Drug Patent Watch

DECEMBER 10, 2024

They can help ensure that these submissions are complete, accurate, and timely, which is critical for advancing drug development programs. They can help ensure that the commercial pharmaceutical manufacturing process is designed to meet regulatory requirements and offer insight into the most effective manufacturing strategies.

Compliance 95

Compliance Pharmaceuticals Pharmaceutical Companies Regulations 95

Drug Patent Watch

DECEMBER 9, 2024

Ancient civilizations in China, Egypt, and India documented the use of herbs for healing. This approach has led to the discovery of numerous potential drug candidates. From Lab to Market: The Long Road of Drug Development Once a promising compound is identified, it enters the long and costly process of drug development.

Drugs 90

Drugs Drug Development Pharmaceuticals Production 90

PPD

JANUARY 2, 2025

Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. Documentation/medical writing : Regional regulatory agencies (such as the U.S.

Clinical Development 98

Clinical Development Clinical Trials Trials Regulations 98

Perficient: Drug Development

NOVEMBER 7, 2023

In this blog, we will explore how we can effectively utilize Langchain, Azure OpenAI Text embedding ADA model and Faiss Vector Store to build a private chatbot that can query a document uploaded from local storage. Step 2: Load your Local Document You need to load your local document using Langchain’s TextLoader class.

Production 59

Production Research 59

Conversations in Drug Development Trends

JANUARY 21, 2025

Bioanalysis during clinical development of a drug is an indispensable process where trials obtain critical data pertinent to pharmacokinetics (PK) and pharmacodynamics (PD) and as readouts that are crucial for assessing the safety and efficacy of the drugs.

Clinical Trials 78

Clinical Trials Laboratories Trials Drug Development 78

Drug Target Review

AUGUST 7, 2024

The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. This continued innovation highlights the complexity of the drug development process, particularly as the field is highly regulated by health authorities around the world.

Drug Development 59

Drug Development Clinical Pharmacology Clinical Trials Drugs 59

Perficient: Drug Development

DECEMBER 18, 2024

Use Accessible Documents Large Print Materials: Provide printed materials in large print for patients with low vision. Braille Documents: Offer key documents in Braille for patients who are blind. Digital Text: Ensure that digital documents are accessible to screen readers.

Treatment 52

Treatment 52

Drug Target Review

DECEMBER 6, 2024

Public datasets, linked papers or supplementary documents often provide essential context about the experimental setup. This document summarises the data analysis process, including the key findings, statistical analyses, and interpretations. The final step is the generation of a report.

RNA 52

RNA Drugs Research Science 52

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

Drug Development 52

Drug Development Clinical Trials Trials Drugs 52

PPD

JULY 8, 2025

AI has applications from the simple to the complex; from automating mundane tasks and accelerating drug development, to increasing accuracy in documentation and uncovering complex correlations within vast datasets. Accelerate your clinical research with our drug development digital solutions from Thermo Fisher Scientific.

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Chemical Biology and Drug Design

MAY 11, 2023

The results suggest that scFv-ACLP fusion proteins may be potential anticancer drug candidates for targeted cancer treatment. Abstract Antibody-directed drugs for targeted cancer treatment have become a hot topic in new anticancer drug development; however, antibody-fused therapeutic peptides were rarely documented.

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Treatment Drug Development Drugs Research 100

Perficient: Drug Development

MARCH 25, 2025

Establish a single source of truth Create a glossary that doesn’t read like a legal document Accept that these definitions will change more often than a teenager’s social media profile It’s not perfect, but it’s governance, not a philosophical treatise on the nature of reality. So very, very wrong.

Government 52

Government Compliance Regulations 52

Alta Sciences

MARCH 4, 2025

Over time, this group of professionals evolved and grew, having regular stakeholder interactions with the FDA and Controlled Substances staff to discuss requirements for drug developers. I have spent the better part of my career working to make drugs safer. About the Author Beatrice Setnik, PhD, Chief Scientific Officer.

Clinical Trials 52

Clinical Trials FDA Drug Development Trials 52

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. Food and Drug Administration (FDA). Bailey J, et al. Trends in Non-Human Primate Use for Research and Testing.

Drug Research 52

Drug Research Research Animal Testing Drugs 52

Conversations in Drug Development Trends

NOVEMBER 12, 2024

There are also nuances for operational planning in cell therapy development programs. While many market-approved cell therapies available today are autologous products, allogeneic interventions are growing more common.

Therapies 72

Therapies Clinical Supply Clinical Trials Trials 72

Perficient: Drug Development

MARCH 12, 2025

Sitecore Cloud SDK The Sitecore Cloud SDK allows developers to integrate with Sitecore’s Digital Experience Platform (DXP) products. You can read the official documentation here. Sitecore Search JS SDK for React The Search JS SDK for React allows developers to create components such as search bars, search results components, etc.

Compliance 52

Compliance Production Marketing 52

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development.

Therapies 59

Therapies FDA Production Disease 59

Perficient: Drug Development

MARCH 5, 2024

Every developer should be instructed to reference and update this document as implementation evolves. Work with your IT and cybersecurity team to thoroughly screen the original author to avoid any potential risks.

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International Government 111

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

We have heard over and over again how the potential for a priority review voucher has allowed small companies with limited resources to invest in the development of drugs for rare pediatric diseases. We heard and felt the anxiety from many of our clients about the uncertainty this caused. After all, this is what incentives are for.

Disease 64

Disease FDA FDA Approval Government 64

ASPET

OCTOBER 12, 2023

To maintain cadence with looming threats in a prolonged field care environment, the broader medical countermeasure (MCM) enterprise must adopt new strategies for CBRN-addressing drug development.

Therapies 100

Therapies Licensing Licensing FDA Approval 100

FDA Law Blog: Drug Discovery

DECEMBER 15, 2024

Valentine We recently published the first part of our review of FDAs draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. In this post we focus in on the draft guidance documents chemistry, manufacturing, and controls (CMC)-specific content.

Therapies 52

Therapies FDA Clinical Development Production 52

Perficient: Drug Development

DECEMBER 12, 2024

Accessible Documents: Provide medical documents and information in accessible formats, such as large print, Braille, and digital text that can be read by screen readers. These tools can help patients access digital information and documents. Voice commands can make these tasks easier for individuals with visual disabilities.

Hospitals 52

Hospitals Production 52

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. They also need to have the medical competencies to manage adverse events often associated with these therapies.

Therapies 97

Therapies Clinical Trials Clinical Research Trials 97

FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

Patient Safety Annex 1 also includes more detailed sections outlining the responsibilities and functions of the Institutional Review Board/Independent Ethics Committee (IRB/IEC), sponsor and investigator with an emphasis on the rights and safety of trial participants.

Clinical Trials 88

Clinical Trials Trials Clinical Research Government 88

Perficient: Drug Development

MAY 5, 2025

ContentArea = 5 ; }); Note that increasing this will increase the document size and make the synchronization job much slower depending on the amount of content and level of nesting in your site. If you are querying draft content you need to configure and enable preview tokens Documentation 4. AddContentGraph ( options => { options.

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Perficient: Drug Development

FEBRUARY 28, 2025

A crucial part of making all content searchable is the Document Extractor , which enables search engines to read and index PDFs and Word documents. Cloud Storage Crawlers fetch files from cloud platforms like AWS S3 or Azure Blob.

Engineering 52

Engineering 52

FDA Law Blog: Drug Discovery

JANUARY 30, 2025

An agreement, a documented good faith effort, and open dialogue between sponsors and the Agency about such efforts and the difficulties encountered, we think, should carry significant weight in the short term to avoid regulatory action that may affect the availability of important treatments for patients.

FDA 105

FDA Trials Disease Drugs 105

KIF1A

JANUARY 13, 2024

Aditi Falnikar’s presentation from our 2023 KAND Conference Read the Article Rare Roundup FDA issues final guidance on rare disease drug development As we continue to explore new therapeutic avenues for treating KAND, it is crucial to think about the regulatory steps those therapies will face.

DNA 105

DNA Regulations Drug Development Disease 105

Conversations in Drug Development Trends

APRIL 4, 2024

Global Impact of ICH M10 Validation Guidelines Harmonization of bioanalytical validation methods is crucial in a world where pharmaceuticals are developed and approved across different regions. The ICH M10 guidelines aim to streamline this process, reducing redundancy in drug development and facilitating faster access to new therapies.

Small Molecule 80

Small Molecule Clinical Trials Pharmaceuticals Pharmaceutical Companies 80

FDA Law Blog: Drug Discovery

MARCH 7, 2024

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?

Clinical Trials 105

Clinical Trials Trials FDA Regulations 105

Advarra

AUGUST 21, 2024

Nowhere is this more painful than in clinical trials, the backbone of drug development. These complex studies typically generate hundreds or thousands of documents to share across clinical trial sites, pharmaceutical sponsors, physicians, patients, and regulators.

Clinical Trials 52

Clinical Trials Trials Compliance Clinical Research 52

Perficient: Drug Development

OCTOBER 26, 2023

Since I referred to various online sources to execute this, I’ve documented the process below. While the documentation suggests creating or overwriting an icon pack to implement a custom icon (refer to: [link] ), I discovered that the method outlined below also works if you simply want to add a single icon other than an SVG.

Packaging 98

Packaging 98

Perficient: Drug Development

APRIL 1, 2024

In the Optimizely Search & Navigation admin view, administrators can set a certain weight of different properties (title, content, summary, or document content). According to the documentation, “The default property weight, 1, does not affect the score. And the boost weight of that matching condition is 2.

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103

Perficient: Drug Development

DECEMBER 19, 2024

Accessible Information and Communication Braille and Large Print: Provide medical documents, consent forms, and educational materials in Braille and large print. Personal Assistance: Provide trained staff or volunteers to assist patients with tasks such as filling out forms, finding their way, and accessing information.

Hospitals 52

Hospitals 52

Perficient: Drug Development

DECEMBER 27, 2024

This makes it a versatile choice for developers working in diverse environments. Rich Documentation One of the hallmarks of a great library is its documentation, and ShadCN does not disappoint. Integrations with Popular Frameworks ShadCN is framework-agnostic but integrates seamlessly with popular tools like React and Next.js.

Marketing 52

Marketing 52

Alta Sciences

FEBRUARY 10, 2025

Whether for a small or large molecule, we provide: Pharmacology, toxicology , and PK studies Analytical method development Formulation development and manufacturing Preclinical safety testing Clinical trial design Data reporting and documentation Want to know more before we get started?

Small Molecule 52

Small Molecule Clinical Trials Drug Development Trials 52

Alta Sciences

OCTOBER 9, 2024

This document examines various analytical techniques that support pharmaceutical product development, with a focus on bioavailability. We take pride in developing, qualifying, and validating robust and rugged analytical procedures to ensure the quality of your products and meet the requirements of regulatory agencies worldwide.

Clinical Trials 52

Clinical Trials Drug Development Pharmaceuticals Trials 52