Thu.Jun 16, 2022

article thumbnail

Project seeks to chart regulatory paths for digital products

MedCity News

The nonprofit Digital Medicine Society is partnering with the likes of Google and the FDA to develop a free resource designed to help digital health startups navigate the regulatory process.

Medicine 104
article thumbnail

Getting (and Keeping) Leadership Alignment

ALULA

Imagine this scene: Fade into a senior leadership team meeting, in progress: "Wait, wait, wait! Didn't we already decide that we were moving forward with the design?" asked Heather. Stefano jumped in, "I thought we agreed on what we were going to do, but we still need to talk through how we're going to do it.". "I remember having a conversation about it but not making a decision," replied Nanda.

98
Insiders

Sign Up for our Newsletter

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

Trending Sources

article thumbnail

Prepping for FDA approval, Grail is partnering with health systems to validate its pan-cancer test

MedCity News

Grail, a company focused on early cancer detection, introduced its test that screens for more than 50 kinds of cancer last year. At AWS’ Thursday conference for healthcare and life sciences innovation, the company’s chief security officer explained how the company is evaluating the test in clinical trials and preparing to file for its FDA approval.

FDA 104
article thumbnail

Biotech spotlight: Karuna Therapeutics' mission to rejuvenate the field of neuroscience

PharmaVoice

An effective treatment for psychiatric disorders such as schizophrenia might require a holistic approach to avoid serious side effects, says CEO Steve Paul.

article thumbnail

Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

article thumbnail

K Health, Mayo Clinic collaborate on algorithm for individualized hypertension treatment

MedCity News

Digital health startup K Health has teamed up with Mayo Clinic Platform to develop an algorithm to help clinicians provide personalized hypertension treatment. The model uses Mayo Clinic Platform’s collection of de-identified datasets from 10 million patients.

article thumbnail

Self-Regulating Footwear for Diabetic Foot Issues

Medgadget

Researchers at the Indian Institute of Science created footwear that can self-regulate the pressure distribution when a person walks, helping to avoid pain and friction that can lead to issues for people with diabetes. Patients with diabetes can have an abnormal gait, sometimes because of pain or numbness in the extremities, potentially leading to complications such as foot ulcers when shoes rub or otherwise damage feet.

More Trending

article thumbnail

Automated Wearable Breast Ultrasound System: Interview with Maryam Ziaei, CEO of iSono Health

Medgadget

iSono Health , a medtech company based in San Francisco, has created the ATUSA System, a wearable 3D ultrasound breast scanning system. The device is worn on the breast, and does not rely on operator experience or skill to obtain consistent, high quality breast scans. As the scanning takes place automatically, it can be used by non-sonographers, such as medical assistants.

article thumbnail

Excited about investing in a promising early-stage healthcare company?

MedCity News

As a VC, if you start thinking about commercialization until after you’ve made the investment, then you’ll need a lot more than just good luck to make these investments generate a good return.

article thumbnail

How to Define Your Sales Pipeline Stages (Plus a free template)

Map My Customers

Every industry, business, sales team, and sales process is unique. So each of their sales pipelines should be, too. A sales pipeline stage that fits into the sales process for one product or service may not for another. Teams that sell durable and disposable goods will have different sales cycle stages than those that sell, say, capital equipment in hospitals, or cars, or pharmaceuticals.

article thumbnail

Recruiting and Retaining Talent Is the Biggest Challenge Facing the Pharmaceutical Industry

PharmExec

Recent increases in employee burnout and turnover must be addressed.

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

3 reasons to include medical affairs in selecting your MLR solution

Vodori

This is a co-authored blog post between Vodori and Marimac Insight, a scientific management consulting company. Considering a new medical, legal, regulatory review software solution at your pharma or device company is a big undertaking. Involving key stakeholders in this process is essential for success and a smooth transition to the new system. While marketing and regulatory teams often lead the promotional review process, it’s critical to include your medical affairs team in the system selecti

Medical 52
article thumbnail

Pitching to Local Doctor’s Offices

Scott’s Directories

The serious profession of doctors causes them to always have an unforgiving schedule. Trying to schedule a marketing meeting with a doctor can take a bit of effort and stubbornness, as doctors are notoriously difficult to pin down. If you have a product or service that you are looking to sell to a doctor, the pitch itself can be an anxiety-inducing part of the process.

Doctors 52
article thumbnail

Using PR to Build Your Healthcare Practice’s Brand

Referral MD

Photo by Glenn Carstens-Peters on Unsplash Ever wondered how to raise your practice profile and build your brand through PR and media? In this week’s episode of the Healthcare Leadership Podcast, host Jennifer Thompson sits down with former reporter, news anchor, and long-time public relations professional Keith Landry to discuss how doctors and medical practices can leverage their expertise and take advantage of PR opportunities.

article thumbnail

9 Best Sales Mapping Software Tools for 2022

Spotio

Looking for the best sales mapping software? Read on. . Sales mapping software is an essential part of every field sales team’s toolbox. . No more drawing and sticking pins in paper maps. Today’s sales reps rely on the latest technology to optimize their territories and increase sales. A glance at several studies underlines the point: Optimizing your territory design can increase sales by up to 7%.

Sales 52
article thumbnail

Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

article thumbnail

Nordic Bioscience and Roche strengthen collaboration

PharmaTimes

The companies will focus on the development of biomarkers for chronic diseases

82
article thumbnail

FDA Publishes Guidance on Regenerative Medicine Therapies

PharmaTech

The new draft guidance describes a standards recognition program for regenerative medicine therapies.

article thumbnail

Viewpoint: Data-driven Decisions Start with Building Trust

Copyright Clearance Center

The post Viewpoint: Data-driven Decisions Start with Building Trust appeared first on Copyright Clearance Center.

75
article thumbnail

Genedrive genetic variant test for infants evaluated by NICE

PharmaTimes

The MT-RNR1 test was assessed under NICE’s diagnostics assessment programme

74
article thumbnail

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

article thumbnail

CASE Act Provisions Are Now Law

Copyright Clearance Center

The post CASE Act Provisions Are Now Law appeared first on Copyright Clearance Center.

84
article thumbnail

Premature Release from Wurster Fluid-Bed Enteric Coatings v3

PharmaTech

This paper explores raw material, formulation, process, and equipment design factors that potentially contribute to unexpected early API release from Wurster coated enteric particles.

40
article thumbnail

Just How ‘Real’ is Real-World Data?

PharmExec

Addressing sources of tension on differentiating types of data.

52
article thumbnail

Walgreens Establishes Clinical Trial Business

Pharmaceutical Commerce

Endeavor aims to tackle diversity obstacles surrounding this segment, while improving the patient experience.

article thumbnail

Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

article thumbnail

FDA Publishes Draft Quality Risk Management Guidance

PharmaTech

The draft ICH Q9(R1) document details the importance of quality risk management principles.

article thumbnail

How Healthcare Access and Treatment Are Evolving to Better Serve 2SLGBTQIA+ Patients

Nixon Gwilt Law

One of the best things about working in healthcare innovation is seeing the impact on historically underserved communities. Sometimes we’re so far ahead of the curve on this technology we forget that not everyone is seeing what we’re seeing. In honor of Pride, we polled our attorneys on the most exciting innovations for 2SLGBTQIA+ ** people and what other healthcare companies can do to better serve these communities.

article thumbnail

US Healthcare Industry Sectors: Facts, Trends, & Statistics

Medico Reach

Infographic content: The onset of the COVID-19 pandemic has pushed significant growth in the US Healthcare Industry, with 2022 being the year of consumer influence. With higher interoperability levels and significantly better price transparency for medical bills and drugs, the US healthcare industry is dead set on growth. Moreover, it is also one of the most colossal and fastest-growing industries and is worth more than $714.5 billion.