Rethinking Clinical Trials

JANUARY 26, 2023

This study is looking at a particular subpopulation, where there is a lack of outcomes data. Patient recruitment is through a network of sites in different geographic locations managed by a collaboration of AROs. Study participants are managed within health systems in-line with local standard of care.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

Pharmaceutical Technology

DECEMBER 15, 2022

This extrapolation leverages data from GlobalData’s World Markets Healthcare and PharmOnline International databases to expand the number of markets in GlobalData’s patient-based sales forecast model from seven major markets (7MM) to 68 markets (68M). The second highest contributing market is APAC, generating 33.2%

Marketing 130

Marketing Sales Clinical Trials Clinical Trials 130

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).

Big Data 40

Big Data Medicine Marketing Clinical Trials 40

Rethinking Clinical Trials

MAY 19, 2023

Colwill Professor and Vice Chair Department of Family and Community Medicine University of Missouri Slides Keywords Electronic Health Record, Pragmatic Clinical Trial Key Points Patients bring patient-generated home blood pressure data into the clinical workflow. It was data that was sitting there without alerts in our system.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

XTalks

MAY 2, 2024

In the afternoon session, the focus shifted to effective management of food safety recalls with Ron Judge of Maple Lodge Farms, followed by Olaf Degen of Bruker Diagnostics introducing advanced rapid detection methods for pathogens. We’re incorporating AI into everything that we do. Xtalks speaking with Jud Sinton.

Compliance 108

Compliance Regulation Production Containment 108

Rethinking Clinical Trials

JULY 6, 2023

Additional considerations are needed for the data management plan, monitoring plan, safety plan, task log, and case report forms in the FDA draft guidance. Interstate licensing and our own institution’s policies are issues that still need to be addressed in terms of oversight and responsibilities.

Trials 130

Trials Clinical Trials Clinical Trials Licensing 130

pharmaphorum

OCTOBER 18, 2022

Medtech giant Beckton Dickinson (BD) has signed a deal with France’s Biocorp to use the latter’s near-field communication (NFC) tags in injectable devices. The Injay tag can confirm a complete injection and transfer that information via an NFC reader to a smartphone or tablet for review by a healthcare professional.

Drug Delivery 52

Drug Delivery Manufacturing Drugs Marketing 52

Rethinking Clinical Trials

OCTOBER 19, 2022

Trials are getting larger and collecting greater volumes of clinical data than ever before, often as part of Common Data Elements (CDEs). These data increasingly include info that might signal physical, mental health or behavioral health risks to patient-subjects (e.g. Vanderbilt University Medical Center. Ethics, IRB, FM-TIPS.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Medicine 130

Intouch Solutions

APRIL 11, 2024

Clinical : Optimized efficiency, inventory management, and service quality of clinical trials. 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.

Compliance 52

Compliance Marketing Drugs Pharma Companies 52

Rethinking Clinical Trials

DECEMBER 20, 2023

It is important to note when you look at the ARIC surveillance data, there is consistently higher risk in black females and males across all ages. First, increasing diversity among trial participants must be a top priority in order to address health disparities and allow for optimal diagnosis and management of CVD in all.

Clinical Trials 169

Clinical Trials Clinical Trials Trials Cardiology 169

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.

Radiology 109

Radiology Marketing Genome Genomics 109

Rethinking Clinical Trials

JULY 9, 2023

Discussion Themes Motivating patients to engage in self-management of health conditions is a challenge, irrespective of whether the intervention is delivered in person or remotely. However, persons in low-income and rural communities have significantly higher odds of receiving a prescription opioid for a new back pain diagnosis.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

Rethinking Clinical Trials

OCTOBER 2, 2023

The PROTEUS Consortium’s objective is to ensure that patients, clinicians, and other decision-makers have high-quality PRO data from clinical trials and clinical practice to make the best decisions they can about treatment options. It collates and synthesizes foundational resources to create a unified, comprehensive resource.

Clinical Trials 152

Clinical Trials Clinical Trials Research Trials 152

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.

Genetic Engineering 130

Genetic Engineering Antibody Clinical Trials Clinical Trials 130

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). Effectiveness of current treatments : Corticosteroids and IL6 Receptor Blockers will still be effective for managing patients with severe COVID-19. On 26 November 2021, WHO designated the variant B.1.1.529

Vaccination 52

Vaccination Vaccine Genome Genomics 52

pharmaphorum

JULY 23, 2019

Focus New developments in data and digital are changing traditional customer journeys and forcing pharmaceutical companies to evolve in order to keep up. The expert panel will consider exclusive research carried out by Tag and pharmaphorum across the US, Europe and Asia-Pacific among senior decision-makers in pharma and FMCG marketing.

Marketing 52

Marketing Production Development Research 52

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. As a result there is a huge demand for trustworthy content.

Regulation 83

Regulation Marketing Sales Branding 83

Rethinking Clinical Trials

MARCH 21, 2023

Symptom management is a cornerstone of quality care, but do we adequately detect and manage symptoms? In a model for systematic symptom monitoring, a patient might report symptoms electronically in real-time via e-reports or e-alerts so the care team can respond proactively and have data to review at the next visit.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

Rethinking Clinical Trials

SEPTEMBER 13, 2023

After enrolling patients for 8 months, the data safety board recommended trial enrollment stop because the prespecified stopping criteria for efficacy had been met. Nearly 2,000 patients were assessed for eligibility and 1,417 patients were enrolled. For moderately experienced operators, VL increased by 6%.

Trials 141

Trials Clinical Trials Clinical Trials Medicine 141

Cloudbyz

JUNE 2, 2020

Now, here comes a scenario where your senior account manager wants to view a report of all the opportunities and their respective stages along with forecasted and actual revenue for a particular account. Go to the Account object in object manager Go to ‘Buttons, Links, and Actions’ and click on new ‘Button or Link Add description.

Production 55

Production 55

Cloudbyz

JUNE 1, 2023

Force.com is designed to simplify the development, delivery, and management of applications and services. For example, if a deal reaches a particular stage, an email notification can be sent to the sales manager. Record Triggers: Flow can respond to changes in Salesforce data, initiating processes when records are created or updated.

Compliance 79

Compliance Development Branding Production 79

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.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

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.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

XTalks

JUNE 28, 2023

Options for managing the symptoms of DMD have been limited. 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.

Gene Therapy 98

Gene Therapy Gene Protein FDA Approval 98

Rethinking Clinical Trials

OCTOBER 26, 2023

Our review of the data from other countries is that having same-day tests available for certain settings and populations is a helpful strategy. Tags #pctGR, @Collaboratory1 The post Grand Rounds October 20, 2023: A National Initiative to Eliminate Hepatitis C in the United States – Why This Matters to Clinical Trialists (Rachael L.

Clinical Research 141

Clinical Research Clinical Trials Clinical Trials Research 141

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.

Production 264

Production Pharma Production Pharma Companies Drugs 264

pharmaphorum

NOVEMBER 16, 2021

. “The FAD is a significant milestone for cenobamate and takes us closer towards reimbursement in England and Wales,” commented Stuart Mulheron, general manager UK & Ireland, Angelini Pharma. 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.

Drugs 90

Drugs Medicine Clinical Trials Clinical Trials 90

Pharmaceutical Technology

JUNE 29, 2022

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. GlobalData is the parent company of Pharmaceutical Technology.

Drugs 246

Drugs FDA Approval Marketing Development 246

pharmaphorum

DECEMBER 23, 2022

Here, Richard Staines reports on phase I/II data unveiled at the American Society of Hematology conference that supports further clinical development of inobrodib in multiple myeloma and other blood cancers. This alone causes expense for cash-strapped hospitals and puts pressure on nursing and medical staff while they manage the side effects.

Development 52

Development Drugs Clinical Development Antibody 52

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. Jeremy Richter – director of regulatory affairs.

Branding 109

Branding Marketing Pharma Companies Life Science 109

Drug Discovery World

OCTOBER 3, 2022

The seminars will include high profile speakers from pharma and biotech covering topics such as The Lab of the Future is Now, Data Handling and Choosing the Right Informatics System, The Sustainable Lab and The Remote Lab: Is This the Future? Product Manager, SPT Labtech. Dr Yahya Anvar, Head of Data Science, OKRA.ai

Drugs 52

Drugs Scientist Bioinformatics Medicine 52

pharmaphorum

NOVEMBER 27, 2022

Empowering labs with automated equipment that produces rich, traceable, and actionable data insights means pharmaceutical companies can ensure drug production runs smoothly – even under stress. Better communication with traceable data. Automation can be such a solution. Reducing capacity issues.

Production 103

Production Manufacturing Drugs Marketing 103

Drug Discovery World

JANUARY 30, 2024

Joel Eichmann, Co-Founder and Managing Director, Green Elephant Biotech, agrees that prices need to come down significantly for CGT to be widely available. Other Challenges: Limited insurance coverage: Many insurance companies are hesitant to cover CGTs due to their high price tags and limited long-term data.

Gene Therapy 71

Gene Therapy Manufacturing Gene Clinical Trials 71

XTalks

OCTOBER 12, 2022

MRI may also be used to evaluate drug dosing regimens, to gain insight about the mechanism of drug action, and to collect imaging biomarker data which could provide an earlier indication of response to therapy than clinical outcomes. Each patient is represented as one data point. Why Image Vascular Perfusion? Figure from Ricart et al.,

Clinical Trials 93

Clinical Trials Clinical Trials Trials Drugs 93

Delveinsight

JULY 22, 2020

The Internet of Things is the interconnection of available medical devices, software applications and other resources to collect and exchange data to provide a reliable, efficient, and smart healthcare service to the patients. Sensors/Devices are the primary data collection point in IoT. New Insight/Data For Research.

Doctors 59

Doctors Doctor Marketing Production 59

XTalks

JUNE 8, 2021

In addition, recent data from a Phase I trial has shown ‘remarkable’ long-term results of the gene therapy in children with the disease. Prior to Zolgensma, treatments could only help manage symptoms and attempt to improve quality of life. With a price tag of over $2.5 Zolgensma Gene Therapy: START Trial.

Gene Therapy 110

Gene Therapy Gene Protein Trials 110

pharmaphorum

JUNE 8, 2021

Dementia specialist Prof Robert Howard of University College London (UCL) was also damning in his assessment of the decision, saying that the FDA has “sidestepped available clinical trial outcomes data that indicate the drug probably doesn’t work.” Accelerated approval is probably a reasonable middle ground here.

Drugs 98

Drugs Marketing FDA Approval Trials 98