Drug Patent Watch

DECEMBER 11, 2024

It is crucial to determine whether you will be working with a CDMO for discovery and drug development all the way through approvals and commercialization or if your work with a CDMO will begin with preclinical development or clinical research. Range of Services The range of services offered by a CDMO is another vital criterion.

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PPD

MARCH 11, 2025

While individual rare diseases affect populations that are small in numbers, collectively they impact millions globally, posing significant health and research challenges. This solution allows researchers to enhance the robustness of their control populations, minimize bias and provide a real-world context to trial outcomes.

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PPD

NOVEMBER 11, 2024

Companies can benefit from solutions such as our Accelerator Drug Development, leveraging the combined strength of Thermo Fisher Scientific’s 360˚ Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) services , which provides CDMO, CRO and clinical trial supply chain capabilities that further streamline (..)

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FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Background on the Grants Program Launched as part of the Orphan Drug Act of 1983, this program aims to encourage research and development of drugs, biologics, medical devices, and medical foods for rare diseases, defined as conditions that affect fewer than 200,000 people in the U.S. The seven awardees included six early-stage trials (e.g.,

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Drug Target Review

DECEMBER 16, 2024

Dr Pooja Hingorani, Senior Medical Director of Oncology Early Development at AbbVie , shares her journey in STEM, from her early days in New Delhi to her impactful career in oncology research and drug development. Opportunities in clinical research and drug development were not always easy to come by.

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PPD

JANUARY 15, 2025

About us The PPD clinical research business of Thermo Fisher Scientific , the world leader in serving science, enables our customers to accelerate innovation and increase drug development productivity.

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Drug Target Review

JULY 3, 2025

Leveraging the extensive breadth of available data to identify entities and relationships across data sources, clinical research experts, therapeutic specialists, machine learning (ML) engineers and others can collectively evaluate areas of interest that may create new opportunities for the asset and a broader clinical strategy.

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PPD

FEBRUARY 10, 2025

In the past, these developers mostly used in-house resources for their clinical monitoring and site management capabilities, whereas today they often prefer functional service provider (FSP) or full-service outsourcing (FSO) models, or a hybrid of the two, to ensure on-time and on-budget delivery of clinical operations.

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Drug Target Review

APRIL 7, 2025

About the author Dr Cyril Clarke, Vice President, Therapeutic Area, GMI Drug Development and Consulting, ICON Biotech Clarke is a clinical pharmacologist with over 30 years experience in clinical research; seventeen of which are within industrial clinical pharmacology.

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Quanticate

JUNE 13, 2025

Clinical research generates vast amounts of diverse data from laboratory tests, patients, medical equipment, and outside sources. By organising and analysing this information, researchers can extract actionable insights that improve patient outcomes, data accuracy, drug efficacy and speed up trials.

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Advarra

DECEMBER 17, 2024

2024 has been a year of growth and evolution in clinical research. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinical research, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.

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Drug Target Review

JULY 21, 2025

In Part 2 of our conversation with Layla Hosseini-Gerami, Chief Data Science Officer at Ignota Labs , we explore the many forms of toxicity and how AI-powered tools like omics and cell painting are transforming early prediction in pre-clinical research.

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PPD

DECEMBER 16, 2024

The drug development industry faces rising costs and increasingly complex protocols as top challenges, with 49% of developers citing costs as their primary concern and 39% pointing to protocol complexity as a key hurdle, according to a recent survey of 150 drug developers worldwide by the PPD clinical research business of Thermo Fisher Scientific.

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Broad Institute

NOVEMBER 25, 2024

Ladders to Cures (L2C) Accelerator By Maria Nemchuk November 25, 2024 Breadcrumb Home Ladders to Cures (L2C) Accelerator The Ladders to Cures (L2C) Accelerator aims to catalyze progress across the research ecosystem and accelerates advances leading to treatments and cures for patients with rare genetic diseases. I’m a rare disease researcher.

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Advarra

MARCH 6, 2025

Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinical research. Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinical trials, which judiciously test and evaluate safety and efficacy.

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Drug Target Review

MAY 23, 2025

At the forefront of this development is Dr Liam Tremble, Principal Scientist at Poolbeg Pharma, whose background as an immunologist and cancer researcher gives him a unique perspective on this promising drug. “It takes a family to develop a drug and identify the opportunities and pitfalls.

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Alta Sciences

DECEMBER 31, 2024

One of the most important factors to consider during the course of your early-phase clinical research is drug-drug interactions (DDIs), which occurs when one drug alters the effect of another, either by reducing its effectiveness or elevating systemic concentrations to potentially dangerous levelsultimately causing side effects.

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PPD

JULY 18, 2025

Before these meetings, it is important to do the necessary research on the agency involved and what information they will want. Sponsors’ planning should include research into what programs they may qualify for and what is required to participate. Regulators might also have specific perspectives on product types or disease areas.

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The Pharma Data

JUNE 15, 2025

Based on these data, it’s reasonable to expect that lonvo-z could enable patients to be free from both physical attacks and the daily burden of prophylactic treatments, offering them greater peace of mind and a significant improvement in their overall well-being.”

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Advarra

NOVEMBER 14, 2024

This collaborative spirit can lead to developing novel methodologies and strategies for monitoring and evaluating clinical trials, ultimately advancing the field of clinical research. This strategy is indispensable for advancing the clinical research field and ultimately improving patient outcomes across the globe.

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Advarra

JULY 3, 2025

10 areas that may impact your organization The third revision (R3) of the ICH E6 Guideline for Good Clinical Practice represents a significant modernization of global clinical research standards. Staff training & protocol compliance: Are your protocols and procedures being updated to incorporate these core tenets of R3?

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PPD

JANUARY 2, 2025

FSP solutions are being more frequently utilized by biotech companies Biotech companies employ contract research organizations (CROs) to handle trial-related functions and services, often delivered through a full-service outsourcing (FSO) model, an FSP model or a mixed model combining both. FSP outsourcing is growing faster than FSO.

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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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Alta Sciences

JUNE 26, 2025

AI Innovations in Ophthalmic Research ARVO is one of the largest global conferences for ophthalmology research , attracting nearly 11,000 attendees from over 60 countries. Hosted by the Association for Research in Vision and Ophthalmology, it serves as a platform for exchanging cutting-edge research findings.

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PPD

JUNE 17, 2025

This approach provides sponsors with the agility, efficiency and speed needed to expand clinical research into emerging markets or remote areas with highly qualified professionals in a cost-efficient manner.

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KIF1A

JUNE 20, 2025

Our goal is to expand this offering to KOALA participants during the upcoming KAND Conference , giving every family the opportunity to contribute valuable at-home data to our growing research efforts. Together, we are taking a major step forward in bringing cutting-edge, patient-centered technology to the forefront of KAND research.

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Quanticate

FEBRUARY 27, 2025

Wearable technologies have become a driving force in modern healthcare, transforming how data is collected, monitored, and analysed in clinical research.

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The Pharma Data

JUNE 20, 2025

Dr. Jason Westin, Professor of Lymphoma and Director of Clinical Research at MD Anderson Cancer Center , remarked on the potential paradigm shift this combination could usher in: “There remains a clear need for effective and well-tolerated treatments for people with this difficult-to-treat disease.

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PPD

FEBRUARY 12, 2025

Its important for your clinical research organization (CRO) to continually assess and invest in capabilities that help drive the success of your clinical program. There are three core areas we are strategically addressing this year. They include: 1.

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The Pharma Data

JUNE 12, 2025

UCB and Biogen are continuing their extensive clinical research program to fully define dapirolizumab pegol’s role in SLE treatment. A second Phase 3 trial is currently underway to further validate these results and hopefully enable eventual submission to regulators for approval.

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Conversations in Drug Development Trends

NOVEMBER 5, 2024

In preparation for World Orphan Drug Congress Europe, we interviewed Nathan Chadwick, Senior Director, Therapeutic Strategy Lead, Rare Disease, and Derek Ansel, MS, LCGC, Vice President, Therapeutic Strategy Lead, Rare Disease, to hear their insights into the current progress in rare disease research and their hopes for 2025.

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PPD

JUNE 20, 2025

The emergence of new drugs and treatment strategies has broadened treatment options that are in development and fueled research into urgently needed new therapeutic approaches for IPF. Several clinical trials have progressed to Phase III and, if successful, have the potential to alter the standard of care.

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Drug Target Review

MAY 5, 2025

Available from: [link] Me et the author Vishal Mehta is a visionary leader in healthcare innovation and the founder of Ubuntu Research, Inc. , a pioneering Knowledge Research Organisation (KRO). The 2024 Biotech Graveyard [Internet]. Fierce Biotech.

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ProRelix Research

MAY 14, 2025

These frameworks are not merely bureaucratic hurdles; they exist to […] The post Regulations for Drug Clinical Trials in the USA: Challenges, Opportunities, and Whats Next appeared first on ProRelix Research.

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ProRelix Research

MAY 13, 2025

The landscape of Indian clinical trial regulations has undergone a profound transformation over the past two decades. Once perceived as a regulatory gray zone, the Indian clinical research ecosystem has […] The post A Closer Look at Compliance and Regulations for Drug Clinical Trials in India appeared first on ProRelix Research.

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New Drug Approvals

JULY 8, 2025

Clinical Trials: Pritelivir is currently in phase II clinical trials, with ongoing research into its effectiveness and safety. Research and Development: Pritelivir is being developed by AiCuris Anti-infective Cures, building upon research from Bayer.

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PPD

APRIL 14, 2025

Medical researchers and practitioners see in their own patients how these ailments interconnect and overlap, as do the pharmaceutical and biotech companies working to develop GLP-1 therapeutics. Metabolic (diabetes) and endocrine research The post Best-in-Class Solutions Accelerate Development of GLP-1 Therapeutics appeared first on PPD.

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