August, 2022

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What to look for when hiring in pharma

World of DTC Marketing

The great resignation has not affected pharma because the jobs within the industry pay very well and most positions and employees like the benefit of having a steady job with good money. However, some pharma companies are having problems filling open positions, and when they do, they often find it wasn’t a good fit. Here are some things to consider to ensure you’re hiring good people.

Pharma 281
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Episode 97 – Trade Shows and Events, What’s changed and what you should do. Part 1

Medical Device Success

Reading time: 2 – 4 minutes. I am honored to have two event planning experts, Lauren Dustman, Senior Manager, Global Events at Hyperfine and Kimberly Stanséll, Meeting, Trade Show and Event Strategy Consultant to guide us today in this conversation. Combined, these ladies manage about 100 shows and events annually. Today’s episode is the first of two episodes about medical trade shows.

Medical 246
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Blister material as a source of nitrosamine impurities

European Pharmaceutical Review

Following numerous recalls, the industry is striving to investigate the causes, sources and ways to mitigate carcinogenic nitrosamine impurities. In a recent paper, published in the International Journal of Pharmaceutics , researchers identified nitrocellulose blister packaging as a potential source of N -nitrosodimethylamine (NDMA) and N -nitrosodiethylamine (NDEA) impurities.

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Tapping into pharma’s growing opportunities in digital health

Pharmaceutical Technology

Soaring patient numbers are stretching hospital capacity across the globe, forcing healthcare providers and their partners to think laterally about how to meet the demand without doubling their resources. Smarter diagnostic tools and more sophisticated remote- and self-care models will have an increasingly important role to play, as long as any advances are seen to deliver excellent outcomes and a better patient experience.

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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

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Digital health app linked to better outcomes in heart failure

pharmaphorum

A study of a mobile health app used to support patients hospitalised with heart failure has concluded that it provided a modest improvement in quality-of-life scores, as well as better clinical outcomes. The finding comes from the large-scale CONNECT-HF cluster study, which looked at various patient engagement and education interventions to see if they could help patients with heart failure do better after discharge from hospital.

Medical 137
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Magnetic Microrobots Assist with Root Canal Treatment

Medgadget

Researchers at the University of Pennsylvania have developed a microrobot system that can help with biofilm disruption, drug delivery, and sample retrieval, all within the restrictive space of the root canal. It can be difficult for dentists to know if they have removed all the infectious material when performing a root canal, and failure to do so will typically result in an infection reoccurring.

Medical 133

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3 shifts in healthcare to expect from telehealth innovations in 2023

MedCity News

The telehealth industry will continue to drive innovation that helps bring telehealth more permanently and creatively into the care continuum. You’ll see device integration and be able to perform even more complicated tests, like dialysis, at home.

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The Price of Innovation: ‘Paying for a Cure’ Remains Costly Proposition

PharmExec

Curative-type therapies offer great hope in further transforming treatments for cancer and other diseases, but addressing the economics of these products—and ultimately the cost-benefit equation—is daunting. What is being done to smooth the path for pricing and reimbursement?

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The potential of virtual reality-based therapy for serious mental disorders

Pharmaceutical Technology

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses. The FDA’s breakthrough device programme is for medical devices or device-led combination products that provide more effective treatment or diagnosis of diseases.

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Pharma Distribution: Carving New Ground

Pharmaceutical Commerce

Pharmaceutical distribution today is anything but monolithic. While companies in this space are grappling with issues ranging from inflation and supply chain disruption to workforce scarcity and DSCSA implementation, there’s still plenty of room for smaller players to stake out part of the terrain to call their own.

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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.

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Smart Socks Help Prevent Falls Among At-Risk Patients

Medgadget

Researchers at the Ohio State University Wexner Medical Center have tested the PUP (Patient is Up) Smart Socks, developed by a medtech company called Palarum , in their ability to reduce falls among at-risk patients. The socks contain pressure sensors that alert caregivers when a patient is attempting to stand up. This can include situations such as a patient getting out of bed to go to the toilet.

Patients 127
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PhRMA lies to protect pharma profits

World of DTC Marketing

PhRMA is lying to protect its profits, and the lies have reached a new height as the Senate moved to adopt modest drug pricing negotiation measures in the Inflation Reduction Act. The bill “could propel us light-years back into the dark ages of biomedical research,” Dr. Michelle McMurry-Heath, president of the Biotechnology Innovation Organization, said last month.

Pharma 255
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3 rules rural health systems must follow for virtual care success

MedCity News

Rural health systems should be the champions of virtual care delivery, according to Jim Weinstein, Microsoft’s senior vice president of health equity and innovation. He and Sheri Dodd, vice president and general manager of Medtronic Care Management Services, laid out recommendations for rural providers to establish scalable and sustainable virtual care programs during a conference held last week by Sanford Health.

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A World of Opportunity

PharmExec

Marie-France Tschudin, president, innovative medicines international, and chief commercial officer at Novartis, taps into life lessons to help bring therapies to people in novel ways­.

Medicine 116
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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Gilead’s Sunlenca receives EC approval to treat HIV

Pharmaceutical Technology

Gilead Sciences has obtained the European Commission (EC) marketing authorisation for Sunlenca (lenacapavir) injection and tablets to treat human immunodeficiency virus (HIV) infection. The twice-yearly treatment is indicated to be administered along with other antiretroviral(s) in adult patients with multi-drug resistant HIV infection who otherwise cannot have a suppressive anti-viral regimen.

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Woman of the Week: COTA’s Miruna Sasu

PharmaVoice

Miruna Sasu is on a mission to use real world data to help wipe out cancer. She believes this audacious goal is within reach, and as president and CEO of COTA, she is inspiring her team to create a “path to care” for oncology patients.

Patients 116
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Bioengineered Cornea Restores Sight

Medgadget

Scientists at Linköping University in Sweden have developed a collagen-based corneal implant that can restore sight to blind patients with corneal disease. The breakthrough could pave the way for such patients to receive effective treatment for corneal disease without requiring a corneal transplant from a human donor. There is a shortage of donor corneas, so creating an off-the-shelf alternative could be very useful.

Food 115
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Why DTC isn’t, and is, marketing

World of DTC Marketing

CPG marketers are trying to maintain market share amid price increases and smaller product sizes, leading to a more significant jump in consumerism. But, in pharma marketing, the changes affect every product category. Consumers share more information online than ever as inflation cuts into their disposable income. I’ve seen posts on everything from opinions on detergents to the best and more inexpensive ice cream.

Marketing 252
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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.

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Worried about long Covid? Support primate research

MedCity News

Nonhuman primates will be critical to our efforts to understand the long-term effects of Covid-19. Yet scientists conducting critical research have faced harassment and threats.

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MHRA approves Pluvicto® and Locametz® for prostate cancer

European Pharmaceutical Review

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for Pluvicto ® (lutetium [ 177 Lu] vipivotide tetraxetan), for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.

Medicine 111
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Moderna signs contract to supply Covid-19 booster vaccines to the US

Pharmaceutical Technology

Moderna has entered a new supply contract with the US Government to deliver 66 million doses of its Covid-19 vaccine booster candidate, mRNA-1273.222. The contract comprises a $1.74bn award to produce and supply these vaccine doses and options to further procure up to 234 million additional doses of the company’s booster candidates. A bivalent booster candidate, the mRNA-1273.222 vaccine comprises Spikevax along with the Omicron BA.4/5 strain messenger RNA (mRNA).

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CCC Now Offering Subscriptions to the JAMA Network and The New England Journal of Medicine Through RightFind

Copyright Clearance Center

August 9, 20 22 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, is now offering subscriptions to select publishers including the JAMA Network and the New England Journal of Medicine (NEJM) through CCC’s advanced content workflow solution, RightFind , to meet the needs of researchers in organizations with fewer than 500 employees.

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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.

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Wearable Tracks Mental States

Medgadget

Researchers at New York University have created a wearable system that can measure electrodermal activity, a property of the skin that is influenced by mental states, such as stress or excitement. The system is called Multimodal Intelligent Noninvasive brain state Decoder for Wearable AdapTive Closed-loop arcHitectures (MINDWATCH) and it can assess electrodermal activity by measuring skin conductance.

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A Saga of 75 years journey of Indian Pharmaceutical Industry

Pharmatutor

A Saga of 75 years journey of Indian Pharmaceutical Industry. Look back of growth drive for Indian pharmaceutical industry after 75 years of independence and future roadmap. admin. Sun, 08/14/2022 - 18:21. Tags. Pharmapedia. Articles.

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Analysis: What CVS Health’s interest in primary and home care means

MedCity News

An expert industry observer said CVS Health’s move into primary care is both offensive and defensive, but perhaps more importantly a natural evolution of a company with such a large healthcare footprint.

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Bristol Myers Squibb aims to improve disability diversity in clinical trials

European Pharmaceutical Review

Dubbed Disability Diversity in Clinical Trials (DDiCT), the initiative aims to provide recommendations on how to improve access, engagement, speed of enrolment and participation of people with disabilities in clinical trials. The goal is to “ensure all patient groups are reflective of the real-world population and aligned with the epidemiology of the disease studies,” a statement said.

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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.

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Digital Thread Solutions Can Speed Scale-up and Shorten Time to Market for Pharma

PM360

In the pharmaceutical business, as with any other business, you can’t market what you haven’t brought to market. It’s no secret that few (if any) other industries face the scientific, economic, and regulatory hurdles in bringing products to the people as this one does. The hurdles are there for good reason, of course. The U.S. Food and Drug Administration (FDA) and their international peers protect us all from ineffective, substandard, and even dangerous compounds, whether produced willfully by

Marketing 105
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EC grants approval for BioMarin’s gene therapy to treat Hemophilia A

Pharmaceutical Technology

The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical ’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency). The treatment is indicated for patients with no history of Factor VIII inhibitors and any detectable antibodies to adeno-associated virus serotype 5 (AAV5).

Medicine 105
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EEG Caps for Brain Organoids

Medgadget

Researchers at Johns Hopkins University have created tiny EEG caps for brain organoids. The team was inspired by full size EEG caps that are used to measure brain activity in human patients. Previously, the Hopkins researchers were forced to use flat electrode arrays that were originally designed to take recordings from cell monolayers, but applying a flat surface to a round organoid only results in measurements from a handful of cells that make full contact.

Leads 109
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Connecting EHR to clinical trials: How to embrace the promise of real-world data

pharmaphorum

We all know that real-world data (RWD) from electronic health records (EHR) could boost clinical trial efficiency and improve patient outcomes – so what’s holding us back? It’s been more than two decades since the ground-breaking potential of using electronic health records (EHR) to inform clinical research was first mooted. Since then, progress has been slow, but the industry now has everything it needs to close the feedback loop between science, evidence, and care, said speakers at a recent Co

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.