Sat.Jun 27, 2020 - Fri.Jul 03, 2020

article thumbnail

A 505(b)(2) Primer: Building the Bridge Between an Approved Drug and Your Novel Therapy

Camargo

This blog features considerations and recommendations for sponsors exploring a 505(b)(2) pathway to drug approval. The post A 505(b)(2) Primer: Building the Bridge Between an Approved Drug and Your Novel Therapy appeared first on Camargo.

Drugs 132
article thumbnail

Estimation of Excess Deaths From COVID-19 in the United States, March to May 2020

JAMA Internal Medicine

This observational study uses NCHS data to evaluate weekly changes in US deaths due to any cause and deaths due to pneumonia, influenza, or COVID-19, by state, from March 1 through May 30, 2020.

113
113
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Digital Transformation and COVID-19: A Catalyst for Change

Intouch Solutions

COVID-19 has been a wake-up call for pharma to evaluate their organization’s digital maturity and ability to serve customers personalized experiences. Is your organization ready? The post Digital Transformation and COVID-19: A Catalyst for Change appeared first on Intouch Solutions.

87
article thumbnail

Salesforce Flows – A How-to Guide

Cloudbyz

In this blog we will learn Salesforce flow and how it is similar to apex coding. Salesforce flow is a declarative way (Drag & Drop) of implementing an automation that is required for a business process alternative to code. Blog covers types of flows, elements, resources and good comparison with a sample apex code. Salesforce flow is a very powerful tool for admins/developers along with process builders and workflows.

article thumbnail

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

article thumbnail

The Stages of Alzheimer’s Disease

My Local Study

Alzheimer’s disease is the most common form of dementia. Dementia is a universal label that defines the symptoms of mental decline associated with Alzheimer’s and other brain conditions. Typically, there are three stages that Alzheimer’s disease slowly progresses through. These are early (mild), middle (moderate), and late (severe). Over 50 million people worldwide have Alzheimer’s.

article thumbnail

Is a “Cytokine Storm” Relevant to COVID-19?

JAMA Internal Medicine

In its most severe form, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), leads to a life-threatening pneumonia and acute respiratory distress syndrome (ARDS). The mortality rate from COVID-19 ARDS can approach 40% to 50%. Although the mechanisms of COVID-19–induced lung injury are still being elucidated, the term cytokine storm has become synonymous with its pathophysiology, both in scientific publications and the media.

More Trending

article thumbnail

Essential Tips for Enrolling Rare Disease Trials

Imperical Blog

The last decade has seen an explosion in clinical trials for therapies focused on rare diseases. PhRMA reports that there are more than 800 orphan drugs currently in development or regulatory review. While rare diseases are rare in a singular sense, when combined, they affect more than 10 percent of the U.S. population. According to the NIH , 95 percent of rare diseases have no approved medicines and more than 85 percent are serious or life-threatening.

Trials 59
article thumbnail

Data Targeting for Rare Diseases

Intouch Solutions

Some 7,000 different rare diseases affect 25-30 million Americans, but how can pharma marketers find them? Data analytics can help. The post Data Targeting for Rare Diseases appeared first on Intouch Solutions.

article thumbnail

What Other Countries Can Learn From Italy During the COVID-19 Pandemic

JAMA Internal Medicine

This Viewpoint explores challenges in the Italian health care system during the coronavirus disease 2019 pandemic and how other countries can plan for optimal actions.

76
article thumbnail

Webinar on the Medical and Legal Aspects of COVID-19

Eye on FDA

Any pandemic is a medical crisis first, but it is also a social crisis and in the case of COVID-19, it has been a financial crisis. On top of that, emerging pathogens push new legal issues into the forefront. Currently with COVID-19 we are at a great crossroads where businesses and services are opening up while at the same time the virus is surging out of control in several states.

article thumbnail

Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

article thumbnail

Informed Consent Issues To Keep In Mind In Clinical Research

Clinical Trial Gurus

Patients rely on the Informed Consent Form (ICF) to learn about the study they are enrolling into. For this reason, regulatory agencies focus on the process of consent. Monitors should therefore be aware of the common errors that occur during the consenting process and help sites document each step accordingly.

article thumbnail

Fireside Chat: The Future of Clinical Trials and Site Engagement

Forte Research Systems®

Fireside Chats, a new virtual series presented by Advarra, launches this month, bringing the research community together to discuss challenges and potential solutions.

article thumbnail

Acute Respiratory Distress Syndrome and Death in Patients With COVID-19 in Wuhan, China

JAMA Internal Medicine

This cohort study describes risk factors and clinical characteristics and outcomes in 201 patients with coronavirus disease 2019 (COVID-19) pneumonia who developed acute respiratory distress syndrome or died.

article thumbnail

How to win with a multichannel approach in pharma

pharmaphorum

This webinar will look at how pharma can use modular content in its multichannel and omnichannel strategies.

article thumbnail

The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

article thumbnail

Syntegon’s North America team is here for you!

Syntegon Technology Pharma Blog

52
article thumbnail

I Interview A Medical Device Expert On His Career and Pick His Brain On Everything! Ep.337

Clinical Trial Gurus

Many people in the pharmaceutical industry underestimate and are underinformed about the importance of medical device trials. An expert in medical device testing explains the many similarities between Investigational New Drug (IND) and pharmaceutical trials. Entering the IND testing arena may offer many opportunities for growth for people who are highly driven and who are able to identify market needs.

Trials 52
article thumbnail

What Constitutes Clinical Research Experience

ECRG Media's Clinical Research Podcast

What Constitutes Clinical Research Experience? Don't forget to Subscribe for new content! Subscribe: [link] Call or Text: 910-502-3732 Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education Send

article thumbnail

Everything you need to know right now about Google’s third-party cookies replacement

Pharma Marketing Network

Earlier this year, Google Chrome announced that they would be phasing out 3rd-party cookies, a change that is expected to take place in 2022. Instead, the company will be using a less invasive solution called Privacy Sandbox, designed to protect user privacy while continuing to allow advertisers to accurately track and measure their digital campaigns.

article thumbnail

How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

article thumbnail

FlexiTab North American Sales and Support

Syntegon Technology Pharma Blog

Sales 52
article thumbnail

What to do about Breast Changes and Symptoms between your Regular Mammograms

Triage Cancer

Accessing preventative services, including cancer screenings, is always important. However, during a pandemic you may be facing additional barriers but reporting symptoms to your doctor and accessing screening is part of early detection. Here are 4 answers to your most common questions from our partner, the Know Your Lemons Foundation. It can be an anxious time when you notice a change in your breast, or going for your first mammogram.

Doctor 52
article thumbnail

What Constitutes Clinical Research Experience

ECRG Media's Clinical Research Podcast

What Constitutes Clinical Research Experience? Don't forget to Subscribe for new content! Subscribe: [link] Call or Text: 910-502-3732 Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education.

article thumbnail

Intouch Team Brings Home Wins From the Hedera20 Hackathon

Intouch Solutions

A team from Intouch Solutions, a full-service agency serving the pharmaceutical industry, won two challenges in a six-week-long virtual hackathon hosted by Hedera, a public distributed ledger and governing body created to support decentralized applications running at web scale. The post Intouch Team Brings Home Wins From the Hedera20 Hackathon appeared first on Intouch Solutions.

52
article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

article thumbnail

Hiring Scam Alert

Pharma Packaging Solutions

Hiring Scam Alert. Someone posing as us (under the names Carton Service or Pharma Packaging Solutions) is contacting potential job seekers and making an offer of employment. Here are the ways you will recognize that this is a scam: The job opportunity is a remote work opportunity. Carton Service Inc./Pharma Packaging Solutions DOES NOT have remote work job opportunities.

article thumbnail

Hospitality Entrepreneur Starting A Site Network To Improve Clinical Research Processes

Clinical Trial Gurus

An entrepreneur with a background in hospitality shares his experience as he poses as a study participant. He quickly discovered that the process for becoming a patient is slightly complicated. After reflecting on how complicated it is to become a study participant, he strongly urges sites to do whatever he can to retain patients by making simple changes such as being more approachable or providing a 24-hour number to patients.

article thumbnail

COVID-19: The Importance of Worldwide Clinical Trials

DM Clinical Research

COVID-19 is currently sweeping through the United States. While most of us are overwhelmed by this disease, scientists are developing plans to beat the virus. Worldwide clinical trials are an important part of that plan. Below, we will explain how these trials will help us better understand- and treat- this coronavirus. Trials Are How Scientists Learn.

article thumbnail

How JAMA & Kaiser Family Foundation Studies Have Concluded Millions of U.S. Adults Import Medications

Pharmacy Checkers

According to a study published in the Journal of the American Medical Association (JAMA), 1.5% of adults in the U.S. who take prescription drugs purchase them from outside the U.S. to save money each year. That’s about 2.3 million people. In 2016, my review of a similar set of data estimated about four million per year. The Kaiser Family Foundation’s 2016 poll data was used to support an estimate showing that 19 million people, 8% of the adult population , have imported lower cost prescription d

article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Federal Court lifts Suspension Period

Pharma in Brief

On June 25, 2020, the Federal Court ( FC ) issued its latest Practice Direction and Order ( FC Update ) regarding Court operations during the pandemic, announcing that its Suspension Period will no longer be in force anywhere in Canada as of June 30, 2020. The FC Update also establishes guidelines for the transition toward more regular operations. Background.