GUEST COLUMNISTS

• Beyond Task Tracking: Why ClinOps Needs Dependency Intelligence

  Clinical trial operations will always need task tracking, but they're not enough on their own. Dependency intelligence shifts the focus toward readiness not reaction.

• To Take On Transverse Myelitis, Researchers Must First Address Heterogeneity And Misguided Outcome Measures

  UNC researcher Irena Dujmovic Basuroski, MD, Ph.D., discusses why transverse myelitis remains difficult to study, how multicenter collaboration and adaptive trial designs may help, and why better clinical, patient-reported, and biomarker-based measures are essential to advancing treatment.

• From Signal To Strategy: What Oncology Basket Trials Can Teach Clinical Development Teams

  AbbVie's Svetlana Kobina discusses how basket trials can help clinical development teams move from early clinical signals to a more disciplined strategy.

• 4 Hidden Gaps In Clinical Trial Preparation For Small Biotechs

  Gaps are not always visible at the executive level, but their consequences are very real — affecting timelines, budgets, data quality, and ultimately the likelihood of regulatory success.

• ImvivaBio's Trial For Off-The-Shelf CAR-T Strategy For Aggressive Malignancies

  ImvivaBio CMO Jan Davidson-Moncada, MD, Ph.D., discusses the company's Phase 1b/2 study for aggressive T-cell malignancies, explaining their unmet need, the rationale for an allogeneic approach, and how they plan to address immune rejection.

• Clinical Trial Per-Patient Cost Analytics For Procurement And Sponsor Strategy

  With the help of Beroe Inc.'s Surya Ponnam, discover how per-patient cost (PPC) analytics is evolving into a core capability for balancing cost, quality, speed, and patient outcomes.

• Expanded Access And Rollover Design Help CytoDyn Reach High-Need Cancer Patients

  CEO Jay Lalezari and CFO Robert E. Hoffman share how CytoDyn meet patient needs when they approach trial design for cancer trials.

• Why Protocol Complexity Is Slowing First Patient In — And How Small Sponsors Can Fix Start-Up Inefficiencies

  Protocol complexity directly affects timelines, costs, and execution quality. Consultant Jessica Cordes explains why this challenge requires sponsors to change their approach to protocol design, feasibility, and start-up.