Insights
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Early Collaboration with FDA for Novel Programs: Maximizing the Emerging Technology Program (ETP)
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Raw Material Control for Biotechs (Part 2): Clinical Development Considerations
Introduction This is part two of the Halloran Insights article on raw material control. Raw Material Control for Biotechs Part one addressed the importance of establishing a level of raw material control at the earliest stages of product development. This article will focus on maturing the raw material control strategy in preparation for a commercial […]
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Egnyte and Lorenz Life Sciences Announce Integration Supporting Regulatory Document Management
May 7, 2024 – LORENZ Life Sciences and Egnyte today announced an integration in the upcoming LORENZ docuBridge 24.1 release, enabling customers to easily use documents created and managed within Egnyte for regulatory submissions. With the new connector, LORENZ is closing the loop and allowing seamless integration between Egnyte workflow processes and LORENZ workflow processes. […]
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Moving from Discovery to Commercialization in Precision Medicine
The revolution in precision medicine, a form of medicine using information about a person’s own genes or proteins to prevent, diagnose, or treat disease, has reached an exciting phase with the advancement of cell and gene therapies (CGTs). Precision medicine, also known as personalized medicine, is an approach to patient care that enables treatments most […]
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Rare But Not Forgotten: Opportunities in Rare Disease Drug Development
This article was co-written by Samantha Zappia, Principal Consultant, SK Regulatory Solutions. The World Orphan Drug Congress (WODC) brings together industry leaders working to advance orphan and rare disease drug development in one place for a unique three-day event. Many attendees arrive with the goal of meeting other players in the industry, learning from successes […]
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Should You Bring Your Trial Master File In-House?
A Trial Master File (TMF) is an ecosystem of documents used by monitors, auditors, assessors, and sponsors to demonstrate that a clinical trial has been conducted in compliance with Good Clinical Practice (GCP) and the approved protocol. The TMF is an essential quality process, enabling documentation of all activity that has been performed during the […]
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Success Planning for an Original NDA / BLA Submission
This comprehensive webinar offers an insightful exploration into the intricate landscape of New Drug Applications (NDAs) and Biologics License Applications (BLAs), elucidating the pivotal regulatory procedures imperative for pharmaceutical companies seeking approval for novel drugs and biologics. Its primary objective is to equip participants with the requisite knowledge and resources essential for navigating the intricate […]
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Critical Steps Towards a Collaborative Partnership and Governance Model
When crucial clinical trial activities are delegated by a sponsor to their vendor, the sponsor must take measures to ensure the vendor or subcontractor is delivering the agreed-upon services. This is effective vendor management in clinical trials, requiring careful selection and review of the vendor’s qualifications. Of importance is the sponsor’s continuous oversight of the […]
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Navigating the Maze: The Vital Role of Collaboration and Leadership in Phase 2 Clinical Trials
In the intricate world of pharmaceutical development, the journey from a promising compound to a market-ready drug is certainly not linear. Amongst the many small wins come obstacles and challenges. How those challenges are managed in pivotal moments often defines success versus failure. One pivotal juncture in this voyage is the phase 2 clinical trial—a critical […]
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Leveraging Outsourcing and Mixed Model Staffing Amid Layoffs: A Strategic Approach
In the dynamic landscape of business, layoffs or losing momentum in a program with faulty data can often feel like a shotgun blast, leaving organizations scrambling to realign resources and maintain productivity. However, amidst the chaos, there lies an opportunity to adopt a more strategic approach to workforce management. As a leader facing either the […]