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 Clinical Trials Research Trials

The rising impact of biomarkers in early clinical development

Drug Target Review

APRIL 7, 2025

In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drug developers for phase I trials, second only to navigating regulatory compliance (- 38 percent). Silver Spring (MD): Food and Drug Administration (US); 2016-.

Clinical Development

Clinical Development Clinical Trials Clinical Pharmacology Trials

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 Drug Development Clinical Development

Up Close and Personal with Jason Boehme, Associate Director, Program Management

Alta Sciences

OCTOBER 15, 2024

He was promoted to Associate Director, Program Management , in 2022, and now oversees a team of program managers who guide end-to-end solutions, including preclinical , clinical , CDMO , regulatory , and bioanalytical solutions. Keep your curiosity about life sciences fresh and keep learning about the drug development process!

Pharmacokinetics

Pharmacokinetics Drug Development Clinical Trials Science

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

Vaccine Clinical Trials Long-Term Care Facilities Trials

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

Clinical Trials Treatment Trials Drug Development

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

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

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 Trials

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 Therapies Regulations

Inside The Altascientist: Understanding Drug Interaction Factors for Safer, More Effective Therapies

Alta Sciences

DECEMBER 31, 2024

One of the most important factors to consider during the course of your early-phase clinical research is drug-drug interactions (DDIs), which occurs when one drug alters the effect of another, either by reducing its effectiveness or elevating systemic concentrations to potentially dangerous levelsultimately causing side effects.

Therapies

Therapies Pharmacokinetics Pharmacogenetics Clinical Trials

Best-in-Class Solutions Accelerate Development of GLP-1 Therapeutics

PPD

APRIL 14, 2025

Expertise that accelerates your clinical development success The PPD clinical research business of Thermo Fisher Scientific has significant experience in customized Phase I-IV metabolic clinical trials. Were applying that expertise and commitment to every aspect of developing and running successful GLP-1 studies.

Clinical Trials

Clinical Trials Trials Clinical Development Disease

Women in STEM with Cristina de Min

Drug Target Review

OCTOBER 16, 2024

My clinical background as a physician led me to drug development, where I realised I could have an even broader impact on patient well-being. The ability to translate clinical experience into scientific innovation was deeply inspiring to me, because it meant contributing to solutions that could benefit far more patients.

Clinical Development

Clinical Development Drug Development Therapies Disease

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

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 Drug Development

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

Clinical Trials Drug Development Trials Clinical Research

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 Disease

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

FDA’s Project Optimus: A new era in oncology drug dosing

Drug Target Review

JANUARY 20, 2025

The oncology drug development landscape is evolving rapidly, driven by the deployment of targeted therapies in precision medicine and regulatory initiatives like the FDAs Project Optimus. It also covers strategies for drug developers who have yet to identify a biomarker, helping them advance their programs effectively.

Clinical Trials

Clinical Trials Trials Drugs Drug Development

Drug Discovery Digest

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

The rising impact of biomarkers in early clinical development

Trending Sources

PPD Early Development Services: Accelerating the Clinical Process

Up Close and Personal with Jason Boehme, Associate Director, Program Management

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

Biochemical assays and deep cyclic inhibition in cancer treatment

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

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

Inside The Altascientist: Understanding Drug Interaction Factors for Safer, More Effective Therapies

Best-in-Class Solutions Accelerate Development of GLP-1 Therapeutics

Women in STEM with Cristina de Min

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

How Improving Diversity Can Benefit Clinical Trials

Can Your CRO Add Value During a Recession?

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.

FDA’s Project Optimus: A new era in oncology drug dosing

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