Alta Sciences

JULY 22, 2024

Insights in FIH studies provide valuable information on potential dosing, efficacy, and safety, and serve as a good guide for the regulatory requirements needed throughout clinical development. jpg Tags Clinical Trials Weight 1

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Conversations in Drug Development Trends

JUNE 13, 2024

At Worldwide, Matt Cooper and Jim Eamma , our Executive Directors, Therapeutic Strategy Leads in Oncology, shed light on the intricacies of modern oncology trials in their recent webinar, “ Navigating the Landscape of Complex & Adaptive Oncology Trials.” How Does Project Optimus Impact Your Study’s Operations?

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Trials Clinical Trials Drug Development Clinical Development 52

Fierce BioTech

DECEMBER 23, 2024

First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.), and often require consistent batches of drug product be administered to groups of research participants within a short timeframe, early phase studies present unique challenges for drug developers not typically experienced in later stages of development.

Pharmacy 52

Pharmacy Trials Clinical Trials Clinical Development 52

Conversations in Drug Development Trends

FEBRUARY 22, 2023

Our rare disease team at Worldwide will be hosting a panel discussion webinar with patient advocates active in Rare Disease Day events to synthesize the most salient conversations taking place. See their conversation below and register for the webinar to hear more from these advocates! So, I decided to pivot.

Disease 52

Disease Clinical Trials Trials Treatment 52

Fierce BioTech

APRIL 10, 2024

Redefining Antibody Specificity Profiling for IND swheeler Wed, 04/10/2024 - 17:56 Thu, 06/06/2024 - 11:00 Resource Type Webinar Kris Raghavan, PhD Fernanda I. Staquicini, PhD Duration 60 minutes Assessment of antibody off-target reactivity is a regulatory requirement for clinical development. So, what are the alternatives?

Clinical Development 52

Clinical Development FDA Drug Development Drugs 52

PPD

OCTOBER 16, 2023

This enables deeper and more meaningful real-world insights on clinical study data. Tokenization can accelerate innovation in clinical trials and drug development. Once in the data lake, tokenized data can be linked using a special linking software based on the data usage agreements to create longitudinal patient data.

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Clinical Trials Trials Research Therapies 98

Conversations in Drug Development Trends

MAY 1, 2024

The clinical trials sector prompted a recent modernization of ICH E8 and a subsequent renovation of ICH E6 to provide updated guidance that is appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources employed to support regulatory and other health policy decisions.

Clinical Research 69

Clinical Research Trials Clinical Trials Research 69

Cytel

APRIL 3, 2024

Thank you to Charlotta Gauffin, Chief Scientific Officer at Dicot, for joining us for our recent webinar, “The Road to First-in-Human Trials: Insights from a Real-World Example.” Thoughtfully and carefully planned nonclinical studies help pave a smooth path toward first-in-human Phase 1 clinical trials.

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Clinical Trials Drugs Trials Drug Development 59

Alta Sciences

MARCH 21, 2024

Watch Now The Altascientist: Central Nervous System Early-phase development of CNS-acting drugs is a complex, challenging undertaking. Watch Now The Altascientist: Central Nervous System Early-phase development of CNS-acting drugs is a complex, challenging undertaking.

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Clinical Trials Trials Drug Development FDA 40

The Pharma Data

DECEMBER 15, 2020

Company plans to meet with regulatory authorities as it evaluates next development steps. Company to host Key Opinion Leader (KOL) webinar to discuss these results today, December 16, at 8:00 am EST; registration link below. Interested parties can register for the webinar here. Kenilworth, N.J. ,

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Clinical Trials Trials Treatment Therapies 40

Agency IQ

APRIL 12, 2024

In drug development, biochemical assays might be used to determine a product’s binding affinity to a target receptor of interest, along with the strength, stability and duration of the target-ligand complex after the product binds to the receptor. What does progressive implementation of a potency assurance strategy mean?

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Production FDA Therapies Biochemical Assays 40

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.

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Clinical Trials Trials Clinical Development Disease 52

Agency IQ

AUGUST 2, 2024

While ASTP/ONC’s work is likely to be higher-level than FDA’s, the strategic plan on AI could, depending on its development, roll down to FDA policy. The HHS announcement also comes with a note that the Department will be hosting a webinar about federal workforce opportunities in this area.

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