The Premier Consulting Blog

MAY 31, 2023

As a cornerstone of the drug development process, nonclinical investigational new drug (IND)-enabling studies are essential for supporting first-in-human (FIH) dosing for novel therapeutics. Pharmacology A typical IND-enabling package includes information on the primary, secondary, and safety pharmacology of the drug.

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The Premier Consulting Blog

AUGUST 8, 2024

Typically, new drug development under the 505(b)(2) pathway requires less capital and time and has a higher success rate versus the 505(b)(1) pathway, where the Sponsor develops safety and effectiveness information from scratch. For example, pharmacokinetic (PK) data from a comparative BA study and PK modeling approaches (e.g.,

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Drug Target Review

JULY 12, 2023

If there is robust gene expression data for the aspect of a disease that we are aiming to reduce or eliminate, the DCT mechanism will find results that can lead us to promising new drug candidates. Author Bio: Brett Hall Brett has been Chief Scientific Officer at Immuneering since November 2019.

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The Premier Consulting Blog

SEPTEMBER 11, 2024

The 505(b)(2) new drug application (NDA) pathway offers a unique opportunity for small molecule developers to bring innovative products to market more efficiently by leveraging existing data they do not own or have right of reference to. The new formulation resulted in a drug product that was very viscous.

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The Pharma Data

OCTOBER 18, 2020

Several clinical sites are screening patients for the Phase 1 a/b multicenter, open-label, dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the maximum tolerated dose or recommended dose in patients with relapsed or refractory AML.

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The Pharma Data

AUGUST 29, 2020

“These positive Phase II results are promising and pave the way for further evaluation of oral LNP023 as a potential monotherapy treatment and standard of care for PNH,” said John Tsai, Head Global Drug Development and Chief Medical Officer, Novartis. “We Blood 2019;134(Suppl 1):3517. 3. Schubart A, et al. 4. Merle NS, et al.

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New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 12] Positron emission tomography imaging revealed that brain KORs were almost completely saturated by the drug 2.5 Drug Discovery. nM vs. 24.0

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Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

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Alta Sciences

APRIL 24, 2025

Altasciences was chosen by a client for an IND-enabling study of a small-molecule GLP-1 receptor agonist in canines. Such diets can increase body adiposity and leptin, and encourage the development of hypertension and glucose intolerance, leading to conditions of human-like obesity.

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PPD

APRIL 14, 2025

Were applying that expertise and commitment to every aspect of developing and running successful GLP-1 studies. Thermo Fisher delivers everything needed for biologics, small molecule and viral vector manufacturing, all the way through validation and regulatory support.

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Agency IQ

JUNE 9, 2023

BY RACHEL COE, MSC JUN 6, 2023 5:00 PM CDT What are nonclinical studies and when are they conducted in drug development? However, this guideline is primarily intended to provide recommendations on evaluating the immune system’s response to small molecule drugs.

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DrugBank

FEBRUARY 26, 2025

Developing Antimicrobial Peptides and Biomolecules In addition to traditional small-molecule antibiotics, researchers are exploring the potential of antimicrobial peptides (AMPs) and other biomolecules. AMPs disrupt bacterial membranes, making them less susceptible to resistance development.

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The Premier Consulting Blog

APRIL 25, 2023

Opinions regarding how the new act will impact the industry vary, with predictions ranging from everything remaining at the status quo to the end of animal testing for new drug development and approvals. In the US, new small molecule drugs are developed under the requirements of Sections 505(b)(1) and 505(b)(2) of the FFDCA.

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Alta Sciences

SEPTEMBER 27, 2024

Featuring two scenarios that explore the complexities of bioanalysis for immunomodulators, The Altascientist offers practical considerations for ensuring accurate bioanalysis, as well as pharmacokinetic, pharmacodynamic , and safety data in clinical trials. Each class of immunomodulator has a defined complexity and mechanism of action.

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Agency IQ

DECEMBER 11, 2023

In 2015, the FDA, along with the American Association for Cancer Research (AACR), held a workshop on dose optimization for small molecules. Pediatric patients: Likewise, reviewers from OCE have persistently voiced the need for pediatric patients to be included earlier in the drug development process as well.

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Drug Target Review

APRIL 25, 2025

2 Liver CIVMs offer several benefits over conventional in vitro systems including prolonged functional activity, enhanced expression of various drug-metabolising enzymes and transporters, and improved cell-cell and cell-ECM (extracellular matrix) interactions. Drug Discov Today 25 (2020) 17931800. AAPS J 24 (2022).

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