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are needed for the data management plan, monitoring plan, safety plan, task log, and case report forms in the FDA draft guidance. For instance, there is no discussion of the role of the health care provider in the DCTs, but it emphasizes the importance of patient voice.

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XTalks

DECEMBER 13, 2023

Current treatments for sickle cell disease include blood transfusions but patients often have episodes of intense pain and an increased risk of stroke. It can also make patients more susceptible to complications like anemia, jaundice, infections and gallstones. Vertex-CRISPR’s Casgevy has a US list price of $2.2

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Gene Therapy FDA Approval Gene In-Vivo 98

XTalks

APRIL 18, 2024

Conversely, a negative result suggests a low probability of amyloid pathology, guiding healthcare providers in clinical decision-making and potentially ruling out Alzheimer’s disease in symptomatic patients. There are currently no FDA-authorized blood tests for detecting Alzheimer’s disease.

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Clinical Trials Clinical Trials In-Vitro Protein 52

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

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Vaccination Vaccine Genome Genomics 52

Rethinking Clinical Trials

SEPTEMBER 22, 2022

The Danish Nationwide Registries include the Danish Patient Registry (a registry of every inpatient and outpatient contact in the Danish free-for-all public healthcare system); the Danish Medicines Registry (a registry of every filed prescription at any pharmacy in Denmark including information on pill strength, pack size, etc.); Key Points.

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XTalks

FEBRUARY 27, 2024

“The accelerated approval of Amtagvi is the first step in realizing Iovance’s ambition to usher in the next generation of cell therapy by bringing this breakthrough to patients with advanced solid tumors,” said Frederick Vogt, PhD, JD, interim CEO and president of Iovance in a news release announcing the approval. percent, including three (4.1

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

Rethinking Clinical Trials

SEPTEMBER 30, 2022

The types of services NFP nurses provide include health assessments, such as prenatal health assessment, monitoring weight and blood pressure; screening for depression, anxiety, intimate partner violence; referrals to health care providers and community resources; educational content; and psychosocial support. pctGR, @Collaboratory1.

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Roots Analysis

JANUARY 28, 2024

Velocity: Big Data needs to be handled promptly as businesses generate data at an unprecedented speed, driven by the growing adoption of Internet of Things (IoT), and technologies, such as RFID tags, sensors, and smart meters are used to deal with the high velocity of data in real-time. It is loosely arranged into categories using meta tags.

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Big Data Medicine Marketing Clinical Trials 40

pharmaphorum

AUGUST 18, 2022

bluebird bio’s Zynteglo has become the first cell-based gene therapy to be approved in the US, getting the nod from the FDA as a treatment for patients with beta thalassaemia who require regular blood transfusions. An FDA advisory committee recommended approval of Zynteglo on the strength of that data in June.

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Gene Therapy FDA Approval Gene Clinical Trials 52

pharmaphorum

NOVEMBER 27, 2022

Modular set ups, remote monitoring systems, and automated batch processing can all assist in helping labs respond to issues as quickly and efficiently as possible. End-to-end monitoring for maximum security. Automation will be a large part of this long-term vision.

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Production Manufacturing Drugs Marketing 104

Delveinsight

JULY 22, 2020

Today the tech-based healthcare industry is providing many unique solutions to the patient’s care which are more efficient and effective than the traditional services. 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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Doctors Doctor Marketing Production 59

XTalks

OCTOBER 12, 2022

However, the role of MRI in new drug clinical trials can involve diagnosis of lesions and determination of their severity, early identification of therapeutic responders to drug treatment and treatment monitoring and follow-up. Each patient is represented as one data point. Figure from Liu et al., Figure from Ricart et al.,

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Clinical Trials Clinical Trials Trials Drugs 93

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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Rethinking Clinical Trials

MARCH 21, 2023

Goldberg Distinguished Professor and Chief of Oncology Physician-in-Chief, North Carolina Cancer Hospital Director, Cancer Outcomes Research Program University of North Carolina Slides Keywords Patient-reported outcomes, Oncology, Clinical Trials Key Points Symptoms are common in cancer care. Quality of life (QOL) was assessed at 6 months.

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XTalks

AUGUST 23, 2021

Dr. Weninger’s fellow panel members echoed that sentiment and sought to address some of the most pressing concerns around trial design, patient safety and data integrity in trials in this post-approval period for aducanumab. Now that [aducanumab] is approved, how will this affect clinical trials going forward?”.

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Clinical Trials Clinical Trials Trials Drugs 52

The Pharma Data

OCTOBER 9, 2021

This designation is predicated on data showing that gantenerumab significantly reduced brain amyloid pillar, a pathological hallmark of Notice, in the ongoing SCarlet RoAD and Marguerite RoAD open- tag extension trials, as well as other studies.

Antibody 52

Antibody In-Vitro Trials Development 52

Rethinking Clinical Trials

OCTOBER 19, 2022

These data increasingly include info that might signal physical, mental health or behavioral health risks to patient-subjects (e.g. This raises a lot of questions: Whose responsibility is it to monitor those risk factors? What should be monitored and how? What do patients and other stakeholders desire?

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XTalks

DECEMBER 21, 2022

This included greater adoption and acceptance of decentralized clinical trial models, emphasis on patient-centric approaches in trials, growing digitization of healthcare and dealing with drug manufacturing challenges. Gene Therapy Approvals. Manufacturer: Ferring Pharmaceuticals A/S. Manufacturer: bluebird bio, Inc.

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Life Science Gene Therapy Gene Clinical Trials 52

XTalks

FEBRUARY 27, 2024

Skyclarys (omobaloxone) was approved in 2023 for the treatment of adults and pediatric patients 16 years of age and older with Friedreich’s ataxia, a rare, neurological disease​​. Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial.

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Research Drugs Gene Therapy Clinical Trials 59

XTalks

SEPTEMBER 27, 2022

About half of patients who do not receive any treatment die within five years of symptom onset. The record-breaking price tag of Skysona is not surprising for one-time gene therapies like it. Patients were also required to have a neurologic function score (NFS) of less than one, indicating limited changes in neurologic function.

FDA Approval 52

FDA Approval Gene Therapy Drugs Gene 52

Intouch Solutions

AUGUST 25, 2021

In this POV, we evaluate the potential impact to the email channel and opportunities to continue to deliver ethical, quality email experiences and personalization for pharma customers, including healthcare providers (HCPs) and patients. The result? Lastly, marketers will be blocked from receiving forward tracking data. ©Intouch Group 2021.

Marketing 52

Marketing Regulation Engineer Branding 52

Camargo

AUGUST 22, 2021

Since its inception, the FDA monitored and analyzed conformance and revised the TRC but has not implemented them until now. 3.3.2: Patient PK and Initial Tolerability Study Reports. 3.4.2: Patient PD and PK/PD Study Reports. The correct STF file-tags are used for datasets and corresponding data definition files.

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XTalks

JANUARY 19, 2024

And if the bar is set too low, patients may not reach optimal exposures and may not get the full benefit of the treatment, explained Dr. Anderson. Since every pharmaceutical is unique, closely monitoring labs such as estimated glomerular filtration rate (eGFR) to detect any changes in renal function with increasing exposures is also critical.

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The Pharma Data

MAY 15, 2021

In the process, I’ve reviewed thousands of research articles, played a key role in publishing real clinical studies and as a surgeon, operated on hundreds of patients often in life-or-death scenarios. All so that I can better understand and help my patients achieve the health they always dreamed of.

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