Conversations in Drug Development Trends

APRIL 3, 2024

Are you aware of the challenges you must address for a successful radiopharmaceutical trial? Enhancing Patient Participation in Radiopharmaceutical Trials Patient recruitment is a critical yet challenging part of radiopharmaceutical trials.

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Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic.

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Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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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. In many cases, higher levels of sponsor oversight are even required by regulation.

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Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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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. What is the regulatory landscape of medical cannabis? There is, however, one cannabis-derived drug product that the FDA has approved, which is Epidiolex (cannabidiol).

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Vial

FEBRUARY 15, 2024

Clinical trials play a crucial role in advancing medical breakthroughs, but effective management is essential to unlock their full potential. Pharmaceutical companies often face challenges in conducting clinical trials due to the need for substantial knowledge, time, and resources. over the forecast period (2022-2030).

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Vial

APRIL 10, 2024

The strong commitment to innovation allows IQVIA to provide advanced analytics, technology solutions, and industry-specific expertise in the health information technologies and clinical research domains. Vial’s track record includes over 750 completed trials and a network of more than 35 research sites.

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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

MARCH 15, 2024

The decision to outsource to a CRO is more than a strategic move; outsourcing to a CRO has multiple benefits , including access to streamlined expertise and risk mitigation in clinical trials. Breakdown of CROs Roles Initially, CROs primarily concentrated on overseeing clinical trial site operations and data management.

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Drug Discovery World

APRIL 14, 2023

Kathryn E Wellen, PhD – Outstanding Achievement in Basic Cancer Research Wellen is an investigator at the Penn Epigenetics Institute and Vice Chair and Professor in the Department of Cancer Biology in the Perelman School of Medicine at the University of Pennsylvania. Vickers’ award lecture will be held on Sunday April 16 at 3pm ET.

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Olympian Clinical Research

SEPTEMBER 3, 2020

Eating a well balanced diet, full of fruits and vegetables, floods your body with antioxidants that then decrease the internal inflammation contributing to and/or caused by depression. . Sleep is especially important in regulating mood. Try to also exercise regularly, make time for meditation, and get plenty of sleep each night.

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Drug Discovery World

JULY 5, 2023

What is clear is that what is needed are methods which can start in the research lab and ‘cross the chasm’ to routine use in a regulated environment. RA: Is Europe a leader in global cancer research? MG: I meet regularly with the brilliant European scientists driving cutting edge global cancer research.

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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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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

SEPTEMBER 28, 2022

AI-based diagnostic software and clinical trials technology proved to be two of the most attractive health investments, alongside mental health and wellness and medical imaging companies. . Which areas of drug discovery research stand to benefit most? . billion in 2021, an increase of 79% from 2020.

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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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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. Maintaining open lines of communication helps address issues as they arise, allowing for real-time clarification and adjustments.

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The Pharma Data

NOVEMBER 10, 2020

This clinical study will evaluate the safety, tolerability, and clinical activity of escalating doses of orally administered capsules of Foralumab. The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. NEW YORK and LONDON, Nov. NEW YORK and LONDON, Nov. and Europe. Dr. Howard L.

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Vial

JUNE 12, 2024

Utilizing PROs enables the active participation of patients in their care outcomes – both in a clinical setting and in clinical research. PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated.

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The Pharma Data

DECEMBER 27, 2020

“The approval of orelabrutinib would not have been possible without the strong support from our partners, physicians, experts and patients who participated in a series of clinical trials,” said Dr. Cui. Data from trials with orelabrutinib have shown sustained efficacy in the treatment of R/R MCL patients,” said Jun Zhu, M.D.,

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PPD

AUGUST 5, 2024

Composite endpoints might include factors such as hospitalization, transplantation and worsening of clinical outcomes. Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success.

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The Pharma Data

DECEMBER 15, 2020

The Phase III trial evaluated the use of the diabetes vaccine Diamyd ® , an antigen-specific immunotherapy based on the auto-antigen GAD (glutamic acid decarboxylase), to induce immunological tolerance and stop the autoimmune destruction of insulin producing cells. STOCKHOLM , Dec.

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The Pharma Data

DECEMBER 14, 2020

Our highly experienced clinical team will be placing 2-Bromo-LSD into multi-center United States clinical research locations without restriction.”. Dost Mustaq , BDA International Investor Relations Contact Email: ir@blifepharma.com Phone: 646-679-4321.

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The Pharma Data

DECEMBER 15, 2020

As the world’s first PPAR pan agonist that completed two confirmatory phase III clinical trials, Chiglitazar Sodium has shown significant and long-lasting hypoglycemic effects in a series of clinical studies, as well as other comprehensive effects including significant insulin sensitization and blood lipid regulation.

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Agency IQ

NOVEMBER 3, 2023

One non-profit organization, the International Society Association for Probiotics and Prebiotics (ISAPP) , which is dedicated to promoting research in this area, has published consensus statements that have helped to define some of these terms and their associated substances. The regulation of dietary supplements in the U.S.

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The Pharma Data

DECEMBER 13, 2020

The STAMP-NAFLD trial was a 12-week, randomized, parallel group study in 120 presumed NASH patients with or without type 2 diabetes (T2DM). The Company additionally announced new preclinical results and plans for a Phase 2b trial focused on patients with noncirrhotic biopsy-proven NASH and coexisting prediabetes or T2DM. and in Europe.

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Drug Discovery World

JULY 1, 2024

million) over a five-year period for Healthy Lifestyle Before and During Pregnancy to Prevent Childhood Obesity (the PRE-STORK Trial). million) was awarded over a five-year period for the Pre-pregnancy Weight Loss and Reducing Childhood Overweight project (PREPARE CHILD), a randomised controlled trial. million ($3.4 million ($3.4

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The Pharma Data

JANUARY 25, 2021

The AD-SAB will work closely with NervGen as the Company plans its upcoming preclinical studies and clinical trials and in the analyses of the results from these studies. He currently serves as chair of the medical and scientific advisory group and as a member of the Board of Directors of the Alzheimer’s Association.

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Alta Sciences

JULY 31, 2024

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025.

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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. billion and now functions as a subsidiary.

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Advarra

JULY 18, 2022

To protect human subjects in clinical research, the Food and Drug Administration (FDA) maintains and enforces specific regulations. Research stakeholders must track, document, and store the required information for trial oversight and monitoring to comply with regulations.

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PPD

JULY 16, 2024

Staying current with PV-relevant regulations and regulatory guidance can be challenging and often requires an FSP PV RI team that spans multiple countries and languages. This research ultimately influenced the creation of a new submission process for the client.

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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. The next question of interest is where the potential is for psilocybin, and what research is being undertaken to advance it?

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The Pharma Data

MARCH 15, 2021

Clinical research is a key component of developing. A critical component of our medicinal product development is clinical research. This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. We are committed to Good Clinical Practice.

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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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PPD

DECEMBER 12, 2023

Navigating the Intricacies of the Follow-the-Sun Model in Clinical Research The implementation of a follow-the-sun model, which leverages global resources in different time zones to assure continuous operations, requires a thoughtful approach to cultures, communication and collaboration for effective results.

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