes. Create an Asp.Net Core Web API Application now by utilizing the template and install packages Azure.Identity and Azure.Security.KeyVault.Secrets from Tools->NuGet Package Manager->Manage NuGet packages for solution.

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FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

The meeting package for Type D meetings should be included with the meeting request. The draft guidance helpfully adds a few examples of appropriate Type D meeting scenarios, and they are: A specific question about an aspect of a complex or innovative trial design (e.g.,

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Drug Target Review

FEBRUARY 1, 2024

This can present challenges when attempting to recruit an enriched patient population for clinical trials. The organizing principle is the data package. Many diagnoses are made clinically based on a patient’s symptoms, as opposed to genetic testing or established biomarker profiles. Is the mechanistic rationale bona fide?

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Olympian Clinical Research

JUNE 27, 2023

Typically, it’s wise to avoid: Dairy products and their alternatives (cow’s milk, cheese, butter) Gluten-containing grains (wheat, barley, rye) High-sugar foods and refined carbohydrates (sugary treats, sodas, processed snacks) Processed and packaged foods with additives, preservatives, and artificial ingredients.

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The Pharma Data

JUNE 25, 2021

efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. overall; and the PREVENT-19 trial in the U.S.

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Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. Also consider CRO oversight, trial management, data handling and record keeping, as well as allocation of responsibilities.

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Packaging FDA Trials Regulations 52

The Pharma Data

DECEMBER 14, 2020

The trial, which will explore the pharmacokinetics and safety of ATX01 in healthy volunteers, is due to start in January 2021. AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01.

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Eye on FDA

APRIL 13, 2022

The agency stated that material facts about the risks were not properly conveyed with particular regard to advising women about the risks during pregnancy and noted that the package insert advises a pregnancy test within 2 weeks prior to therapy initiation and advises on the use of contraception during treatment. The Context.

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Advarra

DECEMBER 12, 2023

Staff turnover can greatly impact the quality and progress of an organization’s clinical trials and research projects. Clinical research organizations everywhere are seeing an influx of employees leaving their positions to go elsewhere. Understanding this issue is essential to a healthy research organization.

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The Pharma Data

MAY 3, 2021

Trials of the vaccine — called Comirnaty in Europe — in the young adolescent population showed similar high efficacy rates to those seen in adult clinical trials of the vaccine. No cases of COVID-19 were seen in the vaccinated trial arm, while 18 cases were reported among placebo recipients. .

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Perficient: Drug Development

AUGUST 14, 2023

Factors to consider: Price Capabilities and features Access level collaborators Easy of use and flexibility: Easy to understand analytics and data Compatibility with Google Analytics 4 Future proof Start with a basic package from a tool like Optimizely Web Experimentation and grow as needed.

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The Pharma Data

MAY 26, 2023

The 6,000-square-meter Shiga site opened in October 2021 to support customers both locally and globally, providing flexible clinical supply solutions, including primary packaging, Catalent’s FastChain ® demand-led supply, white glove handling and logistics. With sites in the U.S.,

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The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. REGN-COV2 was well tolerated in the trial. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S.

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Advarra

SEPTEMBER 8, 2022

As electronic documentation usage increases in clinical trials, organizations must make sure they’re still protecting participants’ health and safety without sacrificing quality or efficacy. Computer systems used for clinical trials fall under Food and Drug Administration (FDA) 21 CFR Part 11.

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Agency IQ

JUNE 28, 2024

New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time. The guidance notes that all approaches should be justified.

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The Pharma Data

NOVEMBER 22, 2020

As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. Trials are also being run in the U.S.,

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The Pharma Data

AUGUST 5, 2020

Emmanuel Caeymaex, UCB’s Executive Vice President Immunology Solutions and Head of US, said the study was the “first and only randomised controlled trial to compare both maintenance dose continuation and dose reduction versus placebo in a broad axSpA population.

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Drug Target Review

AUGUST 6, 2024

Many CDMOs offer end-to-end services, from early-stage development to commercial-scale manufacturing and packaging, ensuring continuity and reducing technology transfer risks. Clinical efficacy requires significant benefits like improved survival, demonstrated through well designed trials with appropriate endpoints and patient criteria.

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Drug Patent Watch

JANUARY 9, 2025

Are you in early-stage clinical trials, or are you gearing up for commercial launch? Take the time to clearly define your technical needs, from drug substance manufacturing to packaging requirements. Your timeline will significantly impact your CDMO requirements.

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Practical Cheminformatics

JANUARY 8, 2024

In November and December, several large pharmas held “AI Day” presentations featuring LLM applications for clinical trial data analysis. These information retrieval capabilities have many applications, from writing computer code and collating clinical trial results to summarizing papers on a specific topic.

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The Premier Consulting Blog

NOVEMBER 8, 2022

e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., typical drug device, biologic device) Two or more separate components, co-packaged (e.g., prefilled syringe) A drug used with a specified device in clinical trials — but that may be used with other devices once marketed (e.g.,

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The Pharma Data

AUGUST 24, 2020

The National Medical Products Administration has granted approval to the West China Hospital of Sichuan University in Chengdu to begin a clinical trial. Although there is speculation that Russia may also be testing vaccines outside of clinical trials, this is the first direct confirmation of it by any country.

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The Premier Consulting Blog

OCTOBER 11, 2022

Clinical trials for ultra-rare diseases can be particularly challenging to mount due to small, geographically-dispersed patient populations. For such trials, the US Food and Drug Administration (FDA) may allow the use of credible real-world data (RWD) and real-world evidence (RWE) in lieu of data collected in a Phase 3 trial.

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The Pharma Data

JANUARY 30, 2021

31, 2021 /PRNewswire/ — Edwards Lifesciences (NYSE: EW) today announced new data from the COMMENCE clinical trial that demonstrate Edwards’ bioprosthetic surgical aortic valve with the company’s novel RESILIA tissue platform show favorable safety and hemodynamic performance through a median of five years follow-up. .

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