Rethinking Clinical Trials

SEPTEMBER 28, 2023

Integrating a community health care workers into the well child care team improves well child care for Medicaid-insured children. Our partners want to know the data and what it takes to collect it in a rigorous way.

Trials 271

Trials Clinical Trials Clinical Trials Research 271

Rethinking Clinical Trials

MARCH 28, 2023

Patients and caregivers are integrated into all phases of PCORnet®.-enabled Data are drawn from millions of EHRs with growing links to patient-reported and payor data. It is one of the only data resources with granular clinical data, lab data, and very large sample sizes. enabled research. Every PCORnet®.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

Rethinking Clinical Trials

OCTOBER 4, 2022

The Clinical Trial Transformation Initiative (CTTI) envisions an evidence generating system with trials that are patient-centered, integrated into health processes, quality, leverage all available data, and improve population health. Key Points. Tech support at the site level is important to addressing problems in a study.

Trials 130

Trials Clinical Trials Clinical Trials Production 130

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?

Compliance 52

Compliance Marketing Drugs Pharma Companies 52

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are needed for the data management plan, monitoring plan, safety plan, task log, and case report forms in the FDA draft guidance.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

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

AUGUST 30, 2023

These PROs have been integrated into RA guidelines and they are recommended by professional societies. The team collected focus group feedback from patients and clinicians and worked with IT professionals to pull data directly from the electronic health record and design an interface that could be used by all patients.

Trials 143

Trials Clinical Research Coordinator Medicine Clinical Trials 143

XTalks

MAY 2, 2024

Several common themes included the integration of technology like blockchain and AI in food safety, the importance of a well-trained workforce and the continuous need for industry collaboration. Hatch also discussed the increasing integration of digital technologies like AI in food safety.

Compliance 110

Compliance Regulation Production Containment 110

Rethinking Clinical Trials

AUGUST 28, 2023

There is also a longitudinal cohort of EHR data for all patients at participating PCP clinics to assess utilization and other broad outcomes. In terms of administrative and regulatory lessons learned, the team reflected that the integration of PT/DC at the forefront of the patient experience is often different from many typical processes.

Trials 130

Trials Research Medicine Doctors 130

XTalks

JUNE 28, 2023

DMD is caused by the absence of dystrophin, a protein that helps maintain the integrity of muscle cells. 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.”

Gene Therapy 98

Gene Therapy Gene Protein FDA Approval 98

Pharmaceutical Technology

APRIL 13, 2023

Although the findings in the report are only preliminary, they shed light at the considerations behind the high price tags of gene therapies. Editorial content is independently produced and follows the highest standards of journalistic integrity. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Gene Therapy 147

Gene Therapy Gene FDA Approval Licensing 147

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.

Compliance 78

Compliance Development Branding Production 78

Rethinking Clinical Trials

SEPTEMBER 22, 2022

Denmark also has registries tracking socioeconomic data such as income and level of education and other types of data that can be linked together for study. The DECODE trial used registry data to identify patients with chronic kidney disease. Learn more. Read about DANFLU-1. pctGR, @Collaboratory1.

Trials 130

Trials Cardiology Vaccination Vaccine 130

Pharmaceutical Technology

JULY 14, 2022

Due to the high price tags associated with these speciality medicines, innovators have naturally favoured big markets with high GDP such as the US and EU-5 (Germany, France, Spain, Italy, and the UK). “The Go-to-market strategies. The choice of where to launch an orphan drug is an important and difficult decision.

Drugs 147

Drugs Medicine Marketing Development 147

Drug Discovery World

NOVEMBER 7, 2022

“There are a lot of research groups that have spent considerable time making drugs that bind very tightly to cereblon, but have then scratched their heads in puzzlement that these drugs fail to work,” says study senior author Gabriel Lander, Professor in the Department of Integrative Structural and Computational Biology at Scripps Research. .

Scientist 52

Scientist Drugs Protein Research 52

Rethinking Clinical Trials

SEPTEMBER 16, 2022

One challenge is that academic medical institutions traditionally have multiple missions, including research, patient care, and education, and systemically integrating learning into clinical operations is novel addition to the traditional missions. How can institutions help move the needle? The argument for LHS model is strong. Learn more.

Clinical Trials 100

Clinical Trials Clinical Trials Trials Research 100

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. Automation will be a large part of this long-term vision.

Production 105

Production Manufacturing Drugs Marketing 105

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

Pharmaceutical Technology

APRIL 5, 2023

But access to these treatments continues to remain limited due to high price tags and variable availability across regions. BL: I’m really excited about the first potential CRISPR approval because it represents two elements; the integration of new technology, and the availability in a generally underserved population.

Gene Therapy 147

Gene Therapy Gene Engineer Production 147

Drug Discovery World

JANUARY 10, 2023

We are vertically-integrated from immunisation through manufacturing and validation. Scientists purchase antibodies with the expectation that they will recognise their intended targets and produce reliable data, but the presence of improperly validated antibodies on the market can make this process both time-consuming and expensive.

Antibody 52

Antibody Protein Reagent Scientist 52

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? Dr Yahya Anvar, Head of Data Science, OKRA.ai Product Manager, SPT Labtech.

Drugs 52

Drugs Scientist Bioinformatics Medicine 52

XTalks

FEBRUARY 27, 2024

Despite high price tags of a couple of million dollars, gene therapy makers say they are working to ensure patients are able to access the treatments through patient assistance programs developed in conjunction with the support of governments. Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial.

Research 59

Research Drugs Gene Therapy Clinical Trials 59

pharmaphorum

FEBRUARY 22, 2021

Bluebird has said it hopes to have some data within the next few weeks that should explore the possibility of a causal link. That is concentrating on determining where the vector integrated into the chromosomes of the two patients with cancer, and if that has resulted in changes to gene expression in neighbouring areas.

Gene Therapy 52

Gene Therapy Gene Gene Sequencing Gene Expression 52

XTalks

DECEMBER 21, 2022

The multi-million-dollar price tags are largely attributable to the high R&D and manufacturing costs associated with making a gene therapy, as the raw materials for producing the therapy can be expensive. Virtual trial processes involve the use of technologies that enable remote data collection and sharing. AI/ML Technology.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 52

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?”.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Drugs 52

Pharmaceutical Technology

JUNE 21, 2023

The high price tag may be hard to defend , but with lifetime treatment costs for haemophilia B reaching as high as $23m for some, the single-dose treatment could prove far more cost-effective. Despite the limited market, the price tags of haemophilia make it potentially lucrative. Haemophilia B is a rare condition.

Gene Therapy 246

Gene Therapy Gene Protein Sales 246

XTalks

FEBRUARY 11, 2021

Case in point, Watson is said to have paid a visit to King’s to try to collaborate with Franklin, amidst growing threats from Pauling’s DNA work, but she rejected the offer after he offended her by saying that she lacked skill in interpreting her own data.

Genetics 119

Genetics DNA Genome Genomics 119

pharmaphorum

SEPTEMBER 30, 2022

This shift enables companies to improve the quality and compliance of the documents and data that make up regulatory submissions and create a data-sharing ecosystem that enhances healthcare. Most of the information is submitted in the form of unstructured PDF documents, with data embedded into them. Submission status quo.

Compliance 52

Compliance Life Science Marketing Production 52

Drug Discovery World

FEBRUARY 21, 2023

Ahead of his presentation in the Automation Technologies Track at SLAS2023, Pillai shares insight on data and how we can connect lab automation to decisions. We need to build very purposeful software and be able to integrate old instruments that are industry standard but capable of communicating with APIs, ELNs, LIMS, and Scheduling Software.”

Scientist 52

Scientist Gene Editing Engineer Bioinformatics 52

Roots Analysis

AUGUST 28, 2022

Furthermore, several live cell imaging and non-destructive fluorescence histological methods measure limited number of biomarkers at a time and the tags introduced may interfere with the natural function of genes and proteins. In fact, platform integration agreements account for 18% of the total deals inked in this domain, since 2016.

Genome 52

Genome Genomics RNA Genome Project 52

Drug Discovery World

FEBRUARY 9, 2023

It also carries a much higher price tag for failure. We are entrenched in the era of big data and are amassing an insurmountable quantity of human-derived data to better inform our efforts in finding treatments. On top of that, pharmaceutical development is extremely complex in itself.

Drugs 52

Drugs Development Big Data Scientist 52

Drug Discovery World

NOVEMBER 13, 2023

The presentations are as follows: Fabian Schmich, PhD, Senior Data Scientist, pRED Informatics, Roche Diagnostics Deutschland, on: ‘scifAI: An explainable machine learning framework applied to functional characterisation of therapeutic antibodies’.

Protein 59

Protein Antibody Engineer Scientist 59

Drug Discovery World

NOVEMBER 9, 2023

Gail Calvert, Field Application Scientist, Sartorius UK, on: ‘Leveraging integrated and advanced technologies for successful cell line development’. Sven Malik, Mr, Senior Application Specialist, Applications, Bruker Daltonics SPR, on: ‘Bruker’s SPR Analyser 4 – State of the art SPR data analysis’.

Engineer 52

Engineer Antibody Protein In-Vivo 52

Drug Discovery World

OCTOBER 21, 2022

The main principle involves a well-defined light source such as that produced by lasers that excites fluorescent tags bound to the cells or particles present in a sample. Another trend is the integration of additional parameters to help characterise samples of interest even further.

Reagent 52

Reagent Antibody Drugs Protein 52

The Pharma Data

MAY 4, 2021

Safety data from the Phase 3 study has also been collected from more than 12,000 vaccinated participants who have a follow-up time of at least six months after the second dose, demonstrating a favorable safety and tolerability profile. Safety data will also be collected during the study. Regulatory Developments.

Vaccination 40

Vaccination Vaccine Production Sales 40

Pharma Marketing Network

JUNE 8, 2020

There’s what I call the real market and so this market really exploded, and I have data in this chapter about it. But I guess to be a bit of a contrarian and backed up with a lot of data. It essentially has two elements. Dave (HR): Oh, no, I think the Specialty Pharmacy. So yeah, there is plenty to talk about there.

HR 40

HR Marketing Doctors Doctor 40