LifeSciVC

APRIL 2, 2024

By Mike Cloonan, CEO of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC An insightful piece on this blog following the JPM healthcare conference noted the “ refreshing burst of enthusiasm ” in the biotech sector. And many are looking for the right investments now.

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LifeSciVC

APRIL 24, 2024

There is a continuum of evidence for a given target – at one end are novel targets with some evidence of importance in disease, and at the other end are “de-risked” targets where the biology is precedented with an approved product or late-stage clinical asset(s). based on “tool” molecule precedent.

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The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.

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Alta Sciences

OCTOBER 30, 2023

Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drug development comes with its own set of clinical development requirements. Read the blog. Watch the video. Read the fact sheet.

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The Premier Consulting Blog

NOVEMBER 20, 2023

Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. billion each year.

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DS in Pharmatics

JANUARY 7, 2023

Multiple other products are in clinical development for solid tumors, genetic deficiencies, and infections that promise more effective […] Cell and gene therapies for treating multiple myeloma, such as CAR-T, have resulted in breakthrough health outcomes for patients.

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Metabolite Tales Blog

JANUARY 26, 2023

Nonetheless, there are some interesting facets to discover, a selection of which we take a look at in a two-part blog on “Metabolism of 2022 FDA approved small molecule drugs.” link] Take a look at our other blogs The post Metabolism of 2022 FDA approved small molecule drugs PART 1 appeared first on Hypha Discovery.

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Labcorp Drug Development

FEBRUARY 3, 2023

Welcome to the February 2023 Labcorp Drug Development Decentralized Clinical Trial (DCT) blog. With Rare Disease Day coming soon on February 28, we are going to focus on how patients, sites and investigators can benefit by improving the design and execution of rare disease trials. What is Rare Disease Day?

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Metabolite Tales Blog

APRIL 4, 2023

In this follow-up blog, “Metabolism of 2022 FDA approved small molecule drugs part 2”, we dig into the other drugs in this set that are cleared by multiple CYPs, mixed phase mechanisms and through involvement of gut metabolism (see Table 1 at the end of this blog). Dermavant’s tapinarof is one such friend.

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FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023.

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The Premier Consulting Blog

JULY 9, 2023

Formally, both of these documents apply solely to marketing approval; informally, however, they are often used as general guidelines during clinical development to avoid obstacles that could result in extensive process changes, product reformulation, or safety qualification efforts. evaluating the safety of) impurities and degradants.

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PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. 2021 [cited 16 December 2021].

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PPD

DECEMBER 14, 2023

In this blog, we’ll explore the benefits associated with employing global resources across time zones for FSP engagements and how PPD ® FSP solutions utilize different regions to drive more efficient clinical development operations.

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H1 Blog

JUNE 7, 2023

Performance data on principal investigators and clinical trial sites provides invaluable insights to pharma companies, helping them leverage successful sites and patient populations to maximize their clinical development feasibility and operations. There is a tendency to want to measure everything.”

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PerkinElmer

MAY 6, 2022

The team concluded: “ExoSTING represents a novel strategy to harness and improve upon natural immune surveillance in the TME and may overcome many of the observed limitations with dose selection of free CDNs, which are currently in the early stages of clinical development.” Commun Biol 4, 497 (2021).

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PPD

MAY 7, 2024

However, it also presents challenges and uncertainties, particularly in relation to the Population, Intervention, Comparator(s) and Outcomes (PICO) framework underpinning the new Joint Clinical Assessments (JCAs). Early scientific advice, either formal or informal, can shape pivotal study design early in the development process.

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Metabolite Tales Blog

OCTOBER 10, 2024

Icenticaftor is a potentiator of the CTFR protein and it is currently in clinical development for treatment of COPD and chronic bronchitis. Major circulating glucuronides of icenticaftor This paper from scientists at Novartis describes the human ADME characteristics of icenticaftor and its major circulating glucuronides.

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LifeSciVC

MARCH 8, 2024

But out of those dark days there can be unicorns (see Nimbus and Jeb’s recent blog post; congrats again to Jeb and the Nimbus team). Once you are public, the dynamic changes significantly yet again and that could certainly be whole blog post on its own that more experienced public operators could do better than myself.

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Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues. Asia, and Europe.

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Molecular Design

JUNE 8, 2023

As the start of the post, I did mention some errors that you don’t want to be making if cheminformatics is your day job and regular readers of this blog will have already guessed that I’m talking about ligand efficiency (LE).

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NIH Director's Blog: Drug Development

SEPTEMBER 26, 2019

2] Clinical development success rates for investigational drugs. McAleer CW, Long CJ, Elbrecht D, Sasserath T, Bridges LR, Rumsey JW, Martin C, Schnepper M, Wang Y, Schuler F, Roth AB, Funk C, Shuler ML, Hickman JJ. Sci Transl Med. 2019 Jun 19;11(497). [2] Hay M, Thomas DW, Craighead JL, Economides C, Rosenthal J. Nat Biotechnol.

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Metabolite Tales Blog

NOVEMBER 17, 2022

Roquinimex (Linomide), a drug developed by Pfizer for the treatment of multiple sclerosis, is structurally related to laquinimod. Figure 3: Roquinimex (linomide) Clinical development of both laquinimod and roquinimex was halted due to serious cardiovascular events. This was unexpected.

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New Drug Approvals

JANUARY 3, 2023

1] It is being developed by Mirati Therapeutics. [1] Identification of the Clinical Development Candidate MRTX849, a Covalent KRASG12C Inhibitor for the Treatment of Cancer.” 1] [2] Adagrasib is an inhibitor of the RAS GTPase family. [1] 1] It is taken by mouth. [1] 1] [3] Synthesis Reference Fell, Jay B et al. 10 (1): 54–71.

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Metabolite Tales Blog

DECEMBER 19, 2023

In nonclinical development, >70% use qualified bioanalysis (BA) methods for non-GLP quantification of metabolite(s), and >80% agreed that a fully validated BA method should be implemented for quantification of active metabolite(s) for compliance when supporting GLP toxicity studies.

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Metabolite Tales Blog

JULY 5, 2023

With metabolic stability in mind, we take a look at the metabolism of some FDA approved synthetic macrocyclic drugs, and a few of those that were/are in clinical development where metabolism data was available. link] Take a look at our other blogs The post Metabolism of macrocyclic drugs appeared first on Hypha Discovery.

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Metabolite Tales Blog

JULY 5, 2023

With metabolic stability in mind, we take a look at the metabolism of some FDA approved synthetic macrocyclic drugs, and a few of those that were/are in clinical development where metabolism data was available. Clin Cancer Res 27 (12): 3298–3306.

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The Premier Consulting Blog

OCTOBER 11, 2022

However, acceptance of that data depends on a sponsor’s understanding of the FDA criteria for historical control groups, study data standards, and clinical meaningfulness. In this article, we review two case studies involving the successful use of RWD or RWE in advancing the clinical development of treatments for rare diseases.

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Molecule Blog

MARCH 17, 2023

Clinical development kicks off when the company files an IND with the FDA , progressing through Phase I for safety, Phase II for early signs of efficacy, and Phase III for determining full approval. To learn more about BioDAOs, check out bio.xyz and the BioDAO Bible.

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The Premier Consulting Blog

OCTOBER 21, 2024

The 2022 FDORA Omnibus Act, enacted on December 29, 2022, further solidified this shift by making confirmatory trials a key component of the clinical development plan, contrasting with earlier practices where they were often a post-approval requirement.

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New Drug Approvals

AUGUST 27, 2023

BTK, a member of the Src-related BTK/Tec family of cytoplasmic tyrosine kinases, is overexpressed in B-cell malignancies; it plays an important role in B-lymphocyte development, activation, signaling, proliferation and survival. Evobrutinib is in clinical development to investigate its potential as a treatment for multiple sclerosis (MS).

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FDA Law Blog: Drug Discovery

OCTOBER 2, 2023

Several of these approvals, including examples in which we were directly involved—Relyvrio for ALS and Skyclarys for Friedreich’s Ataxia—expanded upon the examples FDA previously provided to illustrate their interpretation of the single study plus confirmatory evidence statutory standard (see our earlier blog posts here and here ).

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NIH Director's Blog: Drug Development

SEPTEMBER 29, 2015

References : [1] Clinical development success rates for investigational drugs. The ultimate goal is an integrated “human-on-a-chip,” which can be used to test the effects of drugs or other chemicals before any testing in humans. Hay M, Thomas DW, Craighead JL, Economides C, Rosenthal J. Nat Biotechnol. 2014 Jan;32(1):40-51. [2]

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FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

These meetings have a question-and-answer format to provide clarity to sponsors about the particular topics at hand.

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NIH Director's Blog: Drug Development

JUNE 14, 2016

5] Clinical development success rates for investigational drugs. 2012 Jul 6;337(6090):100-104. [4] 4] Victoza® significantly reduced the risk of major adverse cardiovascular events in the LEADER Trial. Novo Nordisk. 2016 March 4. [5] Hay M, Thomas DW, Craighead JL, Economides C, Rosenthal J. Nat Biotechnol. 2014 Jan;32(1):40-51.

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The Premier Consulting Blog

OCTOBER 26, 2022

Clinical development As product development moves from the initial first-in-human trials to more advanced clinical stages, information pertaining to the process should also be increasing.

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Metabolite Tales Blog

JANUARY 23, 2024

Pharmacokinetics and Disposition of Momelotinib Revealed a Disproportionate Human Metabolite—Resolution for Clinical Development. [link] [10] FDA prescribing information for gepirone. link] [11] Zheng et al., Drug Metabolism and Disposition 46 (3), 237-247; DOI: [link] [12] Asshoff et al.,

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The Premier Consulting Blog

MARCH 7, 2024

As the gene therapy product progresses through clinical development, the health authority expectation will be a potency assay (typically cell-based) that is reflective of the product’s mechanism of action. Depending on the nature of the product, bioassays can be run as proliferation assays, cytotoxicity assays or signaling assays.

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