Drug Target Review

APRIL 7, 2025

For example, transcriptomic processes are showing the potential to identify and track failures in gene expression and gene regulation of amyloid and tau-related biomarkers, understood as precursors to the onset of Alzheimers disease (AD).

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Perficient: Drug Development

NOVEMBER 6, 2023

Perficient’s Generative AI Lab is consistently developing POCs to help clients explore use cases for generative AI and helping them operationalize it with policies, advocacy, controls, and enablement. What Does Our Internal ChatGPT POC Do? The Internal ChatGPT proof of concept was developed on Azure’s OpenAI chat interface.

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Drug Target Review

JUNE 11, 2025

Drug development is plagued by complex challenges, but multimodal AI is unlocking new opportunities. By integrating diverse data sources – from genomics to clinical insights – this approach is accelerating drug discovery, improving patient stratification and boosting success rates.

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Drugs Clinical Trials Drug Development Pharmaceuticals 64

PPD

JUNE 17, 2025

Biopharmaceutical and biotech drug developers have faced increasing challenges in recent years. In the past decade alone, the time needed to complete a clinical trial has increased by 20–30%, and the cost to bring a new drug to market has risen to an average of about $2.6

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Drug Target Review

JULY 7, 2025

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. Institutions must invest in secure housing, specialised veterinary care and rigorous training for handlers.

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Drug Research Research Animal Testing Drugs 52

The Premier Consulting Blog

APRIL 13, 2025

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ from approved products in other countries) to inform doses and development. Legislation with delayed implementation In 2021, the FDA Modernization Act 2.0

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Animal Testing FDA Drug Development Production 52

The Premier Consulting Blog

JANUARY 14, 2025

Pediatric and Rare Cancers Pediatric Oncology Program An initiative for development of new products to treat pediatric patients Maximize the authority of the Best Pharmaceuticals for Children Act (BPCA) to increase the number of requests for pediatric studies of new drugs developed for adult cancers much earlier in the development timeline.

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Perficient: Drug Development

MARCH 27, 2025

Data privacy regulations such as GDPR , HIPAA , and CCPA impose strict requirements on organizations handling personally identifiable information (PII) and protected health information (PHI). However; in regulated industries, their default implementation may introduce compliance risks that must be addressed. What Are Deletion Vectors?

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Compliance Regulations Government International 64

FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3).

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Perficient: Drug Development

AUGUST 19, 2024

Banks have silos, these silos have been created due to mergers, regulations, entities, risk types, chinese walls, data protection, land laws or sometimes just technological challenges over time. The team analyzing the data warehouses, the data lakes and aiding the analytics will have to have this one major organizational goal in mind.

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Alta Sciences

AUGUST 21, 2024

Internships at Altasciences: Q&A With Our Summer Interns nbartlett Thu, 08/22/2024 - 04:44 Internships at Altasciences are more than just a stepping stone—they’re a gateway to real-world-experience and professional growth, giving the next generation opportunities to help shape progress in the drug development industry.

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International Laboratories Science Molecular Biology 40

Perficient: Drug Development

NOVEMBER 27, 2023

In the dynamic environment of highly regulated industries like healthcare and financial services, leaders often balance competing goals to delight customers while cutting costs. This blog was co-authored by Carl Aridas and Joel Thimsen. Build a reliable risk management strategy using accurate estimations and predictions.

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Regulations Compliance International Science 52

PPD

FEBRUARY 10, 2025

Sponsors find that an FSP solution is often the best choice to help advance their drug development projects, whether they need to fill small gaps in services or support large-scale programs with dedicated teams across functions.

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Clinical Trials Trials Clinical Research Research 52

The Pharma Data

NOVEMBER 9, 2020

. “Our initial focus is to develop standardized drug formulations with precise, predictable and efficient API delivery for clinical study and therapeutic use.” ” Prof. SOURCE: XPhyto Therapeutics Corp. . View source version on accesswire.com: [link]. .

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FDA Law Blog: Biosimilars

APRIL 6, 2025

Naomis insights and experience will solidify an already strong team of lawyers and regulatory experts helping our clients navigate the drug approval process, noted Director James Valentine. Palmer, commented. We were sad when he left to gain valued experience as a federal prosecutor but are absolutely thrilled and honored to welcome him back.

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Nurses FDA Compliance Government 59

Drug Target Review

SEPTEMBER 19, 2023

This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938. These guidelines drive the legitimacy of the models towards regulatory approval.

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Pharmaceutical Development Group

DECEMBER 19, 2021

Effective use of Real World Data (RWD) and Real World Evidence (RWE) can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services , expedite a FDA Pre-Submission Review, and lead to FDA Approval. Author Information William E. Spanogle, Ph.D.

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Pharmaceutical Development Group

FEBRUARY 1, 2022

Effective and consistent compilation of NME & NCE Product and Process Development for inclusion in the electronic submission can reduce costs and timelines. has over 30 years of management, full spectrum Regulated Life Sciences, RA, QA, EU-MDR, QMS, PMS, CSV/CSA, and R&D experience. Author Information William E. Spanogle, Ph.D.

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FDA Drug Development Science Pharmaceuticals 52

The Pharma Data

JUNE 6, 2025

Instead, it has become a strategic asset for pharmaceutical and biotechnology firms seeking to enhance commercial execution while managing internal resource limitations and regulatory complexity. These markets are characterized by stringent pricing regulations and decentralized healthcare systems, making localized sales expertise essential.

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Pharmaceutical Companies Compliance Pharmaceuticals International 40

FDA Law Blog: Drug Discovery

MARCH 6, 2024

John counsels FDA-regulated entities on litigation, enforcement, and compliance matters including FDA inspections, Form 483s, Warning and Untitled Letters and Consent Decrees, internal investigations, and data privacy concerns. Adapting to the New Regulatory Framework and Addressing Implementation Challenges.”

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Conversations in Drug Development Trends

AUGUST 9, 2024

However, implementing adaptive trial designs within MRCTs requires careful consideration of international regulatory standards to optimize patient outcomes and resource efficiency. Harmonizing regulatory requirements and complying with all relevant regulations are crucial for the success of adaptive MRCTs.

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Trials Clinical Trials Regulations FDA 80

Pharmaceutical Development Group

JANUARY 7, 2022

Effective and consistent use and application of Data Standards can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services, 505(b) NDA, IND Consulting , NDA Consulting, BLA Consulting , and effective FDA Pre-Submission collectively resulting in FDA Approval.

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FDA FDA Approval Biosimilars Regulations 52

Conversations in Drug Development Trends

MAY 1, 2024

This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials. For example, there are accelerated pathways for oncology drug approval in the U.S., Japan, and China. and the U.S.

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The Premier Consulting Blog

NOVEMBER 12, 2023

This feedback prompted the FDA to release a second paper in 2021 titled “ Artificial Intelligence/Machine Learning (AI.ML)-Based Software as a Medical Device (SaMD) Action Plan ,” which outlined the agency’s five-pillar approach to regulating AI/ML. These standards will help guide the development and maintenance of these devices.

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FDA Drug Development Regulations Science 52

Drug Target Review

JULY 13, 2023

By capitalising on condensate biology, Dewpoint seeks to tackle diseases and targets that have previously lacked sufficient understanding for effective drug discovery. Dewpoint addresses diseases that lacked comprehensive biological understanding, allowing for more meaningful and logical drug discovery efforts.

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Disease Small Molecule Cell Biology Drugs 98

Perficient: Drug Development

APRIL 10, 2025

WCAG, or Web Content Accessibility Guidelines, is a set of international standards developed by the World Wide Web Consortium (W3C) to ensure that web content is accessible to individuals with disabilities. What is WCAG? These guidelines are organized into four principles: Perceivable, Operable, Understandable, and Robust (POUR).

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Pharmacy Compliance International Regulations 52

The Pharma Data

JUNE 30, 2021

This strategic partnership combines Teva’s long-standing commercial presence, extensive distribution network and wide-reaching sales and marketing activities across Europe and international markets with Bioeq’s capabilities in the development of biosimilar drugs for highly regulated countries with stringent quality standards.

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Biosimilars International Licensing Licensing 52

Drug Target Review

OCTOBER 31, 2023

Regulatory affairs workers get to tell a story about a drug to the regulators and – keeping the end in mind, which is the drug label or prescribing information – is a good way to communicate with regulators. Every drug has a story: an end game.

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Cell Biology Pharmaceuticals Science Disease 107

Drug Target Review

MARCH 17, 2025

Neuropsychiatric disorders, affecting millions worldwide, disrupt the brain’s intricate processes of mood regulation, cognition and behaviour. This concept is crucial in early drug discovery because it challenges traditional methods of drug development, where the focus is often on the PK.

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Treatment Licensing Licensing Science 52

Perficient: Drug Development

JANUARY 16, 2024

Establishing Strong Internal Controls Segregation of Duties (SoD): The primary goal of SoD is to ensure there are checks and balances in a transaction; one person is not allowed to have complete control over a transaction from start to finish. Contact us today to navigate the evolving landscape of risk and regulation successfully.

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Compliance Regulations International Production 52

Conversations in Drug Development Trends

JANUARY 6, 2025

Regulators are especially concerned about potential bias in the acquisition of data and the preservation of statistical validity, as adaptations are based on newly collected data compared to those anticipated in study planning.

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Trials Clinical Trials Treatment Disease 75

Conversations in Drug Development Trends

JULY 8, 2024

Individuals with familial cancer syndrome may have inherited mutations that predispose them to cancer development, affecting genes involved in DNA repair and cell cycle regulation. International Atomic Energy Agency (IAEA) The IAEA plays a crucial role in promoting the safe and effective use of radiation in medicine globally.

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Clinical Trials Regulations Therapies Clinical Development 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

FDA Law Blog: Biosimilars

AUGUST 23, 2023

By end of Q2 FY 2023, FDA will enhance its internal systems to support review of DHT-related submissions including capturing key information about clinical trials utilizing DHTs to support tracking the number and rate of change of DHT related submissions. As part of the DHT Framework, a DHT Steering Committee has also been established.

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Production Clinical Trials FDA Drugs 52

Pharmaceutical Development Group

JANUARY 5, 2022

Compliance with these new focus points hinge upon proactive utilization Drug Development Services , effective FDA Pre-Submission, and comprehensive Regulatory Consulting. Collectively leveraged, this will focus on the FDA’s vital points and lead to FDA Drug Approval. Author Information William E. Spanogle, Ph.D.

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Production FDA Regulations Science 40

Perficient: Drug Development

OCTOBER 9, 2024

By centralizing data, businesses can more easily comply with data governance policies, security standards, and privacy regulations, ensuring they meet internal and external data handling requirements. AI’s Role in Omnichannel Analytics Artificial intelligence (AI) plays a pivotal role in this vision.

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Marketing Production Government International 97

PPD

OCTOBER 2, 2024

In a recent survey of drug developers about their outsourcing practices, 41% of respondents increased their use of FSP engagements compared to two years ago. In many cases, higher levels of sponsor oversight are even required by regulation.

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