Alta Sciences

JULY 22, 2024

Insights in FIH studies provide valuable information on potential dosing, efficacy, and safety, and serve as a good guide for the regulatory requirements needed throughout clinical development. jpg Tags Clinical Trials Weight 1

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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. Reflecting Patient Diversity in NASH Trials Data from NASH clinical trials within adult populations may support clinical research into treatment for pediatric populations.

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Agency IQ

FEBRUARY 12, 2024

The consortium is funded by a public-private partnership called the Accelerating Medicines Partnership (AMP) , through which the Foundation for the NIH (FNIH) administers funds provided by industry, government, and nonprofits to scientists working on applicable basic or clinical research to advance gene therapy development for rare diseases.

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Conversations in Drug Development Trends

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. In recognition of the unmet need and medical urgency for innovative therapies in the sickle cell space, the FDA granted exa-cel Priority Review, with a formal decision expected by December 8, 2023.

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Conversations in Drug Development Trends

MARCH 7, 2024

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. In fact, multiple countries within the EU offer incentives to those programs operating under a CTA.

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PPD

NOVEMBER 30, 2023

As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drug development shaped the pharma and biotech industries. These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. Five Predictions for the Drug Development Industry in 2024 1.

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Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. FDA has been holding bi-monthly “Town Hall” meetings to prepare.

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Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Vial

FEBRUARY 8, 2024

To advance new therapies, pharmaceutical, biotech, and medical device companies engage contract research organizations (CROs) for their know-how in navigating the complex landscape of drug development and regulatory pathways and to run clinical trials. At the same time, regulatory bodies like the U.S.

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Conversations in Drug Development Trends

FEBRUARY 26, 2024

With the necessary prioritization of various factors when designing your clinical trial, the patient experience can be overlooked or improperly addressed in study design. However, incorporating the patient experience into your design is one of the best ways to ensure your drug development program is a commercial success.

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Alta Sciences

DECEMBER 14, 2023

. - Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. Exceptional inspection results from major regulators such as the FDA, HC, EMA, and MHRA. Our CDMO team offers formulation development and manufacturing of your API, from discovery through commercialization.

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Quanticate

SEPTEMBER 2, 2024

Clinical research serves as the foundation for advancing medical knowledge, improving patient care, and ensuring the safety and efficacy of new investigational products.

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PPD

NOVEMBER 7, 2023

The underrepresentation of diverse groups in clinical research is an area of regulatory, scientific and industry focus, partly due to the recent U.S. Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.”

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Conversations in Drug Development Trends

AUGUST 9, 2024

Advantages and Operational Challenges in Adaptive MRCTs Adaptive trial designs are gaining popularity in clinical research due to their ability to improve trial efficiency and uphold ethical standards, resulting in faster and more reliable outcomes. These include: FDA (U.S.)

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Alta Sciences

JULY 18, 2023

Menodza share essential approaches and techniques to help you accurately administer drugs to an organ of interest. Top Clinical Scientific Resources The Altascientist Issue 31: The Advantages of Conducting Early Phase Clinical Research in Canada Is conducting early phase clinical studies in Canada the right solution for you?

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thought leadership

AUGUST 14, 2023

In the drug development process, the Investigational New Drug (IND) application holds immense significance for biotech startups. It serves as a comprehensive overview submitted to the US Food and Drug Administration (FDA), outlining the drug and the upcoming clinical trials for evaluating its safety and efficacy.

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Crown Bioscience

MAY 4, 2021

Among the 180+ cancer drugs approved by the FDA since 1995, only 14 have been approved for pediatric use, with another 26 used off-label (i.e. used in a way that is not described in the license), and only three drugs have been approved exclusively for use in children.

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The Premier Consulting Blog

APRIL 18, 2024

This blog will outline three characteristics of a successful nonclinical program to support entry into clinical trials for a cell or gene therapy product. Can you identify a safe AND efficacious clinical dose? As in all nonclinical drug development programs, the goal is to identify potential safety issues in humans.

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Vial

MAY 13, 2024

Introduction The biopharma industry is poised to make revolutionary advances in and redefine drug development, and the current climate for innovation appears ideal. An estimated 80% of clinical trials do not finish on time. What are CROs doing to deliver for sponsors?

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The Pharma Data

DECEMBER 15, 2020

It is funded by the world’s leading charities dedicated to diabetes research, JDRF, and Diabetes UK, guided by both organizations’ strong commitment to facilitate deep interrogation of consolidated community-wide trial data as a means to accelerate clinical research and therapeutic development for T1D.

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Vial

FEBRUARY 15, 2024

Sponsors often contract a CRO to delegate specific day-to-day tasks, streamlining their research processes and enhancing efficiency. Patient recruitment and retention : Recruiting and retaining a sufficient number of eligible participants is one of the major challenges in conducting clinical trials.

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H1 Blog

SEPTEMBER 14, 2023

As pharmaceutical companies turn to CROs (Clinical Research Organizations) for trial design and technology, there are new opportunities emerging with healthcare data intelligence that can help ensure a bright future for the industry and to make trials more effective, efficient and accessible. million data points.”

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Conversations in Drug Development Trends

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. However, patients also play a vital role in engaging directly with the FDA. It also means sponsors are less likely to waste time and resources developing programs that don’t work for patients.”

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The Premier Consulting Blog

JUNE 18, 2023

This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.

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Vial

MARCH 27, 2024

The Costs of Running a Clinical Trial According to a report submitted by Sertkaya and colleagues to the United States Department of Health and Human Services, the average overall cost of conducting phase I , phase II , and phase III clinical trials is approximately $4 million, $13 million, and $20 million respectively [ 6 ].

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Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation.

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Conversations in Drug Development Trends

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Food and Drug Administration (FDA) Parallel Scientific Advice procedure, which aims to increase dialogue between the two agencies and sponsor companies.

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Conversations in Drug Development Trends

FEBRUARY 22, 2023

Cure GM1 Foundation’s mission is to fund research for the benefit of all those who suffer from GM1 gangliosidosis, a lysosomal storage disease that attacks the brain and spinal cord. Richie Kahn: I’m a public health and advocacy guy by training, a clinical researcher by trade, and a patient advocate by necessity.

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NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

This improvement stems from several factors, including the FDA’s emergency use authorization (EUA) of a number of therapies found to be safe and effective for COVID-19. Therapeutics Clinical Working Group : Prioritizes therapeutic agents for testing within an adaptive master protocol strategy for clinical research.

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PPD

SEPTEMBER 16, 2024

The convergence of real-world data (RWD), technology and artificial intelligence (AI) is playing a vital role in accelerating drug development. In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinical research and drug discovery.

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Conversations in Drug Development Trends

NOVEMBER 3, 2022

BioPharma Dive interviewed our Derek Ansel on how to conduct psychedelic clinical research. In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials.

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Advarra

AUGUST 10, 2023

Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. Operation Warp Speed for Rare Diseases looks to accelerate both drug development and approval.

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The Pharma Data

NOVEMBER 16, 2020

Food and Drug Administration (FDA) in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data (with a median duration of at least 2 months). The study also included communities that have historically been under-represented in clinical research and have been disproportionately impacted by COVID-19.

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The Pharma Data

JANUARY 17, 2021

The service is expected to become operational in 2021 and will be available for clinical research and clinical care — starting with private patients, followed by expansion into the public healthcare system over time. “We This press release features multimedia. View the full release here: [link].

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The Pharma Data

MARCH 23, 2023

The broader Sanofi and Regeneron COPD clinical research program includes Phase 3 trials with itepekimab, a fully human monoclonal antibody that binds to and inhibits interleukin-33 (IL-33). AEs leading to deaths were balanced between the two arms (1.7% placebo, 1.5% Itepekimab received Fast Track Designation from the U.S.

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The Pharma Data

OCTOBER 22, 2020

With today’s FDA approval, and regulatory approvals or temporary authorizations in approximately 50 additional countries around the world, Veklury® (remdesivir) is one of the tools available today. ii] The ACTT-1 study sets a high bar for clinical evidence that must be considered as new data emerge. Published online on October 8, 2020.

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NIH Director's Blog: Drug Development

JULY 20, 2017

These results, along with data from another clinical trial expected to begin later this year, will be used by Vertex to select which next-generation targeted drug or combination of drugs will move forward into larger scale Phase III studies. About 30,000 Americans have CF.

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