Rethinking Clinical Trials

MARCH 6, 2024

Schell Professor of Management and Applied Economics MIT Sloan School of Management Slides Keywords Food-as-Medicine, Randomized Clinical Trial, Diabetes Key Points Diabetes is common and costly.              Speaker Joseph Doyle, PhD Erwin H. 9% of the U.S. They also screened for complications and close care gaps.

Clinical Trials 146

Clinical Trials Clinical Trials Medicine Trials 146

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. Hatch also discussed the increasing integration of digital technologies like AI in food safety.

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Compliance Regulation Production Containment 110

Rethinking Clinical Trials

JANUARY 31, 2024

The final key decision point is lifecycle management, which includes monitoring and maintaining the AI product and updating or decommissioning the product. The first key decision point is procurement, which begins with identifying a problem and ends with allocation of resources to either build or buy an AI product or solution.

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Production Development Clinical Trials Clinical Trials 170

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

JANUARY 26, 2023

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. EVOLVE-MI is enrolling 4,000 patients in 3 countries.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

Rethinking Clinical Trials

JUNE 29, 2022

In 2021, the FDA issued 4 draft guidance documents for Real-world data and Real-world evidence intended to guide the selection and management of data sources to appropriately address the study question and support decision-making for drug and biological products. Discussion Themes. and the FDA Draft Guidance for RWD/RWE.

Big Data 130

Big Data Clinical Trials Clinical Trials Drugs 130

pharmaphorum

JANUARY 9, 2023

First introduced in 2020, the global Managed Access Programme (gMAP) has provided Zolgensma (onasemnogene abeparvovec) free of charge to nearly 300 children with the genetic disorder across 36 countries where the therapy has not yet received approval or in which no formal access pathway exists.

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Gene Therapy Genetics Gene Clinical Trials 119

Rethinking Clinical Trials

DECEMBER 20, 2023

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. There are several strategies that will help increase diversity in CVD trials. With the current ability to become pregnant this can affect women up to the age of 50.

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Clinical Trials Clinical Trials Trials Cardiology 179

Rethinking Clinical Trials

FEBRUARY 28, 2024

We are building out what are the core competencies, the technological, legal, ethical, clinical research administration competencies that are needed in addition to data management for a CRC. Under RBM, the process by which study materials get to participants should be considered high risk and monitored accordingly.

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Clinical Trials Clinical Trials Trials Clinical Research 146

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

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. Joanna Carlish, managing director, financial services, Tag Americas.

Regulation 97

Regulation Marketing Sales Branding 97

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.

Big Data 40

Big Data Medicine Marketing Clinical Trials 40

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 54

Production 54

pharmaphorum

JULY 23, 2019

This pharmaphorum webinar, in association with Tag, will examine the challenges that pharma marketing faces to stay ahead of the evolving customer journey and offer expert insight from both the pharma and FMCG sectors on how to convert these challenges into opportunities.

Marketing 52

Marketing Production Development Research 52

pharmaphorum

JANUARY 24, 2022

Francisco Partners is picking up a range of databases and analytics tools – including Health Insights, MarketScan, Clinical Development, Social Programme Management, Micromedex and other imaging and radiology tools – for an undisclosed sum estimated to be in the region of $1 billion.

Radiology 111

Radiology Marketing Genome Genomics 111

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. The European Medicines Agency (EMA) released a separate guidance around DCTs in December 2022.

Trials 130

Trials Clinical Trials Clinical Trials Licensing 130

Rethinking Clinical Trials

FEBRUARY 14, 2024

It had a pragmatic recruitment model with an embedded design, multicenter study without local study investigators and management teams, and broad recruitment that included patients from all 50 states and Puerto Rico.

Clinical Trials 159

Clinical Trials Clinical Trials Cardiology Trials 159

Rethinking Clinical Trials

SEPTEMBER 13, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds September 8, 2023: The DEVICE Trial: An Embedded, Pragmatic Trial of Emergency Airway Management (Matthew Prekker, MD, MPH; Jonathan Casey, MD, MSc) appeared first on Rethinking Clinical Trials. For moderately experienced operators, VL increased by 6%.

Trials 146

Trials Clinical Trials Clinical Trials Medicine 146

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

Rethinking Clinical Trials

FEBRUARY 13, 2023

There was no prescription of pre-surgical, anesthetic, surgical, perfusion, and ICU management procedures. All patients could receive inhalation NO during/after surgery if considered indicated by the treatment team. There was no change in perioperative care. 1,371 patients were randomized with 1,364 in the final analysis. .

Trials 130

Trials Clinical Trials Clinical Trials Research 130

Rethinking Clinical Trials

OCTOBER 2, 2023

The PROTEUS-Practice Guide offers support for designing, implementing, and managing PRO systems in clinical care. The PROTEUS website has web tutorials, checklists, and a handbook on topics such as displaying data for patients and clinicians and researchers. We are pursuing funding.

Clinical Trials 159

Clinical Trials Clinical Trials Research Trials 159

Rethinking Clinical Trials

OCTOBER 26, 2023

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. with the rate of reported acute Hepatitis C cases increasing 400% during 2010-2020.

Clinical Research 146

Clinical Research Clinical Trials Clinical Trials Research 146

Pharmaceutical Technology

MAY 2, 2023

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. They also require better mechanisms for managing IO-related toxicities and improving patients’ quality of life (QOL). Cost-related unmet needs also scored highly.

Genetic Engineering 130

Genetic Engineering Antibody Clinical Trials Clinical Trials 130

Rethinking Clinical Trials

MAY 19, 2023

Vanderbilt has a plan for bridging this gap through care managers. Tags #pctGR, @Collaboratory1 The post Grand Rounds May 12, 2023: Design and Pragmatic Trial of COACH: A Patient Portal/EHR Information System for Home Blood Pressure Monitoring in Hypertension (Richelle J. You can access the portal from desktop and phones.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

Rethinking Clinical Trials

OCTOBER 13, 2022

In Germany, there are two levels of anesthesia, in-room anesthesiologists who are either trainees or a medical specialist (non-management). Patients were registered and randomized centrally in a 1:1 ratio to receive either a handover of anesthesia care or no handover. pctGR, @Collaboratory1.

Trials 130

Trials Clinical Trials Clinical Trials Nurses 130

pharmaphorum

SEPTEMBER 15, 2020

“Digitally native brands are typically agile businesses from the ground up, and agility and flexibility are part of their core makeup,” says Joe Holmes, vice president, marketing services, US at Tag. Jeremy Richter, Tag. Joe began his life at Tag in the UK, bringing efficiencies to his clients, working across all conceivable channels.

Branding 130

Branding Marketing Pharma Companies Life Science 130

Rethinking Clinical Trials

FEBRUARY 20, 2024

However, they saw very wide confidence intervals, which made it difficult to determine the best way to manage patients in this context. Tags #pctGR, @Collaboratory1 The post Grand Rounds February 16, 2024: Clinical Implications of the MINT Trial: p=0.07 (Jeffrey Carson, MD, MACP) appeared first on Rethinking Clinical Trials.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

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.

Drugs 98

Drugs Medicine Clinical Trials Clinical Trials 98

pharmaphorum

JANUARY 11, 2022

The DTx is an on-demand stress management intervention with content synchronised with high-intensity chemotherapy treatment. The post Blue Note leukaemia DTx gets FDA breakthrough tag appeared first on. Other DTxs are aimed at people being treated for breast and lung cancers.

Development 64

Development Production Drugs 64

XTalks

APRIL 18, 2024

Previously, Roche secured an FDA breakthrough tag for another one of its Alzheimer’s blood tests that detects levels of pTau-181 and ApoE4 (apolipoprotein e4). The disease has an estimated $360 billion cost to the US economy. However, the guidance doesn’t say whether it could serve as a study’s primary endpoint on its own.

Clinical Trials 52

Clinical Trials Clinical Trials In-Vitro Protein 52

XTalks

OCTOBER 19, 2023

Despite the premium price tag, the brand has gained a cult following thanks to its inclusion of high quality ingredients and successful word-of-mouth marketing. The new management has committed to maintaining Rao’s sauce’s signature taste. Many voiced worries about potential changes in the popular sauce’s flavor or ingredients.

Branding 59

Branding Packaging Packaging Production 59

Pharmaceutical Technology

JUNE 29, 2022

For example, while orphan drug designations have more than doubled in the last decade compared to the previous one, only 16% of therapies with orphan tags have managed to gain FDA approval in some indications.

Drugs 246

Drugs FDA Approval Marketing Development 246

Drug Discovery World

JULY 25, 2023

Watch this on demand now. Due to technical difficulties, Carsten Rudolph, Managing Director and CEO of Ethris, was unable to participate in the Q&A. We have shown that the excipient does not only work for our SNAP-tag lipid (SNaP) LNP, but also for the commercialised vaccines.

Drugs 52

Drugs Packaging Packaging Manufacturing 52

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

Intouch Solutions

APRIL 11, 2024

Clinical : Optimized efficiency, inventory management, and service quality of clinical trials. Instead, it will be a transformational process that affects various functions of the organization, triggering considerations related to data privacy and security, regulatory compliance, and change management.

Compliance 52

Compliance Marketing Drugs Pharma Companies 52

XTalks

JUNE 28, 2023

Options for managing the symptoms of DMD have been limited. million price tag of Elevidys, a one-time gene therapy. Symptoms of DMD can include difficulties walking and running, falling frequently, fatigue, learning disabilities/difficulties, heart issues and breathing problems.

Gene Therapy 98

Gene Therapy Gene Protein FDA Approval 98

pharmaphorum

DECEMBER 23, 2022

But along with strong efficacy come some considerable risks and costs: cytokine release syndrome (CRS), where a patient’s immune system becomes dangerously over-stimulated, and neurotoxicity are potential side effects that need to be managed. Side effects and cost implications.

Development 52

Development Drugs Clinical Development Antibody 52