PPD

MARCH 11, 2025

Developing treatments for individuals living with rare diseases is critical, but orphan drug development is laden with unique obstacles that necessitate innovative, multifaceted approaches. RWE is transforming rare disease drug development, providing the insights needed to overcome unique challenges.

Drug Development 52

Drug Development Clinical Trials Disease Trials 52

Perficient: Drug Development

JULY 2, 2024

If you use ServiceNow as your knowledge management platform, you might want to make your knowledge articles searchable and accessible from Microsoft Search. By connecting your ServiceNow knowledge articles to Microsoft Search, you can enable your users to find and request them directly from the Microsoft 365 apps.

Production 118

Production 118

Drug Patent Watch

NOVEMBER 20, 2024

Generic drug development is a complex process that involves rigorous scientific research and regulatory assessments. Food and Drug Administration (FDA) plays a crucial role in ensuring the quality and efficacy of generic drugs through various programs and guidelines.

Drug Development 98

Drug Development Science Drugs FDA 98

Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts.

Drug Development 98

Drug Development Pharmacokinetics Compliance Drugs 98

Drug Patent Watch

OCTOBER 16, 2024

As patents for original biologic drugs expire, biosimilars are becoming increasingly important, offering more affordable treatment options for patients and healthcare systems. This article delves into the impact of biosimilars on biologic drug… Source

Biosimilars 115

Biosimilars Drug Development Drugs Pharmaceuticals 115

Drug Patent Watch

OCTOBER 14, 2024

The Food and Drug Administration (FDA) and other regulatory bodies have implemented various measures to ensure that generic drugs are equivalent to their brand-name counterparts in terms of quality, safety, and efficacy. This article will delve… Source

Drug Development 111

Drug Development Drugs FDA Production 111

Drug Target Review

DECEMBER 20, 2024

Artificial intelligence (AI) has revolutionised many industries, yet its adoption in pharmaceutical drug development has been notably slower. For years, AI and machine learning (ML) were often dismissed as little more than advanced statistics with little practical value in drug development.

Clinical Trials 128

Clinical Trials Trials Pharmaceuticals Drug Development 128

Perficient: Drug Development

SEPTEMBER 26, 2023

We’re excited to introduce you to two illuminating articles recently featured on CMSWire.com, “The Heart of Composable Architecture,” and “Navigating the Long Tail of Composable in the Martech Landscape” Both articles were penned by Perficient’s own David San Filippo, Sitecore Principal and Sitecore Technology MVP.

Marketing 110

Marketing Production 110

Drug Patent Watch

DECEMBER 11, 2024

In this article, we will delve into the key criteria for selecting a CDMO, highlighting the essential factors to consider and the importance of effective communication and cultural fit. Your Drugs Development Stage The stage of your drug development is a critical factor in selecting a CDMO.

Pharmaceutical Companies 98

Pharmaceutical Companies Compliance Pharmaceuticals Drug Development 98

Broad Institute

DECEMBER 18, 2023

Brain disorders are difficult to study and many drug candidates have failed in clinical trials, causing pharmaceutical companies to reduce their investments or even exit the field entirely. Your review article discussed the need to study genetically diverse patient samples. Can you expand on that?

Drug Development 130

Drug Development Clinical Trials Drugs Disease 130

Quanticate

SEPTEMBER 13, 2024

In our article, we cover the key trends that have been shaping clinical trials so far in 2024, and those that are predicted to continue into 2025.

Clinical Trials 95

Clinical Trials Trials Drug Development Treatment 95

Drug Target Review

MARCH 24, 2025

Sujeegar Jeevanandam, an expert with 13 years of experience in life sciences R&D, offers valuable insights into the current state and future trajectory of artificial intelligence in drug discovery. This breakthrough could fundamentally change how drugs are developed and tested.

Clinical Trials 59

Clinical Trials Animal Testing Drugs Pharmacokinetics 59

FDA Law Blog: Drug Discovery

MARCH 19, 2023

s Mark Tobolowsky co-authored the peer-reviewed article “ Microdystrophin Expression as a Surrogate Endpoint for Duchenne Muscular Dystrophy Clinical Trials ” in the recently published edition of Human Gene Therapy. Hyman, Phelps & McNamara, P.C.’s

Therapies 98

Therapies Clinical Trials Treatment Trials 98

Drug Target Review

JULY 18, 2023

Artificial Intelligence (AI) is poised to transform the field of target discovery in drug development, offering immense potential to enhance efficacy, personalised medicine, and accelerate the development of innovative compounds.

Drug Development 98

Drug Development Drugs Clinical Development Pharmaceutical Companies 98

Quanticate

JULY 5, 2024

It’s essential for maintaining ethical standards, high-quality outcomes and facilitating global standardisation, enabling multi-center and multinational studies, thereby streamlining the development and approval process for new medical treatments, and maintaining public trust in clinical research.

Clinical Research 111

Clinical Research Drug Development Treatment Research 111

Drug Patent Watch

JUNE 20, 2024

In the high-stakes world of pharmaceuticals, patents play a pivotal role in safeguarding intellectual property and ensuring a return on investment for drug developers. The journey of a drug patent is a complex and intricate one, spanning from the initial filing to its eventual expiry.

Drugs 111

Drugs Drug Development Pharmaceuticals 111

Chemical Biology and Drug Design

JANUARY 21, 2025

ABSTRACT Infectious diseases, including bacterial, fungal, and viral, have once again gained urgency in the drug development pipeline after the recent COVID-19 pandemic. Compound 26 was identified as a promising antiproliferative hit. Tuberculosis (TB) is an old infectious disease for which eradication has not yet been successful.

Drug Development 100

Drug Development Disease Drugs Research 100

Drug Patent Watch

SEPTEMBER 24, 2024

Recent advancements in analytical technologies have significantly impacted the development of generic drugs, enabling more accurate and efficient analysis of complex drug products. This article will explore the latest developments in… Source

Drug Development 59

Drug Development Drugs Production 59

Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

Drug Development 52

Drug Development Treatment FDA Approval Drugs 52

Drug Patent Watch

DECEMBER 17, 2024

Today, they’re strategic partners in drug development and manufacturing, offering end-to-end solutions that can make or break a pharmaceutical company’s success. This shift reflects the increasing complexity of drug development and the need for specialized expertise at every stage of the process.

Pharmaceuticals 90

Pharmaceuticals Therapies Production Pharmaceutical Companies 90

Drug Target Review

DECEMBER 9, 2024

Baker’s model could revolutionise drug development, synthetic biology, and nanotechnology, opening possibilities for new medical treatments, vaccines, nanomaterials, and sensors. Presumably, some of these compositions include proteins synthesised using Bakers AI model.

Engineering 105

Engineering International Drug Development Science 105

Drug Patent Watch

FEBRUARY 26, 2025

In this article, we'll delve into the world of drafting drug patent applications for biologic drugs. To draft a strong patent application, you need to understand the nuances of biologic drug development, including the production process, stability, and formulation. Read the full article here: [link]

Drugs 59

Drugs Government Regulations Compliance 59

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

DECEMBER 6, 2024

In drug discovery and biological research, the scientists workflow often follows a structured and iterative approach to ensure accuracy, reproducibility and scientific integrity. At the heart of any research is the scientific question.

RNA 52

RNA Drugs Research Science 52

Perficient: Drug Development

MARCH 5, 2024

Depending on the size of your marketing team, one high-quality blog article a week could be a big ask. We’ve pulled together seven strategies for how to stock your editorial calendar with the kinds of relevant article topics your healthcare organization’s consumers are asking for. Let’s walk through them.

Marketing 52

Marketing Research 52

Drug Target Review

JANUARY 14, 2025

In the next article, we will discuss the tools scientists can use to execute the workflow described in Figure 1. Figure 1: High-level workflow for early drug discovery. In 2003, he was selected by EE Times as one of the top 13 most influential people in the semiconductor industry.

Drugs 69

Drugs Protein Expression Science Research 69

Drug Patent Watch

JANUARY 30, 2025

Understanding Patent Exclusivity When a new drug is approved, it's granted a period of exclusivity, typically 5-7 years, during which the manufacturer has the sole right to market and sell the product. This exclusivity is a result of the patent protection granted to the drug's developer. Read the full article here: [link]

Marketing 59

Marketing Drugs Production Pharmaceuticals 59

Drug Patent Watch

DECEMBER 12, 2024

The pharmaceutical industry relies heavily on Contract Development and Manufacturing Organizations (CDMOs) to outsource various stages of drug development and manufacturing. With the increasing complexity of drug development and the need for efficient, cost-effective solutions, selecting the right CDMO is crucial.

Drug Development 98

Drug Development Production Clinical Trials Pharmaceutical Companies 98

KIF1A

SEPTEMBER 30, 2023

Read the Article Both of these studies reflect a global effort to understand the genetic underpinnings of disorders so people can find the right treatments sooner. In addition to benefiting awarded sponsors, this pilot program will help create best practices of communication with the FDA during rare disease therapeutic development.

Disease 111

Disease FDA Clinical Trials Therapies 111

Drug Target Review

DECEMBER 11, 2024

This issue poses a significant hurdle for drug developers, with no universal protocol currently in place to address these complexities. In this article, we share our hard-earned insights into overcoming these critical challenges.

International 52

International Laboratories Drugs Pharmacokinetics 52

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

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. Lisa also suggests talking about your studies early on.

Drug Development 52

Drug Development Clinical Trials Trials Drugs 52

Agency IQ

AUGUST 9, 2024

By Sebastian Godoy, MPH Earlier this year, the EMA hosted a multi-stakeholder workshop to discuss regulatory issues surrounding drug development of psychedelic products. Fill out the form to read the full article. EMA has now published a report on the workshop. EMA has now published a report on the workshop.

Drug Development 59

Drug Development Production Drugs 59

Agency IQ

MAY 17, 2024

BY RACHEL COE, MSC Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. During a meeting this week, FDA speakers highlighted the uniqueness of this redesigned meeting type in allowing sponsors to explain how they’ve addressed challenges encountered during product development.

FDA 59

FDA Drugs Drug Development Production 59

KIF1A

MARCH 2, 2024

Read the Article Rare Roundup The Jackson Laboratory offers “Exploring Rare Disease Through Translational Research” MiniCourse Human health is incredibly complex; developing safe, effective treatments requires knowledge of molecular mechanisms, cell biology, and drug administration.

Laboratories 119

Laboratories Cell Biology Disease Research 119

Agency IQ

JULY 22, 2024

While the agency has been working to implement its rule, which has broad-reaching impacts for diagnostics and drug developers, other moves by the Supreme Court and legislators could impact the agency’s next steps. Fill out the form to read the full article. AgencyIQ provides a status update for regulated industry.

FDA 59

FDA Laboratories Regulations Drug Development 59

Drug Target Review

SEPTEMBER 5, 2024

However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company. All types of activities encouraging women in STEM is important, like this article.

Pharma Companies 111

Pharma Companies Licensing Licensing Disease 111