pharmaphorum

NOVEMBER 17, 2021

In the first episode of the ELICIT podcast, a new series produced in partnership with Cerner Enviza, the speakers discuss qualitative real-world evidence and a unique dementia project from Singapore. The post Real-world evidence and qualitative research: the ELICIT podcast appeared first on.

Cerner 52

Cerner 52

pharmaphorum

FEBRUARY 9, 2021

With the launch of Rare Central , Pulse Infoframe offers patient advocacy groups an on-ramp to collecting real-world data, including natural history data, disease-specific data, and patient-reported outcomes. They’re best placed to co-design evidence generation solutions that are meaningful to their communities.”.

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Compounding Pharmaceutical Companies Pharmaceutical Companies Drug Development 98

pharmaphorum

SEPTEMBER 28, 2020

The DHCoE has a network of experts that are available for FDA staff to consult with on topics such as artificial intelligence, wearables, digital therapeutics , real-world evidence, and cybersecurity.

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pharmaphorum

JULY 30, 2021

Biogen and partner Eisai have said they will run a large-scale observational study of Alzheimer’s drug Aduhelm in the US to build evidence for the drug’s efficacy following its controversial approval. The post Biogen adds real-world test for Aduhelm to its confirmatory trial appeared first on.

Labelling 75

Labelling 75

FDA Law Blog: Biosimilars

NOVEMBER 29, 2023

It stated: Deployed models have the capability to be monitored in “real world” use with a focus on maintained or improved safety and performance. Since that time, FDA issued a draft guidance for predetermined change control plans (PCCPs) for Artificial Intelligence/Machine Learning (AI/ML) software functions.

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Labelling Communication 115

pharmaphorum

JULY 26, 2021

We are addressing issues of mistrust and working to reduce systemic issues that deter communities of colour from participating in clinical trials, so that those patients who want to participate, can.”. PhRMA’s principles form part of the body’s response to this manifestation of systemic racism, which it called “as real as any disease”.

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Documentation Hospitals 116

pharmaphorum

FEBRUARY 12, 2021

Orexo will start a new study of its modia app – used to treat people with opioid use disorder – to test how it performs in real-world settings. The real-world studies “will provide further data behind the need for an easily accessible digital treatment option for OUD,” said Orexo in a statement.

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pharmaphorum

APRIL 21, 2021

If NICE is to remain a “beacon of evidence-based medicine”, it must become more agile, more flexible, and more ready to adapt – and COVID-19 has proved that it is more than capable of doing so. Professor Gillian Leng, chief executive, added that COVID-19 had reinforced the need for an evidence-based approach. “I About the author.

Documentation 59

Documentation 59

pharmaphorum

MAY 6, 2022

For life science companies around the world, enabling faster access to innovative drugs and therapies is a complicated challenge. To compete in the digital world, pharma needs to catch up to other industries by creating seamless online experiences, says Takeda’s Jan Deman. Leveraging KOL insights to succeed in a data-driven world.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

AUGUST 31, 2021

External control arms (ECAs) – also known as synthetic control arms – are based on real world data (RWD) pulled from electronic health records, medical claims, wearable devices and other sources of patient data. Still, in 2021, we have seen the industry evolve and develop strategies on how to establish a viable ECA.

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Insurance Coverage and Processing Drug Development Documentation Labelling 72

pharmaphorum

APRIL 30, 2021

We take a look at all these intersecting topics in this issue – with experts from across the industry sharing their advice on how companies can navigate these paradigm shifts. How will NICE fare in a post-Brexit world? Experts from ICON give us their views on the past, present and future of NICE’s standing on the world stage.

Communication 93

Communication Pharmaceutical Companies Pharmaceutical Companies Vaccines 93

PharmaState Academy

MARCH 8, 2024

They craft their message thoughtfully, weaving together clinical data, patient testimonials, and real-world evidence to paint a compelling picture of the benefits your product brings to the table. But amidst the flurry of activity and diverse perspectives, challenges emerge.

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Communication Documentation Hospitals 52

PharmaState Academy

MARCH 6, 2024

They craft their message thoughtfully, weaving together clinical data, patient testimonials, and real-world evidence to paint a compelling picture of the benefits your product brings to the table. But amidst the flurry of activity and diverse perspectives, challenges emerge.

Communication 52

Communication Documentation Hospitals 52

Eye on FDA

OCTOBER 12, 2023

FDA stated in the agency’s press release that the committee’s subject matter jurisdiction will include helping the agency explore and assess issues regarding artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software.

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pharmaphorum

JUNE 10, 2022

But if you’re becoming more involved with the world of digital health, as many pharma companies are these days, you may find that your old FDA knowledge isn’t much help in knowing what will be required of you. FDA’s digital health regulation can be hard to parse, even for experts. Faget said. Faget’s advice? But there is a balance.

Documentation 133

Documentation 133

pharmaphorum

SEPTEMBER 7, 2022

The partnership is important for both companies, as it will assess how well the AI is performing as a biomarker for IPF studies, and could potentially provide early evidence of efficacy for Bridge Bio’s drug to complement clinical measures, such as lung function tests.

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Packaging 124

pharmaphorum

MARCH 30, 2021

Such interventions take the need for robust value claims to a completely different level, with important implications for the evidence companies need to collect, and how they collect and communicate it. One of the big challenges is the real need for a shift in mindset. Rethinking outcomes and value evidence.

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Communication Labelling 64

pharmaphorum

NOVEMBER 25, 2021

The company’s artificial intelligence-powered software uses cognitive behavioural therapy techniques to help patients suffering from a range of mental health issues, including depression and anxiety. At the same time, there are fewer than four mental health workers per 100,000 people in half the worlds’ countries, it added.

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Pharma Marketing Network

JANUARY 11, 2022

Join 1000+ industry executives from Commercial, Marketing, Medical Affairs, Patient Engagement, Market Access, and Real-World Evidence to form new collaborations and gain new business-critical insights.

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pharmaphorum

JANUARY 25, 2021

real-world evidence (RWE). The immense amount of sharing — of data and expertise — among regulators around the world is expected to be the first step toward greater collaboration to help accelerate the launch of products globally. Prediction 4: More emphasis on real-world evidence (RWE).

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Communication Drug Development 124

pharmaphorum

MARCH 10, 2021

1 – that is worrying health officials around the world. . In February, the FDA issued guidelines allowing for faster development of updated coronavirus vaccines, while the EMA is also working on similar guidance for Europe. 1 mutations, as well as variants from the UK and South Africa. So far there are six known cases in the UK.

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Vaccines Immunity Immunization 60

pharmaphorum

DECEMBER 7, 2022

The majority of CT submissions (9/15) did not include the cohort-level real-world patient data collected in the ATUc period. While the ATUc data confirmed efficacy on surrogate outcomes (HbA1c and triglyceride levels), it did not make up for lack of conclusive evidence regarding impact on mortality.

Drug Pricing 101

Drug Pricing Drug Development 101

Drug Channels

OCTOBER 30, 2023

Can't miss content highlights including: Risk-Sharing and Value-Based Contracting: Examine outcomes-based strategies and innovations in value-based contracting arrangements Policy and Regulations: Understand key updates from CMMI, ICER (Institute for Clinical and Economic Review), and policy experts on value-based payment models Value-Based Digital (..)

Pharmaceutical Companies 57

Pharmaceutical Companies Pharmaceutical Companies 57

PharmD Live

MAY 13, 2024

Introduction In an era marked by a rapidly aging population, the challenge of managing polypharmacy—the use of multiple medications by a patient, particularly among those over 65—has emerged as a pivotal issue for healthcare providers. “Health Literacy and Its Impact on Medication Adherence,” Pharmacy Journal , 2018).

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Long-Term Care Facilities Diabetes Nursing Homes Prescription Filling 59

pharmaphorum

JANUARY 5, 2023

During The Economist’s 8th Annual World Cancer Series congress in Brussels November last year, web editor Nicole Raleigh sat down to discuss the event and its themes with Greg Rossi, senior vice president, head of oncology Europe and Canada at AstraZeneca.

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Viseven

JANUARY 13, 2023

HEOR (Health Economics and Outcomes Research) – is a common term used for experts who collect patient and medical data that proves the real value of the product, how it can influence the quality of life of the patient, and its capacity to compete against similar products present on the market. What is HEOR Data?

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Pharmaceutical Companies Pharmaceutical Companies Dosage Drug Pricing 40

pharmaphorum

DECEMBER 15, 2022

Mount Sinai Health System spinoff Rx.Health – whose services have expanded rapidly over the last few years to include digital monitoring and prescribing, virtual healthcare, and real-world registry enrolment – said the DTx will be made available through its own health plan and those operated by other health systems.

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pharmaphorum

NOVEMBER 11, 2021

FIDE’s global healthcare experts provide biopharmaceutical companies with unique insights from early phase research to real-world evidence post-approval. FIDE’s key opinion leaders will add a unique lens to our services for our dermatology clients—one that I have not seen before in the agency and consulting worlds.

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Pharmaceutical Companies Pharmaceutical Companies 94

Pharmaceutical Technology

NOVEMBER 20, 2022

At the time Amanda Pritchard, chief executive of NHS England, doubled down on the issue of medicine access. “If However, these discussions would have to address the aforementioned clinical uncertainties and cost effectiveness issues. NICE has made it clear that future consultation with the drugs’ developers is not out of the question.

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Hospitals Drug Development 111

Pharmaceutical Technology

SEPTEMBER 16, 2022

And despite the recent pandemic that forced the industry to develop and deliver treatments and vaccines all over the world, the issue of reducing emissions has remained high on industry leaders’ agendas. Industry awareness of the issues. However, yearly $34bn worth of medication gets wasted due to temperature fluctuations 3.

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Vaccines Labelling 52

pharmaphorum

MARCH 18, 2021

She added: “There is no evidence of a quality or a batch issue,” in response to speculation that some reports of blood clots might be linked to manufacturing deficiencies. — EU Medicines Agency (@EMA_News) March 18, 2021.

Vaccines 105

Vaccines Immunity Immunization 105

pharmaphorum

NOVEMBER 1, 2021

NICE’s appraisal committee would like to see real-world data gathered for at least three years to explore that further. CBT is generally preferred for more deep-seated insomnia, particularly when it is secondary to mental health issues, but that is not offered routinely in the NHS.

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Documentation 59

LifeProNow

MARCH 10, 2023

To help the FDA implement the ACT for ALS Act, additional funding will strengthen the FDA’s ability to issue new grants and contracts, hire dedicated expert staff and allow the FDA to facilitate access to investigational therapies and medical devices for neurodegenerative diseases such as amyotrophic lateral sclerosis (i.e., standard of care.

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Labelling Packaging Controlled Substances 130

pharmaphorum

NOVEMBER 2, 2022

This is a significant issue, as research has shown that more than one in five adults in the US is living with chronic pain. At the beginning of this year , the US Food and Drug Administration (FDA) issued draft guidance to provide recommendations to companies developing non-addictive alternatives to opioids.

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Dosage 134

pharmaphorum

OCTOBER 1, 2022

He expects to see many new faces presenting, speaking in panel discussions, and much more: “That’s where you get the real deal information, right? Addressing key issues in digital health. In the early days of Frontiers Health, discussion often centred on the importance of evidence. And now there’s evidence in ample supply. “A

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Insurance Coverage and Processing Hospitals 95

PharmaState Academy

MARCH 5, 2024

Although you can participate in the Quiz and learn more on the Topic: Real World Evidence (RWE) for Pharma Marketing! Real World Evidence (RWE) for Pharma Marketing - Quiz Questions: 20 Passing Marks: 80% The number of attempts remaining is 1 Please fill in the required information to participate in the Quiz Competition.

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Adverse Reactions 52

PharmaState Academy

MARCH 12, 2023

A white paper (sometimes called as whitepaper) is an information document issued by an organization to highlight the solution to a problem the functionality of a solution, good, or service. A white paper also provides persuasive and factual evidence of an ideology to overcome a problem facing the society. But that is just the start.

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Pharmaceutical Companies Pharmaceutical Companies Hospitals Communication 52