The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.
- A Multi-Omics Approach For Characterizing Clinical-Scale iPSC Batches
- Global Implications Of Zero Tariffs On Indian Pharma Exports To China
- Why Do So Few Cell Therapies Make The Leap From Lab To GMP?
- Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots
- Careful Outsourcing Proves Key To Targeted Protein Degradation Drug Development
- What Can The Tech Sector's 'Minimally Viable' Concept Teach Biopharma?
- What Biotech Sponsors Should Look For In A CDMO For Sterile Fill/Finish
- New Group Wants 'Phase-Appropriate' Thinking To Retire
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Risk Mitigation Planning For Pharmaceutical Tariffs
Examine the potential ramifications of proposed tariffs on the pharmaceutical and biotechnology sectors, highlighting critical concerns regarding national security and supply chain stability.
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RTSM: Randomization And Cohort Management, IP Inventory Management
Signant’s SmartSignals® RTSM solution helped an innovative biopharmaceutical company secure an FDA Orphan Drug designation for its cardiomyopathy drug.
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Inside A Gene Therapy Facility, Commercialization & Industrialization Project
An inside look at a clinical-stage company focused on bringing its gene therapy from the lab into a clinical setting for patients and families devastated by rare neurological genetic diseases.
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Treating Deficiencies In Employee Training And Mentorship
Investing in employee training and development is not just beneficial for the employees. It also contributes significantly to the organization’s success and competitive advantage.
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Prepping For Commercialization Through Supply Chain Logistics
While cell and gene therapies are bringing new hope to patients experiencing rare and serious diseases, uncover how they're disrupting the biopharma market in new and challenging ways.
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Unified Platform Supports Rapid Implementation Of Rescue Study
Explore how these integrated solutions helped an emerging biopharma to implement a plan for study build and migration with minimal disruption to sites.
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RTSM And Clinical Drug Dispensation
A pharma company used Signant Health's RTSM solution in a Phase 2 schizophrenia trial to ensure drug availability, maintain study balance, prevent duplicate allocations, and manage returns and destruction of unused drugs.
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Overcoming The Complex Logistics Of Autologous Cell Therapy Trials: A Deep Dive Into Challenges And Solutions
Explore critical logistical requirements in autologous cell therapies logistics and learn how to overcome challenges and achieve successful and timely autologous cell therapy trials.
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How Pharmaceutical Manufacturers Can Take Control Of Their Supply Chain
In an increasingly competitive and regulated landscape, the right ERP system is no longer optional—it’s essential to reclaim control and drive growth in pharmaceutical manufacturing.
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From Frustration To Organization: An SSO Platform For Trial Sites
To reap the benefits of tech innovation, sponsors and sites need a single sign-on (SSO) solution that enables streamlined organization across different trials and clinical systems.
CATALENT CORNER
| Insights from Catalent's Clinical Supply Experts |
SPONSORED CONTENT
Impact Of Supplier Choice On APAC Clinical Trial Execution
Learn about strategies Asia-Pacific has become an increasingly complex and congested destination for clinical trials as local and global sponsors alike flock to the region to take advantage of its many benefits, including access to large patient pools. Choosing the right clinical packaging and supply chain partner to support these studies is critical and can vary significantly based upon what countries are involved and the types of services required.