Conversations in Drug Development Trends

APRIL 3, 2024

As with other targeted therapies, radiopharmaceutical development requires unique and specialized strategies to ensure successful execution. Are you aware of the challenges you must address for a successful radiopharmaceutical trial? These include ensuring informed consent, particularly around the risks and benefits of participation.

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Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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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. EMRs give clinical operations teams direct, remote access to an array of patient health information.

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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. He has over 20 years’ experience in biomedical research and pharmaceutical drug discovery. Cell Stem Cell. 2013;13(6):734-44.

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Drug Target Review

DECEMBER 11, 2024

This issue poses a significant hurdle for drug developers, with no universal protocol currently in place to address these complexities. Starting with the right internal standard Selecting the appropriate internal standard (IS) is vital in toxicology, as inaccuracies could obscure toxic metabolites and lead to flawed safety evaluations.

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Codon

NOVEMBER 3, 2024

As an undergraduate biology student, I spent some time in a TB lab working on antibiotic resistance — a growing concern for drug developers. A 1994 review of 14 prospective trials and 12 case-control studies revealed that the BCG vaccine reduced the risk of TB by 50 percent. Subscribe to Asimov Press.

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H1 Blog

SEPTEMBER 26, 2023

Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. A recent McKinsey analysis of drugs and vaccines developed since 2000 shows that it takes nearly ten years to go from clinical testing to approval.

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Vial

MARCH 25, 2024

Introduction Worldwide Clinical Trials vs. Vial. Worldwide Clinical Trials is a mid-size, full-service global contract research organization (CRO) that works with biotech and pharma to advance new medications. With an international presence in nearly 60 countries, Worldwide is supported by over 3,400 team members.

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Conversations in Drug Development Trends

APRIL 4, 2024

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. The ICH M10 guidelines aim to streamline this process, reducing redundancy in drug development and facilitating faster access to new therapies.

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PPD

MARCH 26, 2024

A large majority of drug developers utilize FSP or hybrid FSP/FSO models, half are “heavy users” Heavy users: Those that use FSP or hybrid FSP/FSO models for most of their clinical development outsourcing. Heavy users leverage these models for nearly three-quarters of their outsourcing.

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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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Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions.

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H1 Blog

JULY 19, 2023

Streamlining recruitment and reporting to support advanced oncology drug development In March of 2023, the U.S. In order to qualify for accelerated approval, drug manufacturers must demonstrate that the medication provides meaningful clinical benefit to patients with life-threatening illnesses during their clinical trials.

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Clinical Trials Trials FDA Treatment 52

PPD

MARCH 13, 2024

In every early phase clinical trial, the transportation, chain of custody, environmental monitoring and subsequent analysis of biological samples are the cornerstones of a successful, robust and quality outcome. This significance and focus are ever more apparent when the starting cellular material is imperative to drug product success.

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NIH Director's Blog: Drug Development

OCTOBER 27, 2020

Another promising strategy is drugs that target the proteins within human cells that the virus needs to infect, multiply, and spread. Similarly, COVID-19 patients taking antipsychotic drugs like haloperidol that target SIGMAR1 were half as likely as those taking other types of antipsychotic drugs to require mechanical ventilation.

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Conversations in Drug Development Trends

DECEMBER 12, 2022

Genetic testing provides patients with a diagnosis for their illness, helps patients and family members to understand risks of developing new diseases, and can be used to support clinical trial advancement. Can prior genetic testing results be utilized in a trial, or should a new genetic sample be taken before participating?

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The Pharma Data

OCTOBER 25, 2020

26, 2020 /PRNewswire/ — Gmax Biopharm today announces that the first dose of GMA301 was given to the patient in its phase 1B trial to investigate the drug efficacy to treat pulmonary arterial hypertension (PAH). GMA 301 is the first antibody drug for PAH treatment. Orphan drug designation has been granted by FDA.

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LifeSciVC

JANUARY 16, 2024

The expectation that Pharma will continue buy-ups here is helping to fuel conviction for another strong year ahead for M&A, especially for those acquirers who will rely on inorganic acquisition to build in areas under-represented by internal R&D (e.g., Additional trials (e.g.,

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Agency IQ

APRIL 19, 2024

Meet C3TI, FDA’s new clinical trial innovation hub On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). In particular, regulations in both the U.S.

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DrugBaron

JANUARY 31, 2024

A simple example is called projection, where simple linear combinations of the data are used to extract the internal patterns within very large datasets – tools that were rightly called pattern recognition methods. And pattern recognition is not intelligence.

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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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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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Drug Target Review

JULY 6, 2023

1 Ethical concerns surrounding the use of animal studies is increasing, especially considering 90 percent of drug candidates fail in clinical trials. 2 Therefore, the scientific community is researching and developing efficient ways to test compounds without the use of animals, to avoid unsuccessful outcomes in clinical trials.

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PPD

JUNE 20, 2024

Acceleration in every step of clinical research is critical to pharmaceutical developers. Despite advances in technology and innovation, pharmaceutical leaders say that trials are increasingly complex, particularly when it comes to patient recruitment and site engagement. With a median delay of 12.2

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Vial

MARCH 27, 2024

The Costs of Working with a CRO Running clinical trials is an integral part of the pharmaceutical industry, crucial to the development and approval of new drugs and treatments. However, because these trials come with a significant financial burden, sponsor companies are constantly seeking ways to optimize their operations.

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Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. Vial’s track record includes over 750 completed trials and a network of more than 35 research sites.

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Drug Target Review

JULY 26, 2024

We have a dual aim: to use the power of sequencing for more personalised patient care; and to be able to leverage those datasets to progress various programmes within drug discovery. The second category would be our internal team of researchers. When we think of researchers, we think of at least three different categories.

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The Pharma Data

DECEMBER 14, 2020

15, 2020 /PRNewswire/ — Gmax Biopharm today holds ground-breaking ceremony for its Zhengzhou, China manufacturing site which is the production base for its GMA102 (T2D), GMA105 (obesity), and GMA301A/B (PAH for adult and children) drugs to be launched between 2023-2025, upon approval of respective clinical trials.

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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]. 4] Victoza® significantly reduced the risk of major adverse cardiovascular events in the LEADER Trial.

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PPD

JUNE 17, 2024

With FSO, all clinical trial tasks (study startup, data management, clinical monitoring, pharmacovigilance, regulatory affairs, etc.) Increasingly, sponsors are looking for a hybrid approach that combines FSP and FSO models in a bespoke solution that maximizes clinical trial performance. are outsourced to the CRO.

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Codon

FEBRUARY 13, 2024

A BBC documentary on ‘The Virus that Cures’ was broadcast around the world in 1997, and in the former communist party headquarters in Georgia, American investors helped organize the first major international conference on phage therapy since the 1930s. Still, researchers are trying.

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Drug Target Review

MAY 27, 2024

How does the company see antibody-drug conjugates (ADCs) fitting into this approach? Antibody-drug conjugates have seen explosive growth in the last few years which has materialised with numerous clinical trials demonstrating meaningful improvements in survival.

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FDA Law Blog: Biosimilars

AUGUST 23, 2023

DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites. FDA has made good progress on these initial goals, providing updates on the first four on the Digital Health Technologies (DHTs) for Drug Development website.

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PPD

OCTOBER 2, 2024

Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area.

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The Premier Consulting Blog

JUNE 26, 2023

1 With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant unmet need in oncology. International Agency for Research on Cancer. To schedule a conversation with one of our experts, click here.

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Codon

SEPTEMBER 29, 2024

The average pass rate of phase I trials went up by 5 percent. It wasn’t a silver bullet to the hard problem of drug development, but it wasn’t too far off either. Unlike what many predicted, the rise of computation as a dominant force in drug development did not kill “Big Pharma.”

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Conversations in Drug Development Trends

NOVEMBER 3, 2022

In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. In turn, the FDA’s guidance recognized the difficulty in recruiting for rare diseases and encouraged sponsors to become more resourceful and intentional about trial enrollment.

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