INSIGHTS ON CELL & GENE THERAPY LOGISTICS

• Navigating The Adoption Of Continuous Pharma Manufacturing Amid Unprecedented Global Challenges

  Driving a path forward for continuous manufacturing calls for a closer look at current global challenges, any existing barriers, and the ideas and initiatives necessary to fulfill its potential.

• No Place Like Home: How To Make Decentralized Clinical Trials A Win For Patients, Sponsors & Investigators

  Nearly three out of four biopharmaceutical firms modified traditional protocols to adopt a form of decentralized studies – also known as virtual or siteless trials – in an effort to keep drug development programs on course during COVID-19. This eBook focuses on the integral role Direct-to-Patient Services play in the execution of decentralized trials and how sponsors can maximize these benefits to improve drug development.

• Beyond mRNA Vaccines – Emerging Applications For Lipid Nanoparticle Delivery Technologies

  The potential of lipid nanoparticle-based drug delivery technologies to enable a new generation of medicines was made clear in 2020 when the first two mRNA vaccines for COVID-19 were rapidly developed and authorized for emergency use. What other applications are now being explored for such delivery technologies? Dr. Jay Natarajan, Director of R&D, competence center for LNP technology, answers questions in this interview.

• Clinical Supply Global Optimization: Managing Complex Global Drug Distribution And Expiry

  A global top-ten pharmaceutical company was sponsoring a complex, 8-year Phase III trial across 43 countries. The Sponsor was under intense pressure to reduce trial costs and leverage internal resources. Ultimately, study sites began to run out of medication. They realized that the trial could be better managed if it was outsourced. 

• Six Mistakes Pharmaceutical Companies Make When Implementing Serialization

  This article examines mistakes that are commonly made in the planning and implementation phases of a serialization project, and proposes a solution to avoid each of these issues.

• Advancing Cell And Gene Therapies

  Cells used for cell and gene therapies pass through several process steps and have to be managed as well as transported between these stakeholders in a fast, sterile and seamless manner.

• Covid-19 Impact On Bioprocessing: PART 3 Long-Term Changes

  Although suppliers have proven themselves rather robust in their dealing with the pandemic and business is continuing generally uninterrupted, there will be significant long-term changes.

• Enabling Fast, Appropriate Drug Product Supply For Phase 1 Clinical Trials

  Without the ability to move smoothly from lab concept to manufacture to delivery of GMP clinical supplies to patients, critical milestones could be missed, delaying funding commitments from investors.

• Case Study: Reduced Risk, Spending, And Work In A Global Diabetes Trial

  And as one leading multi-national pharmaceutical company recently learned, managing ancillary materials can be a challenge every bit as complex as the trial itself.

• Delivering Clinical Trial Medications Direct-To-Patient

  In a perfect world, patients enrolled in clinical trials would live a short distance from the investigator site where they receive their treatment. Unfortunately, that is not always the case. In recent years, the direct-to- patient model, which brings medical procedures to a patient’s home, has emerged as a solution for sponsors to increase patient recruitment and retention in clinical trials.