FDA Law Blog: Biosimilars

MARCH 29, 2024

According to GAO, FDA is facing challenges with clinical research inspections to ensure that the sites that oversee the research that lead to drug approvals meet the necessary standards. Complete numbers for 2023 and 2024 are not available, but it appears that FDA was only able to complete 537 BIMO inspections in 2022.

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Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. What is a Pre-Clinical CRO? billion in 2022 and is projected to reach US$10.2

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Drug Patent Watch

DECEMBER 11, 2024

It is crucial to determine whether you will be working with a CDMO for discovery and drug development all the way through approvals and commercialization or if your work with a CDMO will begin with preclinical development or clinical research. 2024, March 13). References Ajinomoto Bio-Pharma Services. 2019, March 6).

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Broad Institute

DECEMBER 11, 2024

#WhyIScience Q&A: A computational biologists world travels have shaped her approach to research By Corie Lok December 11, 2024 Breadcrumb Home #WhyIScience Q&A: A computational biologists world travels have shaped her approach to research Wolu Chukwu talks about how she brings a community-first focus to her work in cancer genetics.

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Conversations in Drug Development Trends

JULY 9, 2024

Due to this meaningful change, the first-ever GLP-1-Based Therapeutics Summit took place in Philadelphia on May 15-16th, 2024, serving as a platform for industry decision-makers to provide invaluable insights for therapeutic strategies.

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PPD

OCTOBER 31, 2024

In response, the PPD clinical research business of Thermo Fisher Scientific conducted its third global survey of 150 drug developers to capture a comprehensive view of these evolving trends. This aims to ensure that treatments are effective across varied demographics and to address historical gaps in clinical research.

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Fierce BioTech

MARCH 12, 2024

Listing Image PPD-TF-logo.png Listing Introduction Get the latest FSP trends, strategies, and projections for biopharma and biotech companies as Lori Boyce, Vice President, PPD FSP Solutions, and Mike Lydon, Director, PPD FSP Solutions, share findings from The 2024 FSP Trends Report. On Demand Start Date Thu, 04/11/2024 - 12:00

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Crucial Data Solutions

DECEMBER 21, 2023

Over the past year, all of us working in clinical research have seen a significant increase in the number of. The post The Year Ahead: What Does EDC Look Like In 2024 and Beyond? appeared first on Crucial Data Solutions.

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Broad Institute

FEBRUARY 19, 2024

But determining whether such tests work effectively across all populations, and how they can guide clinical decision-making, has been a challenge. Now, a team of researchers at the Broad Institute of MIT and Harvard, in collaboration with 10 academic medical centers across the US, has implemented 10 such tests for use in clinical research.

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FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2

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Perficient: Drug Development

FEBRUARY 1, 2024

The conference will take place on February 11-14, 2024, in Orlando, Florida. The SCOPE (Summit for Clinical Ops Executives) conference is a premier event in the field of clinical operations, providing a comprehensive platform for professionals to explore the latest trends and innovations in clinical research.

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PPD

MARCH 26, 2024

The PPD clinical research business of Thermo Fisher Scientific conducts an annual survey of more than 150 leaders at pharmaceutical companies around the globe to assess trends in drug discovery and development, including preferences around outsourcing and functional service provider (FSP) utilization.

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SCIENMAG: Medicine & Health

FEBRUARY 19, 2024

February 19, 2024, Cleveland: Cleveland Clinic researchers have identified a new pathway that contributes to cardiovascular disease associated with high levels of niacin, a common B vitamin previously recommended to lower cholesterol.

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On Medicine

FEBRUARY 8, 2024

In previous research by members of the CHARMER team, older people and their carers told us that they would like their medicines reviewed by doctors during their hospital stay. In a stepped wedge trial , all participating hospitals begin at the same time (1 February 2024) and will act as both a control and intervention (CHARMER approach) site.

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Broad Institute

NOVEMBER 25, 2024

Ladders to Cures (L2C) Accelerator By Maria Nemchuk November 25, 2024 Breadcrumb Home Ladders to Cures (L2C) Accelerator The Ladders to Cures (L2C) Accelerator aims to catalyze progress across the research ecosystem and accelerates advances leading to treatments and cures for patients with rare genetic diseases. Visit broad.io/L2C2023

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PPD

MARCH 28, 2024

Through the first few months of 2024, the economic landscape is showing signs of returning to a semblance of normalcy, mirroring the pre-COVID era. According to Jeffries Equity Research, funding totals exceeded $15 billion in January and February, marking the best monthly tallies in over a year.

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Vial

DECEMBER 8, 2023

With technological innovation and scientific research propelling the development of new therapies, anticipation for the future is high. As we look forward to 2024, several groundbreaking therapies are poised to radically change the landscape of ophthalmology, providing hope and improved treatment options for patients with ocular conditions.

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Alta Sciences

MAY 28, 2024

Altasciences Receives 2024 CRO Leadership Award for Capabilities aasimakopoulos Wed, 05/29/2024 - 17:54 Laval, Québec, May 29, 2024 – Altasciences announced today that it has been recognized for excellence in contract research with a 2024 CRO Leadership Award for Capabilities.

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keypoint

DECEMBER 4, 2023

AI and Machine learning are transforming biomedical research at an astounding pace, enabling transformative insights into disease pathology and etiology, as well as diagnostics, treatment and personalized medicine.

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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. Interested in hearing more insights from Matt?

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PPD

DECEMBER 16, 2024

The drug development industry faces rising costs and increasingly complex protocols as top challenges, with 49% of developers citing costs as their primary concern and 39% pointing to protocol complexity as a key hurdle, according to a recent survey of 150 drug developers worldwide by the PPD clinical research business of Thermo Fisher Scientific.

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Conversations in Drug Development Trends

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. What Differentiates Mid-Size CROs? To learn more about our end-to-end services, contact us today.

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Fierce BioTech

JUNE 14, 2024

How AI Accelerates Clinical & Drug Development Timelines pesurya Fri, 06/14/2024 - 10:59 Wed, 09/11/2024 - 14:00 Resource Type Webinar Viswa Colluru, Ph.D. Embrace this opportunity to stay ahead and lead in a rapidly evolving field by registering for this exclusive webinar sponsored by Dr. Vince Clinical Research.

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Alta Sciences

JUNE 21, 2024

Simpler Clinical Development From Day Dot blussier Fri, 06/21/2024 - 19:10 HTML Connecting the Dots With Comprehensive CRO Solutions When you CONNECT THE DOTS, you open a world of possibilities. At Altasciences, we connect the dots, so you don’t have to. Ready for a simpler drug development journey? Contact us today.

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Alta Sciences

NOVEMBER 18, 2024

Strategic Site Identification for Clinical Trials blussier Mon, 11/18/2024 - 21:10 HTML Start Your Study Faster Watch our latest podcast to discover Altasciences' unique process for identifying and selecting the right clinical sites for your unique project. WATCH NOW Book a visit ; we’d love to host you!

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Alta Sciences

JULY 22, 2024

WATCH THE VIDEO You may also be interested in these resources: Webpage: CNS Drug Development Solutions Webinars: Inside the Pharmacodynamic Toolbox A Review of the FDA's Psychedelic Clinical Research Guidances Image Social_Media_Webinar_CNS_Active_Compounds_v2_04.jpg jpg Tags Clinical Trials Weight 1

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Vial

MARCH 1, 2024

Introduction Contract research organizations (CROs) are essential in pharmaceutical research and development (R&D). from 2024 to reach US$129.8 ’s services include supporting life sciences research, analytical solutions, and diagnostics or developing and manufacturing therapeutic interventions. billion by 2029.

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Vial

FEBRUARY 8, 2024

To advance new therapies, pharmaceutical, biotech, and medical device companies engage contract research organizations (CROs) for their know-how in navigating the complex landscape of drug development and regulatory pathways and to run clinical trials. How do CROs solve the challenges of managing clinical trials?

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Fierce BioTech

DECEMBER 23, 2024

As Phase 1 clinical trials include several different design types with multiple objectives (e.g. First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.),

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Codon

JULY 21, 2024

Xander Balwit offers concrete proposals for raising the welfare of animals used in biomedical research for our final article in Issue 03. Of course, AA and P-line rats are not the only research animals bred for the study of disease. We’ll be on a brief hiatus for the next few weeks as we prepare for the next Issue!

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PPD

JANUARY 5, 2023

In an industry survey led by PPD, Thermo Fisher Scientific’s clinical research business, rare diseases emerged as a top therapeutic area in drug developers’ pipelines, with 39% of global biotech and biopharma leaders pursuing therapies in the broad rare disease space.

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PPD

OCTOBER 24, 2024

Currently there is no cure for hepatitis B, however there are several drugs in clinical development to improve the lives and clinical outcomes for persons with chronic HBV infection, including functional cure strategies. Research and innovation: Continued research is needed to develop better vaccines, treatments and diagnostic tools.

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Alta Sciences

OCTOBER 15, 2024

Up Close and Personal with Jason Boehme, Associate Director, Program Management nbartlett Tue, 10/15/2024 - 09:00 Jason Boehme joined Altasciences in 2018 as Senior Project Manager. Jason started his career as a research assistant carrying out operational phases of drug metabolism and pharmacokinetic studies.

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Alta Sciences

APRIL 16, 2024

Inside The Altascientist: The Benefits of PCR for Your Gene Therapy Programs pmjackson Tue, 04/16/2024 - 19:04 The gene therapy landscape continues to accelerate in preclinical and clinical research, with programs constantly in development for targeted, personalized medicines. WHAT IS THE ALTASCIENTIST ?

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Vial

APRIL 18, 2024

The urgency for novel therapeutic approaches makes ophthalmology a rapidly growing domain of clinical research. Market research indicates significant growth in the ophthalmic clinical trials market, driven by increased disease prevalence, demand for ocular treatments, and rising research funding. from 2023 to 2030.

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Alta Sciences

JANUARY 23, 2024

Altasciences Appoints New General Manager, Clinical Operations pmjackson Tue, 01/23/2024 - 19:52 Laval, Québec, Monday, January 29, 2024 — Altasciences announced the appointment of James Brazeal as General Manager, Clinical Operations, at its clinical facility in Kansas City.

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Drug Target Review

OCTOBER 25, 2024

At Johnson & Johnson, our differentiated Alzheimer’s disease research program is focused on leveraging the latest advancements in precision medicine, data science and digital health to help make earlier diagnosis an option and help treat the right patient with the right treatment at the right time. 2024, July 28). 2020, July 1).

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