INSIGHTS ON CELL & GENE CLINICAL TRIALS

• Building A Bridge Of Equivalence To Facilitate And Implement Rapid Process Changes In Gene Therapy Manufacturing

  A clear path for establishing equivalency is needed to facilitate more rapid advances in the gene therapy field and ultimately to enable lower-cost gene therapies that reach patients faster than ever.

• Case Study: Recovering A Clinical Trial That Has Been Derailed

  When replacing your CRO becomes the only feasible option, a partner experienced in such transitions — as well as sensitive to the impact on your timeline and costs — is invaluable.

• Cell And Gene Therapies: Solving Six Challenges

  This past year has seen remarkable progress in the growth of cell and gene therapies. While advances in cell reprogramming, genetic editing, and manufacturing mean affordable cell and gene therapies for a range of diseases and uses, the go-forward path will require planning around these six major issues.

• GMP-Source® And Phase-Appropriate Use For Early-Stage Clinical Trials

  GMP-Source is a more robust, less rigid alternative to full cGMP production that mirrors nearly all of the oversight and quality standards of full cGMP production while relaxing certain commercial standards, helping companies overcome the hurdles that can stall early development.

• 6 Key Steps For Cell Therapy Clinical Development Success

  While the simplest option for a small or emerging biotech is to outsource protocol and clinical development to a consultant or CRO, a disengaged or absent sponsor is unlikely to have its objectives realized. Prior to engaging with a consultant or CRO, you can take these six steps that are likely to leave both parties engaged in the clinical development process.

• Insights On Cell And Gene Therapy Manufacturing

  Since the early 1990s, gene therapy has revolutionized medicine. In the coming years, it will continue to become more relevant in the treatment and cure of some of the most severe diseases and disorders.

• Guide To Transitioning Clinical Cell Therapy Manufacturing To Commercial Scale

  More and more CGT manufacturers are focusing on automating and closing unit processes earlier in the developmental cycle. This saves significant time, increases efficiency and reduces cost. In this paper, we discuss the automation strategies that CGT manufacturers should consider during this transition. We also provide a manufacturing roadmap that can improve manufacturing efficiencies along the developmental journey.

• The Andelyn Difference

  For this innovative biotech organization, the patient always comes first. Inspired by two young gene therapy pioneers, we are a combination of the names of the children who participated in the momentous Phase I clinical trials at Nationwide Children’s Hospital.

• Mastering 4 Critical Capabilities In Clinical Manufacturing

  Companies engaged in clinical manufacturing must continually make rapid yet precise adjustments. To pivot quickly, companies need the right proficiencies and tools. Learn the keys to adapting operations to suit a more targeted approach to development.

• Vendor Management And Oversight Of Clinical Trials

  Vendor management and oversight of clinical trials continues to be a critical activity for sponsor companies planning and conducting clinical trials. Read how vendor management and oversight is not only a regulatory imperative, it is also a business imperative.