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
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![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.
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![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.
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![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.
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![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.
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![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.
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![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.
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![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.
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![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
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![GettyImages-1483611679-computer-cloud-digital-files-hands-keyboard]( "Human-Centered RTSM Design Enhances Data, Safety, And Operations")
Human-Centered RTSM Design Enhances Data, Safety, And OperationsUncover how this human-centered approach to RTSM prioritizes user experience (UX) and interface design (UI) to reduce complexity, minimize errors, and improve compliance.
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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.
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Advancing Alzheimer's Disease Therapies9/3/2025
By uniting scientific innovation with patient-focused execution, the next generation of alzheimer’s disease (AD) therapies has the potential to deliver a transformative impact on global health.
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Pharma R&D Review 2024: Pleasant Weather Ahead5/16/2024
Gain insights from the 2024 pharma landscape, which reports a record-breaking 22,825 pipeline drugs, led by Pfizer's 32 new candidates and a strong focus on oncology and neurological treatments.
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Transforming Effective Patient Recruitment Within The Changing Health Care Landscape2/6/2026
Revolutionize patient enrollment by closing the "95% gap." Explore an approach that uses digital health and data-driven insights to engage diverse populations where they live.
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Ensuring A Diverse Patient Population In Clinical Trials12/13/2024
In 2025, the FDA will require pharmaceutical companies to include diversity action plans (DAPs) for Phase II and pivotal studies.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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How A Biotech Startup Transformed Their Clinical Trial Supply Management2/25/2026
Don’t let your trial get lost in the shuffle of legacy vendors. See how a high-touch, consultative approach can protect your study’s future.
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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.
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Overcoming Participant Compliance Challenges In A Medical Device Study9/9/2024
Uncover how Catalyst Clinical Research enhanced participant compliance and streamlined scheduling for a TENS device study using the TrialKit platform, with crucial support from CDS.
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Faster Trial Planning and Site Selection4/15/2025
Address the challenges of identifying the most suitable trial sites and investigators while optimizing feasibility planning, reducing screen failure rates, and improving patient retention.
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Ergomed's Solutions To The Challenges of Oncology Trials4/15/2025
Explore a pivotal Phase III global clinical trial investigating neoadjuvant immunotherapy for locally advanced squamous cell carcinoma of the head and neck (LA SCCHN).
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Leading Recruitment With A Strong Alzheimer's Referral Pool2/24/2026
A strong referral network helped the Gainesville site rapidly recruit pTau217‑positive Alzheimer’s participants while upholding high data quality, boosting enrollment and outperforming other sites.
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.
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![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.
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![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
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![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.
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![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.
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![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.
