Clinical Research, Drug Development and Pharmacokinetics

Applying Artificial Intelligence to Transform the Patient Enrollment Paradigm in Clinical Research

PPD

JULY 29, 2024

In today’s data-driven world, AI has become valuable and indispensable, enabling organizations to extract valuable insights from vast amounts of data, make informed decisions and drive innovation across different sectors — including drug development.

Clinical Research

Clinical Research Research Clinical Trials Trials

What recent paediatric guidelines mean for drug developers

Drug Discovery World

JULY 25, 2023

Justin Hay , Senior Director, Amy Cheung Senior Director of Integrated Drug Development, and Patrick Loebs Director, at Certara, examine recent changes in paediatric guidelines and how they affect drug development projects.

Drug Development

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Keys to Success in Vaccine Development for Special Populations

PPD

MAY 11, 2023

The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drug developers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when.

Vaccine

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Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials

Alta Sciences

SEPTEMBER 13, 2023

COMMONLY USED PAIN MODELS As pain models continue to expand, there are still many tried and tested ways to achieve the most accurate results possible, such as pain stimulation, pharmacodynamics (PD), and pharmacokinetics (PK) for early phase analgesic trials. Here are four main pain models we use to assess treatments in clinical trials: 1.

Clinical Trials

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Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

Conversations in Drug Development Trends

AUGUST 9, 2024

Advantages and Operational Challenges in Adaptive MRCTs Adaptive trial designs are gaining popularity in clinical research due to their ability to improve trial efficiency and uphold ethical standards, resulting in faster and more reliable outcomes.

Trials

Trials Clinical Trials Regulations FDA

Where is the promise for plant-based medicines? Part 1: Cannabis

Drug Discovery World

AUGUST 3, 2023

Dr Sodergren told DDW in an exclusive comment: “I am hopeful that over the next few years we will see further investments by governments and funding bodies to accelerate pre-clinical and clinical research programmes.

Clinical Trials

Clinical Trials Regulations Production FDA

Biochemical assays and deep cyclic inhibition in cancer treatment

Drug Target Review

JULY 12, 2023

The goal of DCI in preclinical and clinical assessments is to achieve a manyfold higher drug free-fraction pharmacokinetic (PK) C max level (the plasma concentration of therapy in a specific area of the body) to break tumour addiction to the MAPK signalling pathway followed by a rapid drop off of drug levels enabled by a short plasma half-life.

Biochemical Assays

Biochemical Assays Treatment Bioinformatics Disease

PPD Early Development Services: Accelerating the Clinical Process

PPD

SEPTEMBER 19, 2023

During the drug development process, companies have a choice of different approaches based on their development plan requirements. Benefits of Early Drug Development Services Early development studies include many elements that set them apart from those in later development.

Clinical Trials

Clinical Trials Pharmacokinetics Clinical Development Drug Development

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

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

FDA Trials Regulations Therapies

News from AACR 2024: Wednesday’s highlights

Drug Discovery World

APRIL 11, 2024

On the final day of AACR, the plenary session of the Annual Meeting put artificial intelligence at the forefront and featured a stellar lineup of AI and data science experts who discussed AI and topics such as imaging, precision medicine, and drug development.

Biochemical Assays

Biochemical Assays DNA Science Pharmacokinetics

Altasciences Completes Successful Phase I Trial of Ischemix’ Novel Compound for Treatment of Traumatic Brain Injury (TBI)

Alta Sciences

AUGUST 28, 2023

s novel, proprietary cytoprotective drug candidate, CMX-2043, for the treatment of acute TBI. The trial was performed at Altasciences’ clinical facility in Montréal. The results of the trial showed a well-characterized pharmacokinetic profile, demonstrating dose proportionality over the ranges studied. About Ischemix, Inc.

Trials

Trials Treatment Clinical Pharmacology Pharmacokinetics

Can Your CRO Add Value During a Recession?

PPD

JUNE 20, 2023

As some drug development organizations right-size their workforces , a strong CRO partner will rehire your talent — avoiding destabilization of your clinical research — via rebadging through functional service provider (FSP) engagements. The drug development industry is undoubtedly in a season of change.

Clinical Trials

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How Improving Diversity Can Benefit Clinical Trials

Alta Sciences

JULY 31, 2024

Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025. Why Diversity in Clinical Trials Matters A wide variety of factors, from age or biological sex to environmental conditions and lifestyle choices (e.g.,

Clinical Trials

Clinical Trials Trials Clinical Pharmacology Pharmacokinetics

Article FDA Thank You FDA offers a status check on its diversity in research provisions, one year post-FDORA

Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation.

FDA

FDA Research Clinical Trials Regulations

Better Late Than Never – Unpacking FDA’s Highly Anticipated (and Long Overdue) Draft Guidance on Diversity Action Plans

FDA Law Blog: Drug Discovery

JULY 9, 2024

DAP Content In developing DAPs, the Draft Guidance recommends that sponsors consider whether certain demographic groups may have a different response to a medical product regarding either effectiveness or safety.

FDA

FDA Clinical Trials Disease Trials

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

FEBRUARY 2, 2024

The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996. The document has been updated over time to implement advances in understanding cancer and drug development. In 2005, the guidance was updated to include non-cytotoxic drugs were gaining in importance.

Clinical Trials

Clinical Trials Trials Treatment Production

Analysis Life Sciences Thank You FDA just published its Diversity Action Plan guidance. Here’s what you need to know.

Agency IQ

JUNE 28, 2024

See AgencyIQ’s analysis for more detailed history of FDA’s policy and guidance on diversity in research studies ]. In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. Read AgencyIQ’s extensive analysis of the draft guidance here.]

FDA

FDA Science Clinical Trials Production

Drug Discovery Digest

Applying Artificial Intelligence to Transform the Patient Enrollment Paradigm in Clinical Research

What recent paediatric guidelines mean for drug developers

Trending Sources

Keys to Success in Vaccine Development for Special Populations

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials

Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

Where is the promise for plant-based medicines? Part 1: Cannabis

Biochemical assays and deep cyclic inhibition in cancer treatment

PPD Early Development Services: Accelerating the Clinical Process

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

News from AACR 2024: Wednesday’s highlights

Altasciences Completes Successful Phase I Trial of Ischemix’ Novel Compound for Treatment of Traumatic Brain Injury (TBI)

Can Your CRO Add Value During a Recession?

How Improving Diversity Can Benefit Clinical Trials

Article FDA Thank You FDA offers a status check on its diversity in research provisions, one year post-FDORA

Better Late Than Never – Unpacking FDA’s Highly Anticipated (and Long Overdue) Draft Guidance on Diversity Action Plans

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Analysis Life Sciences Thank You FDA just published its Diversity Action Plan guidance. Here’s what you need to know.

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