pharmaphorum

JULY 14, 2022

A pilot study has been launched by the EMA to see whether it is helpful for regulators to look at the ‘raw data’ from clinical trials submitted in support of new marketing application along with the usual structured analyses from sponsors. It may also help the regulator to define target treatment populations better.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

XTalks

MAY 6, 2022

In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinical trials. Data security: The clinical trial data is backed-up and secure.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Life Science 98

XTalks

MAY 11, 2023

Clinical trials are essential for the development of new treatments for rare diseases, but they can be complex and challenging to execute. Patient input is a crucial component of rare disease clinical trials, as it can provide valuable insights into the patient experience and inform decisions about study design and implementation.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Development 97

pharmaphorum

JANUARY 24, 2022

” Those trials also need to be large, involve a diverse range of individuals, and able to be run at reduced cost, said Landray. Protas will design and run smart clinical trials through collaborations with charities, foundations, academic research teams and industry partners, and will take on both repurposed and experimental drugs.

Trials 97

Trials Drugs Clinical Trials Clinical Trials 97

pharmaphorum

AUGUST 31, 2021

Christopher Boone, global head of health economics and outcomes research at AbbVie, advises: “Evidence generation in drug development is ripe for innovation in the digital era and the expanded use of real-world evidence presents a clear enabler to saving time and money. It is true that RWD contains more potential bias as a result.

Clinical Trials 89

Clinical Trials Clinical Trials Life Science Trials 89

pharmaphorum

JUNE 14, 2021

Rebecca Sanders from Lipodystrophy UK tells us how the patient voice helped convince NICE to approve a much-needed drug for this rare disease, and explores how regulators and pharma companies can help make patient involvement in HTA more impactful. This article appears in our free digital magazine Deep Dive: Market Access 2021.

Drugs 105

Drugs Pharma Companies Licensing Licensing 105

pharmaphorum

MAY 26, 2022

Racial disparities are still commonplace in many clinical trials with white-ethnic groups often overrepresented amongst trial participants. Inadequate clinical trial representations of all populations can therefore leave underrepresented groups vulnerable due to the lack of subgroup-specific data.

Clinical Trials 143

Clinical Trials Clinical Trials Trials Medicine 143

pharmaphorum

JUNE 8, 2021

Dr Jay Mei from Antengene tells us how the Asia Pacific region is opening up to innovative pharma companies, and gives tips for companies navigating this enormous market. At the same time, lots of people with experience at multinational pharmaceutical companies have chosen to return home. About the interviewee.

Marketing 104

Marketing Drugs Regulation Development 104

Drug Discovery World

SEPTEMBER 28, 2022

Its application in pharma, most commonly in drug discovery, has been steadily growing with global partnerships between tech vendors and pharma companies becoming more commonplace. According to Hampleton Patners’ latest Healthtech M&A market report2, digital health companies raised a total of $57.2

Pharma Companies 52

Pharma Companies Drugs In-Vivo Genetics 52

Cloudbyz

MAY 19, 2021

According to Frost & Sullivan reports, more than 400 cell and gene therapies were under trial in the preclinical and phase 3 in 2017-2018 , which later witnessed a 27% Y.O.Y. However, the major challenge is the newness and uncharted territory of the CGT field for service companies.

Gene Therapy 52

Gene Therapy Gene Manufacturing Production 52

pharmaphorum

APRIL 7, 2021

With other drugs in the pipeline too, van de Winkel said the company aims to continue to break new ground with next-generation antibody-based therapies. He notes that it already has 21 partnerships with pharma companies and will aim to keep more product rights than it did in the past. In good shape. We are in a crisis.

Antibody 90

Antibody Life Science Development Regulation 90

pharmaphorum

NOVEMBER 3, 2022

Beyond digital clinical measures, digital solutions are maturing to address major challenges facing clinical research and offer enormous promise to support the key performance indicators (KPIs) for every member of our industry. Pharma companies with more mature digital strategies are able to focus on questions of scale.

Clinical Trials 80

Clinical Trials Clinical Trials Trials Medicine 80

pharmaphorum

OCTOBER 18, 2021

There was a genuine sense of alliance; regulatory bodies and pharma companies coming together to accelerate processes and find the most optimal model for collaboration. What remains very clear is that collaboration between sponsor companies, health authorities and other stakeholders will be required to move this forward.

Vaccination 143

Vaccination Vaccine Regulation Medicine 143

pharmaphorum

MARCH 12, 2021

The pandemic has forced the industry to embrace virtual patient engagement to an extent that would have seemed unachievable little more than a year ago, but there is much more the industry needs to do to ensure that trial designs can truly meet patient needs in a post-COVID world. Our young persons’ advisory groups are busier than ever.”.

Trials 132

Trials Research Pharma Companies Clinical Trials 132

pharmaphorum

FEBRUARY 16, 2022

Eversana’s expansion into real-world data (RWD) handling has gathered pace via an alliance with Thread, a specialist in decentralised clinical trials and electronic clinical outcome assessments (eCOAs). The post Thread, Eversana join forces on real-world data platform appeared first on.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Pharma Companies 52

pharmaphorum

DECEMBER 22, 2021

The ‘PEP Talks’ monthly e-newsletter has approaching 50 pharma companies as subscribers and the inaugural ‘Patient Engagement Day’ on September 01 st achieved an inspirational number of downloads of toolkits for ways to ‘Amplify the Patient Voice’ as the launch theme. VP, Clinical Trial Recruitment. Ross Jackson.

Clinical Trials 104

Clinical Trials Clinical Trials Trials Pharma Companies 104

XTalks

SEPTEMBER 5, 2023

Investigation of the possibility of VAED is crucial during clinical trials for decision-making on vaccine licensing by regulatory agencies. In the majority of cases, the risk of VAED is brought to light during preclinical stages or early clinical trial phases.

Vaccination 96

Vaccination Vaccine Development Clinical Trials 96

pharmaphorum

DECEMBER 15, 2022

For health innovation, digital transformation in the NHS – using digital technology to change and improve services and outcomes for patients, including primary care records, legacy items, and clinical research – is critical. After all, the clinical trial environment in the UK is deteriorating, she said.

Life Science 97

Life Science Medicine Clinical Trials Clinical Trials 97

XTalks

OCTOBER 1, 2020

Lin has made several transitions throughout her career, from being a clinician at an academic center, to academic research, to heading business development in industry. The drug is currently in clinical trials for alcoholic hepatitis (AH), nonalcoholic steatohepatitis (NASH), as well as in COVID-19 patients with acute liver or kidney injury.

Scientist 52

Scientist In-Vitro Research Life Science 52

Pharmaceutical Technology

APRIL 12, 2023

While multiple testing labs that use non-human primates for research were contacted for this article, all declined to comment amidst the most recent news coverage. This is to ensure patient safety, as outlined in The Medicines for Human Use (Clinical Trials) Regulations 2004.

Regulation 245

Regulation Vaccination Vaccine Medicine 245