INSIGHTS ON CELL & GENE REGULATORY ISSUES
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New Medicines, Novel Insights: Accelerating Development Of CAGT
Cell and gene therapies hold tremendous promise for patients with advanced cancers and genetic diseases. Here, experts provide insights designed to accelerate development and market entry.
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Spotlight On India: Regulatory Enhancements, Modernization, And Robust Data Collection
Explore India's adoption of global best practices, 24/7 work cycles, and audit readiness to ensure high standards of Good Clinical Practice, attract more trials, and provide robust data to stakeholders.
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Improving Patient Health And Safety
Engage an experienced CMC program management consultant to collaboratively develop and maintain a robust product development plan (PDP) with your team lead, cross-functional members, and vendors.
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Virus Filtration: Regulations And Mechanisms
In this presentation, Dr. Nigel Jackson, Principal Engineer in R&D, offers an in-depth discussion on regulatory guidance and recent updates pertaining to virus filtration.
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FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection
The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.
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How CSL Behring Worked With EMA/FDA To Develop Hemgenix Potency Assays
Gene therapy products are complicated, and it can be hard to know at which step to measure potency. Here's how CSL Behring did it for Hemgenix.
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Pre-Approval Inspection (PAI) Readiness
Our team of experts are equipped to guide you through every step of any Inspection, especially Pre-Approval Inspections, due to the nature of their criticality.
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CGT Expert Consulting Team
At ProPharma, our Cell and Gene Therapy consulting team offers a comprehensive and integrated approach to early stage cell and gene therapy development. Our expert team provides a range of services, including IND/CTA preparation, manufacturing technology, safety and risk assessment, and development planning, to help our clients navigate the complex and ever-changing landscape of cell and gene therapy development.
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Breaking Down The FDA Draft Guidance, "Rare Diseases: Considerations For The Development Of Drugs And Biological Products"
Raj Bandaru, Associate Director in Regulatory Affairs and U.S. Regulatory Affairs Lead at Accenture provides rich context on parts of the recent FDA Draft Guidance.
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Rocket Pharma's Modality-Agnostic Approach To Rare Disease
Rocket Pharmaceuticals’ president, COO, and head of R&D, Dr. Kinnari Patel, discusses the company’s modality-agnostic approach to treating rare diseases.