GUEST COLUMNISTS

• How Do Cell & Gene Therapy Requirements Differ Between FDA & EMA?

  This article examines the similarities and differences between how the FDA and the European Medicines Agency (EMA) approach cell and gene therapies. Where do the regulatory perspectives align and where do they diverge?

• How One Pharma Exec Uses Her Father’s Cancer Experience To Better Patients’ Clinical Journeys

  Until pharmaceutical executive Christina DiArcangelo's father became a Stage 4 oncology patient, she wasn't wholly aware of the shortcomings of clinical trials. Now, buoyed by personal experience, she's dedicating her professional and personal pursuits to improving the patient experience.

• Expanding Eligibility — And 6 More Tips For Improving Trial Diversity

  It is no secret that people who are ethnically diverse are underrepresented in clinical trials, and that is a trend that needs to change. But how? Discover six ways you can increase trial diversity starting now.

• Embracing Agility In Phase 2 Clinical Trials

  Phase 2 clinical trials are like software development. How so? Ivanna Rosendal explains the connection and makes the case for using a now-ubiquitous software development workflow to improve clinical data management.

• The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups

  How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.

• FDA Releases Final Guidance On Early-Phase Cell & Gene Therapy Trials

  The cell and gene therapy development process involves screening different variants of a product type. To aid this process and to ensure that suitable evidence is gathered so that effective variants of the product are taken through to later-stage trials, the FDA has produced a final guidance, Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial.

• How Can Clinical Research Better Navigate Healthcare Deserts?

  Large swaths of the U.S. remain healthcare deserts, where access to clinical sites, pharmacies, and hospitals is limited. This contributes to underrepresentation in clinical research. What are the roles of technology and community outreach, and what are some current industry efforts to address it?

• The Long-Term Impact Of COVID-19 On Clinical Trials: Part 2

  The COVID-19 pandemic is helping create a “new normal” for the life sciences industry regarding the policies, procedures, and processes of clinical trials. In Part 1, we discussed five factors that more directly impact the clinical trial process and patients. In Part 2, we will discuss six factors that focus on organizational structure and the broader industry.