2001 and Clinical Research - Drug Discovery Digest

2001

Clinical Research

The rising impact of biomarkers in early clinical development

Drug Target Review

APRIL 7, 2025

2 This progress has implications for diagnosis, therapeutic efficacy, and potentially establishing clinically relevant endpoints. 2001) Biomarkers Definitions Working Group Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clinical Pharmacology and Therapeutics. Bagyinszky E, et al. 21(10):3517.

Clinical Development

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Keys to Success in Vaccine Development for Special Populations

PPD

MAY 11, 2023

From study participants’ consent, to minimizing the patient and caregiver burden, to planning for different needs at different stages of the pediatric immune system, there are many factors to consider when conducting clinical research with this specific population.

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Bridging Innovation & Patient Care: The Growing Role of AI

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The Chemistry Clicked: Two NIH-Supported Researchers Win 2022 Nobel Prize in Chemistry

NIH Director's Blog: Drug Development

OCTOBER 11, 2022

Barry Sharpless, Scripps Research, La Jolla, CA, October 5, 2022 marked the second time that he’s received an early-morning congratulatory call from The Royal Swedish Academy of Sciences. 2001, 40 (11), 2004–2021 [2] A stepwise huisgen cycloaddition process: Copper(I)-catalyzed regioselective “Llgation” of azides and terminal alkynes.

Research

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Bridging Innovation & Patient Care: The Growing Role of AI

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Pivotal phase III clinical trial IND submission of the original innovative anticancer drug Chiauranib for the treatment of small cell lung cancer was accepted by the Center of Drug Evaluation of the NMPA.

The Pharma Data

JANUARY 10, 2021

SH ) was founded in Shenzhen on 2001, specializing in the research and development of novel small molecule drugs. At present, Chiauranib has globally applied for more than 40 patents of invention. About CHIPSCREEN BIOSCIENCES. Shenzhen Chipscreen Biosciences Co., Chipscreen Biosciences, Stock Symbol: 688321.

Clinical Trials

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Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials

Alta Sciences

SEPTEMBER 13, 2023

Altasciences’ experienced clinical researchers can accommodate and advise you on your pain management and treatment contributions, the needs of your therapeutic studies, how to best utilize various pain models, and evaluate and assess the efficacy of your treatment. billion people that suffer from chronic pain, globally , (51.6

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Human neuronal cells: possibilities in drug safety testing

Drug Target Review

SEPTEMBER 26, 2023

She completed a PhD at Durham University which focused on investigating the mechanisms of cardiotoxicity of cancer therapies using clinically relevant in vitro human models of cardiac physiology paired with novel methodologies to evaluate structural and functional toxicities. 2001 Sep;24(9):517–26. Adv Drug Deliv Rev. Trends Neurosci.

Drugs

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Navigating the Complex Regulatory CRO Landscape for Oncology Trials in the European Union

Conversations in Drug Development Trends

MAY 23, 2024

Regulatory Harmonization of Clinical Trials in the EU The EU-CTR repealed the Clinical Trial Directive 2001/20/EC (CTD) and national implementing legislation in the EU Member States on 31 January 2022.

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Chipscreen and HISUN reach a strategic cooperation

The Pharma Data

DECEMBER 15, 2020

SH) was founded in Shenzhen on 2001, specializing in the research and development of novel small molecule drugs. Such cooperation will rapidly expand the coverage of the drug product after its launch, providing professional pharmaceutical services to doctors and patients, and benefit more patients.”

Pharmaceuticals

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ReWalk Robotics announces the Appointment of Randel E. Richner, BSN, MPH to its Board of Directors

The Pharma Data

OCTOBER 18, 2020

Founded in 2001, ReWalk has headquarters in the United States, Israel and Germany. ReWalk’s mission is to fundamentally change the quality of life for individuals with lower limb disability through the creation and development of market leading robotic technologies. ReWalk® is a registered trademark of ReWalk Robotics Ltd.

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Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

AUGUST 16, 2024

FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances. Read AgencyIQ analysis here for a detailed discussion of these issues. ]. See AgencyIQ’s analysis of the draft guidance here. ].

FDA

FDA Trials Therapies Regulations

Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting

Agency IQ

APRIL 8, 2024

For BA/BE studies that do not require INDs (a majority of those used in support of generic drug applications), only a subset of FDA’s regulations regarding clinical research apply. This was an area that FDA investigators recently interviewed by the U.S. Government Accountability Office (GAO) flagged as a major concern.

FDA

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Raising Welfare for Lab Rodents

Codon

JULY 21, 2024

FAAH knockouts have been around since 2001, and since then, studies have indicated their potential as “a new mechanistic approach to anti-anxiety therapy.” By contrast, knocking out FAAH makes the animals retain enough pain-signaling to avoid damage. As complicated biological creatures, we require complicated biological models.

Research

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Let's Quit Sugar With Audiobook – Let's Quit Sugar

The Pharma Data

MAY 13, 2021

2001 Nov 16;12(16):3549-52. Clinical Research Strategies for Fructose Metabolism. 2001 Sep;30(3):765-85. Measuring visceral and hepatic fat in clinical practice and clinical research. Colantuoni C, Schwenker J, McCarthy J, Rada P, Ladenheim B, Cadet JL, Schwartz GJ, Moran TH, Hoebel BG. Neuroreport.

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How the Fifty States View Electronic Data as a “Product”

Drug & Device Law

JULY 31, 2023

2001); Isham v. 2001), relied on these other statutes to hold that a road could not be a “product”). 2001) (applying Illinois law); Serpico v. Huntington Ingalls Inc. , 3d 1170, 1173 (9th Cir. 2016) (citations omitted). Accord Stark v. Armstrong World Industries, Inc. , 371, 377 (6th Cir. PADI Worldwide Corp. Engelhardt v.

Production

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The rising impact of biomarkers in early clinical development

Keys to Success in Vaccine Development for Special Populations

Webinars

Trending Sources

The Chemistry Clicked: Two NIH-Supported Researchers Win 2022 Nobel Prize in Chemistry

Webinars

Pivotal phase III clinical trial IND submission of the original innovative anticancer drug Chiauranib for the treatment of small cell lung cancer was accepted by the Center of Drug Evaluation of the NMPA.

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials

Human neuronal cells: possibilities in drug safety testing

Navigating the Complex Regulatory CRO Landscape for Oncology Trials in the European Union

Chipscreen and HISUN reach a strategic cooperation

ReWalk Robotics announces the Appointment of Randel E. Richner, BSN, MPH to its Board of Directors

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting

Raising Welfare for Lab Rodents

Let's Quit Sugar With Audiobook – Let's Quit Sugar

How the Fifty States View Electronic Data as a “Product”

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