Alta Sciences

OCTOBER 15, 2024

As my experience in preclinical research grew, so did my curiosity in the overall drug development process; I wanted to expand into clinical research. Keep your curiosity about life sciences fresh and keep learning about the drug development process! Image blog-thumbnail-up-close-jason_1.jpg

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Drug Development Science 52

The Premier Consulting Blog

APRIL 18, 2024

This blog will outline three characteristics of a successful nonclinical program to support entry into clinical trials for a cell or gene therapy product. Can you identify a safe AND efficacious clinical dose? As in all nonclinical drug development programs, the goal is to identify potential safety issues in humans.

Therapies 52

Therapies Clinical Trials Small Molecule Immune Response 52

Conversations in Drug Development Trends

MAY 30, 2024

This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. The shared placebo design is another approach to accelerating drug development in ALS research.

Treatment 81

Treatment Clinical Trials Small Molecule Therapies 81

H1 Blog

JULY 30, 2024

The recent draft by the FDA introduces additional guidelines for Diversity Action Plans aimed at improving diversity in clinical research. The Impact of Draft Guidance on Drug Development As it stands, drug development is an expensive endeavor, costing approximately $2.3

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FDA Clinical Trials Compliance Pharma Companies 59

H1 Blog

SEPTEMBER 14, 2023

As pharmaceutical companies turn to CROs (Clinical Research Organizations) for trial design and technology, there are new opportunities emerging with healthcare data intelligence that can help ensure a bright future for the industry and to make trials more effective, efficient and accessible. million data points.”

Clinical Trials 59

Clinical Trials Pharmaceutical Companies Trials Pharmaceuticals 59

thought leadership

AUGUST 14, 2023

In the drug development process, the Investigational New Drug (IND) application holds immense significance for biotech startups. It serves as a comprehensive overview submitted to the US Food and Drug Administration (FDA), outlining the drug and the upcoming clinical trials for evaluating its safety and efficacy.

Clinical Trials 40

Clinical Trials FDA Drug Development Trials 40

H1 Blog

MAY 4, 2023

Insights for Thought Leading Stakeholder Engagement to Decrease Medication Non-Adherence Pharmaceutical companies have long recognized the importance of engaging key opinion leaders (KOLs) to gain insight and support for clinical research, drug development, and medical education.

Pharmaceutical Companies 52

Pharmaceutical Companies Clinical Research Pharma Companies Pharmaceuticals 52

PerkinElmer

FEBRUARY 18, 2021

Which high throughput screening (HTS) approach is the most productive in finding hits for drug development: target-based or phenotypic? These simple, stable compounds, used to treat various conditions, are the focus for 78% of preclinical research. Target-based screening is the preferred approach to high-throughput screening.

Biochemical Assays 52

Biochemical Assays Drugs Small Molecule Pharma Companies 52

Conversations in Drug Development Trends

MAY 23, 2024

The CRO landscape is rapidly evolving with the recent implementation of the EU Clinical Trials Regulation No 536/2014 (EU-CTR) and the launch of the Clinical Trials Information System (CTIS). This blog delves into the key aspects of the EU regulatory space and provides insights into navigating these changes effectively.

Trials 52

Trials Clinical Trials Therapies Treatment 52

NIH Director's Blog: Drug Development

OCTOBER 11, 2022

For clinical researchers, click chemistry has emerged as a workhorse in drug discovery and the improved targeting of cancer chemotherapies and other small-molecule drugs. The approach also is being used to improve delivery of antibody-based therapies and to create new biomaterials.

Research 52

Research Small Molecule Science Clinical Research 52

Molecule Blog

MARCH 17, 2023

This can be achieved by providing incentives and governance rights to patients participating in clinical research, shifting biopharma’s focus from profits to patient value. Unlike investment DAOs, BioDAOs generate returns to finance R&D rather than distribute profits to stakeholders.

Engineering 52

Engineering Research Clinical Trials Government 52

NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

The program relies on four expert “working groups” with specific charges: Preclinical Working Group : Shares standardized preclinical evaluation resources and accelerate testing of candidate therapies and vaccines for clinical trials.

Clinical Trials 52

Clinical Trials Trials Hospitals Vaccine 52

NIH Director's Blog: Drug Development

JULY 20, 2017

Caption: Two-year-old Avalyn is among the cystic fibrosis patients who may be helped by targeted drugs. Credit: Brittany Mahoney As NIH Director, I often hear stories of how people with serious diseases—from arthritis to Zika infection—are benefitting from the transformational power of NIH’s investments in basic science.

Clinical Trials 52

Clinical Trials Small Molecule Therapies Disease 52

PPD

NOVEMBER 8, 2022

As 2022 comes to a close, we’re reflecting on the past 12 months as a transformative year for the drug development industry — one that foreshadows both change and opportunity in biopharma and biotech clinical trials in 2023. Six Predictions for the Drug Development Industry in 2023 1.

Clinical Trials 52

Clinical Trials Trials Drug Development Clinical Research 52

FDA Law Blog: Drug Discovery

JULY 9, 2024

FDA issued its draft guidance titled “ Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies ,” (the “Draft Guidance”) which replaces the previous pre-FDORA April 2022 draft guidance of the same name.

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FDA Clinical Trials Disease Trials 59

NIH Director's Blog: Drug Development

JANUARY 5, 2016

Although NIH was not involved in this specific trial, researchers from our National Institute of Allergy and Infectious Diseases (NIAID) and Clinical Research Center were involved in this vaccine’s early Phase I clinical testing in collaborations with the Walter Reed Army Institute of Research [3].

Vaccine 52

Vaccine Science Engineering Disease 52

H1 Blog

NOVEMBER 29, 2023

Breaking the Barriers: How Inaccurate Trial Records Are Delaying Drug Development and Limiting Diverse Patient Populations In an October 2023 report , BMC Medicine completed a follow-up on a 10-year effort to understand, report on and track data sharing challenges with big pharma, specifically for clinical trials.

Clinical Trials 59

Clinical Trials Trials Drug Development Treatment 59

Conversations in Drug Development Trends

OCTOBER 29, 2024

By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?

Clinical Research 72

Clinical Research Disease Research Clinical Trials 72

PPD

JANUARY 2, 2025

Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. This blog explores the value of functional service provider (FSP) models and how they help biotech companies augment their clinical development needs.

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Clinical Development Clinical Trials Trials Regulations 98

FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

Implications for Future of Clinical Research R3 represents an important evolution in GCP, shifting away from a prescriptive model toward a more flexible, risk-based approach.

Clinical Trials 88

Clinical Trials Trials Clinical Research Government 88

Perficient: Drug Development

JANUARY 24, 2025

This blog post delves into the myriad ways in which GenAI can reshape acute care, from enhancing clinical decision-making and optimizing operations to elevating the patient experience and driving innovation.

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Compliance Hospitals Clinical Research Science 52