Conversations in Drug Development Trends

NOVEMBER 10, 2023

 Instead, the medical community and regulating agencies need to balance all aspects when making decisions, working in partnership with their patients. Collaborating If you’re interested in learning more about pain therapeutics research, check out our pain expertise.

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Drug Discovery World

APRIL 14, 2023

The American Association for Cancer Research (AACR) will honour the following cancer researchers, physician-scientists, advocates, and journalists during its annual meeting to be held April 14-19 at the Orange County Convention Center in Orlando, Florida. June’s award lecture will be held on Sunday April 16 at 4:30pm ET.

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Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. He said: “But for this market to become a reality, we need much more research into cannabis products and potential indications.

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Agency IQ

AUGUST 30, 2024

FDA AdComm to discuss patient-centric informed consent The FDA’s Center for Devices and Radiological Health (CDRH) will soon convene its Patient Engagement Advisory Committee to discuss “patient-centered informed consent” policies – notably, not just for medical devices but for “FDA regulated medical products” writ large.

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Drug Discovery World

MAY 17, 2024

Deepika Khedekar , Associate Centralized Clinical Trial Lead at IQVIA Inc, looks at the challenges of utilising artificial intelligence (AI) in oncology clinical research. MIT research 4 tells us a hard truth: about 95% of these trials fall short, leaving behind a trail of broken hopes for cancer patients each year.

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Vial

MAY 28, 2024

In the rapidly expanding world of digital health, Medable and Vial CRO (Contract Research Organization) , two leading technology organizations, are revolutionizing the way clinical research is conducted.

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PPD

AUGUST 16, 2023

However, as the world settles into its post-pandemic state and returns to pre-pandemic paradigms in many areas, the pharmaceutical industry remains dedicated to moving beyond traditional, centralized clinical trial constructs. Fortunately, leading global regulators have launched key initiatives.

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Conversations in Drug Development Trends

FEBRUARY 22, 2023

Rare Disease Day on February 28th is a chance for rare disease communities to come together as one and join in conversation with stakeholders searching for treatments, raising money to support research, and changing the way healthcare and governments interact with patients. What will have the greatest impact on rare disease patients in 2023?

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The Premier Consulting Blog

NOVEMBER 20, 2023

On September 29, 2023, the U.S. Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. This change is driven by the intent to consistently regulate all producers of such devices. billion each year.

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Alta Sciences

DECEMBER 14, 2023

A Closer Look At Our On-Site Compounding Pharmacies shajjar Thu, 12/14/2023 - 21:30 HTML Altasciences' dedicated pharmacists bring a wealth of expertise in controlled substances and complex compounding, ensuring maximum precision and safety standards. Exceptional inspection results from major regulators such as the FDA, HC, EMA, and MHRA.

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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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Vial

FEBRUARY 15, 2024

To address these challenges, many companies outsource their clinical trials to contract research organizations (CROs) with established protocols, global reach, and therapeutic area expertise1. The demand for clinical trial outsourcing services is on the rise. over the forecast period (2022-2030).

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PPD

NOVEMBER 14, 2023

Clinical research requires vast talent across a variety of roles and specialties, as well as across global locations. In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development.

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Vial

FEBRUARY 23, 2024

In 2022, the global market value of patient portals within the clinical research and healthcare industries was estimated to be US $2.9 billion and is expected to climb at a compound annual growth rate (CAGR) of 19.44% between 2023 and 2030.

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FDA Law Blog: Biosimilars

JANUARY 1, 2024

Maybe that’s also why FDA last week publicized the highest number of important Warning Letters of the year (compared with prior releases in 2023). Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Terragene S.A., Shah, M.D.,

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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. The company reported a revenue of $11,116 million for the first nine months of 2023, marking a 4.2% increase on a reported basis and an 4.8%

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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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Drug Target Review

JUNE 6, 2023

Difficult-to-treat and rare, complicated cancers remain a perplexing challenge for IO researchers. Research has shown that these immune system proteins have the ability to trigger anti-cancer immune pathways. Clinical development of IL-18 therapies has been curtailed, however, by the protein’s lack of efficacy.

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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. Read AgencyIQ’s analysis of a lower court’s ruling.

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Drug Discovery World

JULY 25, 2023

These guidelines facilitate open communication between regulators and researchers, enabling the industry to adapt and conduct more robust and efficient paediatric clinical studies, while avoiding unnecessary trials. Neonates also have an increased amount of CSF and immature myelination 3.

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Vial

MARCH 15, 2024

A contract research organizations (CROs) is a third-party firm contracted by sponsors to deliver specialized services aimed at optimizing their research. This article explores the roles of CROs and highlights strategic partnerships between CROs and external vendors, designed to enhance research outcomes.

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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. The road to research on psychedelic products is paved with obstacles.

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PPD

OCTOBER 18, 2023

Continued expansion of the biotech industry is occurring in parallel, with an estimated compound annual growth rate of 13.96% from 2023-2030. There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care.

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Drug Discovery World

JULY 12, 2023

This paid-for advertorial by BC Platforms appeared in DDW Volume 24 – Issue 3, Summer 2023 The use of real-world data (RWD) is demonstrating significant potential to enhance rare and orphan disease clinical research and development. How can researchers gain access to rare and orphan disease patient data, including RWD?

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Agency IQ

FEBRUARY 12, 2024

The overarching goal of the project was to develop a suite of gene therapy resources that could be used by the research community to streamline gene therapy development for rare disorders, making the process more efficient and less costly.

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The Pharma Data

APRIL 12, 2022

20% variant allele frequency reduction – At the time of analysis with > 2 year follow up the survival estimate was 100% in patients who had improvements in bone marrow fibrosis or variant allele frequency – Results were presented at the American Association for Cancer Research annual meeting. Garcia, M.D.,

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KIF1A

JULY 1, 2023

Dylan Verden of KIF1A.ORG summarizes newly published KIF1A-related research and highlights progress in rare disease research and therapeutic development. Using similar logic, researchers measured the movement of KIF1A homodimers (a pair of healthy KIF1A motors, or a pair of mutant KIF1A motors).

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Agency IQ

NOVEMBER 3, 2023

BY CHELSEY MCINTYRE, PHARMD | OCT 30, 2023 10:57 PM CDT Background: What are microbiome-based therapies? In simpler terms, these are live microbes that have actually demonstrated health benefits in clinical research. The regulation of dietary supplements in the U.S. What is the microbiome itself?

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Agency IQ

MARCH 1, 2024

In this piece, AgencyIQ explains what a government shutdown would mean for FDA’s regulatory processes and for the industry it regulates. AgencyIQ thought this would be a good time to go over what a government shutdown means for the FDA, and therefore what regulated industry needs to know. What are the impacts for regulated industry?

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The Anticancer Fund

JUNE 23, 2023

23 June 2023 Language EN Drug repurposing is a strategy for identifying new uses for approved drugs, outside the scope of the original indication. Our intention is to help bring these findings to the attention of the broader cancer research community. It is one of the focus areas of the Anticancer Fund.

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Agency IQ

AUGUST 11, 2023

BY AMANDA CONTI, LAURA DIANGELO, MPH AUG 9, 2023 7:35 PM CDT A new contract notice seeks software support to leverage AI-based data extraction technology. The company highlights several applications relevant to life sciences regulation, including pharmacovigilance and quality assurance and regulatory compliance management.

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Drug Discovery World

JULY 1, 2024

billion) in 2023, 51% higher than 2022, marking the company’s largest annual net profit going back to 1989, according to data from S&P Global Market Intelligence 1. Together, this research aims to generate evidence for advising and guiding future parents before and during pregnancy. It started up on 1 January 2023.

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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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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

JANUARY 24, 2021

Sairiyo is advancing the clinical development of its lead drug candidate, Cepharanthine, a repurposed and reformulated naturally derived compound for the potential treatment of cancer, neurological, inflammatory and infectious diseases. Research and development efforts will be led by Dr. Paul Van Slyke.

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Drug Discovery World

AUGUST 24, 2023

Of course, while the regulation remains a continuous battle, this does not hinder the research being undertaken. As of February 2023, there are no approved therapeutic products containing psilocybin in Canada. To this end, a debate took place in parliament in May 2023 regarding access to psilocybin treatments 6.

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Vial

MAY 15, 2024

Vial | Pros and Cons The unprecedented consequences of the COVID-19 pandemic gave rise to the advent of decentralized clinical trials (DCTs), which are studies that use telemedicine and remote or local healthcare professionals to enable participants to join from different locations.

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