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. The discovery alliance, with a preliminary research period of four years, will aid GSK in progressing up to eight programmes and Wave to develop up to three programmes.

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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. How the NIHR’s Patient Engagement in Clinical Development service can help.

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Clinical Trials Clinical Trials Trials Life Science 116

XTalks

OCTOBER 23, 2024

In this episode, Vera spoke with Morgan Hanger, Executive Director of the Clinical Trials Transformation Initiative (CTTI). CTTI is a public-private partnership dedicated to improving the quality and efficiency of clinical trials, with an ambitious “Transforming Trials 2030” vision.

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Clinical Research Clinical Trials Clinical Trials Life Science 64

Pharmaceutical Technology

JUNE 9, 2023

Co-led by Venrock Healthcare Capital Partners (Venrock) and Enavate Sciences, the financing round has seen participation from new investors Wellington Management and Bain Capital Life Sciences. Upstream Bio CEO Samantha Truex stated: “Our IND has been cleared by the FDA to pursue Phase II programmes in both asthma and CRSwNP.

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Clinical Development Development Life Science Clinical Trials 147

XTalks

FEBRUARY 5, 2025

In this episode, Ayesha spoke with Mario Marcondes, MD, PhD, VP Head of Clinical Development at Nektar Therapeutics , a company focused on the discovery and development of novel therapies for autoimmune disorders and cancer. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

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Clinical Development Development Life Science Clinical Trials 59

pharmaphorum

MAY 27, 2021

Sheila Rocchio highlights four key areas life sciences must improve on as an industry to drive real change in how clinical trials are conducted. This is definitely a time for the life sciences industry to be proud of our accomplishments.

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Clinical Trials Clinical Trials Trials Life Science 119

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

XTalks

JUNE 4, 2024

In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinical trials is increasing. This surge in complexity is driven by escalating drug development costs, heightened competition and advanced scientific innovations. This is the storm that we find ourselves in the midst of.”

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Clinical Development Development Clinical Trials Clinical Trials 110

XTalks

JANUARY 5, 2021

The pandemic itself will also continue to spur innovations and changes such as greater shifts towards decentralized clinical trials and patient-centric approaches. In addition to vaccines, there are handfuls of drugs currently being evaluated in clinical trials for the treatment of COVID-19.

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Life Science Clinical Trials Clinical Trials Trials 98

XTalks

AUGUST 22, 2023

Recruiting participants is perhaps the most challenging aspect of any clinical trial, regardless of the therapeutic area. Yet this one piece is also the most vital, with a trial’s ability to enroll and retain participants being a key predictor of a study’s future success. What is Clinical Trials For All?

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Clinical Trials Clinical Trials Trials Clinical Research 97

XTalks

JANUARY 17, 2024

They discussed the top new trends in oncology trial design that sponsors are either incorporating into clinical trials or need to start planning to include. Evolution in Oncology Clinical Trial Design Recent discussions at ESMO highlight a shift in how clinical trials are designed and conducted.

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Clinical Trials Clinical Trials Trials Gene Therapy 124

XTalks

OCTOBER 4, 2024

The push to increase diversity in clinical trials has gained momentum, but true progress requires more than regulatory mandates. In this webinar, industry leaders and patient advocates discussed how authenticity and the patient voice can be leveraged to enhance diversity in clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 98

XTalks

MAY 19, 2023

Clinical trials play a vital role in advancing patient treatment and medical care. This article delves into ten trends and statistics in the world of clinical trials for 2023. Increasing Number of Registered Clinical Trials As of May 17, 2023, there are 452,604 registered clinical trials globally on ClinicalTrials.gov.

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Clinical Trials Clinical Trials Trials Clinical Research 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

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. There’s also that risk of a perceived coercion or influence.

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Clinical Trials Clinical Trials Trials Clinical Research 101

XTalks

JULY 29, 2024

Orphan drug development poses many challenges that are unique to rare diseases, including recruitment in small patient populations, variable progression with heterogenous clinical manifestations and limited understanding of disease progression and natural history.

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Clinical Trials Clinical Trials Trials Research 105

XTalks

MAY 20, 2021

Today is Clinical Trials Day 2021 — a day for recognizing the importance of clinical research in protecting and improving global health. Amid the alarmist headlines posted by other media outlets, Xtalks has remained balanced in its reporting of COVID-19 clinical trial results and safety data.

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Clinical Trials Clinical Trials Trials Vaccination 105

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

billion Announced : February 2019 Closed : March 2020 In 2019, Danaher, a life sciences and diagnostics innovator, acquired the Biopharma business from General Electric Companys (GE) Life Sciences division. Now operating as Cytiva, the business functions as a standalone company within Danahers Life Sciences segment.

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Life Science Manufacturing Production Clinical Development 105

XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.

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Clinical Trials Clinical Trials Trials In-Vitro 98

XTalks

DECEMBER 12, 2024

Beatrice Doe-Printemps Historically, clinical trials have disproportionately excluded women, people of color and other marginalized groups, leading to results that may not be generalizable to the broader population. For instance, women of childbearing age were excluded from participation in early phase clinical trials in 1977.

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Clinical Trials Clinical Trials Clinical Research Trials 59

XTalks

NOVEMBER 1, 2023

The revolution in clinical research is here, and it’s embodied by a single, powerful word: “patients.” The inclusion of patients during clinical development is not only a moral imperative but a strategic necessity in modern medical research.

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Clinical Trials Clinical Trials Trials Clinical Development 87

Cloudbyz

SEPTEMBER 11, 2024

This prestigious recognition positions Cloudbyz among the top performers in delivering intuitive and scalable EDC solutions to life sciences organizations worldwide. This prestigious recognition positions Cloudbyz among the top performers in delivering intuitive and scalable EDC solutions to life sciences organizations worldwide.

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XTalks

APRIL 2, 2025

Along the way, Dr. Fordyce has built a world class team of drug developers and raised over $1 billion in capital. Dr. Fordyce previously worked in clinical development leadership roles at Gilead Sciences in the 2010s, driving innovation in treatments for HIV and hepatitis.

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XTalks

DECEMBER 10, 2024

The LUNA 3 study enrolled 202 adults with persistent or chronic ITP and severely low platelet counts, averaging just 15,000 per microliter well below the normal range of 150,000 to 450,000 per microliter.

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Trials Protein Clinical Development Drugs 104

XTalks

OCTOBER 12, 2022

Magnetic resonance imaging (MRI) has had a part in clinical trials for more than three decades now. However, the role of MRI in new drug clinical trials can involve diagnosis of lesions and determination of their severity, early identification of therapeutic responders to drug treatment and treatment monitoring and follow-up.

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Clinical Trials Clinical Trials Trials Drugs 93

XTalks

SEPTEMBER 25, 2024

Patient-centricity isn’t a catchphrase in clinical trials—it’s a guiding principle for improving patient experiences. One of the most critical aspects of this is how patients are compensated for their participation in trials. Meghan Harrington VP, Clinical Trial Financial Management Medidata Alicia C.

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Clinical Trials Clinical Trials Trials Clinical Research 75

Outsourcing Pharma

OCTOBER 19, 2020

The CRO and life-sciences tech firm collaborated on a solution capable of meeting challenges tied to starting and conducting global clinical trials.

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Trials Life Science Clinical Trials Clinical Trials 93

XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. COVID-19 Clinical Trials.

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Clinical Trials Clinical Trials Vaccine Vaccination 75

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. That mission is really important to me because I think it’s the only way we’re going to accelerate drug development in rare disease.

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Clinical Trials Clinical Trials Trials Development 97

XTalks

NOVEMBER 15, 2023

This episode features an interview with Dr. Lahar Mehta, Head of Global Clinical Development at Amylyx Pharmaceuticals, who spoke to Xtalks about Amylyx’s clinical trial design of ORION, a Phase III Global Study of AMX0035 (Relyvrio) in Progressive Supranuclear Palsy (PSP).

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Life Science Trials Clinical Trials Clinical Trials 52

XTalks

NOVEMBER 21, 2024

Tirzepatide, a dual GIP (glucose-dependent insulinotropic polypeptide)/GLP-1 (glucagon-like peptide-1) receptor agonist, has been a blockbuster treatment for type 2 diabetes and obesity, along with semaglutide rivals Ozempic and Wegovy from Novo Nordisk.

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Sales Insulin Drugs Trials 105

XTalks

AUGUST 19, 2024

The synergy between clinical trial quality and operations teams is vital for delivering value to sponsors. Clinical trial sponsors often face the challenge of managing complex projects with multiple stakeholders, each with their own priorities and workflows.

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Clinical Trials Clinical Trials Trials Life Science 64

pharmaphorum

SEPTEMBER 3, 2020

In a filing with the US financial regulator Compass laid out its plans to develop the drug known as COMP360, which is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression.

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Drugs Life Science Clinical Development Regulation 116

XTalks

APRIL 3, 2025

XTALKS WEBINAR: Keys to Success in Clinical Trials: A Strategic Guide for Biotechs and Startups Live and On-Demand: Thursday, May 22, 2025 , at 11am EDT (5pm CEST / EU-Central) Register for this free webinar to learn how biotechs can navigate endpoint challenges in clinical trials.

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Trials Clinical Trials Clinical Trials Genetics 59

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 111

XTalks

AUGUST 16, 2024

The effectiveness of clinical trials often depends on the quality and depth of the data utilized. This rich data resource has significant potential to innovate clinical trials, providing real-world, timely insights that can enhance success and streamline trial processes.

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Clinical Trials Clinical Trials Trials Clinical Research 59