INSIGHTS ON CELL & GENE REGULATORY ISSUES

• 2025 Outlook For CGT: Focus On Non-Oncology Indications, In Vivo Gene Editing, And POC

  Leaders from Kiji Therapeutics, Precision Biosciences, and Orgenesis weigh in on what will likely accelerate the development of novel treatments, potentially revolutionizing patient care across a wider range of diseases and bringing the promise of personalized medicine closer to reality in 2025 and beyond.

• Novel Peptide Delivery With Revolo's Woody Bryan, Ph.D.

  Revolo Biotherapeutics President and CEO Woody Bryan, Ph.D. is pushing the boundaries of peptide therapeutic delivery. On this episode of the Business of Biotech, we dig into Dr. Bryan’s transition to the CEO chair at the company and how that coincided with an aggressive strategic decision to alter the course of administration of its peptide candidates in allergic and autoimmune diseases.

• Building Clinical Quality Assurance

  Navigating the intricate clinical development process necessitates a robust Clinical & Development Quality Assurance Department to ensure adherence to health authority regulations.

• Navigating The Regulatory Maze For Medical Device Approval

  Explore the critical components of clinical data assessment necessary for successful marketing applications in the medical device sector.

• The Care And Feeding Of FDA PMAs

  Explore the critical role of the FDA's Premarket Approval (PMA) process for medical devices, highlighting the importance of post-approval management to ensure continued compliance and market access.

• Unraveling The Complexity Of Cell Therapy: Advancements And Challenges

  Cell therapy has emerged as a powerful tool for addressing critical medical challenges, but its rapid evolution necessitates a clear regulatory framework and consistent terminology.

• Developing Bespoke Antisense Oligonucleotides To Treat Rare Diseases

  EveryONE Medicines CEO, Kent Rogers, explains the company’s mission to address a major unmet need in children with rare neurodegenerative diseases, one patient at a time.

• Shedding Light On Photo-Stability Forced Degradation

  Ensure the stability and safety of your drug products by utilizing comprehensive forced degradation and photo-stability testing, guided by ICH and FDA standards, to identify degradation pathways and assess light exposure risks.

• Energy And Specialty Chemistry Solutions

  Safely scale the production of APIs using highly energetic chemistry, backed by decades of expertise, controlled processes, and CGMP-compliant conditions from development to commercial manufacturing.

• Nitrosamine Impurity And Control Testing

  Get access to reliable testing services for the identification and quantification of impurities, ensuring product quality and maintaining patient confidence.