Drug Patent Watch

FEBRUARY 12, 2025

Accelerating Generic Drug Development: Strategies for Success As a pharmaceutical professional, you know how crucial it is to navigate the complex landscape of generic drug development. The generic drug development process involves several stages, from patent research to regulatory approvals.

Drug Development

Drug Patent Watch

APRIL 14, 2025

"Compliance in Generic Drug Development: A Critical Component of Success As the generic drug industry continues to grow, ensuring compliance with regulatory requirements has become a top priority for pharmaceutical companies.

Compliance

Drug Target Review

APRIL 7, 2025

In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drug developers for phase I trials, second only to navigating regulatory compliance (- 38 percent). Silver Spring (MD): Food and Drug Administration (US); 2016-. 113:9861002.

Clinical Development

Perficient: Drug Development

MARCH 25, 2025

Look for folks who: Actually understand the data (a rare breed, cherish them) Can handle details without going cross-eyed Won’t melt down when stuck between the rock of compliance and the hard place of IT Bonus: Give them a fancy title like “Data Integrity Czar.”

Government

Drug Target Review

JUNE 6, 2025

Image credit: Crystal Eye Media / Shutterstock The role of SPICA and manufacturing capabilities Drug development in the radiopharmaceutical space is particularly resource intensive. GMP compliance is non-negotiable in this field.

Therapies

Perficient: Drug Development

JANUARY 6, 2025

Legal Compliance Many countries have regulations and laws that mandate accessibility in public services, including healthcare. Adopting braille and large print is not just a matter of best practice but also legal compliance, ensuring that healthcare providers meet the required standards for accessibility.

Compliance

Perficient: Drug Development

JULY 8, 2025

Building trust with customers requires more than compliance. Ensuring Responsible AI Deployment The report also addresses the ethical dimensions of AI. Issues like data privacy, algorithmic bias, and transparency are top of mind for both marketing and IT leaders. It demands intentional governance.

Marketing

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. Despite these advancements, analysing biologically derived targets remains a formidable challenge due to interference from endogenous molecules.

International

Drug Target Review

APRIL 30, 2025

The future of AI in CGT AI holds tremendous potential to reshape drug discovery and development in CGT. From precise target identification to optimised gene-editing techniques and streamlined clinical trial designs, AI has the capacity to transform every stage of the drug development pipeline.

Drugs

Drug Patent Watch

DECEMBER 12, 2024

Understanding the Pharmaceutical Market Dynamics The pharmaceutical industry is a complex ecosystem where branded drugs and generics coexist, each playing a vital role in patient care and market dynamics. Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period.

Licensing

The Pharma Data

JUNE 24, 2025

By combining USP’s rigorously characterized reference materials with Bio-Techne’s user-friendly, high-resolution analytical instruments, the collaboration intends to streamline workflows, improve data accuracy, and enable greater compliance with global regulatory expectations.

Therapies

Perficient: Drug Development

NOVEMBER 20, 2024

Observe Develop a complete inventory of cryptographic assets from both a network and application perspective. Prioritize assets based on compliance requirements and risk levels. Analyze key exchange mechanisms like TLS and SSL to understand current vulnerabilities.

Government

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

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. Errors jeopardize patient safety, regulatory compliance and trust. But the stakes are uniquely high.

Clinical Research

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.

Drug Development

Perficient: Drug Development

MAY 14, 2025

Can you demonstrate robust security measures and regulatory compliance? Data security and compliance with regulations like HIPAA, GDPR, or PCI are likely critical requirements for your organization. Ask your vendor for clearly defined compliance certifications, and if they conduct regular security audits.

Compliance

DrugBank

JUNE 18, 2025

Drug development is a complex and highly regulated process. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global counterparts, set rigorous standards to ensure that drugs are safe, effective, and high-quality. Regulatory agencies, such as the U.S.

Drug Development

Drug Patent Watch

JANUARY 9, 2025

Navigating the complex landscape of drug development and manufacturing can be a daunting task. Enter the Contract Development and Manufacturing Organization (CDMO) a lifeline for many startups looking to bring their innovative therapies to market. How can you ensure your CDMO is up to scratch?

Compliance

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

Clinical Development

Drug Target Review

JUNE 18, 2025

He works closely with pharmaceutical teams in Europe and North America to help them move faster, think differently and adapt without compromising on quality or compliance. His experience with early-stage drug developers makes one thing clear: traditional approaches to timelines, team structure and risk no longer stand up to today’s demands.

Drugs

ACTO

DECEMBER 17, 2024

These councils bring together diverse expertise from scientists and researchers, data analysts and technology specialists, regulatory compliance experts, as well as commercial operations leaders. Such cross-functional collaboration ensures consistent implementation from drug development through commercialization.

Government

Perficient: Drug Development

FEBRUARY 12, 2025

This transformation will require a delicate balance between innovation and compliance, ensuring that advancements in AI contribute to a secure and efficient payments landscape. These changes require significant adjustments in risk management, compliance frameworks, and operational protocols.

Compliance

Perficient: Drug Development

FEBRUARY 27, 2025

Those Guidelines will be technically sound and used by practitioners across the globe, minimizing risk of non-compliance. However, these standards may not ensure compliance if an organization is not including the right consumers in user research particularly those over the age of 65 and those with disabilities.

Compliance

Perficient: Drug Development

MARCH 12, 2025

This can be useful for data privacy and/or regulatory compliance reasons. Intro In this post, we’ll take a look at a couple Sitecore SDKs commonly used to build XM Cloud head applications. Specifically, we’ll be looking at how to disable cookies used by these SDKs.

Compliance

Drug Patent Watch

FEBRUARY 26, 2025

To draft a strong patent application, you need to understand the nuances of biologic drug development, including the production process, stability, and formulation. This requires a deep understanding of the science behind biologics, as well as the regulatory framework governing their development and approval.

Drugs

The Pharma Data

JUNE 26, 2025

Located in Jiangsu Province, China, the Nantong site serves as a critical component of WuXi AppTec’s expansive Contract Research, Development, and Manufacturing Organization (CRDMO) platform.

Laboratories

Perficient: Drug Development

FEBRUARY 12, 2025

Enhanced Data Encryption: Future developments might include more substantial data encryption capabilities, both in transit and at rest, to protect sensitive information in compliance with Zero Trust principles.

Compliance

Perficient: Drug Development

JANUARY 30, 2025

Compliance with Privacy Regulations Ensuring compliance with data privacy laws is essential not just for protecting customer data but also to avoid legal risks. Use these links sparingly and apply restrictions where possible, especially when sensitive data is involved.

Compliance

Drug Target Review

JUNE 5, 2025

Currently, three FDA-approved disease-modifying drug therapies are available: hydroxyurea, crizanlizumab and L-glutamine, though each has limitations that affect patient compliance. The therapeutic landscape for SCD has evolved significantly in recent years.

Disease

Perficient: Drug Development

JULY 1, 2025

In an industry where personalized engagement, regulatory compliance, and speed-to-market are critical, Salesforce Marketing Clou d offers the flexibility and scalability medical device companies need to stay ahead. Why Salesforce Marketing Cloud?

Marketing

PPD

JUNE 20, 2025

The complexity of diagnosing IPF, understanding its root causes, and translating preclinical findings to clinical success make it a challenging disease for drug development. The road ahead for idiopathic pulmonary fibrosis treatments The landscape of idiopathic pulmonary fibrosis treatment development is poised to evolve significantly.

Clinical Development

Perficient: Drug Development

APRIL 17, 2025

With specialized expertise in patient journeys, medical devices, and artificial intelligence (AI) , we focus on enhanc ing patient experiences and outcomes, accelerat ing software development, ensur ing compliance in device delivery, and transforming the research and development process.

Science

Perficient: Drug Development

MAY 27, 2025

Azure IoT integrates comprehensive security measures, including device identity management, encryption, secure data transmission, and compliance with industry standards. Security Security is a major concern when managing IoT devices, as these devices are often vulnerable to cyberattacks.

Compliance

BioPharma Drive: Drug Pricing

JULY 28, 2025

Its also critical that the solution aligns with regulatory standards for RWD use, ensuring confidence and compliance from the start. A data-agnostic GenAI tool ensures flexibility and usability, helping teams create tailored patient profiles without deep technical expertise. Does the Solution Prioritize Transparency?

Clinical Trials

Alta Sciences

APRIL 24, 2025

Altasciences Preclinical Approaches to GLP-1 RA Development Preclinical studies for first generation GLP-1 RA therapeutics for treatment of diabetes have generally been standard GLP studies, conducted with normal-weight animal models.

Small Molecule

Perficient: Drug Development

FEBRUARY 26, 2025

From business goals and priorities, page views, conversion rate, SEO considerations and marketing campaigns, to compliance and regulations. The goal is to determine those that will stay vs candidates for removal. Various different factors can impact this decision.

Marketing

Drug Target Review

MAY 26, 2025

With a particular focus on biologics, cell, and gene therapies, Galbraiths work is centred on equipping drug developers with the tools, insights, and support needed to advance their therapies from concept to clinic. Harnessing emerging technologies The rapid pace of technological innovation is reshaping the landscape of drug discovery.

Drug Development