PPD

SEPTEMBER 19, 2023

As the PPD clinical development business of Thermo Fisher Scientific, we have access to integrated, end-to-end clinical trial support and delivery solutions. What differentiates PPD Early Development services from others in this space? organ impairment, CNS and rheumatology), special populations (e.g.

Clinical Trials 98

Clinical Trials Pharmacokinetics Drug Development Clinical Development 98

DrugBank

OCTOBER 17, 2024

By harnessing the vast amounts of data generated throughout the development pipeline, pharmaceutical companies can accelerate the discovery of novel therapies, optimize clinical trial design, enhance drug safety monitoring, and deliver personalized medicine, ultimately improving patient outcomes and transforming the future of healthcare.

Drug Development 71

Drug Development Metabolic Stability Clinical Trials Drugs 71

Broad Institute

JULY 17, 2024

Still, more than 90 percent of drug candidates fail in clinical trials, with even more that never make it to the clinical stage. Together, the tools estimate how a drug may impact diverse outcomes of interest to drug developers: general cellular health, pharmacokinetics, and heart and liver function.

Pharmacokinetics 84

Pharmacokinetics Molecular Biology Drugs FDA 84

The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company.

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

The Pharma Data

DECEMBER 21, 2020

Phase I safety, tolerability, and pharmacokinetic study in healthy volunteers expected to start in coming weeks following acceptance of a request for a Clinical Trial Authorization (CTA) granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA). ALLSCHWIL, Switzerland, Dec.

Clinical Trials 40

Clinical Trials Trials Pharmacokinetics Clinical Development 40

New Drug Approvals

OCTOBER 14, 2024

Avenciguat is under investigation in clinical trial NCT05282121 (A Study to Test Whether BI 685509 Alone or in Combination With Empagliflozin Helps People With Liver Cirrhosis Caused by Viral Hepatitis or Non-alcoholic Steatohepatitis (NASH) Who Have High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver)). .;

Pharmacokinetics 57

Pharmacokinetics Disease Trials Clinical Trials 57

Drug Target Review

NOVEMBER 1, 2023

2 Implication of ATX in a large range of human diseases have been highlighted by both fundamental research and clinical trials. 1-5 Implication of ATX in a large range of human diseases have been highlighted by both fundamental research and clinical trials.

Clinical Trials 134

Clinical Trials Small Molecule Trials Disease 134

The Premier Consulting Blog

MAY 31, 2023

While the type, number, and design of these studies vary based on product-specific characteristics, IND-enabling packages submitted to the FDA generally include key information about the pharmacology, pharmacokinetics, and toxicology of the product. All these studies need to be performed under GLP.

Packaging 52

Packaging Pharmacokinetics Small Molecule Clinical Trials 52

Broad Institute

OCTOBER 29, 2024

Importantly, unlike other MCL1 inhibitors that have raised concerns about cardiovascular side effects in early-stage clinical trials, BRD-810 acts quickly within cancer cells and is eliminated from the body in animal models within a few hours. This rapid clearance minimizes the drug’s potential impact on healthy cells.

Drugs 133

Drugs Small Molecule Pharmacokinetics Clinical Trials 133

Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

Trials 80

Trials Clinical Trials Regulations FDA 80

Alta Sciences

AUGUST 12, 2024

Altasciences has over 25 years of experience in metabolic diseases and supports every stage of the development process, from the initial discovery phase and preclinical studies to clinical trials and beyond. We support data management both at our clinics and at external sites.

Drug Development 40

Drug Development Clinical Trials Pharmacokinetics Drugs 40

Vial

MARCH 15, 2024

The decision to outsource to a CRO is more than a strategic move; outsourcing to a CRO has multiple benefits , including access to streamlined expertise and risk mitigation in clinical trials. Breakdown of CROs Roles Initially, CROs primarily concentrated on overseeing clinical trial site operations and data management.

Clinical Trials 52

Clinical Trials Compliance Trials Laboratories 52

The Pharma Data

DECEMBER 9, 2020

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days.

Clinical Trials 40

Clinical Trials Trials Pharmaceuticals Pharmacokinetics 40

The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. CARMIEL, Israel and BOSTON , Dec.

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

Alta Sciences

OCTOBER 15, 2024

Jason started his career as a research assistant carrying out operational phases of drug metabolism and pharmacokinetic studies. He then became an associate toxicologist providing administrative and scientific support to study directors, and subsequently moved into a project management position overseeing Phase I to III clinical trials.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Drug Development Science 52

Alta Sciences

JUNE 9, 2023

Altasciences has the clinical capabilities to demonstrate the biosimilarity of drug products between Asian and non-Asian populations by comparing the pharmacokinetics of the investigational drug in both ethnic groups, providing a safe strategy to save time and money. Speak with an expert today to discuss your next clinical program.

Drug Development 40

Drug Development Clinical Trials Biosimilars Pharmacokinetics 40

The Pharma Data

DECEMBER 28, 2020

The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. The secondary outcome measure of this Phase 2a trial is to evaluate decreases in non-invasive antifibrotic markers from baseline to the end of the study. ” About Hepion Pharmaceuticals.

Clinical Trials 40

Clinical Trials Trials Pharmaceuticals Treatment 40

The ChEMBL-og

APRIL 16, 2024

See [link] and INN clinical candidate drugs (assigned as max_phase = 2 based on INN guidance that states “As a general guide, the development of a drug should progress up to the point of clinical trials (phase II) before an application is submitted to the INN Secretariat for name selection.” See [link] Pref_name curation.

Clinical Trials 108

Clinical Trials FDA Cell Based Assays Compound Screening 108

Conversations in Drug Development Trends

DECEMBER 20, 2023

In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.” The post Trends in Oncology Study Design, from Optimus to Endpoints appeared first on Worldwide Clinical Trials.

Clinical Trials 83

Clinical Trials Trials Pharmacokinetics FDA 83

PPD

MAY 11, 2023

To effectively implement vaccine clinical trials for special populations, it is critical for vaccine developers to partner with a contract research organization (CRO) that has demonstrated experience recruiting and retaining pediatric and elderly study participants — and managing the nuances these patients and their caregivers require.

Vaccine 52

Vaccine Clinical Trials Long-Term Care Facilities Trials 52

The Pharma Data

AUGUST 28, 2020

Celltrion has already begun trials of the treatment, called CT-P59, in July following their clinical trial authorisation application from the UK’s Medicines and Healthcare products Regulatory Agency.

Trials 52

Trials Treatment Clinical Trials Pharmacokinetics 52

PPD

OCTOBER 12, 2023

There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025. Click to enlarge At several steps during CGT development and testing, sensitive, accurate and precise quantitation of CGT drug vectors is required.

Laboratories 52

Laboratories Protein Expression Clinical Trials Pharmacokinetics 52

Advarra

JUNE 20, 2023

Typical clinical development timelines for anticancer drugs average an estimated 6.7 Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community. Barriers to Enrollment Recent findings indicate significant barriers to enrolling patients remain in clinical trials.

Trials 52

Trials Clinical Trials FDA Approval Therapies 52

New Drug Approvals

DECEMBER 24, 2023

“Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. PMC 10540057. PMID 37768671. Diep, John K.; Yu, Rosie Z.; Viney, Nicholas J.; Schneider, Eugene; Guo, Shuling; Henry, Scott; et al.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology Pharmacokinetics 62

DrugBank

MARCH 7, 2024

Moreover, Novo Nordisk and Eli Lilly are expected to unveil new clinical trial data that could highlight additional health benefits of their drugs beyond weight loss and diabetes management, potentially paving the way for broader insurance coverage.

Pharmaceutical Companies 81

Pharmaceutical Companies Clinical Trials Pharmaceuticals Therapies 81

The Pharma Data

JANUARY 3, 2021

Dr Thais Moreira, the lead scientist and coordinator of the clinical trial, stated: “We are delighted to receive positive feedback from patients treated in the clinical trial. The pharmacokinetics of nasally administered Foralumab will also be evaluated. Dr.

Clinical Trials 40

Clinical Trials Science Treatment Trials 40

Alta Sciences

AUGUST 28, 2023

Altasciences Completes Successful Phase I Trial of Ischemix’ Novel Compound for Treatment of Traumatic Brain Injury (TBI) pmjackson Mon, 08/28/2023 - 14:04 Laval, Québec, August 30, 2023 – Altasciences is pleased to have completed a Phase I trial on Ischemix, Inc.’s Learn more about the company at www.ischemix.com.

Trials 40

Trials Treatment Clinical Pharmacology Pharmacokinetics 40

The Premier Consulting Blog

APRIL 15, 2024

From a business standpoint, these studies are critical for obtaining funding and being reassured that the drug will show promise once it enters the clinic. However, when it comes to an IND and supporting a clinical trial, FDA’s primary focus is on healthy volunteer and patient safety.

FDA 52

FDA Pharmacokinetics Laboratories FDA Approval 52

Alta Sciences

JANUARY 31, 2024

Pharmacokinetics, Pharmacodynamics and Toxicokinetics Demystified pmjackson Wed, 01/31/2024 - 14:55 Understanding the effects of a drug, and how it interacts with the body, and vice versa, is critical to ensure it is safe for human use. This is where pharmacokinetic (PK), pharmacodynamic (PD) , and toxicokinetic (TK) analyses step in.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Drug Development Trials 52

Drug Target Review

JULY 1, 2024

Overall, SRP-001’s modulation of pain signalling genes and pathways through endocannabinoid enhancement and FAAH inhibition supports its potential as an effective non-opioid pain therapeutic, validating the planned clinical trials. It addresses both acute and chronic pain, avoiding the addiction risks associated with opioids.

Treatment 59

Treatment Clinical Trials Therapies Molecular Biology 59

The Pharma Data

APRIL 11, 2023

Bayer will present the first clinical Phase 1 results on aryl hydrocarbon receptor (AhR) inhibitor BAY 2416964, the company’s most advanced Immuno-Oncology program. These results, along with a mathematical model-informed approach have supported the currently ongoing dose expansion for BAY 2416964.

Research 40

Research Clinical Trials Small Molecule Trials 40

Drug Target Review

JUNE 12, 2023

With 13 preclinical candidates and three AI-designed drugs currently undergoing clinical trials, Insilico is spearheading a revolution in cancer treatment and beyond. What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties?

Metabolic Stability 92

Metabolic Stability Clinical Trials Small Molecule Pharmacokinetics 92

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. For more on FDORA’s other provisions, see HPM’s complete summary here ). 42 U.S.C. §

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays FDA 64

The Pharma Data

MARCH 5, 2021

” In addition to the Phase 1/2 BRUIN clinical trial, Loxo Oncology at Lilly plans to initiate four global, randomized Phase 3 studies for pirtobrutinib in 2021, three in CLL and one in MCL. About the BRUIN Phase 1/2 Trial. Key secondary objectives include measures of safety, pharmacokinetics, and anti-tumor activity (i.e.

Clinical Trials 52

Clinical Trials Pharmacokinetics Trials Therapies 52

Drug Target Review

SEPTEMBER 19, 2023

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. The organoid technology recreates different disease scenarios in addition to the healthy models with age specific phenotypes and enables recreating drug specific Pharmacokinetics that is more relevant to human in vivo system.

Animal Testing 98

Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

Drug Target Review

JUNE 6, 2023

However, the protein’s preclinical promise has not yet been replicated in clinical trials, where systemic administration is associated with dose-limiting toxicities and a narrow therapeutic index. Some approaches have already reached the clinical trial stage, with others not far behind.

Engineering 98

Engineering Immune Response Biochemical Pharmacology Clinical Trials 98

Agency IQ

DECEMBER 1, 2023

Furthermore, the guidance offered a list of updated clinical outcome measures and offered insight on FDA’s evolving view of decentralized clinical trials and the use of real-world data to supplement trials. The FDA has streamlined its recommendations for sponsors enrolling patients in clinical trials.

FDA 40

FDA Clinical Trials Vaccine Trials 40