Drug Discovery World

OCTOBER 19, 2022

At each stage, there is a continued process of attrition that ultimately limits the number of new APIs making it to the clinical phases, and approximately 90% of new drug candidates advancing to clinical trials fail to achieve final drug approval 2,3. . Consider drug delivery systems early on . Conclusion .

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PPD

AUGUST 14, 2024

Clinical trials have significantly increased in complexity over the last 20 years, creating new challenges. One of the top reported challenges facing drug developers today is recruiting, enrolling and retaining the right patients for studies.

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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. Engaging with regulatory agencies early and continuously is essential.

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an area of regulatory, scientific and industry focus, partly due to the recent U.S. Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.”

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Drug Discovery World

OCTOBER 12, 2022

10-15 years ago, there were few validated medical devices for clinical research, and now we have a lot of technology to choose from. The foremost consideration when choosing sensor technology is to ensure that it is fit-for-purpose and will provide the clinical evidence required for the study. About the author .

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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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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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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Read AgencyIQ analysis here for a detailed discussion of these issues. ].

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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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Agency IQ

MARCH 1, 2024

Must also provide list of recommended documentation for AI contracts. Note: If a link no longer works, it is likely because OIRA has since cleared the document.) Deadline FDA must submit to OMB and post publicly a plan to achieve consistency with OMB’s AI memorandum. This is what OIRA is currently reviewing.

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Agency IQ

FEBRUARY 2, 2024

The documents describe all the guidance documents that are under development and that may be published in a given year. Note: If a link no longer works, it is likely because OIRA has since cleared the document.) This is what OIRA is currently reviewing. Report will contain information specified in the commitment letter.

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Advarra

AUGUST 21, 2024

However, some industries like healthcare and clinical research have had a more fragmented experience in the adoption and seamlessness of their digital experience. Nowhere is this more painful than in clinical trials, the backbone of drug development.

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Drug Discovery World

AUGUST 7, 2024

Even though millions of people are needed to participate in clinical trials, fewer than 5% of Americans 6 have participated in clinical research of any kind. Take as an example patient recruitment, the most time-consuming part of a trial.

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Vial

DECEMBER 13, 2023

A site satisfaction survey conducted by Greenphire revealed that sites and sponsors both seek opportunities to improve clinical trial processes. The 2023 State of Clinical Trial Technology Report by Florence Healthcare presents insights from 450 clinical research sites, sponsors, and CROs.

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PPD

NOVEMBER 9, 2023

However, over the past decade, a trend toward incorporating multiple study populations into one protocol has slowly gathered momentum among drug developers. Improved prioritization Promising pipeline candidates with a strong early development protocol may see a positive impact to the net present value of an early-stage asset.

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Agency IQ

SEPTEMBER 1, 2023

FDA finalizes guidance on oversight of RWE studies, making several significant changes The FDA today finalized a much-anticipated guidance document on how sponsors of drugs and biologics can oversee and make use of their non-interventional studies involving real-world data and evidence.

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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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Vial

APRIL 18, 2024

The urgency for novel therapeutic approaches makes ophthalmology a rapidly growing domain of clinical research. Market research indicates significant growth in the ophthalmic clinical trials market, driven by increased disease prevalence, demand for ocular treatments, and rising research funding.

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Agency IQ

FEBRUARY 2, 2024

The European Commission also implemented its Mission on Cancer , which aims to further cancer research and innovation through funding in the same areas as the cancer plan. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

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PPD

JULY 11, 2023

Patient diversity in clinical research requires a multi-faceted approach. While race and ethnicity are certainly driving factors behind diversifying clinical trials, they are not the only qualities drug developers should keep in mind. Document and track reasons for screen failure.

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Agency IQ

OCTOBER 27, 2023

While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Expect nearly every company to be closely reading this document when it’s eventually published. FDA is also due to revise 24 other guidance documents at that time. AgencyIQ November 18 Shutdown (?)

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FDA Law Blog: Drug Discovery

JULY 9, 2024

Procedures for Submitting the DAP Sponsors should describe the DAP clearly and concisely, with limited cross-referencing to previously submitted documents. For drugs, the relevant CDER/CBER Division may or may not provide feedback; sponsors with specific questions may include them as a topic for discussion in meetings with FDA.

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Drug Discovery World

FEBRUARY 22, 2024

This is the first example of brain repair being documented on MRI for a chronic neurological condition,” says Ari Green, Medical Director of the UCSF Multiple Sclerosis and Neuroinflammation Center and a member of the Weill Institute for Neurosciences.

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Agency IQ

AUGUST 9, 2024

EMA’s psychedelic workshop leaves stakeholders with as many questions as answers Earlier this year, the EMA hosted a multi-stakeholder workshop to discuss regulatory issues surrounding drug development of psychedelic products. EMA has now published a report on the workshop; read on for AgencyIQ’s analysis.

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Agency IQ

MAY 28, 2024

drug supply chain’s heavy reliance on foreign countries, especially those that are considered “adversarial” to the United States, said E&C Committee Chair CATHY MCMORRIS RODGERS (R-Wash.). A number of E&C Committee members remain concerned about the U.S.

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Agency IQ

JUNE 28, 2024

See AgencyIQ’s analysis for more detailed history of FDA’s policy and guidance on diversity in research studies ]. In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. That said, FDA has not done nothing in 2024 related to clinical trial diversity.

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