Rethinking Clinical Trials

AUGUST 28, 2023

Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization. The E6 Good Clinical Practice clinical trial conduct principles was intended to be an improvement of the G8 clinical trial design principles.

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Pharmaceutical Technology

MAY 2, 2023

Despite the significant advances that have been made in the IO field, a huge level of unmet need remains. IO therapies come with a hefty price tag, with ICI therapies in the US typically exceeding $100,000, while cell therapies can exceed $400,000. Cost-related unmet needs also scored highly.

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Drug Discovery World

JANUARY 30, 2024

Viral vector manufacturing At the Advanced Therapies Awards ceremony, Dr Luigi Naldini, Director of the San Raffaele Telethon Institute for Gene Therapy, was awarded a Lifetime Achievement Award in recognition of ‘extraordinary contributions to gene therapy’, a field he has helped shape through his pioneering work on lentiviral vectors.

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Gene Therapy Manufacturing Gene Clinical Trials 71

Pharmaceutical Technology

APRIL 5, 2023

But access to these treatments continues to remain limited due to high price tags and variable availability across regions. But while companies continue studying allogeneic CAR-T therapies, including for their coveted use in solid tumours, such advancements remain challenging. How can we better educate the patients?

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The Pharma Data

JANUARY 31, 2021

The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants. These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.” . CHENGDU, China , Feb. CHENGDU, China , Feb.

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XTalks

APRIL 18, 2024

Conversely, a negative result suggests a low probability of amyloid pathology, guiding healthcare providers in clinical decision-making and potentially ruling out Alzheimer’s disease in symptomatic patients. There are currently no FDA-authorized blood tests for detecting Alzheimer’s disease.

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The Pharma Data

DECEMBER 3, 2020

Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinical development for both adjuvanted vaccines. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI). CHENGDU, China.–(

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XTalks

FEBRUARY 27, 2024

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval.

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pharmaphorum

JANUARY 24, 2022

Francisco Partners is picking up a range of databases and analytics tools – including Health Insights, MarketScan, Clinical Development, Social Programme Management, Micromedex and other imaging and radiology tools – for an undisclosed sum estimated to be in the region of $1 billion.

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Radiology Marketing Genome Genomics 109

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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pharmaphorum

JANUARY 9, 2023

Zolgensma meanwhile is now approved in 45 countries, with over 2,500 patients treated globally across clinical trials, managed access programs, and in the commercial setting. ” Zolgensma is one of the most expensive therapies available, with a price tag of around $2.1

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pharmaphorum

DECEMBER 23, 2021

Daiichi Sankyo has been granted breakthrough status by the FDA for patritumab deruxtecan, a HER3-targeted antibody-drug conjugate (ADC) in clinical trials for lung cancer. The post FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag appeared first on.

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pharmaphorum

DECEMBER 23, 2022

Here, Richard Staines reports on phase I/II data unveiled at the American Society of Hematology conference that supports further clinical development of inobrodib in multiple myeloma and other blood cancers. Results suggest durable epigenetic re-wiring and provide rationale for intermittent clinical dosing. CellCentric, a U.K-based

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Development Drugs Clinical Development Antibody 52

Rethinking Clinical Trials

DECEMBER 12, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds December 8, 2023: A Pragmatic Randomized Trial of the Jumpstart Intervention to Promote Communication about Goals of Care for Hospitalized Patients with Serious Illness (Ruth Engelberg, PhD; Erin Kross, MD; Robert Lee, MD, MS) appeared first on Rethinking Clinical Trials.

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pharmaphorum

JANUARY 11, 2022

“The advancement of innovative therapeutic options for the treatment of the associated distress that often follows a diagnosis is promising for patients and addresses an unmet need,” said Areej El-Jawahri of Massachusetts General Hospital. The post Blue Note leukaemia DTx gets FDA breakthrough tag appeared first on.

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Development Production Drugs 62

Delveinsight

FEBRUARY 23, 2021

Clover Biopharmaceuticals is a clinical-stage biotechnology company based in China. The company plans to use the capital to expand its pipeline of protein-based vaccines and biologic cancer therapies utilizing its innovative and proprietary Trimer-Tag technology platform. LightDeck Diagnostics Gets USD 5.65

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The Pharma Data

JANUARY 31, 2021

In its Phase 1 clinical trial, Clover’s protein-based COVID-19 S-Trimer vaccine candidates in combination with adjuvants from either Dynavax or GlaxoSmithKline plc (GSK, London Stock Exchange: GSK) both performed well and induced high levels of neutralizing antibodies while demonstrating favorable safety and tolerability profiles.

Vaccination 52

Vaccination Vaccine Trials Protein 52

Intouch Solutions

APRIL 11, 2024

Pre-Clinical : Deeper comprehension of the impacts and outcomes associated with a particular drug. Clinical : Optimized efficiency, inventory management, and service quality of clinical trials. HCP Attraction and Engagement Physicians often find themselves involved in repetitive tasks that may have limited clinical significance.

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The Pharma Data

OCTOBER 9, 2021

This designation is predicated on data showing that gantenerumab significantly reduced brain amyloid pillar, a pathological hallmark of Notice, in the ongoing SCarlet RoAD and Marguerite RoAD open- tag extension trials, as well as other studies. Roche’s Chief Medical Officer and Head of Global Product Development.

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Roots Analysis

JANUARY 28, 2024

Velocity: Big Data needs to be handled promptly as businesses generate data at an unprecedented speed, driven by the growing adoption of Internet of Things (IoT), and technologies, such as RFID tags, sensors, and smart meters are used to deal with the high velocity of data in real-time. It is loosely arranged into categories using meta tags.

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The Pharma Data

MARCH 16, 2022

The research scientist at the Max Planck Institute for Medical Research received the award in recognition of his ground-breaking work in establishing various approaches to protein labeling in living cells that have enabled far-reaching advances in chemical and cell biology. Protein labeling (e.g. He is also a co-founder of several companies.

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pharmaphorum

NOVEMBER 16, 2022

The advancements made in drug development over the last decade have seen the arrival of a number of treatments that offer one-time cures and more effective therapies for conditions in smaller patient populations. Advanced therapies have changed the treatment landscape for the industry and for patients. However, with a price tag of €1.58

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XTalks

FEBRUARY 27, 2024

Rare Disease Day 2024, which falls on February 29 this year, is an opportunity to unite under a common cause: to bring attention to the challenges faced by those living with rare diseases and to push for advancements in research, treatment and policy. The FDA introduced its Orphan Drug Act in 1983.

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Rethinking Clinical Trials

MARCH 21, 2023

Goldberg Distinguished Professor and Chief of Oncology Physician-in-Chief, North Carolina Cancer Hospital Director, Cancer Outcomes Research Program University of North Carolina Slides Keywords Patient-reported outcomes, Oncology, Clinical Trials Key Points Symptoms are common in cancer care. Quality of life (QOL) was assessed at 6 months.

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The Pharma Data

NOVEMBER 15, 2020

16, 2020 /PRNewswire/ — Cytiva , a global life sciences leader, is supporting Clover Biopharmaceuticals , a global clinical-stage biotechnology company, to help accelerate the development and manufacturing of a protein-based S-Trimer subunit vaccine candidate. . SHANGHAI , Nov.

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Drug Discovery World

APRIL 17, 2023

Totus Medicines has dosed its first patient in a Phase I clinical trial of TOS-358, a first-in-class covalent PI3Kα inhibitor for the treatment of numerous cancers with known PIK3CA mutations. The study will be conducted in two parts.

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XTalks

AUGUST 19, 2022

XTALKS WEBINAR: How Agile Clinical Trials Unlock Universal Access to Rare Disease Research. Register for this free webinar to learn why the agile clinical trial model is a great fit for many rare disease categories, how to navigate the regulatory landscape for agile clinical trials in rare diseases, how to design studies and more.

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Rethinking Clinical Trials

APRIL 13, 2023

It works to improve health care value and outcomes, advance the science of designing interventions to change behavior and evaluate and disseminate the impact of interventions. Launched in 2016, the Penn Medicine Nudge Unit is the world’s first behavioral design team embedded within a health system.

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Pharmaceutical Technology

JANUARY 27, 2023

In an email to Pharmaceutical Technology , he further described the therapy as “the most important advance for treatment of TTP since the documentation of effectiveness of plasma exchange in 1991”. With these therapies, there is the possibility of there being no clinical benefit and an emergence of adverse events.

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XTalks

JANUARY 19, 2024

Radiobiological and Clinical Considerations from CRO and Emerging Biotech Radiopharmaceuticals are medicinal formulations containing radioisotopes that are used in the field of nuclear medicine primarily for the diagnosis and treatment of various diseases, particularly cancer. Anderson, PharmD, PhD, Radiation Clinical Pharmacologist, A.

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XTalks

DECEMBER 21, 2022

This included greater adoption and acceptance of decentralized clinical trial models, emphasis on patient-centric approaches in trials, growing digitization of healthcare and dealing with drug manufacturing challenges. Decentralized and Virtual Clinical Trials. million for a single infusion.

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Life Science Gene Therapy Gene Clinical Trials 52

Roots Analysis

SEPTEMBER 13, 2023

These molecules can be conjugated with various modalities, such as haptens, enzymes, isotopes, fluorescent tags, carrier proteins, polymers, particle conjugates and photoreactive molecules. Bioconjugation is a subset of conjugation where one of the entity is a biomolecule, such as protein or an antibody.

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Drug Discovery World

NOVEMBER 9, 2023

Gail Calvert, Field Application Scientist, Sartorius UK, on: ‘Leveraging integrated and advanced technologies for successful cell line development’. Sandra Ergueta-Carballo, PhD, Project Coordinator, University of Cambridge, on: ‘Advancing snake envenomation treatment: designing the next generation of antivenoms’.

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Roots Analysis

AUGUST 28, 2022

Recent advances in multi-omics approaches, including genomics, transcriptomics, proteomics, metabolomics, cytometry and imaging, in combination with bioinformatics and biostatistics, have been translated into several popular bioanalytical platforms, such as next-generation sequencing (NGS), single-cell analysis, flow cytometry and mass spectrometry.

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Genome Genomics RNA Genome Project 52

pharmaphorum

OCTOBER 4, 2022

During the first stage of the initiative, more than 2,000 research papers were published, 49 clinical trials were carried out, and more than 30 patents were filed through the support of the US National Cancer Institute (NCI). These datasets are critical as a means to identify how molecular information affects clinical outcomes.”

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Delveinsight

DECEMBER 3, 2020

It has been speculated that modifications to the epigenome drive cell ageing, especially a process known as DNA methylation, by which methyl groups are tagged onto DNA. Ovid has ceased the most other elements of its OV101 Angelman work in response to the setback and turned its goal to its next most advanced asset, OV935.

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Gene Therapy Gene Antibody Research 52

Drug Discovery World

NOVEMBER 13, 2023

Jannick Bendtsen, CEO, PipeBio, on: ‘Accelerating antibody development: Advancing discovery through integrated bioinformatics and machine learning’. He will discuss selection technologies for membrane targets using advances in whole cell panning and comparative deep sequencing.

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