Life sciences expert Rena Roseberg, Ph.D., warns that research and commercial efforts cannot operate within a vacuum. Here, she shares best practices on developing a therapeutic product with solid understanding of its commercial viability.
- Is It Time To Replace RECIST — Or Just Add AI?
- India Opens The Fast Lane For Drug Development
- U.S. Pharma Tariffs And MFN Become Law After April 2 Update
- Clinical Trials Succeed When Patients Talk — And The Entire Ecosystem Listens
- What Really Moves The Needle In Primary Immunodeficiency Research And Treatment
- Clinical Trials Have A Native American Problem
- First-In-Human Porcine Kidney Transplant Trial Builds On Expanded Access Success
GUEST COLUMNISTS
-
![Young female scientist works at work bench in laboratory-GettyImages-899074182]( "What Really Moves The Needle In Primary Immunodeficiency Research And Treatment")
What Really Moves The Needle In Primary Immunodeficiency Research And TreatmentKedrion Biopharma's Nisha Jain details how researchers can improve trials for primary immunodeficiency and shares four factors for improvement.
-
![Kidney issues, medical-GettyImages-1360864678]( "First-In-Human Porcine Kidney Transplant Trial Builds On Expanded Access Success")
First-In-Human Porcine Kidney Transplant Trial Builds On Expanded Access SuccesseGenesis CEO Mike Curtis discusses the first-in-human trial of EGEN-2784, which they're studying whether a porcine kidney can restore near-normal quality of life while awaiting a human transplant.
-
![Elderly man sitting in hospital-GettyImages-1740621426]( "Assigned Slot Allocation Offers A Fair Solution For Oncology Phase 1 Trials (Part 2)")
Assigned Slot Allocation Offers A Fair Solution For Oncology Phase 1 Trials (Part 2)In part two of this series on slot allocation, Nehal Lakhani, MD, Ph.D. proposes assigned slot allocation as an alternative to competitive placement and discusses how the approach might benefit patients and sites.
-
![Patient sitting in waiting room-GettyImages-629772380]( "Slot Allocation Is A Problem For Patients And PIs In Phase 1 Oncology Trials (Part 1)")
Slot Allocation Is A Problem For Patients And PIs In Phase 1 Oncology Trials (Part 1)Given the shift in the size and scope of oncology Phase 1 trials, cohort management and slot allocation strategies must change, too. Nehal Lakhani, MD, Ph.D. explains why competitive slot allocation is no longer optimal for patients or PIs.
-
![MRI scanning in control room-GettyImages-2176245578]( "There's A Gap In Brain Tumor Research — Here's How We Fix It")
There's A Gap In Brain Tumor Research — Here's How We Fix ItBrain tumors are some of the most biologically complex and least improved indications. Biochemistry researcher and scientist Catherine Bladen, Ph.D., argues sustained focus is a key to driving real-world progress.
-
![Glioblastoma in Left Frontal Lobe with Midline Shift-GettyImages-2226756753]( "Lessons Learned While Taking Glioblastoma Drug From Bench To Clinic")
Lessons Learned While Taking Glioblastoma Drug From Bench To ClinicMimiVax CEO Mike Ciesielski recounts the company's transition from academia to industry, hitting on topics like vendor partnerships, FDA conversations, and manufacturer selection.
-
![pharmaceutical inspection identifies pills-GettyImages-2154549420]( "The Much-Feared FDA Form 483, Part 3")
The Much-Feared FDA Form 483, Part 3This final installment in this three-part series offers an example of how the misperception of the 483 as a surrogate for overall quality of a firm can lead to policy errors in attempting to mitigate pricing problems with generic drugs.
-
![Seasonal allergies-GettyImages-2208079266]( "Considerations For Allergic Rhinitis Trials Are Nothing To Sneeze At")
Considerations For Allergic Rhinitis Trials Are Nothing To Sneeze AtInimmune CEO David Burkhart explains how a GSK layoff led to the formation of a new company focused on treating allergic rhinitis. Here, he shares success from the company's approach to site selection, trial design, and timing.
CLINICAL TRIAL WHITE PAPERS
-
![Business Meeting-GettyImages-1831418247]( "Accelerate Drug Development With Master Protocols")
Accelerate Drug Development With Master ProtocolsThrough careful planning, aligned incentives, and an open, adaptive mindset, master protocols become powerful engines for accelerating therapies to market—particularly in high-need therapeutic areas.
-
Unlock The Power Of Clinical Data Science3/9/2026
Discover a unified, AI‑driven approach that helps clinical teams manage growing data complexity, accelerate insight generation, and improve trial oversight to enable faster decisions.
-
AI-Driven Signal Management: The Future Of Drug Safety12/19/2025
By combining autonomy with robust governance, agentic AI enables pharmacovigilance teams to move from reactive to proactive safety management, anticipating risks before they materialize.
-
Empowering Transformation Through Technology4/24/2024
By outlining the transformation of clinical data management into data science, this paper highlights the growing responsibility of data managers as stewards of all clinical trial data and its overall quality.
-
Master Protocols: Implementing Effective Treatment Adaptations8/25/2025
From balancing treatment ratios and managing eligibility to accommodating site-specific readiness and protocol amendments, a well-designed IRT system enables seamless transitions.
-
4 New Approvals In Q3 Across Gene, Cell, RNA Therapies11/13/2025
Q3 2025 brought notable progress across the gene, cell, and RNA therapy landscape, marked by four new global approvals. While regulatory progress continued, clinical development activity slowed.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
Optimizing Recruitment For Urgently Needed Vaccine5/15/2024
Uncover how Citeline Connect helped a late-stage biotech sponsor expedite enrollment of a diverse population of eligible patients impacted by monkeypox for a large Phase 1 and Phase 2 trial of a next-generation vaccine.
-
Automated Trial Monitoring Workflows Make A Lean Team More Efficient1/7/2026
A pharmaceutical therapy developer was looking to automate reports, confirmation letters, and follow-up letters. See what happened when they adopted a cloud-based solution for end-to-end trial management.
-
Delivering Specialist Neurology Support4/17/2025
Explore a strategic approach to a Parkinson’s disease trial that leveraged a global infrastructure and multilingual workforce to provide seamless operational and clinical support.
-
Leveraging A Demand-Led Clinical Supply Model For Program-Level Product Pooling3/12/2026
See how a global biopharmaceutical company was able to address inefficiencies and reduce waste within the clinical supply chain for a high-value therapy that faced strong demand but limited supply.
-
How Optina Diagnostics Used EDC In Earlier Disease Detection5/15/2024
Understand how Optina Diagnostics streamlined operations and achieved significant milestones by leveraging Castor's tools in its effort to revolutionize the diagnostic process for Alzheimer’s.
-
Early-Stage Development In Rare Pediatric Oncology4/11/2025
Learn about the strategic approach a biotechnology company utilized to address significant hurdles in launching a Phase 1 clinical trial for a novel therapy targeting a rare pediatric cancer.
NEWSLETTER ARCHIVE
- 04.17.26 -- Continue To Choose New AI-Related Projects
- 04.16.26 -- Lessons Learned While Taking Glioblastoma Drug From Bench To Clinic
- 04.15.26 -- Best Practices In Designing An Adaptive, Open-Label RCT Phase 3 Oncology Trial
- 04.15.26 -- STREAM Edition: Continue To Choose New AI-Related Projects
- 04.14.26 -- Manipulating Costs And Technology Prices In Clinical Research
RECRUITMENT AND DIVERSITY
This section includes some helpful resources regarding patient recruitment and diversity in clinical trials, including this link to the FDA's guidance on diversity action plans.
-
![Elderly man sitting in hospital-GettyImages-1740621426]( "Assigned Slot Allocation Offers A Fair Solution For Oncology Phase 1 Trials (Part 2)")
In part two of this series on slot allocation, Nehal Lakhani, MD, Ph.D. proposes assigned slot allocation as an alternative to competitive placement and discusses how the approach might benefit patients and sites.
-
![Patient sitting in waiting room-GettyImages-629772380]( "Slot Allocation Is A Problem For Patients And PIs In Phase 1 Oncology Trials (Part 1)")
Given the shift in the size and scope of oncology Phase 1 trials, cohort management and slot allocation strategies must change, too. Nehal Lakhani, MD, Ph.D. explains why competitive slot allocation is no longer optimal for patients or PIs.
-
![translate foreign language with internet software-GettyImages-2215567295]( "Bridging Language And Medicine: Best Practices In French Regulatory Medical Writing")
Poor translations are not just clunky. They can be risky. Medical-linguistic consultant Farah Ayadi, PharmD, explains its implications for safety, regulatory submissions, and downstream operational or financial outcomes.
FOCUS ON PATIENTS
-
![Hospital, holding hands and kid in bed, healthcare, cancer-GettyImages-2120554524]( "Clinical Trials Succeed When Patients Talk — And The Entire Ecosystem Listens")
Patient advocate and founder of MIB Agents Ann Graham knows intimately the importance of including patient feedback into trial design. She explains value of — and offers practical advice — for doing just that.
-
![Kidney issues, medical-GettyImages-1360864678]( "First-In-Human Porcine Kidney Transplant Trial Builds On Expanded Access Success")
eGenesis CEO Mike Curtis discusses the first-in-human trial of EGEN-2784, which they're studying whether a porcine kidney can restore near-normal quality of life while awaiting a human transplant.
-
![translate foreign language with internet software-GettyImages-2215567295]( "Bridging Language And Medicine: Best Practices In French Regulatory Medical Writing")
Poor translations are not just clunky. They can be risky. Medical-linguistic consultant Farah Ayadi, PharmD, explains its implications for safety, regulatory submissions, and downstream operational or financial outcomes.
