pharmaphorum

OCTOBER 1, 2020

Many companies in the life sciences industry are slow to adopt new technologies. Running clinical trials costs a lot of money! Many clinical trials fail. For example, it can be difficult to recruit patients or they may drop out during the trial. What is meant by automating clinical trials?

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Clinical Trials Clinical Trials Trials Production 107

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. Clinical Data Pipeline for Data Review and Analyses.

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Clinical Trials Clinical Trials Trials Life Science 98

pharmaphorum

DECEMBER 9, 2021

If the UK creates regulatory frameworks that drastically diverge from those of its “science allies”, it could become a late – or even no – launch market for new treatments. The same principle applies to regulation,” she went on. ” Prerequisites for global competitiveness. .

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Regulation Medicine Life Science Development 85

XTalks

JANUARY 29, 2021

This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. Several oncology products now have “blockbuster” status where sales exceed $1 billion annually. Herceptin (Trastuzumab) and Mabthera (Rituximab).

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Clinical Trials Clinical Trials Production Trials 104

Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?

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Clinical Trials Clinical Trials Trials Production 52

Drug Discovery World

MARCH 30, 2023

Likang Life Sciences has been granted implied approval by China’s National Medical Products Administration (NMPA) for the clinical trial of its innovative personalised neoantigen-targeted vaccine LK101 Injection for advanced solid tumours. Hence, there is a need to increase clinical investigations in this promising area.”

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Regulation Vaccination Vaccine Trials 52

pharmaphorum

APRIL 11, 2022

Dudley Tabakin, CEO of VivoSense, describes how this financing is set to accelerate the development of novel digital biomarkers and improve digital clinical outcome assessments. The wearable market was starting to proliferate, and people were starting to ask questions. How can this data be incorporated into clinical trials?”.

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Clinical Trials Clinical Trials Trials Development 107

pharmaphorum

FEBRUARY 11, 2021

Pharma companies face many challenges when involving patients in the design of clinical trials – but doing so can have huge benefits further down the line, improving the sustainability and quality of research. Involving patients in discussions.

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Clinical Trials Clinical Trials Trials Clinical Research 89

XTalks

MAY 28, 2024

The traditional clinical trials model is facing scrutiny. VivoSense , a pioneering company in the field of digital health technologies (DHTs) and digital endpoints for clinical trials, is aiming to enhance the efficiency and efficacy of clinical research. Integrating DHTs Across Drug Development Phases Dr.

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Clinical Development Development Clinical Trials Clinical Trials 116

pharmaphorum

JUNE 11, 2021

Abel Archundia discusses how COVID-19 has highlighted the importance of securing clinical trials against cyber threats. However, data-intensive, decentralised clinical trials also present a major risk to healthcare participants through cybercrime and data privacy vulnerability.

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Clinical Trials Clinical Trials Trials Compliance 107

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.

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Clinical Trials Clinical Trials Trials Development 97

XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. percent show less reliability). Optimal methods for bioinformatic analysis are still needed.

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Clinical Trials Clinical Trials Trials FDA Approval 98

Pharmaceutical Technology

OCTOBER 28, 2022

Designed to explain either the risk management plan (RMP) or clinical trial results (CTR) in a way that a child can understand, lay summaries are now a required document for all clinical trials in the European Union (EU) following changes to EU Clinical Trials Regulations (EU-CTR) regulations earlier this year.

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Clinical Trials Clinical Trials Life Science Trials 130

Cloudbyz

MARCH 25, 2021

Any life science solution built on the Salesforce platform enables a cloud based communication model for the customers, partners, and all other stakeholders. market share as of 2020H1. Further, the market size of salesforce solutions is expected to reach $55,307.6mn by 2030, growing at a CAGR% of 18.9%

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Cloudbyz

MARCH 25, 2021

Any life science solution built on the Salesforce platform enables a cloud based communication model for the customers, partners, and all other stakeholders. market share as of 2020H1. Further, the market size of salesforce solutions is expected to reach $55,307.6mn by 2030, growing at a CAGR% of 18.9%

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

The Pharma Data

NOVEMBER 10, 2020

Crohn’s Disease Therapeutics Market Size $4.7 Phase1b/2 clinical study to be conducted in the United States and several European countries. The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. The CD therapeutic market size will be worth $4.7 Billion by 2025. and Europe.

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Life Science Clinical Trials Clinical Trials Trials 40

Drug Discovery World

FEBRUARY 12, 2024

“In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. We’re already seeing biotechs making breakthroughs with AI in this area, with more than 150 small molecule drugs discovered and 15 already in clinical trials.

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Genome Genomics Life Science Gene Therapy 139

pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.

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Clinical Trials Clinical Trials Trials Clinical Research 104

ACRP blog

APRIL 5, 2023

AI is increasingly important in drug discovery and development as well as clinical trials, operations, pharmacovigilance, and many other areas.” “AI is increasingly important in drug discovery and development as well as clinical trials, operations, pharmacovigilance, and many other areas.”

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Big Data Clinical Trials Clinical Trials Life Science 52

XTalks

AUGUST 3, 2023

While most post-marketing activities are typically oriented towards marketing, sales, and commercialization of the drug, pharmacovigilance is fundamentally patient-centric, focusing on the safety and efficacy of pharmaceutical products once they reach the market. How is this shift affecting your post-marketing work?

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Regulation Marketing Life Science Drugs 97

The Pharma Data

NOVEMBER 8, 2020

The US Food and Drug Administration (FDA) has authorized the restart of AstraZeneca ’s clinical trial for the Oxford coronavirus vaccine AZD1222 in the US, after regulators in the UK, Brazil, South Africa and Japan had already confirmed it was safe to proceed. .

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Clinical Trials Clinical Trials Manufacturing Trials 40

XTalks

JULY 15, 2024

The drug has been evaluated in five clinical trials for PBH. Avexitide differs from the current lot of GLP-1s on the market, which are agonists of the GLP-1 receptor. Agonist engagement of the receptor is involved in insulin and glucose regulation, and hence has therapeutic implications for diseases like diabetes and obesity.

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Insulin Drugs Life Science Marketing 52

XTalks

JULY 15, 2024

The drug has been evaluated in five clinical trials for PBH. Avexitide differs from the current lot of GLP-1s on the market, which are agonists of the GLP-1 receptor. Agonist engagement of the receptor is involved in insulin and glucose regulation, and hence has therapeutic implications for diseases like diabetes and obesity.

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Insulin Drugs Life Science Marketing 52

pharmaphorum

NOVEMBER 24, 2021

The pandemic has propelled issues for the pharmaceutical industry to the top of the political and public agenda, from clinical trial recruitment to the journey required for medicines or vaccines to reach patients. The Government has committed to relooking at regulation as it determines its own independent trading policy.

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Life Science Regulation Medicine Vaccination 85

Drug Discovery World

MAY 6, 2024

Thanks to a prestigious academic legacy, Europe has long been a dominant region for life sciences. Europe is traditionally a life sciences powerhouse, with a strong tradition in pharmaceutical discovery. The oldest, still active pharmaceutical company worldwide, Merck, started life in 1668 in Darmstadt, Germany.

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Drugs Life Science Gene Editing Gene 59

XTalks

JULY 11, 2024

Susvimo, a refillable eye implant, received US Food and Drug Administration (FDA) approval in 2021, but its initial rollout faced challenges due to septum dislodgement cases that prompted Roche to issue a voluntary market recall in October 2022. Clinical trials have demonstrated the efficacy and safety of Susvimo in treating wet AMD.

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FDA Approval Clinical Trials Clinical Trials Sales 104

Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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Clinical Research Compliance Research Regulation 52

XTalks

OCTOBER 18, 2022

A clinical research organization (CRO) is a company that delivers outsourced services to plan, manage and execute clinical trials for biotechnology, pharmaceutical, and medical device companies. Read on to learn why life science and clinical research professionals are choosing a career with Medpace.

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Clinical Research Research Clinical Trials Clinical Trials 111

pharmaphorum

SEPTEMBER 7, 2020

PRISYM ID makes new senior appointment to drive further growth in clinical trials arena. Wokingham, United Kingdom —4 September 2020 — PRISYM ID, a leading provider of regulated content and label management solutions, has announced the appointment of Robert Bowdish as Director of Clinical Trials Sales for North America.

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Clinical Trials Clinical Trials Sales Compliance 52

Drug Discovery World

NOVEMBER 24, 2022

With European life sciences R&D investment at a 20-year low, biopharmaceutical associations and MEPs are calling on the EU to modernise its policies. DDW’s Diana Spencer asks what will be needed for Europe to compete in the growing global market for advanced therapies. . The current situation . Europe accounted for a 19.3%

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Gene Therapy Gene Clinical Trials Clinical Trials 98

Drug Discovery World

FEBRUARY 6, 2024

As AI-designed drugs start to enter large-scale clinical trials, DDW’s Diana Spencer investigates how new digital tools are reinventing and reshaping drug discovery for the future. By making lab automation as easy as using a smartphone, the Flex robot democratises access to automation in life sciences research.”

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Marketing Medicine Genome Genomics 69

pharmaphorum

JUNE 22, 2021

PRISYM ID announces six further projects go live as medical device and life science organizations prepare for the future. Labelling software firm has implemented six new software systems in the last few months in a sign that the market is now rebalancing after the upheavals of the last 12 months.

Life Science 52

Life Science Clinical Trials Clinical Trials Marketing 52

FDA Law Blog

AUGUST 4, 2022

Gain insight and training in core regulatory concepts for life sciences attorneys, business executives, and policy analysts. It is important for attorneys who do not have regulatory practices and life sciences executives who deal with FDA-regulated products to have a familiarity with these concepts.

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Life Science Clinical Trials Clinical Trials Regulation 40

Pharma in Brief

MAY 29, 2023

The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations ( CSP Regulations ) and to reflect changes to Health Canada’s administrative practices. Certificate of Supplementary Protection Regulations , SOR/2017-165

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Regulation Sales Clinical Trials Clinical Trials 59

pharmaphorum

FEBRUARY 4, 2021

It comes as PRISYM ID announces five new business wins for the start of 2021, with new accounts spanning clinical trials, pharmaceutical and medical device sectors and with significant growth of the company’s flagship PRISYM 360 platform in the Cloud. The challenge now is to lock in these gains.

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Life Science Clinical Trials Clinical Trials Regulation 52

pharmaphorum

MARCH 24, 2021

The UK drugs regulator is now asking that all applications for new medicines or indications detail the efforts made to involve patients in the drug development process. . In future, the hope is that it may encourage a higher level of patient involvement in its final assessment of whether clinical trials are approved or drugs are licensed.

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Drugs Clinical Trials Clinical Trials Trials 69

Drug Discovery World

OCTOBER 24, 2023

While attending Life Science Baltics 2023, Diana Spencer spoke to Monika Paule , CEO and Co-founder of Caszyme, about creating a company based on CRISPR gene editing and some of the challenges of operating in this dynamic area of research. Caszyme was founded in 2017 by the pioneers of CRISPR gene editing technologies.

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Gene Editing Gene Life Science Regulation 105