Clinical Development, Clinical Research and Pharmacokinetics

Clinical Development

Clinical Research

Pharmacokinetics

The rising impact of biomarkers in early clinical development

Drug Target Review

APRIL 7, 2025

As pharmacological indicators, biomarkers overcome the static nature of traditional in vitro cellular studies by providing more dynamic models of pharmacokinetic processes that reflect active biological mechanisms. Biomarkers can play a crucial role throughout clinical development, especially in early phases.

Clinical Development

Clinical Development Clinical Trials Clinical Pharmacology 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

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PPD Early Development Services: Accelerating the Clinical Process

PPD

SEPTEMBER 19, 2023

Whichever route a company takes, deliberate decision-making around the nature and timing of early phase studies is important to manage risks in the clinical development process. 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

Targeting the immunotherapy potential of cytokines IL-12 and IL-18 with new advancements in protein engineering

Drug Target Review

JUNE 6, 2023

Clinical development of IL-18 therapies has been curtailed, however, by the protein’s lack of efficacy. We are currently selecting our lead IL-18 variant on the basis of potency for the IL-18 receptor, optimal pharmacokinetic profile and in vivo efficacy for inhibiting tumour growth.

Engineering

Engineering Immune Response Biochemical Pharmacology Clinical Trials

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.

Vaccine

Vaccine Clinical Trials Long-Term Care Facilities Trials

4 Unique Challenges of Oncology Trials

Advarra

JUNE 20, 2023

Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54 Typical clinical development timelines for anticancer drugs average an estimated 6.7

Trials

Trials Clinical Trials FDA Approval Therapies

Poxel Announces Additional Positive Phase 2a Results, and Phase 2b Plan for PXL770, an Oral First-in-Class AMPK Activator, in NASH

The Pharma Data

DECEMBER 13, 2020

The Phase 2b trial will also evaluate efficacy on other histology endpoints (fibrosis), assessment of metabolic and non-metabolic parameters, pharmacokinetic assessment as well as safety and tolerability. Harrison, MD, Director, Summit Clinical Research. The Phase 2b trial is expected to begin during the second half of 2021.

Trials

Trials Disease Treatment Pharmacokinetics

Analysis Life Sciences Thank You FDA’s Diversity Action Plan: Questions, answers, and what we (don’t) know so far

Agency IQ

AUGUST 9, 2024

By Laura DiAngelo, MPH | Aug 2, 2024 6:30 PM CDT A refresher on FDA’s Diversity Action Plan (DAP) guidance: 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.]

Science

Science FDA Production Drugs

Women in STEM with Cristina de Min

Drug Target Review

OCTOBER 16, 2024

It’s an exciting process—anticipating development risks, predicting outcomes, and aligning these with the greater vision of medical advancement. The true joy comes from navigating these complexities and asking the right questions early on, because these foundational steps are critical to the success of any clinical development process.

Clinical Development

Clinical Development Drug Development Therapies Disease

BioSpace Global Roundup, Oct. 15

The Pharma Data

OCTOBER 14, 2020

Priothera will use the funds to progress the clinical development of mocravimod, a modulator of sphingosine 1 phosphate (S1P) receptors, to enhance the curative potential of allogeneic hematopoietic stem cell transplantation (HSCT) for treating AML. Axol Bioscience – Based in the U.K.,

Clinical Trials

Clinical Trials Trials Pharmaceuticals Pharmaceutical Companies

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. Does your CRO look after your most valuable resources?

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

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

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.] representative population.

FDA

FDA Science Clinical Trials Production

Bristol Myers Squibb Announces Interim Results from Long-Term Study Reinforcing Efficacy and Safety Profile of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis

The Pharma Data

SEPTEMBER 1, 2020

study investigator and Professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and clinical research director, UCSF MS Center. Pregnancy outcomes in the ozanimod multiple sclerosis clinical development program. Author: Minton. Presentation Number: P1133.

Clinical Trials

Clinical Trials Treatment Trials Disease

Drug Discovery Digest

The rising impact of biomarkers in early clinical development

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

Trending Sources

PPD Early Development Services: Accelerating the Clinical Process

Targeting the immunotherapy potential of cytokines IL-12 and IL-18 with new advancements in protein engineering

Keys to Success in Vaccine Development for Special Populations

4 Unique Challenges of Oncology Trials

Poxel Announces Additional Positive Phase 2a Results, and Phase 2b Plan for PXL770, an Oral First-in-Class AMPK Activator, in NASH

Analysis Life Sciences Thank You FDA’s Diversity Action Plan: Questions, answers, and what we (don’t) know so far

Women in STEM with Cristina de Min

BioSpace Global Roundup, Oct. 15

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.

Bristol Myers Squibb Announces Interim Results from Long-Term Study Reinforcing Efficacy and Safety Profile of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis

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