FDA Law Blog: Drug Discovery

MARCH 7, 2024

Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post. DMC charters have also grown longer and more detailed.

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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. Sci Rep 9, 18911 (2019). 2021 [cited 16 December 2021].

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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. Listen here. The Altascientist : Issue No.

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NIH Director's Blog: Drug Development

SEPTEMBER 26, 2019

As BOCs are put to work in testing new drug candidates and especially treatment combinations, the hope is that we can do a better job of predicting early on which chemical compounds will prove safe and effective in humans. For those drug candidates that are ultimately doomed, “failing early” is key to reducing drug development costs.

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Conversations in Drug Development Trends

MAY 30, 2024

This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. The shared placebo design is another approach to accelerating drug development in ALS research.

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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. Other Questions.

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Metabolite Tales Blog

DECEMBER 19, 2023

Metabolite Bioanalysis in Drug Development: Recommendations from the IQ Consortium Metabolite Bioanalysis Working Group A Metabolite Bioanalysis Working Group comprised of experts from 14 different pharma companies have proposed recommendations around best practice in metabolite bioanalysis during drug development.

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FDA Law Blog: Drug Discovery

JUNE 12, 2024

We are looking forward to seeing the START pilot program chart a path for a broader application of this more enhanced communication approach and FDA’s continued collaboration to facilitate development of new drugs for rare diseases, as we know there are many programs that would benefit from this approach, not just those included in the pilot.

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FDA Law Blog: Drug Discovery

OCTOBER 2, 2023

Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. In the December 2019 Guidance, FDA writes that the clinical context for a disease (i.e.,

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The Premier Consulting Blog

JULY 9, 2023

(Degradants are impurities arising from the degradation of the drug substance or a reaction with an excipient and/or the immediate container.) What sets this guidance apart from ICH Q3A and ICH Q3B is that it applies to all stages of clinical development, not just to approval. evaluating the safety of) impurities and degradants.

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NIH Director's Blog: Drug Development

JUNE 14, 2016

Several years ago, the Food and Drug Administration (FDA) recommended that drug developers take special care to show that potential drugs to treat diabetes don’t adversely affect the cardiovascular system [1]. 5] Clinical development success rates for investigational drugs. Novo Nordisk.

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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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NIH Director's Blog: Drug Development

SEPTEMBER 29, 2015

While these neural constructs appear to have a bright future in drug development, they also hold great promise for evaluating the neurotoxicity of non-pharmacologic chemicals and for understanding the processes associated with normal and abnormal brain development. Hay M, Thomas DW, Craighead JL, Economides C, Rosenthal J.

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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. In a 2021 publication, Rothhammer et al.

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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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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. Unlike investment DAOs, BioDAOs generate returns to finance R&D rather than distribute profits to stakeholders.

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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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The Premier Consulting Blog

OCTOBER 26, 2022

The MPD is best created and controlled by a sponsor, rather than by a contract development and manufacturing organization (CDMO) assigned to perform the process and assay development.

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FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

In our experience with INTERACT meetings prior to their formalization as part of PDUFA, these meetings were often limited to very early development where there were novel CMC/manufacturing issues.

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PPD

NOVEMBER 8, 2022

As 2022 comes to a close, we’re reflecting on the past 12 months as a transformative year for the drug development industry — one that foreshadows both change and opportunity in biopharma and biotech clinical trials in 2023. Six Predictions for the Drug Development Industry in 2023 1.

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FDA Law Blog: Drug Discovery

JULY 9, 2024

FDA issued its draft guidance titled “ Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies ,” (the “Draft Guidance”) which replaces the previous pre-FDORA April 2022 draft guidance of the same name.

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PPD

JANUARY 2, 2025

Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. This blog explores the value of functional service provider (FSP) models and how they help biotech companies augment their clinical development needs.

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Agency IQ

AUGUST 2, 2024

Troy Tazbaz (Director, DHCoE) and DHCoE Digital Health Specialist JOHN NICOL published a blog post in late July 2024 that potentially previews the contents of that guidance – the post is entitled “A Lifecycle Management Approach toward Delivering Safe, Effective AI-enabled Health Care.”

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The Premier Consulting Blog

FEBRUARY 11, 2025

Identifying a safe and effective dose for registrational trials is one of the most critical and complex aspects of early-stage drug development for rare diseases. Traditionally, early drug development focuses on ensuring the safety of clinical doses, with regulatory authorities prioritizing patient protection.

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FDA Law Blog: Drug Discovery

DECEMBER 15, 2024

This is even more so in rare disease CGT programs where clinical development can be more streamlined, so CMC product development is expected to happen at a more rapid rate. It is important that sponsors do not miss an opportunity to engage with CBER on CMC topics.

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

All the while, this efficiency in clinical development requires accelerating CMC by having early-stage studies serve as large stage studies. However, as we noted above, the CMC topics covered in this draft guidance will be covered in Part 2 of this blog coverage.

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