PPD

OCTOBER 17, 2024

This expansion represents a significant opportunity for both drug developers and patients, while also presenting a new and diverse set of challenges for drug developers, particularly in clinical trial execution.

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Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. The global preclinical CRO market was estimated to be valued at US$5.7

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Clinical Research Clinical Trials Research Trials 52

PPD

FEBRUARY 10, 2025

A recent white paper from the PPD clinical research business of Thermo Fisher Scientific details how these functions have evolved over the years to the point where multiple outsourcing models are now commonly utilized.

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Clinical Trials Trials Clinical Research Research 52

PPD

SEPTEMBER 6, 2023

Under the stresses of the COVID-19 pandemic, drug development organizations faced difficult decisions about keeping staff employed and productive. Benefits of Rebadging Under an FSP Model in Clinical Research A functional service partnership (FSP) model in clinical research can help sponsors navigate unforeseen staffing challenges.

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Clinical Research Regulations Packaging Drug Development 59

Conversations in Drug Development Trends

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA. Our mission is a lofty one.

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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.

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Trials Clinical Trials Regulations FDA 80

PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. Researchers often employ cell therapy studies for oncology indications, and the U.S.

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Trials Clinical Trials Drug Development Therapies 69

Drug Target Review

MARCH 4, 2025

Phenomix Sciences, built on over a decade of clinical research at the Mayo Clinic, is disrupting this outdated approach. The research demonstrated that obesity is not one disease, but many; each of which should be treated with different interventions, says Bagnall.

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Therapies Treatment Clinical Trials Science 52

Conversations in Drug Development Trends

JUNE 21, 2024

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Interested in hearing more insights from Matt?

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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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Clinical Trials Clinical Development Clinical Research Trials 52

Crown Bioscience

MAY 4, 2021

In addition, owing to the rarity of these diseases, it can be extremely challenging to gain to patients and perform the clinical research necessary for regulatory approval. In August 2020, new US legislation was passed which promises to have a major influence on the way companies approach pediatric drug development.

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Research Pharmaceutical Companies Licensing Licensing 52

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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Clinical Research Clinical Development International Engineering 52

PPD

OCTOBER 18, 2023

Access to a laboratory partner that already possesses the equipment, knowledge and personnel can save time and money. For rapid expansion of late-stage assay platforms, speed and a proven track record are pivotal.

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Laboratories Assay Development Small Molecule Drug Development 52

Vial

DECEMBER 5, 2023

Next-generation sequencing (NGS) has revolutionized scientific research and clinical genomics due to high-throughput multiplexing and shed light on genome structure, function, and dynamics. It has become a fundamental tool for researchers to explore the complexities of genetic information and conduct genetic-informed drug development.

Clinical Trials 52

Clinical Trials Trials RNA Bioinformatics 52

Drug Target Review

SEPTEMBER 26, 2023

CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact.

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Drugs FDA Disease Animal Testing 111

Perficient: Drug Development

FEBRUARY 1, 2024

The SCOPE (Summit for Clinical Ops Executives) conference is a premier event in the field of clinical operations, providing a comprehensive platform for professionals to explore the latest trends and innovations in clinical research. Reach out to connect with us.

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Science Clinical Research Clinical Trials Trials 59

H1 Blog

NOVEMBER 29, 2023

Breaking the Barriers: How Inaccurate Trial Records Are Delaying Drug Development and Limiting Diverse Patient Populations In an October 2023 report , BMC Medicine completed a follow-up on a 10-year effort to understand, report on and track data sharing challenges with big pharma, specifically for clinical trials.

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Clinical Trials Trials Drug Development Treatment 59

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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Pharma Companies Clinical Trials Compliance Trials 52

Alta Sciences

DECEMBER 14, 2023

Regulatory Excellence - Licenses for Schedule I through IV drug substances. 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.

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Compounding Pharmacies Pharmacy Clinical Pharmacology Clinical Supply 40

Conversations in Drug Development Trends

MAY 23, 2024

By: Sarah Bly, Regulatory Science and Innovation and Matt Cooper, Executive Director, Therapeutic Strategy Lead, Oncology The European Union (EU) presents a unique set of regulatory challenges and opportunities for clinical trials in oncology. However, they also bring unique regulatory challenges.

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Trials Clinical Trials Therapies Treatment 52

PPD

DECEMBER 12, 2023

Drug developers using functional service partnerships (FSPs) are taking an increasing interest in the follow-the-sun business model to optimize operations, transitioning work across global locations as the sun rises and sets. Clinical research and post-marketing surveillance involves ongoing data analysis and interpretation.

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Compliance Clinical Research Trials Clinical Trials 52

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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Clinical Trials Trials Compliance Clinical Research 52

The Premier Consulting Blog

APRIL 18, 2024

Development of cell and gene therapies is growing rapidly, given the major advances in genomic technologies and increasing scientific understanding of genetic regulation and immunology. Can you identify a safe AND efficacious clinical dose? Prior to clinical trials, the focus is typically on evaluating safety.

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Therapies Clinical Trials Small Molecule Immune Response 52

Vial

MAY 1, 2024

The company has a history of strongly advocating for clinical trials driven by artificial intelligence (AI) using research data captured in a secure, compliant cloud platform to help expedite the drug development process. Read more here about how Vial’s EDC system compares with that of industry giants.

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Clinical Trials Trials Compliance Engineering 52

Perficient: Drug Development

JULY 24, 2023

How are you making a difference for our clients, colleagues, and communities? As a lead business consultant in the computer system validation department, I plan, write, implement, and review the computer systems validation plan and protocols within highly regulated industries. Thanks for joining me today, Kaushal.

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Regulations Science Clinical Research Pharmaceuticals 52

Conversations in Drug Development Trends

APRIL 3, 2024

Complying with Unique Radiopharmaceutical Regulations The regulatory landscape for radiopharmaceuticals is intricate, reflecting the drugs’ complexity. By emphasizing transparency and patient autonomy, trials can maintain ethical standards while fostering trust and participation.

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Trials Clinical Trials Compliance Treatment 81

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 This desperation is apparent through the higher suicide rates for individuals suffering from high levels of pain. However,

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NIH Director's Blog: Drug Development

JULY 20, 2017

Years of hard work, supported by the National Institutes of Health and the Cystic Fibrosis Foundation, painstakingly worked out the normal function of the protein that is altered in CF, called the cystic fibrosis transmembrane regulator (CFTR). Credit: Zhang & Chen, 2016, Cell 167, 1586–1597.

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Clinical Trials Small Molecule Therapies Disease 52

Perficient: Drug Development

SEPTEMBER 25, 2024

Collaboration barriers : Disparate teams often struggle to share insights and work cohesively, slowing down the research process. Regulatory compliance : Keeping up with evolving data management regulations adds another layer of complexity to clinical trials.

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Clinical Trials Trials Science Production 52

Drug Target Review

OCTOBER 25, 2024

The Role of Biomarkers in Alzheimer’s Disease Drug Development. FMNL2 regulates gliovascular interactions and is associated with vascular risk factors and cerebrovascular pathology in alzheimer’s disease – acta neuropathologica. link] Cummings J. Adv Exp Med Biol. 2019;1118:29-61. doi: 10.1007/978-3-030-05542-4_2.

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Disease Clinical Trials Therapies Science 59

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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Pharmaceuticals Clinical Trials Small Molecule Disease 40

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. Policy-wise, this is still a work in progress.

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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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Disease Clinical Trials Trials Treatment 52

Agency IQ

MAY 28, 2024

FDA’s Laboratory Developed Test (LDT) Rule Quick background: The FDA recently published a new final rule to formally extend regulatory oversight over laboratory developed tests (LDTs), which the agency has long maintained are a subset of in vitro diagnostics (IVDs) and therefore should be regulated as a medical device in the U.S.

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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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FDA Trials Therapies Regulations 40

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. Corey Davis Ph.D., LifeSci Advisors LLC cdavis@lifesciadvisors.com. Follow NervGen on Twitter (@NervgenC) and LinkedIn (NervGen Pharma Corp.)

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