Advarra

JANUARY 11, 2024

The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines.

Vaccine 52

Vaccine Therapies Clinical Trials Small Molecule 52

The Premier Consulting Blog

APRIL 18, 2024

Development of cell and gene therapies is growing rapidly, given the major advances in genomic technologies and increasing scientific understanding of genetic regulation and immunology. Can you identify a safe AND efficacious clinical dose? Prior to clinical trials, the focus is typically on evaluating safety.

Therapies 52

Therapies Clinical Trials Small Molecule Immune Response 52

Advarra

NOVEMBER 29, 2022

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.

Therapies 52

Therapies FDA Clinical Trials Production 52

Drug Discovery World

SEPTEMBER 23, 2022

An interesting week for clinical research and drug approvals, with rare diseases being a key focus for both the FDA and European Commission. The last week has seen data emerge on how Omicron infection could protect against influenza, how breast cancer cells evade therapies, and two approvals on rare diseases in the US and EU.

FDA Approval 130

FDA Approval FDA Drugs Therapies 130

Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Biosimilars Clinical Trials Production 40

Conversations in Drug Development Trends

JUNE 21, 2024

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Check out this webinar on navigating the landscape of oncology clinical trials.

Clinical Trials 64

Clinical Trials Clinical Research Immune Response Therapies 64

Agency IQ

FEBRUARY 12, 2024

BY RACHEL COE, MSC | FEB 7, 2024 10:21 PM CST The Bespoke Gene Therapy Consortium A collaborative effort, the Bespoke Gene Therapy Consortium (BGTC) was launched in October 2021 to “accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease.”

FDA 40

FDA Therapies Clinical Trials Virus 40

Drug Discovery World

JULY 5, 2023

The scientific community has 50 years of research fundamentals under their belts to make a substantial difference in patient care, particularly in the areas of immunotherapy and precision oncology. These types of therapies are often more effective and have fewer side effects. We’re starting to see that this goal is realisable.

Research 246

Research Immune Response Pharmaceutical Companies Treatment 246

Drug Discovery World

APRIL 14, 2023

He is being recognised for his revolutionary contributions to developing the first gene-edited cell-based therapy for cancer that involves the genetic re-engineering of a patient’s own T cells to combat their disease, and for demonstrating that adoptive T-cell therapy can induce remission and in some cases cure patients with advanced cancer.

Clinical Trials 130

Clinical Trials Research Science Clinical Research 130

Agency IQ

NOVEMBER 3, 2023

regulatory landscape for probiotics and other microbiome-based therapies Probiotics, a type of microbiome-based therapy containing live micro-organisms, are broadly available on drug store and grocery store shelves, but the regulatory classifications for products containing the same micro-organism can differ dramatically.

Therapies 40

Therapies Science FDA Production 40

PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. Researchers often employ cell therapy studies for oncology indications, and the U.S.

Trials 52

Trials Clinical Trials Therapies Drug Development 52

Drug Discovery World

AUGUST 10, 2022

But decades of research led to improvements in cancer therapy, centred around the idea that one’s immune system could aid in treatment. Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2. Developing the first CAR T cell therapy. Training T cells to target tumours.

Therapies 246

Therapies Virus Treatment Engineering 246

PPD

NOVEMBER 14, 2023

Clinical research requires vast talent across a variety of roles and specialties, as well as across global locations. In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development.

Clinical Research 52

Clinical Research Clinical Development International Engineering 52

Vial

MAY 28, 2024

In the rapidly expanding world of digital health, Medable and Vial CRO (Contract Research Organization) , two leading technology organizations, are revolutionizing the way clinical research is conducted.

Clinical Trials 52

Clinical Trials Clinical Research Compliance Trials 52

Drug Target Review

JUNE 6, 2023

We are in an era of immuno-oncology (IO) revolution with many approved therapies now available to treat a broad range of cancers. Difficult-to-treat and rare, complicated cancers remain a perplexing challenge for IO researchers. Clinical development of IL-18 therapies has been curtailed, however, by the protein’s lack of efficacy.

Engineering 98

Engineering Immune Response Biochemical Pharmacology Clinical Trials 98

Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. My mission is to see cannabis regulators understand basic science and to consult experienced scientists to refine regulations.

Clinical Trials 130

Clinical Trials Regulations Production FDA 130

Drug Discovery World

APRIL 14, 2023

Clinical trials are, undoubtedly, an essential part of the drug development process, providing us with valuable information about the safety and efficacy of new treatments and therapies.

Clinical Trials 130

Clinical Trials Trials Pharmaceuticals Vaccine 130

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Read AgencyIQ analysis here for a detailed discussion of these issues. ].

FDA 40

FDA Trials Regulations Therapies 40

PPD

OCTOBER 18, 2023

There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care. Continued expansion of the biotech industry is occurring in parallel, with an estimated compound annual growth rate of 13.96% from 2023-2030.

Laboratories 52

Laboratories Assay Development Small Molecule Packaging 52

Conversations in Drug Development Trends

APRIL 3, 2024

By: Sue Batchelor, Executive Director, Oncology Project Management Radiopharmaceuticals represent a cutting-edge frontier in oncology treatment, offering the promise of highly targeted therapy with the potential to revolutionize cancer care. Are you aware of the challenges you must address for a successful radiopharmaceutical trial?

Trials 81

Trials Clinical Trials Compliance Treatment 81

Olympian Clinical Research

SEPTEMBER 3, 2020

Sleep is especially important in regulating mood. Resources for good sleep hygiene and Cognitive Behavioral Therapy for sleep can be found with a simple online search. The post Battling Depression In A World Of Isolation: Tips For Managing COVID Depression appeared first on Olympian Clinical Research.

Clinical Trials 98

Clinical Trials Clinical Research Treatment Trials 98

Vial

APRIL 10, 2024

The strong commitment to innovation allows IQVIA to provide advanced analytics, technology solutions, and industry-specific expertise in the health information technologies and clinical research domains. This approach replaces paper sources, supports productivity-enhancing workflows, and ensures compliance with relevant regulations.

Clinical Trials 52

Clinical Trials Trials Compliance Clinical Research 52

Crown Bioscience

MAY 4, 2021

Why are cancer treatments for children lagging behind the latest advancements in clinical oncology? Crown Bioscience Director Mike Batey takes a closer look at pediatric cancer and how recent regulatory changes and additional research focus may deliver new therapies for kids.

Research 52

Research Pharmaceutical Companies Licensing Licensing 52

Drug Discovery World

SEPTEMBER 28, 2022

Yet despite this, the biggest players in the global pharma sector are increasingly opening their doors to partnerships with AI and machine learning companies, cognisant of the potential benefits these could provide across broad therapy areas such as oncology, autoimmune and rare diseases. . How AI can streamline drug discovery .

Pharma Companies 130

Pharma Companies Hospitals Clinical Trials Drugs 130

Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Read AgencyIQ’s analysis of a lower court’s ruling.

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Clinical Trials Regulations 40

The Pharma Data

MARCH 11, 2021

Retevmo was approved under the FDA’s Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/2 trial’s endpoints of overall response rate (ORR) and duration of response (DoR). Session Title: Targeted Therapy and Ovarian Cancer Trials. Session Type: Clinical Trials Plenary Session. Abstract Number: 442.

Research 52

Research Clinical Trials FDA Approval Trials 52

Drug Target Review

AUGUST 22, 2023

This Q&A explores how pre-clinical research is being used to identify potential therapies for Huntington’s disease, a devastating condition that currently lacks disease- modifying treatments. Extracellular mutant Huntingtin may play a role in seeding aggregates, though the exact clinical impact is still unknown.

Therapies 98

Therapies Disease RNA Treatment 98

The Pharma Data

JANUARY 24, 2021

This marks the third US clinical site that has obtained both study level and site IRB approval through a central IRB. There are 3 pending US clinical study sites that are expected to receive site IRB approval in 1Q2021. The MU team thrives on pushing the envelope of what’s possible in urological medicine. Dr. Laurence H.

Pharmaceutical Companies 52

Pharmaceutical Companies Virus Clinical Research Pharmaceuticals 52

The Anticancer Fund

JUNE 23, 2023

While other regimens have shown similar promising results, the authors note that in low and middle income countries this simple and low-cost treatment may be suitable as a maintenance therapy in high-risk LGG patients. Gauthier Bouche & Pan Pantziarka Gauthier Bouche (MD) is Director of Clinical Research at the Anticancer Fund.

Drugs 52

Drugs Trials Clinical Trials Treatment 52

The Pharma Data

DECEMBER 17, 2020

Goater is CEO at Surface Oncology, an immuno-oncology company developing next-generation antibody therapies. Thérin is the president of Advanced Therapies at Siemens Healthineers. Prior to SpringWorks, Smith was the executive vice president of Gene Therapy at Bamboo Therapeutics. Immune Regulation – U.K.-based

Small Molecule 52

Small Molecule Engineering Pharmaceuticals Clinical Development 52

Conversations in Drug Development Trends

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Ultimately, our goal is to bring safe and effective new therapies to patients.

Clinical Research 69

Clinical Research Trials Research Clinical Trials 69

The Pharma Data

JANUARY 7, 2021

As CEO of Freeline, a liver-directed gene therapy company, she scaled the company from preclinical stage to a fully integrated biotechnology organization, which included a broad, internally developed pipeline, two programs in clinical development and a commercial-scale, high-quality CMC and manufacturing platform.

Small Molecule 52

Small Molecule Clinical Development Production Science 52

The Pharma Data

DECEMBER 14, 2020

“With the acquisition of this intellectual property, we have solved the problem that has plagued psychedelic therapies for so many decades. Our highly experienced clinical team will be placing 2-Bromo-LSD into multi-center United States clinical research locations without restriction.”.

Bioethics 40

Bioethics Clinical Research Regulations Compliance 40

The Pharma Data

SEPTEMBER 29, 2021

The new FIND-CKD study extends our clinical research for finerenone to a non-diabetic population where the unmet need is high for brand spanking new treatments to delay disease progression.”. They also control how much water and electrolytes are in the body, regulating blood pressure.

Clinical Development 52

Clinical Development Disease Clinical Trials Trials 52

The Pharma Data

APRIL 12, 2022

Currently, available therapies do not address the underlying disease biology and have not shown a consistent effect on both biomarkers of disease modification and overall survival. vice president and global head of oncology clinical development at AbbVie. The BCL-2 family of proteins are known regulators of the apoptosis pathway.3

Medical Schools 52

Medical Schools Trials Disease Clinical Development 52

The Pharma Data

NOVEMBER 9, 2020

Cancer immunotherapies such as immune checkpoint inhibitors (ICIs) have shown promising clinical outcomes over the past two decades; and they are often used for patients with advanced cancers once other therapies have reached the end of their effectiveness. NBTXR3 is injected one time, directly into solid tumors. Abstract ID: 410.

Immune Response 40

Immune Response Therapies Clinical Trials Treatment 40