Rethinking Clinical Trials

JULY 6, 2023

Over the past several years, a variety of factors have accelerated the need for decentralized trials, including the push to make trials more accessible, the increased speed of science, the possibility of environmentally conscious trials, and the need to be flexible in a rapidly changing world.

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Pharmaceutical Technology

MAY 2, 2023

Combining data from all markets, efficacy-related needs were identified as the most important unmet needs category. IO therapies come with a hefty price tag, with ICI therapies in the US typically exceeding $100,000, while cell therapies can exceed $400,000. Cost-related unmet needs also scored highly.

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Rethinking Clinical Trials

AUGUST 10, 2023

” The key to quality of AI and utilizing AI in a beneficial way relates to the quality of the data. It’s important for organizations to recognize this and upgrade their data in order to these technologies more effectively and efficiently. The key is to have a deep understanding and control over the data being used.

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Roots Analysis

MARCH 1, 2024

Examples of such technologies include DNA Taggants (a unique DNA tag used in the product / packaging that can be scanned using a designated instrument / equipment), invisible printing technologies, digital watermark technologies and hidden markers / print technologies.

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Packaging Packaging Production Manufacturing 52

Intouch Solutions

APRIL 11, 2024

Pharmacovigilance : Early identification of adverse drug reactions, higher data integrity and faster response times. Precision engagement is a data-driven approach developed for marketing and sales needs. Some of them could be internal (CRM data and physicians profiling, etc.) So, what is precision engagement?

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Rethinking Clinical Trials

JANUARY 17, 2024

UPMC set clear criteria based on the published data at the time for who could and could not receive Remdesivir. All eligible patients were gathered from data warehouse and manual EHR entry. The first drug that used the new process was Remdesivir in May 2020. We know there is a digital gap in disadvantaged patients and elderly patients.

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Clinical Trials Clinical Trials Antibody Trials 169

Rethinking Clinical Trials

AUGUST 23, 2022

Participating organizations included FDA, NIH, academic institutions, pharmaceutical and device companies, patient advocacy groups, community groups, and data groups, and representatives from each organization had opportunity to extend invitation to others. Learn more. pctGR, @Collaboratory1.

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Rethinking Clinical Trials

OCTOBER 26, 2023

There is now a cure for Hepatitis C, but many people are not able to access it. point of care diagnostic tests, provide broad access to curative Hepatitis C medications with a national subscription model, with Medicare co-pay assistance and commercial insurance coverage. Rates are the highest among 20-39-year-olds.

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Pharmaceutical Technology

APRIL 5, 2023

But access to these treatments continues to remain limited due to high price tags and variable availability across regions. What we now need to do better at is access; both in other countries and within countries beyond the premier centers and big cities…to give access to all patients who could benefit from these advanced therapies.

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Roots Analysis

JANUARY 28, 2024

Big Data in healthcare refers to the vast amount of data that is continuously expanding and cannot be efficiently stored or processed using traditional tools. Within the healthcare sector, structured data includes demographic details, vital indicators (like, height, weight, blood pressure, blood glucose).

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Rethinking Clinical Trials

AUGUST 18, 2022

The recruitment plan needs to include study materials that are tailored and accessible to the research population. If we are focusing on equity, we need to give participants what they need, such as transit vouchers, childcare considerations, utilizing telehealth, flexible hours, accessible community locations, and compensation.

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Drug Discovery World

JANUARY 30, 2024

Developing value-based payment models that consider long-term benefits could improve access. Other Challenges: Limited insurance coverage: Many insurance companies are hesitant to cover CGTs due to their high price tags and limited long-term data. Increased clinical data and evidence of cost-effectiveness can improve coverage.

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pharmaphorum

NOVEMBER 19, 2021

Roche’s oral treatment Evrysdi for the rare genetic disease spinal muscular atrophy (SMA) will be made available on the NHS in England, after NICE reached a three-year access agreement with the company. million price tag make it is the most expensive treatment ever approved for NHS funding.

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The Pharma Data

NOVEMBER 29, 2021

1.1.529 a variant of concern, named Omicron, on the advice of WHO’s Technical Advisory Group on Virus Evolution (TAG-VE). WHO encourages countries to contribute the collection and sharing of hospitalized patient data through the WHO COVID-19 Clinical Data Platform to rapidly describe clinical characteristics and patient outcomes.

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Rethinking Clinical Trials

JULY 27, 2022

It is a decentralized, fully remote trial, and data are largely patient reported. One thing that has been a struggle is the diversity in the population and the equity in access to trials. ACTIV-6 is testing medication doses approved by the FDA for other purposes, i.e., repurposed drugs. Learn more about ACTIV-6.

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Rethinking Clinical Trials

AUGUST 28, 2023

Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization. Annex-2 of E6(R3) will include additional considerations of GCP principles focused on decentralized elements, pragmatic elements and real-world data sources.

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Rethinking Clinical Trials

AUGUST 28, 2023

Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization. Annex-2 of E6(R3) will include additional considerations of GCP principles focused on decentralized elements, pragmatic elements and real-world data sources.

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Clinical Trials Clinical Trials Trials Development 130

pharmaphorum

JANUARY 24, 2022

A private equity group has agreed to take over most of IBM Watson Health, seven years after the business was launched with a pledge to revolutionise healthcare data analysis. For its part, IBM has said that the Watson for Oncology product has been improving year-on-year as the AI crunches more and more data.

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XTalks

JUNE 28, 2023

The FDA said it will review the data from this trial “as quickly as possible to consider if further action, such as a revised indication or withdrawal of Elevidys, may be necessary.” million price tag of Elevidys, a one-time gene therapy. In a media call, Sarepta CEO Douglas Ingram revealed the $3.2

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Pharmaceutical Technology

JUNE 29, 2022

Additionally, pricing and access for rare disease therapies continue to be scrutinized closely. In a series of data-driven deep dives, we will examine how the development of orphan drug therapies has evolved over the years, and use the FDA’s orphan drug program as a barometer of these advances.

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Cloudbyz

JUNE 2, 2020

Purpose: This blog will show you how to create dynamic contextual reports that users can access directly from the record, (ie: Account or Opportunity). Create a folder called ‘Dynamic Reports’ Share the folder to users who should access these reports. So, each custom filter you add has a tag as shown in the below picture.

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Production 55

Rethinking Clinical Trials

SEPTEMBER 30, 2022

We are largely looking at state data but are thinking about federal data that we can access. . – Is there a loss to follow up due to families moving out of state? We are working to see if we can set up agreements with North Carolina and Georgia to capture the majority of migration from South Carolina.

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XTalks

JULY 12, 2021

The FDA based the decision on the fact that there is “no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.”. The backtracking from the FDA is unusual as the revision was not prompted by new data or information.

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Rethinking Clinical Trials

JULY 9, 2023

Many of these communities are served by federally qualified health centers that often lack options to provide accessible nonpharmacologic alternatives. Especially in studies involving chronic conditions, having long-term follow-up data to answer the core effectiveness question in a hybrid trial means there could be a long wait for results.

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The Pharma Data

DECEMBER 3, 2020

The manuscript describing the detailed results will be accessible on an online preprint server shortly. We and our collaborators are steadfast in our commitment to the development of safe, effective and accessible COVID-19 vaccines for the global population.”. About Trimer-Tag © Technology. About COVID-19 S-Trimer Vaccine.

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pharmaphorum

NOVEMBER 16, 2021

NHS patients in England and Wales with drug-resistant epilepsy are in line for access to another treatment option, after NICE recommended routine use of Angelini group company Arvelle Pharma’s Ontozry. An opinion from the Scottish Medicine Consortium (SMC) on the use of the drug by NHS Scotland is expected to be published early in 2022.

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pharmaphorum

AUGUST 28, 2020

The world is awash with data, and while retailers and TV subscription services have perfected the art of collection and curation, public health has been trailing behind. Data inadequacies. At this moment, people recognise that monitoring infectious diseases, in the US or globally, is challenging because data takes time.

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Pharmaceutical Technology

MARCH 22, 2023

The pharmaceutical industry began using radio frequency identification (RFID) tags in the early 2000s. Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. Twenty years ago, the cost of implementing RFID tags and the ecosystem (software) was much more expensive than today.

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pharmaphorum

AUGUST 17, 2020

In this article Joanna Carlish, managing director of financial services at Tag Americas , and Robb DeFilippis, Tag Americas’ managing director, life sciences, go head-to-head to discuss marketing within a regulated industry. Virtual connections. Is there legacy branding? How can we help consolidate all of that material?

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pharmaphorum

JANUARY 11, 2021

While bluebird has conducted pioneering work in gene therapy for blood disorders and in cancer cell therapy, products have been delayed by issues with filing data for the FDA. Zynteglo is already in beta-thalassemia in Europe, where the company will seek to expand access despite its hefty $1.8 million price tag.

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pharmaphorum

SEPTEMBER 15, 2020

This gives them huge amounts of customer data that allows them to shape and personalise the way they engage with their customers, not least thanks to the direct-to-consumer sales model they often offer. Jeremy Richter, Tag. Build on the rapid responses to COVID-19. About the interviewees.

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Branding Marketing Pharma Companies Life Science 109

pharmaphorum

JUNE 8, 2021

AA provides earlier patient access to a promising treatment but requires sponsors to conduct an additional trial to verify benefit. Though good luck taking the drug off the market if future data doesn't support the its efficacy. The post FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag appeared first on.

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pharmaphorum

MAY 10, 2022

The FDA awarded a fast-track designation to lecanemab in December and has also given the drug breakthrough tag as a treatment for early-stage Alzheimer’s, and Biogen and Eisai will be hoping the drug can sidestep the controversy that engulfed Aduhelm from the moment it was approved.

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Delveinsight

JULY 22, 2020

The method of services delivery and design has transformed to the extent that people can access healthcare services from thousands of miles away with just a smartphone. IoT relies on the data collected from devices and provides valuable insights that help in providing the best possible healthcare solution to the patient.

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pharmaphorum

JUNE 2, 2021

As is often the case, the initial guidance will form the basis for negotiations with Roche on the price of the drug, in the hope that an agreement can be reached that will provide access to the medicine by NHS England. Comments can be submitted until 23 June.

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Intouch Solutions

AUGUST 25, 2021

Updates to the Apple Mail app will allow users to change their privacy settings and allow Apple to hide their data in emails. There has been exponential growth in user concerns in recent years and, as a result, companies are addressing these concerns and becoming increasingly transparent about how they use consumer data.

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Cloudbyz

JUNE 1, 2023

Record Triggers: Flow can respond to changes in Salesforce data, initiating processes when records are created or updated. They’re typically initiated by a change in record data. Integration: Salesforce Flow can integrate with external systems through callouts, giving it the ability to interact with data outside of Salesforce.

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