Drug Target Review

APRIL 7, 2025

In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drug developers for phase I trials, second only to navigating regulatory compliance (- 38 percent).

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PPD

SEPTEMBER 6, 2023

Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster. LEARN HOW The post How to Optimize Drug Development by Combining FSO and FSP Models appeared first on PPD Inc.

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Drug Target Review

JANUARY 14, 2025

Drug discovery scientists spend their days developing and testing complex hypotheses, leveraging data and expertise through workflows that utilise available tools. Defining the research question A well-defined research question is the cornerstone of an effective scientific workflow in drug discovery.

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PPD

OCTOBER 21, 2024

Meeting the never-ending challenges of drug development in this active environment — including pressure to identify drug prospects earlier and hire more conservatively — frequently leads biotech companies to outsource some portion of clinical development functions.

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FDA Law Blog: Drug Discovery

APRIL 21, 2025

One area drawing increasing attention is how these changes will affect the drug development and review process. As reported by the Wall Street Journal last week , reviews of both innovative and follow-on drugs have been caught in a traffic jam, largely due to a leadership vacuum at the Center for Drug Evaluation and Research (CDER).

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The Premier Consulting Blog

APRIL 13, 2025

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ One great example is the FDAs 505(b)(2) New Drug Application (NDA) pathway. Legislation with delayed implementation In 2021, the FDA Modernization Act 2.0

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Drug Target Review

DECEMBER 6, 2024

In drug discovery and biological research, the scientists workflow often follows a structured and iterative approach to ensure accuracy, reproducibility and scientific integrity. Figure 1: High-level workflow for early drug discovery Once the raw data has been gathered, the next step is to gain a thorough understanding of the data.

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Drug Target Review

DECEMBER 11, 2024

This shift in focus is especially critical in toxicology, where accurate target analysis plays a vital role in identifying toxic effects and ensuring patient safety, particularly as the field transitions from traditional drugs to the promising realm of biotherapeutics, especially for rare diseases.

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Drug Target Review

OCTOBER 30, 2024

Now take a step further: envision testing drugs in these organoids to identify the ones that can treat disease safely and effectively without needing to run expensive clinical trials first. 12 Testing drugs in vitro in organoid cultures A clear validation of the utility of organoids is in drug discovery and development.

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SCIENMAG: Medicine & Health

MARCH 26, 2024

Credit: Redox Medicine […]

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DrugBank

MAY 15, 2024

The road to developing effective drugs is fraught with both promise and challenge, particularly when it comes to what scientists call "undruggable" targets. The Evolution of Drug Discovery: From Dark Rooms to Precision Targets In the past, drug discovery often felt like a lucky guess.

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Alta Sciences

MARCH 4, 2025

The CCALC is a grassroots organization that was founded by several pharmaceutical industry members seeking clarity around the conduct of abuse and dependence potential assessments for novel drugs in development. I have spent the better part of my career working to make drugs safer.

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Quanticate

JULY 5, 2024

It’s essential for maintaining ethical standards, high-quality outcomes and facilitating global standardisation, enabling multi-center and multinational studies, thereby streamlining the development and approval process for new medical treatments, and maintaining public trust in clinical research.

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DS in Pharmatics

APRIL 25, 2025

Navigating the complexities of drug development demands more than internal resources. From overcoming technical hurdles and avoiding costly or inappropriate development paths to meeting regulatory standards, every stagediscovery to marketpresents unique challenges.

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Production Drugs International Drug Development 52

NIH Director's Blog: Drug Development

OCTOBER 27, 2020

Science, 2020 One way to fight COVID-19 is with drugs that directly target SARS-CoV-2, the novel coronavirus that causes the disease. That’s the strategy employed by remdesivir , the only antiviral drug currently authorized by the U.S. Food and Drug Administration to treat COVID-19. Credit: DE Gordon et al.,

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Alta Sciences

AUGUST 21, 2024

Internships at Altasciences: Q&A With Our Summer Interns nbartlett Thu, 08/22/2024 - 04:44 Internships at Altasciences are more than just a stepping stone—they’re a gateway to real-world-experience and professional growth, giving the next generation opportunities to help shape progress in the drug development industry.

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Drug Target Review

SEPTEMBER 26, 2023

These cells demonstrate considerable promise for uncovering drug-induced perturbations to neuronal function such as seizure, and their use extends further to sedation, anti-epileptic drug discovery and modelling of neurological diseases.

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PPD

MARCH 26, 2024

The PPD clinical research business of Thermo Fisher Scientific conducts an annual survey of more than 150 leaders at pharmaceutical companies around the globe to assess trends in drug discovery and development, including preferences around outsourcing and functional service provider (FSP) utilization. Substantial global capabilities.

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The Pharma Data

NOVEMBER 9, 2020

Dr. Löbenberg holds Health Canada licences for research and analytical testing of a wide range of psychedelic compounds under the Controlled Drugs and Substance Act and research and analytical testing licences for cannabis under the Cannabis Act. . DMT (N,N-dimethyltryptamine). Prof. Dr. Löbenberg. ” Prof.

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DrugBaron

JANUARY 31, 2024

Both the cost and the time required for each new drug approval have increased exponentially for decades (aptly tagged ‘Eroom’s Law’, being the inverse of price drops and speed gains in the semiconductor industry). There is, of course, no evidence of whether the claims made for AI in discovery and development are hype or reality.

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Drug Target Review

JULY 13, 2023

Drug discovery is a complex and vital field that continually seeks to identify new therapeutic targets and develop effective treatments. In recent years, a novel approach known as condensate biology has emerged, revolutionising the way researchers think about drug discovery and development.

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Conversations in Drug Development Trends

APRIL 4, 2024

Developing pharmaceuticals is a complex process, requiring stringent bioanalytical method validation guidelines to ensure drug safety and efficacy. To help integrate these various regulatory standards, the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use was founded in 2016.

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LifeSciVC

APRIL 17, 2025

By Aimee Raleigh, Principal at Atlas Venture, as part of the From The Trenches feature of LifeSciVC Drug discovery and development is a long, and often fraught, journey it typically takes more than a decade to progress from idea to approved drug, and less than 10% of drugs that enter the clinic succeed in achieving commercialization.

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DrugBank

JANUARY 15, 2025

Introduction Orphan drugs, specifically developed to treat rare diseases, represent a unique and challenging pharmaceutical industry segment.   The Orphan Drug Paradox Orphan drug development is often described as a "high-risk, high-reward" endeavor.

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Drug Target Review

NOVEMBER 15, 2023

Drug discovery is an interdisciplinary process that relies heavily on expert input from diverse and multifaceted teams, from medicinal, synthetic, and computational chemists to biologists and drug metabolism and pharmacokinetics (DMPK) scientists.

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Drug Target Review

MARCH 17, 2025

Advancing drug candidates across key therapeutic areas Dr John Donello brings over 25 years of experience in pharmaceutical drug discovery, development and collaborations. “The classic paradigm with todays psychiatry drugs involves patients chronically taking a daily medication,” says Donello.

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The Pharma Data

DECEMBER 11, 2020

Microsoft is calling on the world’s leaders to affirm that international law protects healthcare facilities and to take action to enforce the law,” the company said. “We Most of the attacks were thwarted by security protections, Microsoft said, but governments should step up to help combat the hackers.

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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]. In fact, the evidence suggests that such drugs might even offer some protection against heart disease.

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Drug Target Review

AUGUST 9, 2024

What is drug formulation? Drug formulation is the process of designing and producing a final medicinal product from an active pharmaceutical ingredient (API). 1 The goal is to create a dosage form that delivers the drug effectively to the intended site of action with optimal patient benefit and a good commercial value.

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LifeSciVC

OCTOBER 5, 2023

An oft-cited motive for biotech peers leaving their current roles is the aspiration to re-engage in the genuine work of scientific innovation and drug development, evading the trappings of bureaucracy in larger organizations. Reflecting on my seven-year journey at Synlogic, I’m reminded of our nascent days in drug development.

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PPD

JUNE 7, 2023

Food and Drug Administration (FDA) for approval , much work remains for drug developers aiming to advance treatments for pediatric populations. As drug developers seek approval for new NASH therapeutics, the developers must also prepare related pediatric investigational plans.

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New Drug Approvals

APRIL 2, 2025

1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] 2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2] Suzetrigine is taken by mouth. [1] ESI-MS m/z calc.475.0922,

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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. This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938.

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PPD

MARCH 13, 2024

This significance and focus are ever more apparent when the starting cellular material is imperative to drug product success. The role of the clinical logistics monitor (CLM) is a focal point of contact and an escalation point to the internal and external teams.

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PPD

FEBRUARY 10, 2025

Sponsors find that an FSP solution is often the best choice to help advance their drug development projects, whether they need to fill small gaps in services or support large-scale programs with dedicated teams across functions.

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Clinical Trials Trials Clinical Research Research 52

FDA Law Blog: Biosimilars

AUGUST 23, 2023

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

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Drug Target Review

SEPTEMBER 19, 2024

Could you give us an overview of IRLAB’s current drug development pipeline? The pipeline currently includes five drug candidates, all of which have the potential to revolutionise the treatment of PD.

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