Pharmaceutical Technology

DECEMBER 14, 2022

GSK has entered a strategic partnership with Wave Life Sciences to progress the discovery and development of oligonucleotide therapies for new genetic targets. On completion of the first-in-patient clinical trial by Wave, GSK will be in charge of the development and marketing works.

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Life Science Development Gene Therapy Genetics 162

XTalks

NOVEMBER 1, 2023

Stephanie Manson Brown, VP & Head of Clinical Development & Scientific Innovation of R&D at Allergan Aesthetics at AbbVie. Allergan Aesthetics is focused on creating products and technologies that drive the advancement of aesthetic medicine. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

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Life Science Clinical Trials Clinical Trials Clinical Development 105

Camargo

NOVEMBER 22, 2021

This year, Camargo is highlighting one of our own, Manager of Life Science Solutions Andrea Miller, who cared for her husband Tom throughout his battle with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s Disease. We wanted to participate in a clinical trial. They had made it an oral product.

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Clinical Trials Clinical Trials Trials Research 198

XTalks

JANUARY 20, 2022

Life science consulting can be a rewarding career and the job outlook is promising for the future. . Perhaps you have heard of life science consulting jobs but do not exactly know what type of work is involved, or the education and experience needed to become a life science consultant. Job Description.

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Life Science Production Marketing Big Data 98

XTalks

FEBRUARY 14, 2023

The life science industry is constantly evolving, making it difficult to stay ahead of the curve. Digital transformation is burgeoning and we aim to cover some of the dominant emerging technologies that are currently running the life science industry by storm.

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Life Science Clinical Trials Clinical Trials Development 98

pharmaphorum

OCTOBER 28, 2022

The sooner a human-centred perspective is applied to the development of either a drug or device product, the more likely the product will be adopted and used because it’s been designed around what the end consumer wants and needs. This will ensure that you are developing a product these audiences will use.

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Life Science Production Development Drugs 105

pharmaphorum

DECEMBER 8, 2022

Life Sciences Council. Do you know about the Life Sciences Council (LSC)? The LSC has a website on Gov.uk, but the page says Life Sciences Council. A post from the director of health and life sciences at Innovate UK, Richard J Hebdon, also bigged up the news before the Council met about four health missions.

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Life Science Medicine Branding Research 105

Pharmaceutical Technology

JUNE 20, 2023

Most of us have heard of ChatGPT and AI but where and how do they fit into the life sciences ecosystem? AI-powered solutions in healthcare While the impact of AI will be far-reaching, its pattern-matching abilities and processing speed means AI has the potential to revolutionise the field of life sciences and medicine, in particular.

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Life Science Clinical Trials Clinical Trials Regulation 130

pharmaphorum

NOVEMBER 17, 2020

Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research. Gareth Powell is a business development officer for the NIHR Clinical Research Network (CRN).

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Clinical Trials Clinical Trials Trials Life Science 116

XTalks

FEBRUARY 14, 2024

This includes first-in-class immunotherapy products such as novel antibodies and CAR T-cell treatments targeting CTLA-4. OncoImmune was founded in 2000 based on the scientific discoveries of the company’s founders who moved their lead product from a basic concept into clinical trials for multiple indications.

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Life Science DNA Production Clinical Trials 119

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 111

XTalks

APRIL 3, 2024

Bruce Culleton, MD Chief Executive Officer ProKidney ProKidney’s lead product candidate, REACT, is an investigational cell therapy designed to stabilize or improve kidney function in patients with chronic kidney disease with diabetes as the primary cause. The candidate is currently being evaluated in Phase II and Phase III clinical trials.

Life Science 105

Life Science Clinical Trials Clinical Trials Manufacturing 105

pharmaphorum

JANUARY 6, 2023

From enabling patient choice during clinical trials to strengthening vital partnerships across the quality ecosystem, connected data will become the lifeblood that enables life sciences teams to collaborate efficiently and effectively in 2023. Data will unlock clinical and economic value in Europe’s challenging landscape.

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Life Science Development Research Production 111

XTalks

MAY 12, 2021

In the life sciences, like many industries, working from home will likely remain more prevalent than it was pre-pandemic even after it’s safe for employees to return to the office. However, this trying year has highlighted the shortfalls the life science industry continues to struggle with.

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Life Science Engineer Clinical Trials Clinical Trials 95

XTalks

JANUARY 8, 2024

Whether it’s for a treatment for a chronic ambulatory condition, precision medicine or cell and gene therapy, there is a massive uptick in clinical trial complexity. It’s important to make sure that with this increase in clinical trial complexity, we don’t make our trials overly burdensome to sites or patients,” says Markham.

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Clinical Trials Clinical Trials Trials Gene Therapy 105

Pharmaceutical Technology

MARCH 10, 2023

In an email to Pharmaceutical Technology , an NHSBT spokesperson said the centre will “support early phase clinical trials and preclinical work, providing a route to eventual commercial scale production”. In the past, researchers have often had to seek help from outside the UK, thus delaying clinical trials and patient access.

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Gene Therapy Manufacturing Gene Clinical Trials 264

Pharmaceutical Technology

NOVEMBER 7, 2022

As a vertically integrated company, SHL Medical prides itself on being an end-to-end partner, offering in-house capabilities at every stage – from design, development and production to final assembly, labelling and packaging. The company’s most prominent products are its autoinjectors, which are seeing growing global demand.

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Production Life Science Manufacturing Drug Delivery Systems 130

XTalks

MAY 17, 2023

The Foundation for the National Institutes of Health (FNIH) announced this week that the Accelerating Medicines Partnership Bespoke Gene Therapy Consortium (AMP BGTC) has selected eight rare diseases for its clinical trial portfolio.

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Gene Therapy Clinical Trials Clinical Trials Gene 98

XTalks

DECEMBER 20, 2022

While clinical trials are becoming more complex, oncology trials have generally had a greater level of complexity than trials in many other disease spaces. Despite this, the number of oncology trials worldwide has increased dramatically over the past two decades. Regulatory Considerations.

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Clinical Trials Clinical Trials Trials Regulation 97

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

XTalks

JANUARY 19, 2022

The way in which clinical trials are conducted is entering a new dimension as clinical trial operations are becoming more adaptable. The COVID-19 pandemic certainly has pushed to the forefront of clinical trials, the digital evolution in clinical research. MRI scan, endoscopy, etc.)

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Clinical Trials Clinical Trials Trials Clinical Research 98

XTalks

NOVEMBER 14, 2024

This therapy, the first of its kind to be administered directly into the brain, addresses a rare genetic disorder that severely affects motor function and dopamine production. Kebilidi has a known safety profile from clinical trials. for this purpose.

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Gene Therapy FDA Approval Gene Clinical Trials 105

Pharmaceutical Technology

MAY 16, 2023

The Foundation for the National Institutes of Health (FNIH) has announced its plans to prioritise eight rare diseases to provide industry standards for manufacturing, preclinical testing and product analytical testing for gene therapy development.

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Gene Therapy Gene Research Clinical Trials 227

pharmaphorum

MAY 30, 2022

Josh Sackman, president and co-founder of AppliedVR, and Web Sun, president and co-founder of Komodo Health, relay how their newly formed collaboration reshapes the clinical trial process by using data, helping to cut costs and allowing for evaluation of broader patient populations. .

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Clinical Trials Clinical Trials Trials Big Data 97

Pharmaceutical Technology

FEBRUARY 15, 2023

JSR Life Sciences’ business unit Similis Bio is planning to collaborate with Novel351k for the development of three biosimilar programmes targeting cancer and autoimmune diseases. Under the terms of the initial deal, Similis Bio will handle the development of cell lines, analytics, process development, and cGMP production.

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Development Life Science Manufacturing Clinical Trials 147

XTalks

MAY 2, 2022

Lecanemab, the product of Phase IIb clinical research completed by BioArctic and collaborator Eisai, is one therapy making strides this year for Alzheimer’s disease. Lecanemab , the product of Phase IIb clinical research completed by BioArctic and collaborator Eisai, is one such therapy making strides this year.

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Clinical Trials Clinical Trials Antibody Trials 98

Cloudbyz

JANUARY 27, 2021

Clinical Trial Management (CTMS). Clinical Trial Budget Management. ☰ Setting up a virtual clinical trial: Things to consider. For the last many years, although the virtual trial has found its popularity, sponsors and researchers have always been hesitant to embrace it wholeheartedly for many reasons.

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Clinical Trials Clinical Trials Trials Packaging 98

Pharmaceutical Technology

APRIL 3, 2023

The deal will see Polyplus join the German life science group’s portfolio allowing the latter to leverage expertise in transfection reagents and plasmid DNA for gene therapy. Polyplus, based in Strasbourg, France, produces key components in the production of viral vectors used in cell and gene therapies.

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Gene Therapy Gene DNA Reagent 246

XTalks

FEBRUARY 9, 2023

Leading clinical trials technology platform provider Medable announced a new partnership with Nova Scotia Health Innovation Hub for a two-year pilot study to improve oncology trial access for patients in rural Nova Scotia through Medable’s decentralized clinical trial (DCT) platform.

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Clinical Trials Clinical Trials Trials Clinical Research 98

XTalks

JANUARY 7, 2025

These strategic deals have reshaped the competitive landscape, spurred innovation and enabled companies to diversify their product offerings, expand into new markets and enhance operational efficiencies. This merger aimed to create a broader and more diversified product portfolio in medical devices and therapies. billion in 2021.

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Life Science Manufacturing Production Clinical Development 105

XTalks

DECEMBER 12, 2024

In clinical research, this includes designing trials that elevate the patient voice, reduce barriers to participation, and represent the diverse populations who will ultimately use these medical products. Access to information: Limited resources and educational materials hinder informed decision-making about trial participation.

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Clinical Trials Clinical Trials Clinical Research Trials 59

XTalks

JANUARY 29, 2025

Highlights include expansion of biotech operations in Philadelphia, acquisition of a new pharma-device facility near Dublin, Ireland, and a new Center of Excellence for advanced drug delivery and drug-device combination product assembly in Rockford, Illinois.

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Drug Delivery Production Packaging Packaging 52

XTalks

APRIL 13, 2022

Pediatric rare disease clinical trials are vital to determining the safety and efficacy of medications for children living with a rare disease. Therefore, pediatric rare disease clinical trials are vital to determining the safety and efficacy of medications for children living with a rare disease.

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Clinical Trials Clinical Trials Clinical Research Trials 98

XTalks

NOVEMBER 1, 2023

Basadonna, MD, Chief Medical Officer, Head of Global Medical Strategy, and Annabel de Maria, Chief Patient Officer, recently spoke on a webinar where they shared insights on how to increase patient engagement in clinical trials. The webinar was moderated by their colleague Giulia Pierini, Patient Engagement Principal at Alira Health.

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Clinical Trials Clinical Trials Trials Clinical Development 87

XTalks

APRIL 7, 2025

Optum Life Sciences expert provides insights on the latest trends. For manufacturers developing GLP-1s or in the market, its invaluable to understand the nuances of how real-world evidence (RWE) can be harnessed to demonstrate the clinical and economic value of weight loss medications.

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Life Science Research Trials Manufacturing 52

XTalks

APRIL 11, 2025

In 2024 its first year operating as a standalone global biosimilars enterprise BioconBiologics launched more than 60 products across emerging and established markets. Clinical trials further demonstrated Jobevnes comparable performance in treating glioblastoma, renal cell carcinoma and advanced cervical and ovarian cancers.

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Antibody Marketing Clinical Trials Clinical Trials 104

Cloudbyz

JUNE 10, 2023

21 CFR Part 11 is a crucial component of regulatory compliance in clinical trials and, more broadly, any industry subject to the regulations of the U.S. This blog post will serve as a comprehensive guide to understanding and implementing 21 CFR Part 11 compliance in your clinical trials. Let’s explore.

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