Drug Patent Watch

JANUARY 15, 2025

Identifying drug patents is crucial for various stakeholders, including researchers, legal professionals, and business strategists. Understanding Google Patents Google Patents is a search engine that allows users to search the full text of patent documents from around the world. Implications for Pharmaceutical Stakeholders 1.

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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. EMRs give clinical operations teams direct, remote access to an array of patient health information.

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The Premier Consulting Blog

NOVEMBER 6, 2024

Developers must ensure that their CMC documentation is comprehensive, covering both the APIs and the device. Drug/Biologic/Device combination products are subject to the requirements of all three FDA centers: CDER, Center for Biologics Evaluation and Research (CBER), and CDRH.

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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. As such, research organizations must critically evaluate both their clinical priorities and operational procedures to ensure compliance.

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Alta Sciences

FEBRUARY 19, 2025

Researchers must characterize the anti-drug-antibody (ADA) response in preclinical and clinical studies and report any ADA-positive samples as a risk-based approach. These documents provide recommendations and considerations for clinical pharmacology , nonclinical safety assessments, and bioanalytical method validation.

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The Pharma Data

JUNE 12, 2025

The most commonly documented Grade 3 or higher TEAEs were thrombocytopenia (59%), neutropenia (59%), and anemia (49%). Vice President of Early Clinical Development and Translational Research at Johnson & Johnson Innovative Medicine.

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Codon

APRIL 17, 2025

Still, despite the genus first being documented in 1839, the broader scientific community had been unaware of its capacity for mimicry. “During the winter,” the researchers write in their study, “the plants grew quickly though the leaves showed poor mimicry of the artificial plant's leaves. Nobody yet knows.

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Alta Sciences

MARCH 4, 2025

Addressing New Challenges in Human Abuse Potential Research The CCALC has held face-to-face meetings in collaboration with industry, academia, and the FDA once every two to three years since inception, and has provided much of the industry perspective on the practical challenges and solutions to assessing abuse and dependence potential.

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Broad Institute

MAY 19, 2025

Researchers at the Broad Institute Ben Neale and Mark Daly are co-leading the study, which allows people across the US to sign up to have their DNA analyzed as part of this effort. Neale is a core institute member and co-director of the Stanley Center for Psychiatric Research at the Broad Institute.

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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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Alta Sciences

NOVEMBER 15, 2024

4 Essential Topics to Cover in Your First CRO Meeting pmjackson Fri, 11/15/2024 - 19:22 Starting a partnership with a contract research organization (CRO) is a sometimes intimidating—yet exciting—first step in your drug development journey. IND, CTA, NDA, BLA). “If Image thumbnail_Blog_Chad and Lisa_v3.jpg Tags About Altasciences Weight 16

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DrugBank

JUNE 18, 2025

While these regulations protect public health, they also introduce significant challenges for pharmaceutical researchers. Even drugs that complete clinical trials may face delays or rejections if submission documents are incomplete or do not align with regulatory expectations.

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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. Prepare questions that are aligned with existing guidance documents, regulations and agency precedents — to demonstrate an understanding of the applicable framework and scientific rigor.

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Drug Target Review

JULY 10, 2025

As new instruments were developed – such as MGISP-Smart 8 and PrepALL – it became clear that their flexibility could serve a wider array of research needs. One key initiative was the creation of internal documentation and operational expertise tailored to customised automation. Customisation is complex and expensive. That’s a problem.”

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Perficient: Drug Development

MARCH 18, 2025

Whether you’re managing projects, supporting customers, or conducting research, Copilot Agents empower you to achieve more with less effort. Medical Research Assist in compiling and analyzing research data, generating reports, and identifying trends in medical studies.

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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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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

MAY 26, 2025

Multimodal AI, allowing document and image uploads, offers advantages beyond voice. He is also a co-founder of Incubate Bio a techbio providing a service to life sciences companies who are looking to accelerate their research and lower their wet lab costs through in silico modelling. The optimal interaction method depends on the task.

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The Pharma Data

JUNE 16, 2025

“ANDEMBRY, the first monoclonal antibody discovered and developed entirely by CSL, offers people living with this life-threatening condition long-term control over their disease along with a convenient administration method,” said Bill Mezzanotte, MD, Executive Vice President, Head of Research & Development at CSL.

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Drug Target Review

JUNE 14, 2025

This ‘silo problem’ can impede innovation and slow research progress. IK: That’s absolutely part of the discussion – capturing experimental conditions and other metadata that may be documented somewhere, but does not always accompany the primary data when it’s handed over for analysis. RS: What about metadata collection?

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Laboratories Science Bioinformatics Molecular Biology 69

Conversations in Drug Development Trends

JANUARY 21, 2025

Jayaprakash Kotha, MBBS, PhD, ASCP (SH), Vice President, Bioanalytical Laboratory Satish Kumar, MBB, Head of Process Improvement Continuous Innovation is a Cornerstone of Bioanalysis Approximately 80% of drugs that begin the research process fail to reach approval. What is one contributing factor that sets the 20% that do apart from the rest?

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Clinical Trials Laboratories Trials Drug Development 78

sptlabtech

DECEMBER 6, 2024

The growing importance of 3D cell culture 3D cell culture has become an essential tool for advancing research in biology, medicine, and drug discovery. Case study: Automation-enabled human intestinal organoid research By using organ-specific cell types, organoids better replicate the complex structure and function of organs.

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Small Molecule Research Drugs Science 52

Drug Target Review

JUNE 26, 2025

This ‘silo problem’ can impede innovation and slow down research progress. Even if these scripts don’t adhere to formal coding standards or lack proper documentation – things software developers prioritise – they work for the scientists and provide access to the data they need.

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Laboratories Science Molecular Biology Bioinformatics 52

Codon

APRIL 14, 2025

While I deeply respect that tolerance, it can keep the field stuck: if we see pain as par for the course, it’s easy to overlook chances to make biological research faster, cheaper, and more efficient. Of course, biological research is shaped by different pressures than hardware projects.

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FDA Law Blog: Biosimilars

JUNE 4, 2025

This Assessment does not itself prescribe specific remedies for the ills it diagnoses; those are supposedly coming in the future Strategy document. For example, it describes a replication crisis, which it suggests should be addressed by government agencies to confirm both safety and efficacy findings from industry-funded research.

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Science Daily: Pharmacology News

APRIL 1, 2025

While the threat that microplastics pose to human and ecological health has been richly documented and is well known, nanoplastics, which are smaller than one micrometer (1/50th the thickness of an average human hair), are far more reactive, far more mobile and vastly more capable of crossing biological membranes.

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thought leadership

JUNE 30, 2025

In an era of increasing scrutiny and demand for transparency in clinical research, the European Union (EU) has taken significant strides to enhance public access to clinical trial data and ensure the integrity of the research process. The EU Clinical Trial Regulation (CTR) (No.

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Perficient: Drug Development

MAY 28, 2025

Its capabilities, once confined to research labs, are now accessible to millions, and the pace of innovation shows no signs of slowing. As someone deeply immersed in the world of AI research and its societal implications, I see a critical juncture before us. The risk of “data leakage” is very real.

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FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

Implications for Future of Clinical Research R3 represents an important evolution in GCP, shifting away from a prescriptive model toward a more flexible, risk-based approach.

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FDA Law Blog: Biosimilars

MARCH 6, 2025

Both guidance documents recommend data management practices for collecting data for use in developing, tuning, and testing an artificial intelligence model and making changes to said model. If data are excluded because of data quality issues, the rationale and criteria for the exclusions should be documented in the DCP.

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FDA Law Blog: Biosimilars

APRIL 8, 2025

Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Under GDUFA III alone, DPD published 32 GDUFA guidance documents and MAPPs to ensure the successful implementation of GDUFA.

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The Pharma Data

JUNE 9, 2025

This includes countries facing sustained community outbreaks, those with localized clusters, or nations documenting sporadic, travel-related cases—particularly those involving MPXV clade Ib. Evaluating vaccine effectiveness and documenting implementation lessons.

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Drug Patent Watch

JANUARY 8, 2025

With billions of dollars invested in research and development, protecting your intellectual property is not just importantit’s essential. A robust patent strategy can make or break a company’s success. Proactive Defense Measures The best defense is often a good offense.

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Advarra

MARCH 7, 2025

Clinical research is a vital driver of medical progress. With more than three decades of experience, Advarra is dedicated to advancing clinical research by providing expert oversight. Clinical research tests new treatments and therapies to determine their safety, effectiveness, and potential to improve health outcomes.

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FDA Law Blog: Biosimilars

APRIL 10, 2025

As it relates to the FDA, FOIA serves as a vital tool for stakeholders including patients, researchers, and regulated industry to better understand the Agencys scientific, policy and regulatory decision-making. However, not all information contained in FDA records is disclosable.

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Perficient: Drug Development

NOVEMBER 12, 2024

GPAI system transparency requirements All GPAI models will have to draw up and maintain up-to-date technical documentation and make information and documentation available to downstream providers of AI systems. watermarking), to carry out lawful text- and data-mining exceptions as envisaged under the Copyright Directive.

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Perficient: Drug Development

NOVEMBER 25, 2024

Organizations are discovering AI Agents aren’t just theoretical – they’re practical problem-solvers across multiple domains: An Agentic team that can reverse engineer legacy software, documenting business requirements and how the software currently works.

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